Richard Pizzi is editor of The Hospitalist. He has been an editor at Frontline Medical Communications since 2015, and previously served as editor of MDedge publications Hospitalist News and ID Practitioner. He has also worked as an editor and in editorial management roles for HIMSS Media, MedTech Media, and the American Association for Clinical Chemistry. Follow him on Twitter @richpizzi

HIV research update: Early August 2016

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HIV research update: Early August 2016

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Text message reminders are a promising intervention that can be used to increase HIV care compliance when logistically feasible, according to a meta-analysis published in AIDS Care.

©alexskopje/ThinkStock.com

A study published in AIDS found that people living with HIV who are older than age 65years are at higher risk of comorbidities than are other fee-for-service Medicare beneficiaries.

A study in Thailand found a marked divergence of HIV DNA values between untreated and treated groups that occurred within the first 2 weeks of antiretroviral therapy (ART) and increased with time. The authors conclude that very-early ART offers the opportunity to significantly reduce the frequency of cells harboring HIV DNA.

An independent source of HIV RNA contributes to viral rebound within the cerebrospinal fluid after treatment interruption, according to a study in Virus Evolution. The most likely source of compartmentalized HIV RNA is a CNS reservoir that would need to be targeted to achieve complete HIV eradication, investigators said.

A recent six-site U.S. study discovered that 36% of nondrinking persons living with HIV in routine clinical care had a prior alcohol use disorder.

A study in HIV Medicine found that treatment of patients infected with hepatitis C virus and coinfected with HCV/HIV with all-oral direct-acting antiviral combinations, under real-life conditions, led to high and similar rates of sustained virologic response 12 weeks after the end of therapy.

A first-of-its-kind study in Tanzania demonstrated a significantly increased risk of acquiring HIV for lymphatic filariasis-infected individuals.

A clinical trial of HIV-infected adults treated with efavirenz-based antiretroviral therapy found that the late virologic failure rate was very low after successful suppression. The authors said virologic monitoring, if achievable in routine clinical practice, involving infrequent measurements might be considered.

The introduction of a low viral load threshold provides crucial improvements in recent infection testing algorithms, according to a study in AIDS. However, the authors said it does not eliminate non-zero “false-recent” rates, and mean durations of “recent” infection must be consistently estimated.

The risk of virologic failure in a population of HIV-infected patients on antiretroviral therapy, who achieved viral suppression at less than 20 copies/mL, was no different for patients who remained fully suppressed, compared with those who experienced subsequent episodes of very low level viremia.

A British study found that HIV self-testing among men who have sex with men represents an opportunity to reduce barriers to HIV testing and enhance prevention and access to care.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV patients, and should be diagnosed early in HIV care to optimize treatment outcomes, according to a report in Tropical Medicine & International Health.

A recent study found that higher HIV RNA and wasting before antiretroviral therapy were independent risk factors for pneumonia in early ART-treated HIV-infected infants.

New information increases concerns about the association between the hormonal contraceptive depot medroxyprogesterone acetate and HIV acquisition risk in women, researchers said in a recent study. If the association is causal, the magnitude of effect is likely a hazard ratio of 1.5, although investigators said data for other hormonal contraceptive methods are largely reassuring.

A study of virally suppressed HIV-infected men with extensive antiretroviral exposure found no consistent associations between use of specific ART drugs and both subclinical coronary plaque presence and extent. Investigators said the findings support the hypothesis that, among virally suppressed persons, type of ART used is not in general a major determinant of subclinical coronary plaque risk.

More cost-effective and impactful HIV-prevention investments could be achieved across sub-Saharan Africa if domestic and international funders were to align strategically to build an aggregate funding pattern guided by the emerging understanding of local dynamics and epidemic drivers, a Lancet HIV study found.

A cross-sectional cohort study found evidence of endothelial dysfunction in HIV infection and in untreated compared to treated HIV infection, although asymmetric dimethylarginine (a marker of endothelial dysfunction) was not associated with subclinical atherosclerosis.

A modeling study in the journal AIDS concluded that, in mature HIV epidemics, between 3%-6% of transmission events are attributable to acute HIV infection among people who inject drugs.

The HIV epidemic serves as an amplifier of TB outbreaks by providing a reservoir of susceptible hosts, a study in eLife found, but HIV coinfection is not a direct driver for the emergence and transmission of drug-resistant strains.

 

 

A recent study of HIV-infected patients coinfected with hepatitis B and C viruses found that, despite increasing use of antiretrovirals, no clear reduction in end-stage liver disease risk was observed. The authors said treatment with direct acting antivirals for HCV and wider use of tenofovir-based regimens for HBV should be prioritized for coinfected patients.

HIV incidence, prevalence, and undiagnosed infections can be estimated using HIV case surveillance data and information on first CD4 test result after diagnosis, according to analysis published in JAIDS.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Text message reminders are a promising intervention that can be used to increase HIV care compliance when logistically feasible, according to a meta-analysis published in AIDS Care.

©alexskopje/ThinkStock.com

A study published in AIDS found that people living with HIV who are older than age 65years are at higher risk of comorbidities than are other fee-for-service Medicare beneficiaries.

A study in Thailand found a marked divergence of HIV DNA values between untreated and treated groups that occurred within the first 2 weeks of antiretroviral therapy (ART) and increased with time. The authors conclude that very-early ART offers the opportunity to significantly reduce the frequency of cells harboring HIV DNA.

An independent source of HIV RNA contributes to viral rebound within the cerebrospinal fluid after treatment interruption, according to a study in Virus Evolution. The most likely source of compartmentalized HIV RNA is a CNS reservoir that would need to be targeted to achieve complete HIV eradication, investigators said.

A recent six-site U.S. study discovered that 36% of nondrinking persons living with HIV in routine clinical care had a prior alcohol use disorder.

A study in HIV Medicine found that treatment of patients infected with hepatitis C virus and coinfected with HCV/HIV with all-oral direct-acting antiviral combinations, under real-life conditions, led to high and similar rates of sustained virologic response 12 weeks after the end of therapy.

A first-of-its-kind study in Tanzania demonstrated a significantly increased risk of acquiring HIV for lymphatic filariasis-infected individuals.

A clinical trial of HIV-infected adults treated with efavirenz-based antiretroviral therapy found that the late virologic failure rate was very low after successful suppression. The authors said virologic monitoring, if achievable in routine clinical practice, involving infrequent measurements might be considered.

The introduction of a low viral load threshold provides crucial improvements in recent infection testing algorithms, according to a study in AIDS. However, the authors said it does not eliminate non-zero “false-recent” rates, and mean durations of “recent” infection must be consistently estimated.

The risk of virologic failure in a population of HIV-infected patients on antiretroviral therapy, who achieved viral suppression at less than 20 copies/mL, was no different for patients who remained fully suppressed, compared with those who experienced subsequent episodes of very low level viremia.

A British study found that HIV self-testing among men who have sex with men represents an opportunity to reduce barriers to HIV testing and enhance prevention and access to care.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV patients, and should be diagnosed early in HIV care to optimize treatment outcomes, according to a report in Tropical Medicine & International Health.

A recent study found that higher HIV RNA and wasting before antiretroviral therapy were independent risk factors for pneumonia in early ART-treated HIV-infected infants.

New information increases concerns about the association between the hormonal contraceptive depot medroxyprogesterone acetate and HIV acquisition risk in women, researchers said in a recent study. If the association is causal, the magnitude of effect is likely a hazard ratio of 1.5, although investigators said data for other hormonal contraceptive methods are largely reassuring.

A study of virally suppressed HIV-infected men with extensive antiretroviral exposure found no consistent associations between use of specific ART drugs and both subclinical coronary plaque presence and extent. Investigators said the findings support the hypothesis that, among virally suppressed persons, type of ART used is not in general a major determinant of subclinical coronary plaque risk.

More cost-effective and impactful HIV-prevention investments could be achieved across sub-Saharan Africa if domestic and international funders were to align strategically to build an aggregate funding pattern guided by the emerging understanding of local dynamics and epidemic drivers, a Lancet HIV study found.

A cross-sectional cohort study found evidence of endothelial dysfunction in HIV infection and in untreated compared to treated HIV infection, although asymmetric dimethylarginine (a marker of endothelial dysfunction) was not associated with subclinical atherosclerosis.

A modeling study in the journal AIDS concluded that, in mature HIV epidemics, between 3%-6% of transmission events are attributable to acute HIV infection among people who inject drugs.

The HIV epidemic serves as an amplifier of TB outbreaks by providing a reservoir of susceptible hosts, a study in eLife found, but HIV coinfection is not a direct driver for the emergence and transmission of drug-resistant strains.

 

 

A recent study of HIV-infected patients coinfected with hepatitis B and C viruses found that, despite increasing use of antiretrovirals, no clear reduction in end-stage liver disease risk was observed. The authors said treatment with direct acting antivirals for HCV and wider use of tenofovir-based regimens for HBV should be prioritized for coinfected patients.

HIV incidence, prevalence, and undiagnosed infections can be estimated using HIV case surveillance data and information on first CD4 test result after diagnosis, according to analysis published in JAIDS.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Text message reminders are a promising intervention that can be used to increase HIV care compliance when logistically feasible, according to a meta-analysis published in AIDS Care.

©alexskopje/ThinkStock.com

A study published in AIDS found that people living with HIV who are older than age 65years are at higher risk of comorbidities than are other fee-for-service Medicare beneficiaries.

A study in Thailand found a marked divergence of HIV DNA values between untreated and treated groups that occurred within the first 2 weeks of antiretroviral therapy (ART) and increased with time. The authors conclude that very-early ART offers the opportunity to significantly reduce the frequency of cells harboring HIV DNA.

An independent source of HIV RNA contributes to viral rebound within the cerebrospinal fluid after treatment interruption, according to a study in Virus Evolution. The most likely source of compartmentalized HIV RNA is a CNS reservoir that would need to be targeted to achieve complete HIV eradication, investigators said.

A recent six-site U.S. study discovered that 36% of nondrinking persons living with HIV in routine clinical care had a prior alcohol use disorder.

A study in HIV Medicine found that treatment of patients infected with hepatitis C virus and coinfected with HCV/HIV with all-oral direct-acting antiviral combinations, under real-life conditions, led to high and similar rates of sustained virologic response 12 weeks after the end of therapy.

A first-of-its-kind study in Tanzania demonstrated a significantly increased risk of acquiring HIV for lymphatic filariasis-infected individuals.

A clinical trial of HIV-infected adults treated with efavirenz-based antiretroviral therapy found that the late virologic failure rate was very low after successful suppression. The authors said virologic monitoring, if achievable in routine clinical practice, involving infrequent measurements might be considered.

The introduction of a low viral load threshold provides crucial improvements in recent infection testing algorithms, according to a study in AIDS. However, the authors said it does not eliminate non-zero “false-recent” rates, and mean durations of “recent” infection must be consistently estimated.

The risk of virologic failure in a population of HIV-infected patients on antiretroviral therapy, who achieved viral suppression at less than 20 copies/mL, was no different for patients who remained fully suppressed, compared with those who experienced subsequent episodes of very low level viremia.

A British study found that HIV self-testing among men who have sex with men represents an opportunity to reduce barriers to HIV testing and enhance prevention and access to care.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV patients, and should be diagnosed early in HIV care to optimize treatment outcomes, according to a report in Tropical Medicine & International Health.

A recent study found that higher HIV RNA and wasting before antiretroviral therapy were independent risk factors for pneumonia in early ART-treated HIV-infected infants.

New information increases concerns about the association between the hormonal contraceptive depot medroxyprogesterone acetate and HIV acquisition risk in women, researchers said in a recent study. If the association is causal, the magnitude of effect is likely a hazard ratio of 1.5, although investigators said data for other hormonal contraceptive methods are largely reassuring.

A study of virally suppressed HIV-infected men with extensive antiretroviral exposure found no consistent associations between use of specific ART drugs and both subclinical coronary plaque presence and extent. Investigators said the findings support the hypothesis that, among virally suppressed persons, type of ART used is not in general a major determinant of subclinical coronary plaque risk.

More cost-effective and impactful HIV-prevention investments could be achieved across sub-Saharan Africa if domestic and international funders were to align strategically to build an aggregate funding pattern guided by the emerging understanding of local dynamics and epidemic drivers, a Lancet HIV study found.

A cross-sectional cohort study found evidence of endothelial dysfunction in HIV infection and in untreated compared to treated HIV infection, although asymmetric dimethylarginine (a marker of endothelial dysfunction) was not associated with subclinical atherosclerosis.

A modeling study in the journal AIDS concluded that, in mature HIV epidemics, between 3%-6% of transmission events are attributable to acute HIV infection among people who inject drugs.

The HIV epidemic serves as an amplifier of TB outbreaks by providing a reservoir of susceptible hosts, a study in eLife found, but HIV coinfection is not a direct driver for the emergence and transmission of drug-resistant strains.

 

 

A recent study of HIV-infected patients coinfected with hepatitis B and C viruses found that, despite increasing use of antiretrovirals, no clear reduction in end-stage liver disease risk was observed. The authors said treatment with direct acting antivirals for HCV and wider use of tenofovir-based regimens for HBV should be prioritized for coinfected patients.

HIV incidence, prevalence, and undiagnosed infections can be estimated using HIV case surveillance data and information on first CD4 test result after diagnosis, according to analysis published in JAIDS.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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NIAID to test new yellow fever vaccine

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NIAID to test new yellow fever vaccine

The National Institute of Allergy and Infectious Diseases (NIAID) has initiated a phase I clinical trial of an investigational vaccine designed to protect against yellow fever virus.

According to an NIAID statement, the study will evaluate whether an experimental vaccine developed by the pharmaceutical manufacturer Bavarian Nordic is “safe, tolerable and has the potential to prevent yellow fever virus infection.”

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

Bavarian Nordic’s experimental yellow fever vaccine, called MVA-BN-YF, is based on the company’s proprietary MVA-BN platform, which uses an attenuated version of the Modified Vaccinia Ankara (MVA) virus as a vaccine vector to carry yellow fever virus genes into the body. Bavarian Nordic says that more than 7,600 people, including 1,000 who are immunocompromised, have been safely vaccinated with MVA-BN–based vaccines.

The NIAID statement noted that prior studies have suggested that combining MVA-BN with ISA 720, an experimental immune-boosting adjuvant, induces a strong immune response after a single dose of vaccine. One goal of the study will be to assess whether two doses of unadjuvanted vaccine or a single dose of ISA 720 adjuvanted vaccine could provide protection against yellow fever.

NIAID said the placebo-controlled, double-blinded clinical trial will enroll 90 healthy men and women aged 18-45 years who have never been infected with a flavivirus. Participants will be divided into six groups: One will receive the currently licensed yellow fever vaccine (15 participants) and five groups (15 participants each) will receive the investigational Bavarian Nordic vaccine, either with or without an adjuvant. The investigational vaccine will be administered intramuscularly while the licensed yellow fever vaccine will be administered subcutaneously. Trial participants will receive one or two doses of vaccine or placebo, separated by a month.

According to NIAID’s statement, the multisite trial will be conducted by NIAID-funded Vaccine and Treatment Evaluation Units at the University of Iowa, Iowa City, and Saint Louis (Mo.) University. The Emory Vaccine Center in Decatur, Ga., will assist in evaluating data.

Yellow fever infection usually causes fever, back pain, headache, nausea, vomiting, fatigue, and weakness, but roughly 15% of infected patients develop severe disease manifested as jaundice, hemorrhage, and shock, resulting in potentially fatal kidney, liver, or heart conditions.

The current yellow fever vaccine can produce severe adverse complications, such as neurologic side effects, multiple organ system dysfunction and death, and thus cannot be given to infants, the elderly, pregnant women, and those with compromised immune systems. More than 105 million people in Africa have been vaccinated against yellow fever since 2006, according to the World Health Organization (WHO), but a new outbreak of the disease has caused an estimated 84,000-170,000 severe illnesses and 29,000 to 60,000 deaths in 2013.

For more details about the trial, visit the National Institutes of Health Clinical Trials website.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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The National Institute of Allergy and Infectious Diseases (NIAID) has initiated a phase I clinical trial of an investigational vaccine designed to protect against yellow fever virus.

According to an NIAID statement, the study will evaluate whether an experimental vaccine developed by the pharmaceutical manufacturer Bavarian Nordic is “safe, tolerable and has the potential to prevent yellow fever virus infection.”

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

Bavarian Nordic’s experimental yellow fever vaccine, called MVA-BN-YF, is based on the company’s proprietary MVA-BN platform, which uses an attenuated version of the Modified Vaccinia Ankara (MVA) virus as a vaccine vector to carry yellow fever virus genes into the body. Bavarian Nordic says that more than 7,600 people, including 1,000 who are immunocompromised, have been safely vaccinated with MVA-BN–based vaccines.

The NIAID statement noted that prior studies have suggested that combining MVA-BN with ISA 720, an experimental immune-boosting adjuvant, induces a strong immune response after a single dose of vaccine. One goal of the study will be to assess whether two doses of unadjuvanted vaccine or a single dose of ISA 720 adjuvanted vaccine could provide protection against yellow fever.

NIAID said the placebo-controlled, double-blinded clinical trial will enroll 90 healthy men and women aged 18-45 years who have never been infected with a flavivirus. Participants will be divided into six groups: One will receive the currently licensed yellow fever vaccine (15 participants) and five groups (15 participants each) will receive the investigational Bavarian Nordic vaccine, either with or without an adjuvant. The investigational vaccine will be administered intramuscularly while the licensed yellow fever vaccine will be administered subcutaneously. Trial participants will receive one or two doses of vaccine or placebo, separated by a month.

According to NIAID’s statement, the multisite trial will be conducted by NIAID-funded Vaccine and Treatment Evaluation Units at the University of Iowa, Iowa City, and Saint Louis (Mo.) University. The Emory Vaccine Center in Decatur, Ga., will assist in evaluating data.

Yellow fever infection usually causes fever, back pain, headache, nausea, vomiting, fatigue, and weakness, but roughly 15% of infected patients develop severe disease manifested as jaundice, hemorrhage, and shock, resulting in potentially fatal kidney, liver, or heart conditions.

The current yellow fever vaccine can produce severe adverse complications, such as neurologic side effects, multiple organ system dysfunction and death, and thus cannot be given to infants, the elderly, pregnant women, and those with compromised immune systems. More than 105 million people in Africa have been vaccinated against yellow fever since 2006, according to the World Health Organization (WHO), but a new outbreak of the disease has caused an estimated 84,000-170,000 severe illnesses and 29,000 to 60,000 deaths in 2013.

For more details about the trial, visit the National Institutes of Health Clinical Trials website.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The National Institute of Allergy and Infectious Diseases (NIAID) has initiated a phase I clinical trial of an investigational vaccine designed to protect against yellow fever virus.

According to an NIAID statement, the study will evaluate whether an experimental vaccine developed by the pharmaceutical manufacturer Bavarian Nordic is “safe, tolerable and has the potential to prevent yellow fever virus infection.”

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

Bavarian Nordic’s experimental yellow fever vaccine, called MVA-BN-YF, is based on the company’s proprietary MVA-BN platform, which uses an attenuated version of the Modified Vaccinia Ankara (MVA) virus as a vaccine vector to carry yellow fever virus genes into the body. Bavarian Nordic says that more than 7,600 people, including 1,000 who are immunocompromised, have been safely vaccinated with MVA-BN–based vaccines.

The NIAID statement noted that prior studies have suggested that combining MVA-BN with ISA 720, an experimental immune-boosting adjuvant, induces a strong immune response after a single dose of vaccine. One goal of the study will be to assess whether two doses of unadjuvanted vaccine or a single dose of ISA 720 adjuvanted vaccine could provide protection against yellow fever.

NIAID said the placebo-controlled, double-blinded clinical trial will enroll 90 healthy men and women aged 18-45 years who have never been infected with a flavivirus. Participants will be divided into six groups: One will receive the currently licensed yellow fever vaccine (15 participants) and five groups (15 participants each) will receive the investigational Bavarian Nordic vaccine, either with or without an adjuvant. The investigational vaccine will be administered intramuscularly while the licensed yellow fever vaccine will be administered subcutaneously. Trial participants will receive one or two doses of vaccine or placebo, separated by a month.

According to NIAID’s statement, the multisite trial will be conducted by NIAID-funded Vaccine and Treatment Evaluation Units at the University of Iowa, Iowa City, and Saint Louis (Mo.) University. The Emory Vaccine Center in Decatur, Ga., will assist in evaluating data.

Yellow fever infection usually causes fever, back pain, headache, nausea, vomiting, fatigue, and weakness, but roughly 15% of infected patients develop severe disease manifested as jaundice, hemorrhage, and shock, resulting in potentially fatal kidney, liver, or heart conditions.

The current yellow fever vaccine can produce severe adverse complications, such as neurologic side effects, multiple organ system dysfunction and death, and thus cannot be given to infants, the elderly, pregnant women, and those with compromised immune systems. More than 105 million people in Africa have been vaccinated against yellow fever since 2006, according to the World Health Organization (WHO), but a new outbreak of the disease has caused an estimated 84,000-170,000 severe illnesses and 29,000 to 60,000 deaths in 2013.

For more details about the trial, visit the National Institutes of Health Clinical Trials website.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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FDA approves generic version of Tamiflu

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The Food and Drug Administration has approved the first generic version of Tamiflu (oseltamivir phosphate), a medication for the treatment of influenza A and B.

The announcement was made Aug. 3, 2016, on the Drugs@FDA website and in an email from the FDA’s Division of Drug Information (DDI). Tamiflu was first approved in 1999.

Oseltamivir phosphate is intended for use in patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours, and for prevention of influenza in patients 1 year of age and older. According to the FDA, the drug does not treat or prevent illness caused by viral infections other than the influenza virus, and does not prevent bacterial infections that may happen with the flu.

Products in the FDA generic approval application submitted by Natco Pharma Ltd., an India-based drug company, include the oral capsule form of the drug, in 30-, 45-, and 75-mg strengths.

The FDA acknowledged in its approval that it does not know if oseltamivir phosphate is effective in patients who start treatment after 2 days of developing symptoms, or have weakened immune systems. The most common side effects reported by patients using oseltamivir phosphate in clinical trials included nausea and vomiting.

For more information on oseltamivir phosphate, see the Tamiflu drug label.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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The Food and Drug Administration has approved the first generic version of Tamiflu (oseltamivir phosphate), a medication for the treatment of influenza A and B.

The announcement was made Aug. 3, 2016, on the Drugs@FDA website and in an email from the FDA’s Division of Drug Information (DDI). Tamiflu was first approved in 1999.

Oseltamivir phosphate is intended for use in patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours, and for prevention of influenza in patients 1 year of age and older. According to the FDA, the drug does not treat or prevent illness caused by viral infections other than the influenza virus, and does not prevent bacterial infections that may happen with the flu.

Products in the FDA generic approval application submitted by Natco Pharma Ltd., an India-based drug company, include the oral capsule form of the drug, in 30-, 45-, and 75-mg strengths.

The FDA acknowledged in its approval that it does not know if oseltamivir phosphate is effective in patients who start treatment after 2 days of developing symptoms, or have weakened immune systems. The most common side effects reported by patients using oseltamivir phosphate in clinical trials included nausea and vomiting.

For more information on oseltamivir phosphate, see the Tamiflu drug label.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The Food and Drug Administration has approved the first generic version of Tamiflu (oseltamivir phosphate), a medication for the treatment of influenza A and B.

The announcement was made Aug. 3, 2016, on the Drugs@FDA website and in an email from the FDA’s Division of Drug Information (DDI). Tamiflu was first approved in 1999.

Oseltamivir phosphate is intended for use in patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours, and for prevention of influenza in patients 1 year of age and older. According to the FDA, the drug does not treat or prevent illness caused by viral infections other than the influenza virus, and does not prevent bacterial infections that may happen with the flu.

Products in the FDA generic approval application submitted by Natco Pharma Ltd., an India-based drug company, include the oral capsule form of the drug, in 30-, 45-, and 75-mg strengths.

The FDA acknowledged in its approval that it does not know if oseltamivir phosphate is effective in patients who start treatment after 2 days of developing symptoms, or have weakened immune systems. The most common side effects reported by patients using oseltamivir phosphate in clinical trials included nausea and vomiting.

For more information on oseltamivir phosphate, see the Tamiflu drug label.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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Ebola research update: July 2016

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The struggle to defeat Ebola virus disease continues globally, although that effort may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.

A study in the Journal of Infectious Diseases showed that responding to the challenges of confronting both the Ebola and Lassa fever viruses in West Africa will require continued investments in the development of countermeasures (e.g., vaccines, therapeutic agents, and diagnostic assays), infrastructure, and human resources.

CDC/Daniel J. DeNoon

The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a U.S.-Liberia joint Clinical Research Partnership, has opened PREVAIL IV, a treatment trial for men who have survived Ebola virus disease (EVD) but continue to have evidence of Ebola virus genetic material, RNA, in their semen.

A report in Morbidity and Mortality Weekly Report (MMWR) revealed that the Sierra Leone Ministry of Health and Sanitation was able to prevent the transmission of Ebola virus within and beyond a family cluster by identifying contacts of a deceased woman who tested positive for the virus, monitoring them for Ebola signs and symptoms, ensuring timely treatment for anyone with Ebola, and conducting an epidemiologic investigation to identify the source of infection.

Lumbar punctures in three Ebola patients, presenting with behavioral modifications with ideation slowing and aggressiveness, found Ebola virus in all cerebrospinal fluids. The authors said this discovery contributes to the discussion of the concept of a specific Ebola virus encephalitis.

Researchers examined antibodies from Ebola or Marburg disease survivors 1-14 years post recovery and found persistent levels of antibodies to glycoprotein, recombinant nucleoprotein, and viral protein 40. The authors said survival of infection caused by one species imparted cross-reactive antibody responses to other filoviruses.

Yisheng Biopharma Co., a company focusing on biological vaccines and pharmaceutical products, and the United States Army Medical Research Institute of Infectious Diseases announced preliminary positive animal results of an Ebola virus-like particle–based vaccine in combination with PIKA adjuvant, a Toll-like receptor 3 (TLR3) agonist.

The U.S. Centers for Disease Control and Prevention released a supplement to MMWR chronicling the major aspects of the agency’s response to the 2014-2016 Ebola epidemic in West Africa. The reports summarized the CDC’s work, primarily during the first year and a half of the epidemic.

A study in eLife employed new human and animal occurrence data to expand upon the way in which potential bat EVD reservoir species are incorporated into a zoonotic niche map. The authors stated that it represents the most up-to-date estimate of the extent of EVD zoonotic risk in Africa.

New research in PLoS Neglected Tropical Diseases spotlights several potential host species and geographical regions as high-probability targets for future surveillance of Ebola and other filoviruses.

Soligenix Inc., a biopharmaceutical company focused on developing and commercializing products to treat rare diseases, announced positive preliminary proof-of-concept results on the development of a heat stable subunit Ebola vaccine.

A systematic review published in the American Journal of Infection Control of existing research pertinent to EVD and social media found that the utility of social media research – particularly focusing on Twitter and YouTube – to public health practitioners is warranted.

Governments and global health care organizations have a moral imperative to provide the required medical care to Ebola virus disease survivors, but must also seize the opportunity to collect evidence necessary to inform future guidelines for effective and safe medical care, researchers stated in a study published in the Journal of Hospital Infection.

The pharmaceutical manufacturer Merck announced that its investigational vaccine for Ebola Zaire, V920 was granted Breakthrough Therapy Designation by the Food and Drug Administration, and that the European Medicines Agency has granted the vaccine PRIME (PRIority MEdicines) status.

A study in the Journal of Infectious Diseases did not find strong evidence supporting respiratory or fomite-associated transmission of EVD in West Africa.

Investigators demonstrated the immunogenicity and protective efficacy of FILORAB1, a recombinant, bivalent, inactivated rabies virus–based Ebola virus vaccine, in rhesus and cynomolgus monkeys.

Cellular polyamines and hypusination are required for Ebolavirus gene expression and replication, a finding with implications for development of Ebola therapeutics, according to a study published in mBio.

The QuickNavi-Ebola immunochromatography (IC) assay is expected to be a useful tool for rapid diagnosis of Ebola virus disease, according to a study in The Journal of Infectious Diseases.

rpizzi@frontlinemedcom.com

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The struggle to defeat Ebola virus disease continues globally, although that effort may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.

A study in the Journal of Infectious Diseases showed that responding to the challenges of confronting both the Ebola and Lassa fever viruses in West Africa will require continued investments in the development of countermeasures (e.g., vaccines, therapeutic agents, and diagnostic assays), infrastructure, and human resources.

CDC/Daniel J. DeNoon

The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a U.S.-Liberia joint Clinical Research Partnership, has opened PREVAIL IV, a treatment trial for men who have survived Ebola virus disease (EVD) but continue to have evidence of Ebola virus genetic material, RNA, in their semen.

A report in Morbidity and Mortality Weekly Report (MMWR) revealed that the Sierra Leone Ministry of Health and Sanitation was able to prevent the transmission of Ebola virus within and beyond a family cluster by identifying contacts of a deceased woman who tested positive for the virus, monitoring them for Ebola signs and symptoms, ensuring timely treatment for anyone with Ebola, and conducting an epidemiologic investigation to identify the source of infection.

Lumbar punctures in three Ebola patients, presenting with behavioral modifications with ideation slowing and aggressiveness, found Ebola virus in all cerebrospinal fluids. The authors said this discovery contributes to the discussion of the concept of a specific Ebola virus encephalitis.

Researchers examined antibodies from Ebola or Marburg disease survivors 1-14 years post recovery and found persistent levels of antibodies to glycoprotein, recombinant nucleoprotein, and viral protein 40. The authors said survival of infection caused by one species imparted cross-reactive antibody responses to other filoviruses.

Yisheng Biopharma Co., a company focusing on biological vaccines and pharmaceutical products, and the United States Army Medical Research Institute of Infectious Diseases announced preliminary positive animal results of an Ebola virus-like particle–based vaccine in combination with PIKA adjuvant, a Toll-like receptor 3 (TLR3) agonist.

The U.S. Centers for Disease Control and Prevention released a supplement to MMWR chronicling the major aspects of the agency’s response to the 2014-2016 Ebola epidemic in West Africa. The reports summarized the CDC’s work, primarily during the first year and a half of the epidemic.

A study in eLife employed new human and animal occurrence data to expand upon the way in which potential bat EVD reservoir species are incorporated into a zoonotic niche map. The authors stated that it represents the most up-to-date estimate of the extent of EVD zoonotic risk in Africa.

New research in PLoS Neglected Tropical Diseases spotlights several potential host species and geographical regions as high-probability targets for future surveillance of Ebola and other filoviruses.

Soligenix Inc., a biopharmaceutical company focused on developing and commercializing products to treat rare diseases, announced positive preliminary proof-of-concept results on the development of a heat stable subunit Ebola vaccine.

A systematic review published in the American Journal of Infection Control of existing research pertinent to EVD and social media found that the utility of social media research – particularly focusing on Twitter and YouTube – to public health practitioners is warranted.

Governments and global health care organizations have a moral imperative to provide the required medical care to Ebola virus disease survivors, but must also seize the opportunity to collect evidence necessary to inform future guidelines for effective and safe medical care, researchers stated in a study published in the Journal of Hospital Infection.

The pharmaceutical manufacturer Merck announced that its investigational vaccine for Ebola Zaire, V920 was granted Breakthrough Therapy Designation by the Food and Drug Administration, and that the European Medicines Agency has granted the vaccine PRIME (PRIority MEdicines) status.

A study in the Journal of Infectious Diseases did not find strong evidence supporting respiratory or fomite-associated transmission of EVD in West Africa.

Investigators demonstrated the immunogenicity and protective efficacy of FILORAB1, a recombinant, bivalent, inactivated rabies virus–based Ebola virus vaccine, in rhesus and cynomolgus monkeys.

Cellular polyamines and hypusination are required for Ebolavirus gene expression and replication, a finding with implications for development of Ebola therapeutics, according to a study published in mBio.

The QuickNavi-Ebola immunochromatography (IC) assay is expected to be a useful tool for rapid diagnosis of Ebola virus disease, according to a study in The Journal of Infectious Diseases.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The struggle to defeat Ebola virus disease continues globally, although that effort may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.

A study in the Journal of Infectious Diseases showed that responding to the challenges of confronting both the Ebola and Lassa fever viruses in West Africa will require continued investments in the development of countermeasures (e.g., vaccines, therapeutic agents, and diagnostic assays), infrastructure, and human resources.

CDC/Daniel J. DeNoon

The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a U.S.-Liberia joint Clinical Research Partnership, has opened PREVAIL IV, a treatment trial for men who have survived Ebola virus disease (EVD) but continue to have evidence of Ebola virus genetic material, RNA, in their semen.

A report in Morbidity and Mortality Weekly Report (MMWR) revealed that the Sierra Leone Ministry of Health and Sanitation was able to prevent the transmission of Ebola virus within and beyond a family cluster by identifying contacts of a deceased woman who tested positive for the virus, monitoring them for Ebola signs and symptoms, ensuring timely treatment for anyone with Ebola, and conducting an epidemiologic investigation to identify the source of infection.

Lumbar punctures in three Ebola patients, presenting with behavioral modifications with ideation slowing and aggressiveness, found Ebola virus in all cerebrospinal fluids. The authors said this discovery contributes to the discussion of the concept of a specific Ebola virus encephalitis.

Researchers examined antibodies from Ebola or Marburg disease survivors 1-14 years post recovery and found persistent levels of antibodies to glycoprotein, recombinant nucleoprotein, and viral protein 40. The authors said survival of infection caused by one species imparted cross-reactive antibody responses to other filoviruses.

Yisheng Biopharma Co., a company focusing on biological vaccines and pharmaceutical products, and the United States Army Medical Research Institute of Infectious Diseases announced preliminary positive animal results of an Ebola virus-like particle–based vaccine in combination with PIKA adjuvant, a Toll-like receptor 3 (TLR3) agonist.

The U.S. Centers for Disease Control and Prevention released a supplement to MMWR chronicling the major aspects of the agency’s response to the 2014-2016 Ebola epidemic in West Africa. The reports summarized the CDC’s work, primarily during the first year and a half of the epidemic.

A study in eLife employed new human and animal occurrence data to expand upon the way in which potential bat EVD reservoir species are incorporated into a zoonotic niche map. The authors stated that it represents the most up-to-date estimate of the extent of EVD zoonotic risk in Africa.

New research in PLoS Neglected Tropical Diseases spotlights several potential host species and geographical regions as high-probability targets for future surveillance of Ebola and other filoviruses.

Soligenix Inc., a biopharmaceutical company focused on developing and commercializing products to treat rare diseases, announced positive preliminary proof-of-concept results on the development of a heat stable subunit Ebola vaccine.

A systematic review published in the American Journal of Infection Control of existing research pertinent to EVD and social media found that the utility of social media research – particularly focusing on Twitter and YouTube – to public health practitioners is warranted.

Governments and global health care organizations have a moral imperative to provide the required medical care to Ebola virus disease survivors, but must also seize the opportunity to collect evidence necessary to inform future guidelines for effective and safe medical care, researchers stated in a study published in the Journal of Hospital Infection.

The pharmaceutical manufacturer Merck announced that its investigational vaccine for Ebola Zaire, V920 was granted Breakthrough Therapy Designation by the Food and Drug Administration, and that the European Medicines Agency has granted the vaccine PRIME (PRIority MEdicines) status.

A study in the Journal of Infectious Diseases did not find strong evidence supporting respiratory or fomite-associated transmission of EVD in West Africa.

Investigators demonstrated the immunogenicity and protective efficacy of FILORAB1, a recombinant, bivalent, inactivated rabies virus–based Ebola virus vaccine, in rhesus and cynomolgus monkeys.

Cellular polyamines and hypusination are required for Ebolavirus gene expression and replication, a finding with implications for development of Ebola therapeutics, according to a study published in mBio.

The QuickNavi-Ebola immunochromatography (IC) assay is expected to be a useful tool for rapid diagnosis of Ebola virus disease, according to a study in The Journal of Infectious Diseases.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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HIV research update: Late July 2016

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A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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New HIV antiretroviral guidelines embrace PrEP, early ART

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The International Antiviral Society–USA has updated its recommendations for the use of antiretroviral drugs to treat or to prevent HIV infection in adults.

In light of new evidence emerging since its 2014 report on antiretroviral drugs (ARVs), the International Antiviral Society–USA convened a panel of HIV experts to review data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences that would change previous recommendations or ratings. The resulting recommendations were published online in the Journal of the American Medical Association. (JAMA. 2016;316[2]:191-210. doi:10.1001/jama.2016.8900)

The panel concluded that newer data support the “widely accepted” recommendation that antiretroviral therapy (ART) should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. They said optimal initial regimens for most patients should include two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). The panel concluded that other effective regimens may include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with two NRTIs.

©grandeduc/Thinkstock

Also of note are the panel’s recommendations for certain special populations. The panel said HIV-infected pregnant women should initiate ART for their own health and to reduce the likelihood of HIV transmission to the infant. HIV-infected patients with hepatitis B virus (HBV) coinfection should initiate a recommended ART regimen that contains tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF), lamivudine or emtricitabine, and a third component.

In addition, the panel said ART should be started within the first 2 weeks after diagnosis for most acute opportunistic infections, with the possible exception of acute cryptococcal meningitis, and ART should be started within the first 2 weeks of initiation of tuberculosis treatment for those with CD4 cell counts of 50/mcL or less and within the first 2-8 weeks for those with CD4 cell counts above 50/mcL.

For prevention of HIV infection, the panel concluded that preexposure prophylaxis (PrEP) should be considered for anyone from a population whose HIV incidence is at least 2% per year, or for HIV-seronegative partners of HIV-infected persons who do not have viral suppression. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. Also, postexposure prophylaxis should be started as soon as possible after exposure.

For the complete list of ARV recommendations, see the report in JAMA (doi:10.1001/jama.2016.8900).

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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The International Antiviral Society–USA has updated its recommendations for the use of antiretroviral drugs to treat or to prevent HIV infection in adults.

In light of new evidence emerging since its 2014 report on antiretroviral drugs (ARVs), the International Antiviral Society–USA convened a panel of HIV experts to review data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences that would change previous recommendations or ratings. The resulting recommendations were published online in the Journal of the American Medical Association. (JAMA. 2016;316[2]:191-210. doi:10.1001/jama.2016.8900)

The panel concluded that newer data support the “widely accepted” recommendation that antiretroviral therapy (ART) should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. They said optimal initial regimens for most patients should include two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). The panel concluded that other effective regimens may include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with two NRTIs.

©grandeduc/Thinkstock

Also of note are the panel’s recommendations for certain special populations. The panel said HIV-infected pregnant women should initiate ART for their own health and to reduce the likelihood of HIV transmission to the infant. HIV-infected patients with hepatitis B virus (HBV) coinfection should initiate a recommended ART regimen that contains tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF), lamivudine or emtricitabine, and a third component.

In addition, the panel said ART should be started within the first 2 weeks after diagnosis for most acute opportunistic infections, with the possible exception of acute cryptococcal meningitis, and ART should be started within the first 2 weeks of initiation of tuberculosis treatment for those with CD4 cell counts of 50/mcL or less and within the first 2-8 weeks for those with CD4 cell counts above 50/mcL.

For prevention of HIV infection, the panel concluded that preexposure prophylaxis (PrEP) should be considered for anyone from a population whose HIV incidence is at least 2% per year, or for HIV-seronegative partners of HIV-infected persons who do not have viral suppression. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. Also, postexposure prophylaxis should be started as soon as possible after exposure.

For the complete list of ARV recommendations, see the report in JAMA (doi:10.1001/jama.2016.8900).

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The International Antiviral Society–USA has updated its recommendations for the use of antiretroviral drugs to treat or to prevent HIV infection in adults.

In light of new evidence emerging since its 2014 report on antiretroviral drugs (ARVs), the International Antiviral Society–USA convened a panel of HIV experts to review data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences that would change previous recommendations or ratings. The resulting recommendations were published online in the Journal of the American Medical Association. (JAMA. 2016;316[2]:191-210. doi:10.1001/jama.2016.8900)

The panel concluded that newer data support the “widely accepted” recommendation that antiretroviral therapy (ART) should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. They said optimal initial regimens for most patients should include two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). The panel concluded that other effective regimens may include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with two NRTIs.

©grandeduc/Thinkstock

Also of note are the panel’s recommendations for certain special populations. The panel said HIV-infected pregnant women should initiate ART for their own health and to reduce the likelihood of HIV transmission to the infant. HIV-infected patients with hepatitis B virus (HBV) coinfection should initiate a recommended ART regimen that contains tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF), lamivudine or emtricitabine, and a third component.

In addition, the panel said ART should be started within the first 2 weeks after diagnosis for most acute opportunistic infections, with the possible exception of acute cryptococcal meningitis, and ART should be started within the first 2 weeks of initiation of tuberculosis treatment for those with CD4 cell counts of 50/mcL or less and within the first 2-8 weeks for those with CD4 cell counts above 50/mcL.

For prevention of HIV infection, the panel concluded that preexposure prophylaxis (PrEP) should be considered for anyone from a population whose HIV incidence is at least 2% per year, or for HIV-seronegative partners of HIV-infected persons who do not have viral suppression. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. Also, postexposure prophylaxis should be started as soon as possible after exposure.

For the complete list of ARV recommendations, see the report in JAMA (doi:10.1001/jama.2016.8900).

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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Hepatitis outlook: July 2016

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Hepatitis outlook: July 2016

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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U.S. to jump-start antibiotic resistance research

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Fri, 01/18/2019 - 16:06
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U.S. to jump-start antibiotic resistance research

The Centers for Disease Control and Prevention is providing $67 million to help U.S. health departments address antibiotic resistance and related patient safety concerns.

The new funding was made available through the CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), according to a CDC statement, and will support seven new regional laboratories with specialized capabilities allowing rapid detection and identification of emerging antibiotic resistant threats.

A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.
James Gathany/CDC
A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.

The CDC said it would distribute funds to all 50 state health departments, six local health departments (Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia), and Puerto Rico, beginning Aug. 1, 2016. The agency said the grants would allow every state health department lab to test for carbapenem-resistant Enterobacteriaceae and ultimately perform whole genome sequencing on intestinal bacteria, including Salmonella, Shigella, and many Campylobacter strains.

The agency intends to provide support teams in nine state health departments for rapid response activities designed to “quickly identify and respond to the threat” of antibiotic-resistant gonorrhea in the United States, and will support high-level expertise to implement antimicrobial resistance activities in six states.

The CDC also said the promised funding would strengthen states’ ability to conduct foodborne disease tracking, investigation, and prevention, as it includes increased support for the PulseNet and OutbreakNet systems and for the Integrated Food Safety Centers of Excellence, as well as support for the National Antimicrobial Resistance Monitoring System (NARMS).

Global partnerships

Complementing the new CDC grants was an announcement from the U.S. Department of Health & Human Services that it would partner with the Wellcome Trust of London, the AMR Centre of Alderley Park (Cheshire, U.K.), and Boston University School of Law to create one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.

According to an HHS statement, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will bring together “multiple domestic and international partners and capabilities to find potential antibiotics and move them through preclinical testing to enable safety and efficacy testing in humans and greatly reducing the business risk,” to make antimicrobial development more attractive to private sector investment.

HHS said the federal Biomedical Advanced Research and Development Authority (BARDA) would provide $30 million during the first year of CARB-X, and up to $250 million during the 5-year project. CARB-X will provide funding for research and development, and technical assistance for companies with innovative and promising solutions to antibiotic resistance, HHS said.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within the CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Joe Larsen, PhD, acting BARDA deputy director, in the HHS statement.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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The Centers for Disease Control and Prevention is providing $67 million to help U.S. health departments address antibiotic resistance and related patient safety concerns.

The new funding was made available through the CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), according to a CDC statement, and will support seven new regional laboratories with specialized capabilities allowing rapid detection and identification of emerging antibiotic resistant threats.

A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.
James Gathany/CDC
A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.

The CDC said it would distribute funds to all 50 state health departments, six local health departments (Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia), and Puerto Rico, beginning Aug. 1, 2016. The agency said the grants would allow every state health department lab to test for carbapenem-resistant Enterobacteriaceae and ultimately perform whole genome sequencing on intestinal bacteria, including Salmonella, Shigella, and many Campylobacter strains.

The agency intends to provide support teams in nine state health departments for rapid response activities designed to “quickly identify and respond to the threat” of antibiotic-resistant gonorrhea in the United States, and will support high-level expertise to implement antimicrobial resistance activities in six states.

The CDC also said the promised funding would strengthen states’ ability to conduct foodborne disease tracking, investigation, and prevention, as it includes increased support for the PulseNet and OutbreakNet systems and for the Integrated Food Safety Centers of Excellence, as well as support for the National Antimicrobial Resistance Monitoring System (NARMS).

Global partnerships

Complementing the new CDC grants was an announcement from the U.S. Department of Health & Human Services that it would partner with the Wellcome Trust of London, the AMR Centre of Alderley Park (Cheshire, U.K.), and Boston University School of Law to create one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.

According to an HHS statement, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will bring together “multiple domestic and international partners and capabilities to find potential antibiotics and move them through preclinical testing to enable safety and efficacy testing in humans and greatly reducing the business risk,” to make antimicrobial development more attractive to private sector investment.

HHS said the federal Biomedical Advanced Research and Development Authority (BARDA) would provide $30 million during the first year of CARB-X, and up to $250 million during the 5-year project. CARB-X will provide funding for research and development, and technical assistance for companies with innovative and promising solutions to antibiotic resistance, HHS said.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within the CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Joe Larsen, PhD, acting BARDA deputy director, in the HHS statement.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The Centers for Disease Control and Prevention is providing $67 million to help U.S. health departments address antibiotic resistance and related patient safety concerns.

The new funding was made available through the CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), according to a CDC statement, and will support seven new regional laboratories with specialized capabilities allowing rapid detection and identification of emerging antibiotic resistant threats.

A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.
James Gathany/CDC
A CDC microbiologist holds up a petri dish, on the right, inoculated with a carbapenem-resistant Enterobacteriaceae (CRE) bacterium that proved to be resistant to all of the antibiotics tested.

The CDC said it would distribute funds to all 50 state health departments, six local health departments (Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia), and Puerto Rico, beginning Aug. 1, 2016. The agency said the grants would allow every state health department lab to test for carbapenem-resistant Enterobacteriaceae and ultimately perform whole genome sequencing on intestinal bacteria, including Salmonella, Shigella, and many Campylobacter strains.

The agency intends to provide support teams in nine state health departments for rapid response activities designed to “quickly identify and respond to the threat” of antibiotic-resistant gonorrhea in the United States, and will support high-level expertise to implement antimicrobial resistance activities in six states.

The CDC also said the promised funding would strengthen states’ ability to conduct foodborne disease tracking, investigation, and prevention, as it includes increased support for the PulseNet and OutbreakNet systems and for the Integrated Food Safety Centers of Excellence, as well as support for the National Antimicrobial Resistance Monitoring System (NARMS).

Global partnerships

Complementing the new CDC grants was an announcement from the U.S. Department of Health & Human Services that it would partner with the Wellcome Trust of London, the AMR Centre of Alderley Park (Cheshire, U.K.), and Boston University School of Law to create one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.

According to an HHS statement, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will bring together “multiple domestic and international partners and capabilities to find potential antibiotics and move them through preclinical testing to enable safety and efficacy testing in humans and greatly reducing the business risk,” to make antimicrobial development more attractive to private sector investment.

HHS said the federal Biomedical Advanced Research and Development Authority (BARDA) would provide $30 million during the first year of CARB-X, and up to $250 million during the 5-year project. CARB-X will provide funding for research and development, and technical assistance for companies with innovative and promising solutions to antibiotic resistance, HHS said.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within the CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Joe Larsen, PhD, acting BARDA deputy director, in the HHS statement.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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Hepatitis outlook: July 2016

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Tue, 12/13/2016 - 10:27
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Hepatitis outlook: July 2016

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Visit http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c to learn more.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Visit http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c to learn more.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Visit http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c to learn more.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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Hepatitis outlook: July 2016

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log10 copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log10 IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log10 U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

 

 

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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References

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Article Type
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Hepatitis outlook: July 2016
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Hepatitis outlook: July 2016
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hepatitis, HCV, HBV
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hepatitis, HCV, HBV
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