Best HCV value? Screen all baby boomers, treat all infections

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Best HCV value? Screen all baby boomers, treat all infections

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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AT THE LIVER MEETING 2014

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Inside the Article

Vitals

Key clinical point: Screening adults born in 1945-1965 and treating all who have HCV with oral anti-HCV regimens is most cost effective.

Major finding: The strategy’s incremental cost of $36,585 is below the $50,000 per QALY threshold for cost effectiveness.

Data source: A computer simulation analysis that compared four strategies for screening and treatment, with treatment costs based on an estimated $1,000/day for sofosbuvir.

Disclosures: Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead, which markets sofosbuvir, and Bristol-Myers Squibb.

Best HCV Value? Screen All Baby Boomers, Treat All Infections

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

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Best HCV value? Screen all baby boomers, treat all infections

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi
Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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AT THE LIVER MEETING 2014

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Inside the Article

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Key clinical point: Screening adults born in 1945-1965 and treating all who have HCV with oral anti-HCV regimens is most cost effective.

Major finding: The strategy’s incremental cost of $36,585 is below the $50,000 per QALY threshold for cost effectiveness.

Data source: A computer simulation analysis that compared four strategies for screening and treatment, with treatment costs based on an estimated $1,000/day for sofosbuvir.

Disclosures: Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead, which markets sofosbuvir, and Bristol-Myers Squibb.

Better thromboprophylaxis didn’t reduce emboli after trauma

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Better thromboprophylaxis didn’t reduce emboli after trauma

SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening
Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening
Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Delivering prophylactic therapies against venous thromboembolism sooner and to more patients admitted for trauma failed to reduce the risk of pulmonary embolism in a 6-year study of data on 23,863 patients.

Dr. Matthew J. Pommerening and his associates at the University of Texas, Houston, retrospectively studied data on the management and outcomes of 11,292 adults admitted to their level 1 trauma center in 2006-2008 before implementation of a performance-improvement program, and 12,571 patients admitted in 2009-2011, after the program was in place.

Dr. Matthew J. Pommerening
Dr. Matthew J. Pommerening

The performance-improvement program included sequential interventions such as audits for missed doses of thromboprophylactic medications, goals for earlier and more aggressive chemical prophylaxis, and placing prophylactic filters in the inferior vena cava (IVC) in high-risk patients.

Overall, 1% of patients developed a pulmonary embolism. Comparing rates of pulmonary emboli, deaths from pulmonary embolism, or mortality in the preprogram and postprogram time periods, however, showed no significant differences, he said at the annual clinical congress of the American College of Surgeons.

One percent of patients in both time periods developed a pulmonary embolism. The rate of death from pulmonary embolism was 7% in the earlier period and 8% in the later period. Mortality rates were 4.5% in both periods.

That’s despite great improvements in reducing the proportion of patients who got no prophylaxis from 45% in the earlier period to 11% under the improvement program. The use of prophylactic IVC filters increased from 3% in the earlier period to nearly 8% under the program. The time to initiation of prophylaxis decreased from 57 hours to 32 hours, on average.

The proportion of patients who missed a dose of thromboprophylaxis did not change significantly, from 39% in the earlier period to 36% under the program.

“Current prophylactic strategies and therapies for pulmonary embolism may be inadequate,” Dr. Pommerening said, perhaps due to inadequate dosing or inadequate therapies. The utility or potential thrombogenicity of IVC filters is a topic of “serious discussion” at his institution, he said.

“There’s still room for improvement,” he added, by eliminating missed doses and reducing the 11% of patients who got no prophylaxis, he added.

The time to diagnosis of pulmonary embolism and the proportion of emboli located in the main pulmonary artery did not differ significantly by time period.

The size of the study may not have provided enough power to detect differences in rates of emboli between time periods with such a low overall rate of pulmonary emboli to begin with, he said.

The investigators have started to look at whether the performance improvement program made any difference in the rate of deep-vein thrombosis.

Dr. Pommerening reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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AT THE ACS CLINICAL CONGRESS

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Inside the Article

Vitals

Key clinical point: Current thromboprophylaxis strategies may not reduce pulmonary emboli after trauma.

Major finding: Pulmonary embolism occurred in 1% of trauma patients in each time period.

Data source: Retrospective study of 23,863 patients admitted before or after initiation of a thromboprophylaxis improvement program.

Disclosures: Dr. Pommerening reported having no financial disclosures.

Vigorous Exercise Better in PCOS

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Vigorous Exercise Better in PCOS

HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

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HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

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Vigorous exercise better in PCOS

HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

HONOLULU – An hour of vigorous exercise per week decreased the risk for metabolic syndrome in women with polycystic ovary syndrome by 22%, a retrospective study of 326 women found.

Moderate-intensity exercise for at least 150 minutes per week also was beneficial, compared with inactivity, but vigorous exercise produced added benefits in risk for metabolic syndrome, body mass index (BMI), cholesterol levels, glucose tolerance, and insulin resistance, Dr. Eleni A. Greenwood said at the annual meeting of the American Society for Reproductive Medicine.

The results point to “the power of sweat” when recommending exercise to women with polycystic ovary syndrome (PCOS), she said.

Dr. Eleni A. Greenwood
Dr. Eleni A. Greenwood

The observational study of women seen at a single PCOS clinic in 2006-2013 compared three groups: those who reported exercising vigorously for at least 75 minutes per week; those who reported moderate-intensity exercise for at least 150 minutes per week but not vigorous exercise, or “inactive” women who reported neither of these activity levels, which are recommended by the U.S. Department of Health & Human Services.

Patients reported activity on the self-administered International Physical Activity Questionnaire, which defines vigorous exercise as hard physical effort that makes you breathe much harder than normal and moderate-intensity exercise as moderate physical effort that makes you breathe somewhat harder than normal. They were evaluated systematically for evidence of metabolic dysfunction.

Among the 56% of women who reported activity that met HHS recommendations, 83% reported vigorous activity and 17% reported moderate activity. The other 44% were classified as inactive.

The proportion of women with metabolic syndrome was lowest in the vigorous activity group (33%), higher in the moderate activity group (36%), and highest in the inactive group (47%), reported Dr. Greenwood of the University of California, San Francisco, and her associates.

Doing 60 minutes of vigorous exercise per week decreased the odds of metabolic syndrome by 22% after adjusting for the influence of age, BMI, and total volume of exercise as measured by metabolic equivalents, she said.

There was a significant trend toward lower BMI with more intense activity. The mean BMI was 27 kg/m2 in the vigorous activity group, 30 kg/m2 in the moderate activity group, and 31 kg/m2 in the inactive group, she said. The mean HDL cholesterol level was significantly higher in the vigorous exercise group (56 mg/dL), compared with the moderate exercise group (46 mg/dL) or the inactive group (51 mg/dL).

Measures of glucose tolerance using the 2-hour oral glucose tolerance test trended significantly better in the vigorous exercise group – a mean of 93 mg/dL with vigorous exercise, 104 mg/dL with moderate exercise, or 106 mg/dL in the inactive group. Fasting glucose measurements did not differ significantly between groups.

Significant trends toward better measures of insulin resistance were seen with more vigorous activity. Fasting insulin levels were 6.9 mU/L in the vigorous exercise group, 9.8 mU/L with moderate exercise, and 11 mU/L in the inactive group. Scores on the homeostatic model assessment of estimated insulin resistance were 1.5 in the vigorous exercise group, 2.2 in the moderate exercise group, and 2.4 in the inactive group.

Significant trends toward smaller waist circumference and rate of acanthosis nigricans were seen with more vigorous activity. The mean waist circumference was 33 inches in the vigorous exercise group and 35 inches in the other two groups. In the vigorous exercise group, 24% had acanthosis nigricans, compared with 30% in the moderate exercise group and 40% in the inactive group.

The mean age in each group was 28 years.

“Vigorous activity is associated with additional benefits, compared to moderate activity,” Dr. Greenwood said. “Women with PCOS should strive to meet HHS guidelines through vigorous physical activity.”

She reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Key clinical point: Tell patients with PCOS that vigorous exercise is better than moderate exercise.

Major finding: Metabolic syndrome was present in 33% with vigorous exercise, 36% with moderate exercise, and 47% with inactivity.

Data source: An analysis of clinical data and questionnaire results from 326 women with PCOS.

Disclosures: Dr. Greenwood reported having no financial disclosures. Her associates reported associations with Nora Therapeutics, Ferring Pharmaceuticals, and Ziva Medical.

Drug Combination Successful in Hepatitis C Plus HIV

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Drug Combination Successful in Hepatitis C Plus HIV

BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

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BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

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Drug Combination Successful in Hepatitis C Plus HIV
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Drug combination successful in hepatitis C plus HIV

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Drug combination successful in hepatitis C plus HIV

BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).

Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Shyamasundaran Kottilil
Dr. Shyamasundaran Kottilil

The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.

He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.

Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.

Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.

No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.

Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.

Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Key clinical point: Hepatitis C can be treated successfully in patients with HIV using ledipasvir and sofosbuvir.

Major finding: Ledipasvir plus sofosbuvir for hepatitis C produced a sustained virologic response in 49 of 50 patients (98%).

Data source: A prospective study of 50 patients with genotype 1 hepatitis C infection and HIV.

Disclosures: Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.

Sofosbuvir-containing regimens dominate hepatitis C treatment

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BOSTON – Since their approval in late 2013, the direct-acting antiviral agents sofosbuvir and simeprevir have taken over treatment of hepatitis C with real-world success that approximates clinical trial results, two separate and ongoing longitudinal, observational studies show.

Sofosbuvir-containing regimens produced sustained virologic response (SVR) rates of 85%-90% in patients with genotype 1 infection in one study and 79%-88% in the other.

Dr. Donald M. Jensen
Dr. Donald M. Jensen

In one study, researchers analyzed data for 2,063 patients who started and completed treatment for hepatitis C since January 2014 at 43 academic medical centers and 13 community medical centers in North America and Europe participating in the HCV-Target study, Dr. Donald M. Jensen and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Among patients with genotype 1 hepatitis C infection, 68% were treated with an off-label combination of sofosbuvir plus simeprevir with or without ribavirin, 23% received sofosbuvir plus pegylated interferon plus ribavirin, and 9% received sofosbuvir plus ribavirin alone, reported Dr. Jensen, professor of medicine and director of the Center for Liver Diseases at the University of Chicago.

Among patients with genotype 2 or 3 hepatitis C infection, 99% and 92% received sofosbuvir plus ribavirin, respectively.

The off-label combination of sofosbuvir plus simeprevir with or without ribavirin also was common in two subgroups, patients with cirrhosis and patients who had undergone liver transplantation.

That combination – sofosbuvir plus simeprevir with or without ribavirin – produced an SVR at 4 weeks in 89% of patients with genotype 1 hepatitis C, ranging from 92% in patients without cirrhosis to 87% in those with cirrhosis and 75% in patients with prior decompensation, he reported. And if they’d previously failed protease inhibitor therapy, the SVR rate at 4 weeks was 81%, ranging from 79% in those with cirrhosis to 85% without cirrhosis.

Treating patients with genotype 1 infection with sofosbuvir plus pegylated interferon plus ribavirin led to an SVR rate at 4 weeks of 85%, ranging from 70% in cirrhotic patients to 90% without cirrhosis.

In patients with genotype 2 infection, treatment with sofosbuvir plus ribavirin produced an SVR rate at 4 weeks of 90%, ranging from 88% in patients with cirrhosis to 91% without cirrhosis.

A secondary analysis suggested good concordance between SVR rates at 4 weeks and 12 weeks. The positive predictive value for SVR at 12 weeks if there was SVR at 4 weeks was 97% for patients treated with sofosbuvir and simeprevir with or without ribavirin, 94% for those treated with sofosbuvir, pegylated interferon, and ribavirin, and 98% for patients treated with sofosbuvir and ribavirin.

Rates of serious adverse events and premature discontinuation of therapy were “very low,” Dr. Jensen said.

In a separate study of patients who started treatment for hepatitis C between January and April of 2014 at 119 practices, researchers analyzed data on 955 patients who completed treatment. Because SVR rates at 12 weeks are pending for some patients, an intent-to-treat analysis included 822 patients and 743 patients who were in a per-protocol analysis.

Forty percent of patients were treated with sofosbuvir plus pegylated interferon and ribavirin, 24% received sofosbuvir and ribavirin, and 34% were treated with sofosbuvir and simeprevir with or without ribavirin, reported Dr. Douglas Dieterich and his associates.

SVR was achieved at 12 weeks by 79% of patients in the intent-to-treat analysis and by 88% in the per-protocol analysis, reported Dr. Dieterich, professor of medicine at Mount Sinai School of Medicine, New York.

“This is comparable to data reported in clinical trials,” he said. Notably, 72% of patients who previously failed treatment and then received sofosbuvir, pegylated interferon, and ribavirin achieved SVR at 12 weeks, “exactly as predicted by the Food and Drug Administration,” he added.

Dr. Dieterich reported ties with Merck, Idenix Pharmaceuticals, Janssen Pharmaceuticals, Gilead, and Bristol-Myers Squibb, and his associates reported ties with dozens of companies. Dr. Jensen reported ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, and Janssen Pharmaceuticals, Gilead, Merck, Vertex, and GSK.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Since their approval in late 2013, the direct-acting antiviral agents sofosbuvir and simeprevir have taken over treatment of hepatitis C with real-world success that approximates clinical trial results, two separate and ongoing longitudinal, observational studies show.

Sofosbuvir-containing regimens produced sustained virologic response (SVR) rates of 85%-90% in patients with genotype 1 infection in one study and 79%-88% in the other.

Dr. Donald M. Jensen
Dr. Donald M. Jensen

In one study, researchers analyzed data for 2,063 patients who started and completed treatment for hepatitis C since January 2014 at 43 academic medical centers and 13 community medical centers in North America and Europe participating in the HCV-Target study, Dr. Donald M. Jensen and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Among patients with genotype 1 hepatitis C infection, 68% were treated with an off-label combination of sofosbuvir plus simeprevir with or without ribavirin, 23% received sofosbuvir plus pegylated interferon plus ribavirin, and 9% received sofosbuvir plus ribavirin alone, reported Dr. Jensen, professor of medicine and director of the Center for Liver Diseases at the University of Chicago.

Among patients with genotype 2 or 3 hepatitis C infection, 99% and 92% received sofosbuvir plus ribavirin, respectively.

The off-label combination of sofosbuvir plus simeprevir with or without ribavirin also was common in two subgroups, patients with cirrhosis and patients who had undergone liver transplantation.

That combination – sofosbuvir plus simeprevir with or without ribavirin – produced an SVR at 4 weeks in 89% of patients with genotype 1 hepatitis C, ranging from 92% in patients without cirrhosis to 87% in those with cirrhosis and 75% in patients with prior decompensation, he reported. And if they’d previously failed protease inhibitor therapy, the SVR rate at 4 weeks was 81%, ranging from 79% in those with cirrhosis to 85% without cirrhosis.

Treating patients with genotype 1 infection with sofosbuvir plus pegylated interferon plus ribavirin led to an SVR rate at 4 weeks of 85%, ranging from 70% in cirrhotic patients to 90% without cirrhosis.

In patients with genotype 2 infection, treatment with sofosbuvir plus ribavirin produced an SVR rate at 4 weeks of 90%, ranging from 88% in patients with cirrhosis to 91% without cirrhosis.

A secondary analysis suggested good concordance between SVR rates at 4 weeks and 12 weeks. The positive predictive value for SVR at 12 weeks if there was SVR at 4 weeks was 97% for patients treated with sofosbuvir and simeprevir with or without ribavirin, 94% for those treated with sofosbuvir, pegylated interferon, and ribavirin, and 98% for patients treated with sofosbuvir and ribavirin.

Rates of serious adverse events and premature discontinuation of therapy were “very low,” Dr. Jensen said.

In a separate study of patients who started treatment for hepatitis C between January and April of 2014 at 119 practices, researchers analyzed data on 955 patients who completed treatment. Because SVR rates at 12 weeks are pending for some patients, an intent-to-treat analysis included 822 patients and 743 patients who were in a per-protocol analysis.

Forty percent of patients were treated with sofosbuvir plus pegylated interferon and ribavirin, 24% received sofosbuvir and ribavirin, and 34% were treated with sofosbuvir and simeprevir with or without ribavirin, reported Dr. Douglas Dieterich and his associates.

SVR was achieved at 12 weeks by 79% of patients in the intent-to-treat analysis and by 88% in the per-protocol analysis, reported Dr. Dieterich, professor of medicine at Mount Sinai School of Medicine, New York.

“This is comparable to data reported in clinical trials,” he said. Notably, 72% of patients who previously failed treatment and then received sofosbuvir, pegylated interferon, and ribavirin achieved SVR at 12 weeks, “exactly as predicted by the Food and Drug Administration,” he added.

Dr. Dieterich reported ties with Merck, Idenix Pharmaceuticals, Janssen Pharmaceuticals, Gilead, and Bristol-Myers Squibb, and his associates reported ties with dozens of companies. Dr. Jensen reported ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, and Janssen Pharmaceuticals, Gilead, Merck, Vertex, and GSK.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Since their approval in late 2013, the direct-acting antiviral agents sofosbuvir and simeprevir have taken over treatment of hepatitis C with real-world success that approximates clinical trial results, two separate and ongoing longitudinal, observational studies show.

Sofosbuvir-containing regimens produced sustained virologic response (SVR) rates of 85%-90% in patients with genotype 1 infection in one study and 79%-88% in the other.

Dr. Donald M. Jensen
Dr. Donald M. Jensen

In one study, researchers analyzed data for 2,063 patients who started and completed treatment for hepatitis C since January 2014 at 43 academic medical centers and 13 community medical centers in North America and Europe participating in the HCV-Target study, Dr. Donald M. Jensen and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Among patients with genotype 1 hepatitis C infection, 68% were treated with an off-label combination of sofosbuvir plus simeprevir with or without ribavirin, 23% received sofosbuvir plus pegylated interferon plus ribavirin, and 9% received sofosbuvir plus ribavirin alone, reported Dr. Jensen, professor of medicine and director of the Center for Liver Diseases at the University of Chicago.

Among patients with genotype 2 or 3 hepatitis C infection, 99% and 92% received sofosbuvir plus ribavirin, respectively.

The off-label combination of sofosbuvir plus simeprevir with or without ribavirin also was common in two subgroups, patients with cirrhosis and patients who had undergone liver transplantation.

That combination – sofosbuvir plus simeprevir with or without ribavirin – produced an SVR at 4 weeks in 89% of patients with genotype 1 hepatitis C, ranging from 92% in patients without cirrhosis to 87% in those with cirrhosis and 75% in patients with prior decompensation, he reported. And if they’d previously failed protease inhibitor therapy, the SVR rate at 4 weeks was 81%, ranging from 79% in those with cirrhosis to 85% without cirrhosis.

Treating patients with genotype 1 infection with sofosbuvir plus pegylated interferon plus ribavirin led to an SVR rate at 4 weeks of 85%, ranging from 70% in cirrhotic patients to 90% without cirrhosis.

In patients with genotype 2 infection, treatment with sofosbuvir plus ribavirin produced an SVR rate at 4 weeks of 90%, ranging from 88% in patients with cirrhosis to 91% without cirrhosis.

A secondary analysis suggested good concordance between SVR rates at 4 weeks and 12 weeks. The positive predictive value for SVR at 12 weeks if there was SVR at 4 weeks was 97% for patients treated with sofosbuvir and simeprevir with or without ribavirin, 94% for those treated with sofosbuvir, pegylated interferon, and ribavirin, and 98% for patients treated with sofosbuvir and ribavirin.

Rates of serious adverse events and premature discontinuation of therapy were “very low,” Dr. Jensen said.

In a separate study of patients who started treatment for hepatitis C between January and April of 2014 at 119 practices, researchers analyzed data on 955 patients who completed treatment. Because SVR rates at 12 weeks are pending for some patients, an intent-to-treat analysis included 822 patients and 743 patients who were in a per-protocol analysis.

Forty percent of patients were treated with sofosbuvir plus pegylated interferon and ribavirin, 24% received sofosbuvir and ribavirin, and 34% were treated with sofosbuvir and simeprevir with or without ribavirin, reported Dr. Douglas Dieterich and his associates.

SVR was achieved at 12 weeks by 79% of patients in the intent-to-treat analysis and by 88% in the per-protocol analysis, reported Dr. Dieterich, professor of medicine at Mount Sinai School of Medicine, New York.

“This is comparable to data reported in clinical trials,” he said. Notably, 72% of patients who previously failed treatment and then received sofosbuvir, pegylated interferon, and ribavirin achieved SVR at 12 weeks, “exactly as predicted by the Food and Drug Administration,” he added.

Dr. Dieterich reported ties with Merck, Idenix Pharmaceuticals, Janssen Pharmaceuticals, Gilead, and Bristol-Myers Squibb, and his associates reported ties with dozens of companies. Dr. Jensen reported ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, and Janssen Pharmaceuticals, Gilead, Merck, Vertex, and GSK.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Key clinical point: Real-world results with sofosbuvir-containing regimens are consistent with clinical trial results.

Major finding: Sofosbuvir-containing regimens produced sustained virologic response rates of 85%-90% in patients with genotype 1 infection in one study and 79%-88% in the other.

Data source: Two ongoing, multicenter, longitudinal, observational studies with data so far on 2,063 patients and 822 patients with hepatitis C, respectively.

Disclosures: Dr. Jensen reported ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, Janssen Pharmaceuticals, Gilead, Merck, Kadman, Vertex, and GSK. Dr. Dieterich ties with Merck, Idenix Pharmaceuticals, Janssen Pharmaceuticals, Gilead, and Bristol-Myers Squibb, and his associates reported ties with dozens of companies.

Achieving Sustained Response Key to Successful HCV Treatment

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Achieving Sustained Response Key to Successful HCV Treatment

BOSTON – Risks for mortality, hepatocellular carcinoma, and liver transplantations were significantly lower in patients with hepatitis C who achieved a sustained virologic response after treatment, compared with patients without a sustained response, in a meta-analysis of long-term follow-up data on 23,309 patients.

In patients with a sustained virologic response (SVR), the risk of death was 62%-84% lower, the risk of developing hepatocellular carcinoma was 68%-79% lower, and the risk of liver transplantation was 90% lower, compared with patients who did not achieve a SVR, Andrew M. Hill, Ph.D., and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Andrew M. Hill, Ph.D.
Andrew M. Hill, Ph.D.

The cohort included 15,067 patients with hepatitis C without cirrhosis, HIV, or prior transplantation; 4,987 patients with hepatitis C and cirrhosis; 1,170 patients with hepatitis C who had undergone liver transplantation; and 2,085 patients coinfected with hepatitis C and HIV.

Treatment consisted primarily of pegylated interferon plus ribavirin. “These analyses need to be repeated for studies of direct acting antivirals,” said Dr. Hill of the University of Liverpool, England.

In the current study, SVR was associated with a 62% reduction in the risk of death in the general group of mono-infected patients without cirrhosis or transplantation, an 84% reduction in patients with cirrhosis, and a 73% reduction in those coinfected with HIV, multivariate analyses showed.

The 5-year risk of all-cause mortality was 4.5% after SVR and 10.5% with no SVR in the general group of patients with HCV. In those with cirrhosis, mortality rates were 3.6% after SVR or 11.3% with no SVR. In patients who also had HIV, mortality rates were 1.3% after SVR and 10% with no SVR, Dr. Hill reported.

The 5-year risk of developing hepatocellular carcinoma as 2.9% after SVR and 9.3% with no SVR in the general group with HCV. In patients with cirrhosis, hepatocellular carcinoma rates were 5.3% with SVR and 13.9% with no SVR. In patients who had HIV, hepatocellular carcinoma rates were 0.9% after SVR and 10% with no SVR.

Reinfection with HCV can complicate the results of treatment, Dr. Hill said. The 5-year reinfection rates were 0.9% in low-risk patients, 8.2% in IV drug users or prisoners, and 23.6% in patients coinfected with HIV.

“The cost-effectiveness of treatment of hepatitis C depends on the extent of reductions in the risk of liver transplantation, hepatocellular carcinoma, and all-cause mortality,” he said.

The World Health Organization and UNITAID funded the study. Dr. Hill reported financial associations with Janssen Pharmaceuticals.

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BOSTON – Risks for mortality, hepatocellular carcinoma, and liver transplantations were significantly lower in patients with hepatitis C who achieved a sustained virologic response after treatment, compared with patients without a sustained response, in a meta-analysis of long-term follow-up data on 23,309 patients.

In patients with a sustained virologic response (SVR), the risk of death was 62%-84% lower, the risk of developing hepatocellular carcinoma was 68%-79% lower, and the risk of liver transplantation was 90% lower, compared with patients who did not achieve a SVR, Andrew M. Hill, Ph.D., and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Andrew M. Hill, Ph.D.
Andrew M. Hill, Ph.D.

The cohort included 15,067 patients with hepatitis C without cirrhosis, HIV, or prior transplantation; 4,987 patients with hepatitis C and cirrhosis; 1,170 patients with hepatitis C who had undergone liver transplantation; and 2,085 patients coinfected with hepatitis C and HIV.

Treatment consisted primarily of pegylated interferon plus ribavirin. “These analyses need to be repeated for studies of direct acting antivirals,” said Dr. Hill of the University of Liverpool, England.

In the current study, SVR was associated with a 62% reduction in the risk of death in the general group of mono-infected patients without cirrhosis or transplantation, an 84% reduction in patients with cirrhosis, and a 73% reduction in those coinfected with HIV, multivariate analyses showed.

The 5-year risk of all-cause mortality was 4.5% after SVR and 10.5% with no SVR in the general group of patients with HCV. In those with cirrhosis, mortality rates were 3.6% after SVR or 11.3% with no SVR. In patients who also had HIV, mortality rates were 1.3% after SVR and 10% with no SVR, Dr. Hill reported.

The 5-year risk of developing hepatocellular carcinoma as 2.9% after SVR and 9.3% with no SVR in the general group with HCV. In patients with cirrhosis, hepatocellular carcinoma rates were 5.3% with SVR and 13.9% with no SVR. In patients who had HIV, hepatocellular carcinoma rates were 0.9% after SVR and 10% with no SVR.

Reinfection with HCV can complicate the results of treatment, Dr. Hill said. The 5-year reinfection rates were 0.9% in low-risk patients, 8.2% in IV drug users or prisoners, and 23.6% in patients coinfected with HIV.

“The cost-effectiveness of treatment of hepatitis C depends on the extent of reductions in the risk of liver transplantation, hepatocellular carcinoma, and all-cause mortality,” he said.

The World Health Organization and UNITAID funded the study. Dr. Hill reported financial associations with Janssen Pharmaceuticals.

BOSTON – Risks for mortality, hepatocellular carcinoma, and liver transplantations were significantly lower in patients with hepatitis C who achieved a sustained virologic response after treatment, compared with patients without a sustained response, in a meta-analysis of long-term follow-up data on 23,309 patients.

In patients with a sustained virologic response (SVR), the risk of death was 62%-84% lower, the risk of developing hepatocellular carcinoma was 68%-79% lower, and the risk of liver transplantation was 90% lower, compared with patients who did not achieve a SVR, Andrew M. Hill, Ph.D., and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Andrew M. Hill, Ph.D.
Andrew M. Hill, Ph.D.

The cohort included 15,067 patients with hepatitis C without cirrhosis, HIV, or prior transplantation; 4,987 patients with hepatitis C and cirrhosis; 1,170 patients with hepatitis C who had undergone liver transplantation; and 2,085 patients coinfected with hepatitis C and HIV.

Treatment consisted primarily of pegylated interferon plus ribavirin. “These analyses need to be repeated for studies of direct acting antivirals,” said Dr. Hill of the University of Liverpool, England.

In the current study, SVR was associated with a 62% reduction in the risk of death in the general group of mono-infected patients without cirrhosis or transplantation, an 84% reduction in patients with cirrhosis, and a 73% reduction in those coinfected with HIV, multivariate analyses showed.

The 5-year risk of all-cause mortality was 4.5% after SVR and 10.5% with no SVR in the general group of patients with HCV. In those with cirrhosis, mortality rates were 3.6% after SVR or 11.3% with no SVR. In patients who also had HIV, mortality rates were 1.3% after SVR and 10% with no SVR, Dr. Hill reported.

The 5-year risk of developing hepatocellular carcinoma as 2.9% after SVR and 9.3% with no SVR in the general group with HCV. In patients with cirrhosis, hepatocellular carcinoma rates were 5.3% with SVR and 13.9% with no SVR. In patients who had HIV, hepatocellular carcinoma rates were 0.9% after SVR and 10% with no SVR.

Reinfection with HCV can complicate the results of treatment, Dr. Hill said. The 5-year reinfection rates were 0.9% in low-risk patients, 8.2% in IV drug users or prisoners, and 23.6% in patients coinfected with HIV.

“The cost-effectiveness of treatment of hepatitis C depends on the extent of reductions in the risk of liver transplantation, hepatocellular carcinoma, and all-cause mortality,” he said.

The World Health Organization and UNITAID funded the study. Dr. Hill reported financial associations with Janssen Pharmaceuticals.

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