The Road to HCV Elimination with Joseph Lim, MD

What are the largest factors creating barriers to hepatitis C virus (HCV) elimination?
 

Dr. Lim: In 2020 there remain important barriers to access to treatment because of the high cost of drugs used to eradicate HCV. There are still opportunities for us to interact with major payors to ensure adequate access, both with private commercial payers, as well as with Medicaid. We know very well that there are existing barriers that impact a significant proportion of patients, but if you look at data from the private sector, it turns out that we are doing pretty well; At least 80% of payers are covering direct-acting antiviral (DAA) medications with minimal restriction.

However, with Medicaid it is quite the reverse story; In about two-thirds of states, there are at least one or more restrictions based on the stage of their fibrosis, sobriety requirements for alcohol and drug use, and specialty providers to prescribe the medication, among others. Based on data from the National Viral Hepatitis Roundtable, it is clear that there are still many states where if you have mild disease, or recently used drugs or alcohol, or are in a rural area where you do not have access to a gastroenterologist or infectious disease specialist, you cannot get treatment. That is still a major concern for access to care.

When we think about elimination, eradication, and extinction of human diseases, HCV represents one of the few for which we actually have the tools to cure the condition permanently with a simple regimen of 1 to 3 pills per day for 2 or 3 months, with a cure rate exceeding 95%. This is truly remarkable and provides us with a historic opportunity to eradicate HCV in the United States and worldwide.

When we can diagnose HCV and offer treatment, we have a very good success rate—but therein lies the challenge. The key rate limiting steps to achieving elimination are found in ongoing deficits in the HCV care cascade, including screening, diagnosis, linkage to care, and treatment. We believe that right now only about 50% of affected persons have been diagnosed, and therefore much work remains to be done in the screening/diagnosis step of the care cascade if we are to achieve meaningful progress towards HCV elimination.

In that spirit, there have been important advances in terms of policy and legislation to support broader population-based screening. The CDC and US Preventive Services Task Force initially recommended that all baby boomers (those born between 1945 and 1965) should be screened for HCV, in addition to those with established risk factors. These include individuals who have used drugs, either through a nose or through the vein, had a blood transfusion before 1992, tattoos or body piercings, accidental needlestick exposures, or high risk sexual contacts, However, data show that risk factor-based screening simply does not work. It is difficult for clinicians to routinely ask sensitive questions about historical risk factors.

Despite the remarkable success in development of curative therapies for HCV, the rate of new incident HCV infections has not been going down—It has actually been doubling to tripling over the last 5 years. We now have what we call a bi-modal distribution of HCV, which includes baby boomers and a second younger group, between age 18 and 34. The primary route of transmission in this younger cohort is injection drug use, which is largely tied to the opiate epidemic.

It is in this context that within the last year, 4 different organizations—the CDC, the United States Preventive Services Task Force (USPSTF), the American Association for the Study of Liver Diseases (AASLD), and the Infectious Diseases Society of America (IDSA)—have expanded their guidance documents to now recommend one-time HCV screening in all adults age 18 or older plus all pregnant women regardless of age. This guidance replaces the old guidelines focused on baby boomers and individuals with risk factors. This represents a fundamental and consequential shift in US strategy to improve population-based screening.

There is also a sense that a treatment as prevention strategy can be particularly impactful in reducing spread among high-risk populations, especially in persons who inject drugs (PWID). The concept is that if you can effectively remove HCV in high-risk populations by treating active users, this may prevent spread of HCV to others who would otherwise be exposed. Although HCV treatment in patients with active drug use has historically been viewed with skepticism, and in fact remains an exclusion factor by some payors, DAA therapy in PWID is strongly recommended by the AASLD/IDSA guidelines and is increasingly embraced in both specialty and non-specialty (eg, methadone clinics, community health centers, prison clinics) settings.

Could you please elaborate more on the updated CDC guidelines and the impact that those are having in practice?

Dr. Lim: Although the revised screening guidelines by CDC and other organizations represent a critical step to promote awareness by clinicians regarding the compelling evidence to support universal HCV screening of all American adults, the reality is that just because there is a recommendation for it, does not mean that it will always be followed. Clinicians in primary care and specialty practices alike are already burdened by guideline fatigue, and an ever-growing list of mandates of standard clinical practice such as colon cancer screening, mammography, cholesterol checks, etc., and now all of this in the context of COVID-19. This further complicates the task of implementing HCV screening recommendations in real-world clinical practice.

New data published this year show that the screening rates among baby boomers have increased from approximately 10% to 20% since the original recommendations in 2014. Although this represents an important step in the right direction, it is clear there is significant room for improvement. It remains to be seen what impact this transition from birth cohort screening to universal screening of all Americans age 18 and older will have on our ability to identify previously unidentified infected persons.

In 2016 the World Health Organization (WHO) Global Health Sector Strategy called for the elimination of HCV as a major health threat by 2030. At the current rate of transmission, and considering all the barriers you mentioned that still exist, do you think that this is still a realistic timeframe? Is there any other action that physicians specifically maintain to help reach the goal?

Dr. Lim: WHO's vision was to eliminate hepatitis C by 2030 as defined as the following: 1) diagnose 90% of infected persons, 2) offer treatment to 80% of infected persons, and 3) reduce HCV-associated mortality by 65%.

Unfortunately, the United States is highly unlikely to meet this goal by 2030. Based on recently published models, only 3 of 50 states may have a chance at meeting the elimination target by that deadline. But as a country, we already know that is just simply not going to happen—unless there are dramatic changes in governmental and multi-stakeholder commitment.

Globally, there are an estimated 12 countries that are projected to achieve elimination by 2030. Some of the most prominent examples include Egypt, The Republic of Georgia, Australia, Italy, and Japan. The United States is not in this grouping, and in fact our current models suggest that we may not even achieve this goal by 2050.

There is much work that needs to be done to address some of the systemic and institutional infrastructure issues that will support effective implementation of screening, diagnosis, and linkage of care. Drug access—although that remains an important issue—is actually not the driving factor in terms of our inability to meet our targets. Within the United States, the Department of Health and Human Services has taken the lead on developing a US-based strategy. Although there has been strong language to articulate what is required and the intentionality to work on HCV elimination, this has not yet been associated with adequate funding at the federal level. Without this funding, we are destined to make only modest progress towards elimination targets within the short and intermediate timeframe.  Despite these challenges, organizations such as the AASLD, CDC, National Viral Hepatitis Roundtable, World Hepatitis Alliance, and the Coalition for Global Hepatitis Elimination remain vocal advocates to secure necessary resources and will continue to lead US efforts to implement effective strategies on the road to viral hepatitis elimination. These organizations cannot fulfill this mission alone—each of us as clinicians play a vital role in carrying out CDC and USPSTF recommendations in our individual clinical settings to ensure broad-based screening and diagnosis, timely linkage to care, and antiviral treatment.

What are the largest factors creating barriers to hepatitis C virus (HCV) elimination?
 

Dr. Lim: In 2020 there remain important barriers to access to treatment because of the high cost of drugs used to eradicate HCV. There are still opportunities for us to interact with major payors to ensure adequate access, both with private commercial payers, as well as with Medicaid. We know very well that there are existing barriers that impact a significant proportion of patients, but if you look at data from the private sector, it turns out that we are doing pretty well; At least 80% of payers are covering direct-acting antiviral (DAA) medications with minimal restriction.

However, with Medicaid it is quite the reverse story; In about two-thirds of states, there are at least one or more restrictions based on the stage of their fibrosis, sobriety requirements for alcohol and drug use, and specialty providers to prescribe the medication, among others. Based on data from the National Viral Hepatitis Roundtable, it is clear that there are still many states where if you have mild disease, or recently used drugs or alcohol, or are in a rural area where you do not have access to a gastroenterologist or infectious disease specialist, you cannot get treatment. That is still a major concern for access to care.

When we think about elimination, eradication, and extinction of human diseases, HCV represents one of the few for which we actually have the tools to cure the condition permanently with a simple regimen of 1 to 3 pills per day for 2 or 3 months, with a cure rate exceeding 95%. This is truly remarkable and provides us with a historic opportunity to eradicate HCV in the United States and worldwide.

When we can diagnose HCV and offer treatment, we have a very good success rate—but therein lies the challenge. The key rate limiting steps to achieving elimination are found in ongoing deficits in the HCV care cascade, including screening, diagnosis, linkage to care, and treatment. We believe that right now only about 50% of affected persons have been diagnosed, and therefore much work remains to be done in the screening/diagnosis step of the care cascade if we are to achieve meaningful progress towards HCV elimination.

In that spirit, there have been important advances in terms of policy and legislation to support broader population-based screening. The CDC and US Preventive Services Task Force initially recommended that all baby boomers (those born between 1945 and 1965) should be screened for HCV, in addition to those with established risk factors. These include individuals who have used drugs, either through a nose or through the vein, had a blood transfusion before 1992, tattoos or body piercings, accidental needlestick exposures, or high risk sexual contacts, However, data show that risk factor-based screening simply does not work. It is difficult for clinicians to routinely ask sensitive questions about historical risk factors.

Despite the remarkable success in development of curative therapies for HCV, the rate of new incident HCV infections has not been going down—It has actually been doubling to tripling over the last 5 years. We now have what we call a bi-modal distribution of HCV, which includes baby boomers and a second younger group, between age 18 and 34. The primary route of transmission in this younger cohort is injection drug use, which is largely tied to the opiate epidemic.

It is in this context that within the last year, 4 different organizations—the CDC, the United States Preventive Services Task Force (USPSTF), the American Association for the Study of Liver Diseases (AASLD), and the Infectious Diseases Society of America (IDSA)—have expanded their guidance documents to now recommend one-time HCV screening in all adults age 18 or older plus all pregnant women regardless of age. This guidance replaces the old guidelines focused on baby boomers and individuals with risk factors. This represents a fundamental and consequential shift in US strategy to improve population-based screening.

There is also a sense that a treatment as prevention strategy can be particularly impactful in reducing spread among high-risk populations, especially in persons who inject drugs (PWID). The concept is that if you can effectively remove HCV in high-risk populations by treating active users, this may prevent spread of HCV to others who would otherwise be exposed. Although HCV treatment in patients with active drug use has historically been viewed with skepticism, and in fact remains an exclusion factor by some payors, DAA therapy in PWID is strongly recommended by the AASLD/IDSA guidelines and is increasingly embraced in both specialty and non-specialty (eg, methadone clinics, community health centers, prison clinics) settings.

Could you please elaborate more on the updated CDC guidelines and the impact that those are having in practice?

Dr. Lim: Although the revised screening guidelines by CDC and other organizations represent a critical step to promote awareness by clinicians regarding the compelling evidence to support universal HCV screening of all American adults, the reality is that just because there is a recommendation for it, does not mean that it will always be followed. Clinicians in primary care and specialty practices alike are already burdened by guideline fatigue, and an ever-growing list of mandates of standard clinical practice such as colon cancer screening, mammography, cholesterol checks, etc., and now all of this in the context of COVID-19. This further complicates the task of implementing HCV screening recommendations in real-world clinical practice.

New data published this year show that the screening rates among baby boomers have increased from approximately 10% to 20% since the original recommendations in 2014. Although this represents an important step in the right direction, it is clear there is significant room for improvement. It remains to be seen what impact this transition from birth cohort screening to universal screening of all Americans age 18 and older will have on our ability to identify previously unidentified infected persons.

In 2016 the World Health Organization (WHO) Global Health Sector Strategy called for the elimination of HCV as a major health threat by 2030. At the current rate of transmission, and considering all the barriers you mentioned that still exist, do you think that this is still a realistic timeframe? Is there any other action that physicians specifically maintain to help reach the goal?

Dr. Lim: WHO's vision was to eliminate hepatitis C by 2030 as defined as the following: 1) diagnose 90% of infected persons, 2) offer treatment to 80% of infected persons, and 3) reduce HCV-associated mortality by 65%.

Unfortunately, the United States is highly unlikely to meet this goal by 2030. Based on recently published models, only 3 of 50 states may have a chance at meeting the elimination target by that deadline. But as a country, we already know that is just simply not going to happen—unless there are dramatic changes in governmental and multi-stakeholder commitment.

Globally, there are an estimated 12 countries that are projected to achieve elimination by 2030. Some of the most prominent examples include Egypt, The Republic of Georgia, Australia, Italy, and Japan. The United States is not in this grouping, and in fact our current models suggest that we may not even achieve this goal by 2050.

There is much work that needs to be done to address some of the systemic and institutional infrastructure issues that will support effective implementation of screening, diagnosis, and linkage of care. Drug access—although that remains an important issue—is actually not the driving factor in terms of our inability to meet our targets. Within the United States, the Department of Health and Human Services has taken the lead on developing a US-based strategy. Although there has been strong language to articulate what is required and the intentionality to work on HCV elimination, this has not yet been associated with adequate funding at the federal level. Without this funding, we are destined to make only modest progress towards elimination targets within the short and intermediate timeframe.  Despite these challenges, organizations such as the AASLD, CDC, National Viral Hepatitis Roundtable, World Hepatitis Alliance, and the Coalition for Global Hepatitis Elimination remain vocal advocates to secure necessary resources and will continue to lead US efforts to implement effective strategies on the road to viral hepatitis elimination. These organizations cannot fulfill this mission alone—each of us as clinicians play a vital role in carrying out CDC and USPSTF recommendations in our individual clinical settings to ensure broad-based screening and diagnosis, timely linkage to care, and antiviral treatment.

What are the largest factors creating barriers to hepatitis C virus (HCV) elimination?
 

Dr. Lim: In 2020 there remain important barriers to access to treatment because of the high cost of drugs used to eradicate HCV. There are still opportunities for us to interact with major payors to ensure adequate access, both with private commercial payers, as well as with Medicaid. We know very well that there are existing barriers that impact a significant proportion of patients, but if you look at data from the private sector, it turns out that we are doing pretty well; At least 80% of payers are covering direct-acting antiviral (DAA) medications with minimal restriction.

However, with Medicaid it is quite the reverse story; In about two-thirds of states, there are at least one or more restrictions based on the stage of their fibrosis, sobriety requirements for alcohol and drug use, and specialty providers to prescribe the medication, among others. Based on data from the National Viral Hepatitis Roundtable, it is clear that there are still many states where if you have mild disease, or recently used drugs or alcohol, or are in a rural area where you do not have access to a gastroenterologist or infectious disease specialist, you cannot get treatment. That is still a major concern for access to care.

When we think about elimination, eradication, and extinction of human diseases, HCV represents one of the few for which we actually have the tools to cure the condition permanently with a simple regimen of 1 to 3 pills per day for 2 or 3 months, with a cure rate exceeding 95%. This is truly remarkable and provides us with a historic opportunity to eradicate HCV in the United States and worldwide.

When we can diagnose HCV and offer treatment, we have a very good success rate—but therein lies the challenge. The key rate limiting steps to achieving elimination are found in ongoing deficits in the HCV care cascade, including screening, diagnosis, linkage to care, and treatment. We believe that right now only about 50% of affected persons have been diagnosed, and therefore much work remains to be done in the screening/diagnosis step of the care cascade if we are to achieve meaningful progress towards HCV elimination.

In that spirit, there have been important advances in terms of policy and legislation to support broader population-based screening. The CDC and US Preventive Services Task Force initially recommended that all baby boomers (those born between 1945 and 1965) should be screened for HCV, in addition to those with established risk factors. These include individuals who have used drugs, either through a nose or through the vein, had a blood transfusion before 1992, tattoos or body piercings, accidental needlestick exposures, or high risk sexual contacts, However, data show that risk factor-based screening simply does not work. It is difficult for clinicians to routinely ask sensitive questions about historical risk factors.

Despite the remarkable success in development of curative therapies for HCV, the rate of new incident HCV infections has not been going down—It has actually been doubling to tripling over the last 5 years. We now have what we call a bi-modal distribution of HCV, which includes baby boomers and a second younger group, between age 18 and 34. The primary route of transmission in this younger cohort is injection drug use, which is largely tied to the opiate epidemic.

It is in this context that within the last year, 4 different organizations—the CDC, the United States Preventive Services Task Force (USPSTF), the American Association for the Study of Liver Diseases (AASLD), and the Infectious Diseases Society of America (IDSA)—have expanded their guidance documents to now recommend one-time HCV screening in all adults age 18 or older plus all pregnant women regardless of age. This guidance replaces the old guidelines focused on baby boomers and individuals with risk factors. This represents a fundamental and consequential shift in US strategy to improve population-based screening.

There is also a sense that a treatment as prevention strategy can be particularly impactful in reducing spread among high-risk populations, especially in persons who inject drugs (PWID). The concept is that if you can effectively remove HCV in high-risk populations by treating active users, this may prevent spread of HCV to others who would otherwise be exposed. Although HCV treatment in patients with active drug use has historically been viewed with skepticism, and in fact remains an exclusion factor by some payors, DAA therapy in PWID is strongly recommended by the AASLD/IDSA guidelines and is increasingly embraced in both specialty and non-specialty (eg, methadone clinics, community health centers, prison clinics) settings.

Could you please elaborate more on the updated CDC guidelines and the impact that those are having in practice?

Dr. Lim: Although the revised screening guidelines by CDC and other organizations represent a critical step to promote awareness by clinicians regarding the compelling evidence to support universal HCV screening of all American adults, the reality is that just because there is a recommendation for it, does not mean that it will always be followed. Clinicians in primary care and specialty practices alike are already burdened by guideline fatigue, and an ever-growing list of mandates of standard clinical practice such as colon cancer screening, mammography, cholesterol checks, etc., and now all of this in the context of COVID-19. This further complicates the task of implementing HCV screening recommendations in real-world clinical practice.

New data published this year show that the screening rates among baby boomers have increased from approximately 10% to 20% since the original recommendations in 2014. Although this represents an important step in the right direction, it is clear there is significant room for improvement. It remains to be seen what impact this transition from birth cohort screening to universal screening of all Americans age 18 and older will have on our ability to identify previously unidentified infected persons.

In 2016 the World Health Organization (WHO) Global Health Sector Strategy called for the elimination of HCV as a major health threat by 2030. At the current rate of transmission, and considering all the barriers you mentioned that still exist, do you think that this is still a realistic timeframe? Is there any other action that physicians specifically maintain to help reach the goal?

Dr. Lim: WHO's vision was to eliminate hepatitis C by 2030 as defined as the following: 1) diagnose 90% of infected persons, 2) offer treatment to 80% of infected persons, and 3) reduce HCV-associated mortality by 65%.

Unfortunately, the United States is highly unlikely to meet this goal by 2030. Based on recently published models, only 3 of 50 states may have a chance at meeting the elimination target by that deadline. But as a country, we already know that is just simply not going to happen—unless there are dramatic changes in governmental and multi-stakeholder commitment.

Globally, there are an estimated 12 countries that are projected to achieve elimination by 2030. Some of the most prominent examples include Egypt, The Republic of Georgia, Australia, Italy, and Japan. The United States is not in this grouping, and in fact our current models suggest that we may not even achieve this goal by 2050.

There is much work that needs to be done to address some of the systemic and institutional infrastructure issues that will support effective implementation of screening, diagnosis, and linkage of care. Drug access—although that remains an important issue—is actually not the driving factor in terms of our inability to meet our targets. Within the United States, the Department of Health and Human Services has taken the lead on developing a US-based strategy. Although there has been strong language to articulate what is required and the intentionality to work on HCV elimination, this has not yet been associated with adequate funding at the federal level. Without this funding, we are destined to make only modest progress towards elimination targets within the short and intermediate timeframe.  Despite these challenges, organizations such as the AASLD, CDC, National Viral Hepatitis Roundtable, World Hepatitis Alliance, and the Coalition for Global Hepatitis Elimination remain vocal advocates to secure necessary resources and will continue to lead US efforts to implement effective strategies on the road to viral hepatitis elimination. These organizations cannot fulfill this mission alone—each of us as clinicians play a vital role in carrying out CDC and USPSTF recommendations in our individual clinical settings to ensure broad-based screening and diagnosis, timely linkage to care, and antiviral treatment.