Download the full issue as a PDF.
Who Should Treat Hep C?
January 14, 2015
Nezam H. Afdhal, MD
Director of Hepatology, Beth Israel Deaconess Medical Center; Professor of Medicine, Harvard Medical School
The really incredible advances in the treatment of hepatitis C makes the issue of who should be treating these patients a very relevant question moving forward into 2015. The advent of all-oral direct-acting anti-virals, which are safe, simple and effective with good tolerability and short duration, has made this an issue that should be examined. Consider ledipasvir/sofosbuvir, a single fixed-dose combination pill with a greater than 95 percent cure rate that was approved by the FDA for genotype 1 HCV in October 2014.
The simplicity and safety of this treatment should enable almost any physician with an interest in HCV to treat a patient. The pretreatment workup consists of simple blood tests, genotyping and determination of viral load and staging of disease with noninvasive serum tests such as FibroTest or a FibroScan to determine the presence of advanced fibrosis or cirrhosis. We have previously proposed an algorithm which can be used in primary care to determine that patients are suitable to be treated by primary care physicians and which should be referred to either a infectious disease (ID) specialist or a gastroenterologist.1 The algorithm utilizes FibroScan® and FibroTest to identify which patients are at risk for advanced fibrosis. Since these patients require screening for esophageal varices and hepatocellular carcinoma, it is more appropriate that they undergo specialty evaluation.
If, over the course of the next 10 years, we treat 1 million patients — which is necessary if we are to impact the natural history of disease — the cost to the health-care system would be almost $100 billion.
The issue of which specialist is most appropriate to treat hepatitis C has also raised some questions in the ID and GI communities. I would consider that anyone who has developed a real interest in hepatitis C treatment can treat the majority of patients with hepatitis C. The continuously updated AASLD and IDSA guidelines are an excellent source to help physicians keep current with the ever-changing treatment landscape. Certainly, the majority of patients with mild disease would prefer to be treated closer to home rather than visit a specialty center. One of the questions we should ask is how effective in real life is therapy outside of both clinical trials and specialty liver centers? We’re fortunate to have several large registries that have recently looked at effectiveness of treatment with all-oral simeprevir and sofosbuvir in both community and academic settings. The results from both the TRIO and the TARGET networks show little difference in cure rates between the sites of patient care, and the overall SVR is within 10 percent of that reported in the clinical trials.2,3 Hepatitis C, however, has a broad spectrum of disease with approximately 25 percent of patients developing cirrhosis and at risk for hepatocellular carcinoma and liver failure. Thus, whoever decides to treat hepatitis C must be aware of the indications for referral to a specialty liver center with the capacity for evaluation of appropriate treatments and liver transplantation.
Unfortunately, although I truly believe that hepatitis C can be easily treated within the community, including by internists and family physicians, the reality is that issues associated with both the cost of treatment and access to therapy have made this extremely difficult. Hepatitis C medications cost almost $100,000 or more for a full course of treatment and thus represent a significant burden to the health-care system. If, over the course of the next 10 years, we treat 1 million patients — which is necessary if we are to impact the natural history of disease — the cost to the health-care system would be almost $100 billion.
This high cost of therapy has resulted in prioritization of care with restricted access for some patients. Currently, the majority of third-party payors and state Medicaid programs have limited access to treatment for those patients with advanced fibrosis or cirrhosis. In our practice, we have found that the current restrictions require almost one or two full-time personnel to devote continuous effort to help patients obtain treatment. In smaller GI or ID practices, this would create both unnecessary expense and significant effort. It is hard to imagine that an average internal medicine or family practice would have the resources to devote the time and personnel needed to obtain prior approval and authorization for treatment of any significant number of hepatitis C patients. In addition, certain state Medicaid plans — such as New York — have suggested that treatment be provided only by physicians with documented and proven experience in managing HCV patients.
In my experience, this potential rationing of health care to only those with advanced disease makes little clinical or pharmacoeconomic sense. Treatment duration can be shortened in patients who do not have cirrhosis, resulting in a lower cost per SVR. In addition, these patients have reported equal improvements in a variety of physical, emotional and health-related outcomes as is reported for patients with more advanced disease.
Finally, it is ironic that we have the ability to essentially eradicate hepatitis C from the U.S. population within the next decade using simple, safe and highly effective therapies, but we appear to lack both the economic, societal and political wherewithal to make this a reality. The conversation within the GI community should not only be who should treat hepatitis C, but also how can we make this incredible opportunity a reality for our patients?
Dr. Afdhal has received research support from Merck, Vertex Gilead, AbbVie and BMS. He also serves as a consultant/on the advisory board for Merck, Gilead, Echosens, Glaxo Smith Kline, Vertex, Novartis, Boehringer Ingelheim, Ligand, Springbank, Medgenics, Kadmon, Jannsen, AbbVie and Achillion. Dr. Afdhal receives stock options from Springbank and is editor of Journal of Viral Hepatitis.
Director of Hepatology, Beth Israel Deaconess Medical Center; Professor of Medicine, Harvard Medical School
The really incredible advances in the treatment of hepatitis C makes the issue of who should be treating these patients a very relevant question moving forward into 2015. The advent of all-oral direct-acting anti-virals, which are safe, simple and effective with good tolerability and short duration, has made this an issue that should be examined. Consider ledipasvir/sofosbuvir, a single fixed-dose combination pill with a greater than 95 percent cure rate that was approved by the FDA for genotype 1 HCV in October 2014.
The simplicity and safety of this treatment should enable almost any physician with an interest in HCV to treat a patient. The pretreatment workup consists of simple blood tests, genotyping and determination of viral load and staging of disease with noninvasive serum tests such as FibroTest or a FibroScan to determine the presence of advanced fibrosis or cirrhosis. We have previously proposed an algorithm which can be used in primary care to determine that patients are suitable to be treated by primary care physicians and which should be referred to either a infectious disease (ID) specialist or a gastroenterologist.1 The algorithm utilizes FibroScan® and FibroTest to identify which patients are at risk for advanced fibrosis. Since these patients require screening for esophageal varices and hepatocellular carcinoma, it is more appropriate that they undergo specialty evaluation.
If, over the course of the next 10 years, we treat 1 million patients — which is necessary if we are to impact the natural history of disease — the cost to the health-care system would be almost $100 billion.
The issue of which specialist is most appropriate to treat hepatitis C has also raised some questions in the ID and GI communities. I would consider that anyone who has developed a real interest in hepatitis C treatment can treat the majority of patients with hepatitis C. The continuously updated AASLD and IDSA guidelines are an excellent source to help physicians keep current with the ever-changing treatment landscape. Certainly, the majority of patients with mild disease would prefer to be treated closer to home rather than visit a specialty center. One of the questions we should ask is how effective in real life is therapy outside of both clinical trials and specialty liver centers? We’re fortunate to have several large registries that have recently looked at effectiveness of treatment with all-oral simeprevir and sofosbuvir in both community and academic settings. The results from both the TRIO and the TARGET networks show little difference in cure rates between the sites of patient care, and the overall SVR is within 10 percent of that reported in the clinical trials.2,3 Hepatitis C, however, has a broad spectrum of disease with approximately 25 percent of patients developing cirrhosis and at risk for hepatocellular carcinoma and liver failure. Thus, whoever decides to treat hepatitis C must be aware of the indications for referral to a specialty liver center with the capacity for evaluation of appropriate treatments and liver transplantation.
Unfortunately, although I truly believe that hepatitis C can be easily treated within the community, including by internists and family physicians, the reality is that issues associated with both the cost of treatment and access to therapy have made this extremely difficult. Hepatitis C medications cost almost $100,000 or more for a full course of treatment and thus represent a significant burden to the health-care system. If, over the course of the next 10 years, we treat 1 million patients — which is necessary if we are to impact the natural history of disease — the cost to the health-care system would be almost $100 billion.
This high cost of therapy has resulted in prioritization of care with restricted access for some patients. Currently, the majority of third-party payors and state Medicaid programs have limited access to treatment for those patients with advanced fibrosis or cirrhosis. In our practice, we have found that the current restrictions require almost one or two full-time personnel to devote continuous effort to help patients obtain treatment. In smaller GI or ID practices, this would create both unnecessary expense and significant effort. It is hard to imagine that an average internal medicine or family practice would have the resources to devote the time and personnel needed to obtain prior approval and authorization for treatment of any significant number of hepatitis C patients. In addition, certain state Medicaid plans — such as New York — have suggested that treatment be provided only by physicians with documented and proven experience in managing HCV patients.
In my experience, this potential rationing of health care to only those with advanced disease makes little clinical or pharmacoeconomic sense. Treatment duration can be shortened in patients who do not have cirrhosis, resulting in a lower cost per SVR. In addition, these patients have reported equal improvements in a variety of physical, emotional and health-related outcomes as is reported for patients with more advanced disease.
Finally, it is ironic that we have the ability to essentially eradicate hepatitis C from the U.S. population within the next decade using simple, safe and highly effective therapies, but we appear to lack both the economic, societal and political wherewithal to make this a reality. The conversation within the GI community should not only be who should treat hepatitis C, but also how can we make this incredible opportunity a reality for our patients?
Dr. Afdhal has received research support from Merck, Vertex Gilead, AbbVie and BMS. He also serves as a consultant/on the advisory board for Merck, Gilead, Echosens, Glaxo Smith Kline, Vertex, Novartis, Boehringer Ingelheim, Ligand, Springbank, Medgenics, Kadmon, Jannsen, AbbVie and Achillion. Dr. Afdhal receives stock options from Springbank and is editor of Journal of Viral Hepatitis.
References
1. Bonder A, Afdhal NH. Biopsy No More; Changing the Screening and Diagnostic Algorithm for Hepatitis Clin Gastroenetrol Hepatol 2013;11:309-31
2. Jensen DM et al. Safety and efficacy of sofosbuvir containing regimens for Hepatitis C; Real world experience in a diverse longitudinal observational cohort AASLD, Boston, 2014
3. Dietrich D et al. Evaluation of sofosbuvir and simeprevir based regimens in the TRIO network: academic and community treatment of a real-world heterogeneous population. AASLD, Boston 2014
1. Bonder A, Afdhal NH. Biopsy No More; Changing the Screening and Diagnostic Algorithm for Hepatitis Clin Gastroenetrol Hepatol 2013;11:309-31
2. Jensen DM et al. Safety and efficacy of sofosbuvir containing regimens for Hepatitis C; Real world experience in a diverse longitudinal observational cohort AASLD, Boston, 2014
3. Dietrich D et al. Evaluation of sofosbuvir and simeprevir based regimens in the TRIO network: academic and community treatment of a real-world heterogeneous population. AASLD, Boston 2014
We have the means but not the MONEY...So sad my HEALTH is tied to GREED>>>>>>>
ReplyDelete