Making an Impact: Institute Research Informs Hepatitis C Treatment Guidelines
Updated guidelines from the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) for the treatment of hepatitis C now allow for a shorter 8-week treatment regimen for Black patients. These revised guidelines are based in part on a study led by Assistant Professor Julia Marcus and colleagues from Kaiser Permanente comparing the effectiveness of 8- and 12-week treatment regimens for the treatment of hepatitis C. Their study results showed that an 8-week treatment regimen was just as effective as 12 weeks in Black patients and did not support treatment guidelines that recommend against the use of a shorter course of treatment in Black patients. We spoke with Dr. Marcus to learn more about the updated guidelines and her research.
Q: The AASLD and IDSA just released updated national clinical guidelines for the treatment of hepatitis C. To provide a little background, can you tell us about the most common treatment options for hepatitis C?
A: As of just a few years ago, hepatitis C virus (HCV) can now be treated with highly effective, direct-acting antiviral agents, usually within 8 to 12 weeks. Patients who have not been previously treated and have HCV genotype 1, the most common type of HCV infection in the U.S., can be treated with the combination of ledipasvir and sofosbuvir for 12 weeks. An even shorter regimen, just 8 weeks, can be used in patients who are healthier, specifically those without liver cirrhosis, HIV infection, or a high HCV viral load. But, until recently, clinical guidelines recommended that Black patients not be considered for shorter courses of treatment, even if they otherwise met criteria for 8 weeks.
Q: Can you explain the reasoning behind the race-based treatment guidelines?
A: The guidelines cited several studies that showed lower rates of HCV cure, also called sustained virologic response, in Black compared with white patients after 8 weeks of treatment. But those studies used a measure called the odds ratio, which can vastly overestimate the magnitude of an effect when measuring a common outcome like HCV cure. In a systematic review, we found that the differences in 8-week cure rates between Black and white patients was actually <5% across studies. Even more important, though, is that white patients are not relevant to the question of whether Black patients should receive 8 or 12 weeks of treatment. Researchers have a tendency to default to white patients as a reference group, which in this case was a distraction from the clinically relevant question.
Q: Your work comparing the effectiveness of 8- and 12-week treatment regimens is cited in the new guidelines. Can you provide an overview of your study and describe the change in the new guidelines?
A: We looked at patients with HCV infection at Kaiser Permanente Northern California who were eligible for 8 weeks of ledipasvir/sofosbuvir, and who received either 8 or 12 weeks of treatment. Among Black patients eligible for 8 weeks, there was no difference in cure rates between those treated for 8 and 12 weeks. On the basis of our study, as well as a subsequent study with similar findings, the new guidelines now allow the shorter, 8-week regimen of ledipasvir/sofosbuvir for Black patients.
Q: What are your thoughts on the implementation of the new guidelines into practice? Would more widespread use of the shorter treatment course have important implications for access given the medication’s high cost?
A: There are huge cost implications here. Because ledipasvir/sofosbuvir costs more than $1,000 per pill, a healthcare system can save at least $31,500 for every patient who can be successfully treated for 8 instead of 12 weeks, increasing the overall number of patients who can be treated. Perhaps more important, though, is the elimination of race-based guidelines, which can perpetuate racism through misdiagnosis, undertreatment, or – in this case – overtreatment of Black patients.
Follow Dr. Marcus on Twitter @JuliaLMarcus
Marcus JL, Hurley LB, Chamberland S, et al. No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients. Clin Gastroenterol Hepatol. 2018;16(6):927–935. doi:10.1016/j.cgh.2018.03.003