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Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals, or Daclatasvir+Sofosbuvir
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Daclatasvir+Sofosbuvir-new studies, VX135, Daclatasvir Phase 3 IFN-free, EMA Compassionate Use, Accelerated EMA Marketing Review Recommendation
Hepatology March 28 2014 Accepted Unedited
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record
Liesl M. Hagan1, Mark S. Sulkowski2, Raymond F. Schinazi1 1Center for AIDS Research, Emory University School of Medicine and Veterans Affairs Medical Center, Atlanta, Georgia, 30322, USA; 2Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287
Treatment guidance for chronic hepatitis C (CHC) released by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) offer two options for interferon-ineligible/intolerant individuals with genotype 1 infection: sofosbuvir/ribavirin (SOF/RBV) for 24 weeks, or sofosbuvir/simeprevir (SOF/SMV) for 12 weeks. A 24-week course of SOF/RBV costs approximately US$169,000, with sustained virologic response (SVR) rates ranging from 52-84%; 12 weeks of SOF/SMV costs approximately $150,000, with SVR between 89% and 100%. Because SOF/SMV is currently used off-label, debate exists among physicians and payers about whether it should be prescribed and covered. This paper presents a cost-effectiveness analysis of these two treatment regimens accounting for costs of drugs, treatment-related medical care, re-treatment for individuals who do not achieve SVR, and natural history of continued HCV infection after failed re-treatment. The model uses a lifetime horizon and a societal perspective.
Results: In the base case scenario, SOF/SMV dominated SOF/RBV in a modeled 50-year-old cohort of treatment-naïve and treatment-experienced subjects, excluding those who failed prior therapy with telaprevir or boceprevir. SOF/SMV yielded lower costs and more quality-adjusted life years (QALYs) for the average subject compared to SOF/RBV ($165,336 and 14.69 QALYs vs. $243,586 and 14.45 QALYs, respectively). In base case cost-analysis, the SOF/SMV treatment strategy saved $91,590 per SVR compared to SOF/RBV. Under all one-way sensitivity scenarios, SOF/SMV remained dominant and resulted in cost savings.
Conclusions: These results suggest that a 12-week course of SOF/SMV is a more cost-effective treatment for genotype 1 CHC than 24 weeks of SOF/RBV among interferon-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision-making as well as pharmaceutical pricing.
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