Younossi ZM, Gordon SC, Saab S, Ahmed A, Brogan A, Cure S. A decision-analytic Markov model to evaluate the health outcomes of sofosbuvir for previously untreated patients with chronic hepatitis C virus genotype 1 infection. Poster presented at the American Association for the Study of Liver Diseases; November 1, 2013.

BACKGROUND & AIM: Sofosbuvir (SOF) is a nucleotide polymerase inhibitor with excellent clinical efficacy in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1 in combination with pegylated interferon alfa and ribavirin (PR) for 12 weeks. A decision-analytic Markov model evaluated the health outcomes of SOF compared with current treatment options.

METHODS: The analysis modeled a cohort of treatment-naïve chronic HCV genotype 1 patients with an average age of 52 and 17% with cirrhosis to 100 years of age from a US third-party payer perspective. SOF+PR was compared with telaprevir (TLV)+PR for 24-48 weeks, boceprevir (BOC)+PR for 28-48 weeks, and PR for 48 weeks. Sustained virologic response (SVR) and adverse event rates were based on phase III clinical trials (SVR = 92% and 80% for SOF+PR, 82% and 66% for TLV+PR, 64% and 55% for BOC+PR, and 58% and 33% for PR in non-cirrhotics and cirrhotics, respectively). Transition probability and utility were based on a literature review and consensus by a panel of 4 hepatologists.

RESULTS: The SOF+PR regimen resulted in the best outcomes compared with TLV+PR, BOC+PR, and PR, with the lowest numbers of patients with liver-related complications. In addition, analysis of the number needed to treat (NNT), which is the number of patients who would need to be treated with SOF+PR rather than the comparator to achieve one positive outcome or avoid one negative outcome, also indicated favorable outcomes with SOF+PR.

CONCLUSIONS: The SOF-based regimen was projected to yield better health outcomes. Large discrepancies in efficacy, side effect, and adherence rates have been reported for currently available regimens in the real-world vs. clinical trial settings. Additional analyses are necessary to determine the potential impact of the greater expected real-world differences between the SOF-based regimen and other therapies.

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