What is the efficacy of sofosbuvir in the treatment of hepatitis C (hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Answer

Approval for sofosbuvir was supported by data from several phase 3 studies that evaluated 12 or 16 weeks of treatment with the drug combined with either ribavirin or ribavirin plus PEG-IFN alfa. Three of these studies evaluated sofosbuvir plus ribavirin in genotype 2 or 3 patients who were either treatment-naïve, [106] treatment-experienced [107] or PEG-IFN intolerant, ineligible, or unwilling. [107] The fourth study evaluated sofosbuvir in combination with PEG-IFN/ribavirin in treatment-naïve patients with genotypes 1, 4, 5 or 6. [106]

In these studies, sofosbuvir-based therapy was found to be superior to historical controls [106] or to placebo, [107] or noninferior to currently available treatment options [106] based on the proportion of patients who had a SVR12 after completing therapy. Patients who achieve SVR12 are considered cured of HCV. Trial participants taking sofosbuvir-based therapy achieved SVR12 rates of 50%-90%.

During the FDA’s review, data from two additional phase 3 studies were added to the new drug application (NDA) as a result of the "Breakthrough Designation" status. In the first study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Eighty-four percent of patients in this trial achieved SVR12. [108] The second study evaluated sofosbuvir and ribavirin for 12 weeks in patients with genotype 2 HCV infection coinfected with HIV-1. [109]


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