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Clinical Trial
. 2013 May 16;368(20):1878-87.
doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.

Sofosbuvir for previously untreated chronic hepatitis C infection

Eric Lawitz  1 , Alessandra Mangia, David Wyles, Maribel Rodriguez-Torres, Tarek Hassanein, Stuart C Gordon, Michael Schultz, Mitchell N Davis, Zeid Kayali, K Rajender Reddy, Ira M Jacobson, Kris V Kowdley, Lisa Nyberg, G Mani Subramanian, Robert H Hyland, Sarah Arterburn, Deyuan Jiang, John McNally, Diana Brainard, William T Symonds, John G McHutchison, Aasim M Sheikh, Zobair Younossi, Edward J Gane
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Free article
Clinical Trial

Sofosbuvir for previously untreated chronic hepatitis C infection

Eric Lawitz et al. N Engl J Med. .
Free article

Abstract

Background: In phase 2 trials, the nucleotide polymerase inhibitor sofosbuvir was effective in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection.

Methods: We conducted two phase 3 studies in previously untreated patients with HCV infection. In a single-group, open-label study, we administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4, 5, or 6 (of whom 98% had genotype 1 or 4). In a noninferiority trial, 499 patients with HCV genotype 2 or 3 infection were randomly assigned to receive sofosbuvir plus ribavirin for 12 weeks or peginterferon alfa-2a plus ribavirin for 24 weeks. In the two studies, the primary end point was a sustained virologic response at 12 weeks after the end of therapy.

Results: In the single-group study, a sustained virologic response was reported in 90% of patients (95% confidence interval, 87 to 93). In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir-ribavirin group and the peginterferon-ribavirin group. Response rates in the sofosbuvir-ribavirin group were lower among patients with genotype 3 infection than among those with genotype 2 infection (56% vs. 97%). Adverse events (including fatigue, headache, nausea, and neutropenia) were less common with sofosbuvir than with peginterferon.

Conclusions: In a single-group study of sofosbuvir combined with peginterferon-ribavirin, patients with predominantly genotype 1 or 4 HCV infection had a rate of sustained virologic response of 90% at 12 weeks. In a noninferiority trial, patients with genotype 2 or 3 infection who received either sofosbuvir or peginterferon with ribavirin had nearly identical rates of response (67%). Adverse events were less frequent with sofosbuvir than with peginterferon. (Funded by Gilead Sciences; FISSION and NEUTRINO ClinicalTrials.gov numbers, NCT01497366 and NCT01641640, respectively.).

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