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N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.

Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.

Author information

1
From the Toronto Centre for Liver Disease, Toronto (J.J.F.), University of British Columbia, Vancouver (E.Y.), and University of Alberta, Edmonton (S.D.S.) - all in Canada; Weill Cornell Medical College, New York (I.M.J.); Université Paris-Est, Créteil (C.H.), Service d'Hépatologie, Hôpital Beaujon, INSERM UMR 1149, Université Paris Diderot, Clichy (T.A.), and Université d'Auvergne, Clermont Ferrand (A.A.) - all in France; Ruane Medical and Liver Health Institute (P.J.R.), Kaiser Permanente Los Angeles Medical Center (W.J.T.), Cedars-Sinai Medical Center (T.T.T.), Los Angeles, and Gilead Sciences, Foster City (J.M., A.O., E.S., Y.Z., D.M.B., J.G.M.) - all in California; Ludwig Maximilian University, Munich (N.G.) and Johann Wolfgang Goethe University Medical Center, Frankfurt am Main (S.Z.) - both in Germany; Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M.) and Santa Maria Annunziata Hospital, Florence (F.M.) - both in Italy; University of Hong Kong (C.-L.L.) and the Chinese University of Hong Kong (H.L.Y.C.) - both in Hong Kong; Cliniques Universitaires de Bruxelles Hôpital Erasme, Université Libre de Bruxelles, Brussels (C.M.); and King's College Hospital Foundation Trust, London (K.A.).

Abstract

BACKGROUND:

A simple treatment regimen that is effective in a broad range of patients who are chronically infected with the hepatitis C virus (HCV) remains an unmet medical need.

METHODS:

We conducted a phase 3, double-blind, placebo-controlled study involving untreated and previously treated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection, including those with compensated cirrhosis. Patients with HCV genotype 1, 2, 4, or 6 were randomly assigned in a 5:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir in a once-daily, fixed-dose combination tablet or matching placebo for 12 weeks. Because of the low prevalence of genotype 5 in the study regions, patients with genotype 5 did not undergo randomization but were assigned to the sofosbuvir-velpatasvir group. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.

RESULTS:

Of the 624 patients who received treatment with sofosbuvir-velpatasvir, 34% had HCV genotype 1a, 19% genotype 1b, 17% genotype 2, 19% genotype 4, 6% genotype 5, and 7% genotype 6. A total of 8% of patients were black, 19% had cirrhosis, and 32% had been previously treated for HCV. The rate of sustained virologic response among patients receiving sofosbuvir-velpatasvir was 99% (95% confidence interval, 98 to >99). Two patients receiving sofosbuvir-velpatasvir, both with HCV genotype 1, had a virologic relapse. None of the 116 patients receiving placebo had a sustained virologic response. Serious adverse events were reported in 15 patients (2%) in the sofosbuvir-velpatasvir group and none in the placebo group.

CONCLUSIONS:

Once-daily sofosbuvir-velpatasvir for 12 weeks provided high rates of sustained virologic response among both previously treated and untreated patients infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis. (Funded by Gilead Sciences; ClinicalTrials.gov number, NCT02201940.).

PMID:
26571066
DOI:
10.1056/NEJMoa1512610
[Indexed for MEDLINE]
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