Abergel, A

Agarwal, K

Asselah, T

Brainard, DM

Chan, HLY

Feld, JJ

Gruener, N

Hézode, C

Jacobson, IM

Lai, CL

Mangia, A

Mazzotta, F

McHutchison, JG

McNally, J

Moreno, C

Osinusi, A

Ruane, PJ

Shafran, SD

Svarovskaia, E

Towner, WJ

Tran, TT

Yoshida, E

Zeuzem, S

Zhu, Y

Jordan J. Feld

Ira M. Jacobson

Christophe Hézode

Tarik Asselah

Peter J. Ruane

Norbert Gruener

Armand Abergel

Alessandra Mangia

Ching-Lung Lai

Henry L.Y. Chan

Francesco Mazzotta

Christophe Moreno

Eric Yoshida

Stephen D. Shafran

William J. Towner

Tram T. Tran

John McNally

Anu Osinusi

Evguenia Svarovskaia

Yanni Zhu

Diana M. Brainard

John G. McHutchison

Kosh Agarwal

Stefan Zeuzem

Crossref

New England Journal of Medicine

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

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. opens in new tab.)published_or_final_versio

HKU Scholars Hub

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

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HKU Scholars Hub