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Gastroenterology. 2016 Nov;151(5):902-909. doi: 10.1053/j.gastro.2016.07.038. Epub 2016 Jul 30.

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial.

Author information

1
Auckland Clinical Studies, Auckland, New Zealand. Electronic address: edgane@adhb.govt.nz.
2
Swedish Medical Center, Seattle, Washington.
3
Indianapolis Gastroenterology Research Foundation, Indianapolis, Indiana.
4
Christchurch Hospital and University of Otago, Christchurch, New Zealand.
5
Digestive CARE-South Florida Center of Gastroenterology, Wellington, Florida.
6
Borland-Groover Clinic, Jacksonville, Mississippi.
7
Henry Ford Hospital and Health System, Detroit, Michigan.
8
North Shore/Long Island Jewish PRIME, Manhasset, New York.
9
University of Colorado, Aurora, Colorado.
10
Fundación De Investigación De Diego, San Juan, Puerto Rico.
11
Queens Liver Center, Honolulu, Hawaii.
12
Digestive Health Specialists, Winston-Salem, North Carolina.
13
Gilead Sciences, Foster City, California.
14
Huntington Medical Research Institutes Liver Center, Pasadena, California.
15
Massachusetts General Hospital, Boston, Massachusetts.
16
Medical University of South Carolina, Charleston, South Carolina.
17
Cumberland Research Associates, LLC, Fayetteville, Georgia.
18
Indiana University School of Medicine, Indiana.
19
Stanford University Medical Center, Palo Alto, California.

Abstract

BACKGROUND & AIMS:

Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections whose prior course of antiviral therapy has failed, and the feasibility of shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients.

METHODS:

We performed a multicenter, open-label trial at 32 sites in the United States and 2 sites in New Zealand from March 3, 2015 to April 27, 2015. Our study included 128 treatment-naïve and treatment-experienced patients (1 with HCV genotype 1b; 33 with HCV genotype 2; 74 with HCV genotype 3; 17 with genotype HCV 4; and 3 with HCV genotype 6), with or without compensated cirrhosis. All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination tablet) and GS-9857 (100 mg) once daily for 6-12 weeks. The primary end point was sustained virologic response 12 weeks after treatment (SVR12).

RESULTS:

After 6 weeks of treatment, SVR12s were achieved by 88% of treatment-naïve patients without cirrhosis (29 of 33; 95% confidence interval, 72%-97%). After 8 weeks of treatment, SVR12s were achieved by 93% of treatment-naïve patients with cirrhosis (28 of 30; 95% CI, 78%-99%). After 12 weeks of treatment, SVR12s were achieved by all treatment-experienced patients without cirrhosis (36 of 36; 95% CI, 90%-100%) and 97% of treatment-experienced patients with cirrhosis (28 of 29; 95% CI, 82%-100%). The most common adverse events were headache, diarrhea, fatigue, and nausea. Three patients (1%) discontinued treatment due to adverse events.

CONCLUSIONS:

In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatment-naïve patients or 12 weeks in treatment-experienced patients) to be safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis. ClinicalTrials.gov ID: NCT02378961.

KEYWORDS:

Clinical Trial; DAA; Direct-Acting Antiviral; Non-Genotype 1 HCV

Comment in

PMID:
27486033
DOI:
10.1053/j.gastro.2016.07.038
[Indexed for MEDLINE]
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