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Hepatology. 2017 Oct;66(4):1083-1089. doi: 10.1002/hep.29256. Epub 2017 Aug 26.

Sofosbuvir-velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct-acting antiviral regimen.

Author information

1
Auckland Clinical Studies, Auckland, New Zealand.
2
Liver Institute of Virginia, Richmond, VA.
3
Borland Groover Clinic, Jacksonville, FL.
4
University of Florida, Gainesville, FL.
5
Christchurch Hospital and University of Otago, Christchurch, New Zealand.
6
South Florida Center of Gastroenterology, Wellington, FL.
7
Orlando Immunology Center, Orlando, FL.
8
Gilead Sciences, Inc, Foster City, CA.
9
St. Vincent's Hospital, Melbourne, Australia.
10
Johns Hopkins University School of Medicine, Baltimore, MD.

Abstract

The optimal retreatment strategy for patients chronically infected with hepatitis C virus who experience virologic failure after treatment with direct-acting antiviral-based therapies remains unclear. In this multicenter, open-label, phase 2 study, we evaluated the efficacy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjusted ribavirin administered for 24 weeks in patients who did not achieve sustained virologic response after prior treatment with direct-acting antiviral regimens that included the nucleotide analogue nonstructural protein 5B inhibitor sofosbuvir plus the nonstructural protein 5A inhibitor velpatasvir with or without the nonstructural protein 3/4A protease inhibitor voxilaprevir. The primary efficacy endpoint was the proportion of patients achieving sustained virologic response at 12 weeks after the cessation of treatment. In total, 63 of 69 (91%; 95% confidence interval, 82%-97%) patients achieved sustained virologic response at 12 weeks, including 36 of 37 (97%; 95% confidence interval, 86%-100%) patients with hepatitis C virus genotype 1 infection, 13 of 14 (93%; 95% confidence interval, 66%-100%) patients with genotype 2 infection, and 14 of 18 (78%; 95% confidence interval, 52%-94%) patients with genotype 3 infection. Most adverse events were of mild or moderate severity. The most frequently reported adverse events were fatigue, nausea, headache, insomnia, and rash. One patient (1%) with genotype 1a infection discontinued all study drugs due to an adverse event (irritability).

CONCLUSION:

Retreatment of patients who previously failed direct-acting antiviral-based therapies with sofosbuvir-velpatasvir plus ribavirin for 24 weeks was well tolerated and effective, particularly those with hepatitis C virus genotype 1 or 2 infection. (Hepatology 2017;66:1083-1089).

PMID:
28498551
DOI:
10.1002/hep.29256
[Indexed for MEDLINE]

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