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Clinical Trial
. 2017 Jul 1;65(1):6-12.
doi: 10.1093/cid/cix260.

Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study

David Wyles  1 , Norbert Bräu  2   3 , Shyam Kottilil  4 , Eric S Daar  5 , Peter Ruane  6 , Kimberly Workowski  7 , Anne Luetkemeyer  8 , Oluwatoyin Adeyemi  9 , Arthur Y Kim  10 , Brian Doehle  11 , K C Huang  11 , Erik Mogalian  11 , Anu Osinusi  11 , John McNally  11 , Diana M Brainard  11 , John G McHutchison  11 , Susanna Naggie  12 , Mark Sulkowski  13 ; ASTRAL-5 Investigators
Affiliations
Clinical Trial

Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study

David Wyles et al. Clin Infect Dis. .

Abstract

Background: A safe, simple, effective, and pan-genotypic regimen to treat hepatitis C virus (HCV) infection in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains a medical need. We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.

Methods: This phase 3, open-label, single-arm study at 17 sites in the United States enrolled patients with HCV of any genotype and HIV-1 coinfection, including those with compensated cirrhosis. All patients received sofosbuvir-velpatasvir once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12). Efficacy and safety were assessed in all patients receiving at least 1 dose of treatment.

Results: Of 106 patients, 91 (86%) were men, 48 (45%) were black, and 19 (18%) had cirrhosis. SVR12 was achieved by 101 of 106 (95% [95% confidence interval {CI}, 89%-99%]) patients: 74 of 78 (95% [95% CI, 87%-99%]) with genotype 1; all 11 (100% [95% CI, 72%-100%]) with genotype 2; 11 of 12 (92% [95% CI, 62%-100%]) with genotype 3; and all 5 (100% [95% CI, 48%-100%]) with genotype 4. All 19 patients with cirrhosis had SVR12. Two patients relapsed, 2 were lost to follow-up, and 1 withdrew consent. Two discontinued treatment due to adverse events and 2 had serious adverse events. The most common adverse events were fatigue (25%), headache (13%), upper respiratory tract infection (8%), and arthralgia (8%).

Conclusions: Sofosbuvir-velpatasvir for 12 weeks was safe and provided high rates of SVR12 in patients coinfected with HCV and HIV-1.

Clinical trials registration: NCT02480712.

Keywords: ASTRAL-5; HCV-HIV coinfection; hepatitis C virus; sofosbuvir; velpatasvir.

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Figures

Figure 1.
Figure 1.
Patient disposition.
Figure 2.
Figure 2.
Median creatinine clearance by antiretroviral regimen type and treatment visit. Abbreviations: IQR, interquartile range; PT, posttreatment; TDF, tenofovir disoproxil fumarate.
See this image and copyright information in PMC

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