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, Norbert Braü, Shyam Kottilil, Eric S. Daar, Peter Ruane, Kimberly Workowski, Anne Luetkemeyer, Oluwatoyin Adeyemi, Arthur Y. Kim, Brian Doehle, K. C. Huang, Erik Mogalian, Anu Osinusi, John McNally, DIana M. Brainard, John G. McHutchison, Susanna Naggie, Mark Sulkowski

Research output: Contribution to journalArticlepeer-review

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 (SVR 12). 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. SVR 12 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 SVR 12. 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 SVR 12 in patients coinfected with HCV and HIV-1.

Original languageEnglish (US)
Pages (from-to)6-12
Number of pages7
JournalClinical Infectious Diseases
Volume65
Issue number1
DOIs
StatePublished - Jul 1 2017

Keywords

  • ASTRAL-5
  • HCV-HIV coinfection
  • hepatitis C virus
  • sofosbuvir
  • velpatasvir

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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