Sofosbuvir-based direct-acting antiviral therapies for HCV in people receiving opioid substitution therapy: An analysis of phase 3 studies

Jason Grebely, Jordan J. Feld, David Wyles, Mark Sulkowski, Liyun Ni, Joe Llewellyn, Heshaam M. Mir, Nika Sajed, Luisa M. Stamm, Robert H. Hyland, John McNally, Diana M. Brainard, Ira Jacobson, Stefan Zeuzem, Marc Bourlière, Graham Foster, Nezam Afdhal, Gregory J. Dore

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Background. Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods. Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/ velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible. Results. Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%, P = .06), SVR12 (94% vs 97%, P = .06), relapse (0.5% vs 2.1%, P = .19), adverse events (78% vs 77%, P = .79), or serious adverse events (3.6% vs 2.4%, P = .24). There was no difference in SVR12 in patients with cirrhosis (99% vs 95%, P = .25) or those with G3 (95% vs 95%, P = .77) in those receiving OST. Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). Conclusion. Sofosbuvir-based therapies are effective and safe in patients receiving OST.

Original languageEnglish (US)
Article numberofy001
JournalOpen Forum Infectious Diseases
Volume5
Issue number2
DOIs
StatePublished - Feb 1 2018

Keywords

  • DAA
  • Drug use
  • Hepatitis C virus
  • Interferon-free
  • Ledipasvir
  • PWID
  • Sofosbuvir
  • Velpatasvir
  • Voxilaprevir

ASJC Scopus subject areas

  • Infectious Diseases
  • Oncology

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