Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials

Clin Infect Dis. 2016 Dec 1;63(11):1479-1481. doi: 10.1093/cid/ciw579. Epub 2016 Aug 23.

Abstract

In this analysis of the ASTRAL trials (non-opioid substitution therapy [OST], n = 984; OST, n = 51) evaluating the once-daily, pan-genotypic regimen of sofosbuvir/velpatasvir for hepatitis C virus infection, OST did not impact completion, adherence, sustained virologic response (SVR12), or safety. SVR12 was 96% (95% confidence interval, 87%, >99%) in those receiving OST.

Keywords: HCV; OST; PWID; sofosbuvir; velpatasvir.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Carbamates / administration & dosage
  • Carbamates / adverse effects
  • Carbamates / therapeutic use*
  • Data Interpretation, Statistical
  • Drug Administration Schedule
  • Drug Resistance, Viral
  • Drug Therapy, Combination*
  • Female
  • Genotype
  • Hepacivirus / drug effects
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / blood
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / genetics
  • Hepatitis C, Chronic / virology
  • Heterocyclic Compounds, 4 or More Rings / administration & dosage
  • Heterocyclic Compounds, 4 or More Rings / adverse effects
  • Heterocyclic Compounds, 4 or More Rings / therapeutic use*
  • Humans
  • Liver Cirrhosis / drug therapy
  • Male
  • Medication Adherence
  • Middle Aged
  • Opiate Substitution Treatment*
  • Ribavirin / therapeutic use
  • Sofosbuvir / administration & dosage
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Sustained Virologic Response
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Carbamates
  • Heterocyclic Compounds, 4 or More Rings
  • Ribavirin
  • velpatasvir
  • Sofosbuvir