Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection

J Viral Hepat. 2018 Oct;25(10):1180-1188. doi: 10.1111/jvh.12917. Epub 2018 May 8.

Abstract

Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12 weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8 weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12 months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8 weeks. The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38 years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n = 23) were HIV-positive, 93% (n = 28) had genotype 1a infection and 53% (n = 16) had ever injected drugs. Median maximum ALT in the preceding 12 months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT > 10 x ULN was documented in 83% (n = 25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log10 IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n = 1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.

Keywords: acute; direct-acting antiviral; hepatitis C; recent; treatment.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anilides / administration & dosage
  • Anilides / adverse effects
  • Anilides / pharmacology
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Antiviral Agents / pharmacology
  • Australia / epidemiology
  • Carbamates / administration & dosage
  • Carbamates / adverse effects
  • Carbamates / pharmacology
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • England / epidemiology
  • Female
  • Genotype
  • Hepacivirus / drug effects
  • Hepacivirus / genetics*
  • Hepatitis C / drug therapy*
  • Hepatitis C / epidemiology
  • Hepatitis C / virology
  • Humans
  • Intention to Treat Analysis
  • Macrocyclic Compounds / administration & dosage
  • Macrocyclic Compounds / adverse effects
  • Macrocyclic Compounds / pharmacology
  • Male
  • Middle Aged
  • New Zealand / epidemiology
  • Prospective Studies
  • RNA, Viral / blood
  • Ribavirin / administration & dosage
  • Ribavirin / adverse effects
  • Ribavirin / pharmacology
  • Ritonavir / administration & dosage
  • Ritonavir / adverse effects
  • Ritonavir / pharmacology
  • Safety
  • Sulfonamides / administration & dosage
  • Sulfonamides / adverse effects
  • Sulfonamides / pharmacology
  • Treatment Outcome
  • Uracil / administration & dosage
  • Uracil / adverse effects
  • Uracil / analogs & derivatives
  • Uracil / pharmacology

Substances

  • ABT-267
  • ABT-333
  • ABT-450
  • Anilides
  • Antiviral Agents
  • Carbamates
  • Macrocyclic Compounds
  • RNA, Viral
  • Sulfonamides
  • Ribavirin
  • Uracil
  • Ritonavir