Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis.

Abstract

Patients infected with hepatitis C virus (HCV) treated with interferon-free direct-acting antivirals may still require ribavirin. However, ribavirin is associated with adverse events that can limit its use. This open-label, multicentre, Phase 3 study evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir + dasabuvir (OBV/PTV/r + DSV) with low-dose ribavirin for 12 weeks in genotype 1a-infected patients without cirrhosis. The primary efficacy endpoint was sustained virologic response at post-treatment Week 12 (SVR12). The primary safety endpoint was haemoglobin <10 g/dL during treatment and decreased from baseline. Overall, 105 patients enrolled. The SVR12 rate was 89.5% (n/N = 94/105; 95% CI, 83.7-95.4). The study did not achieve noninferiority versus the historic SVR12 rate for OBV/PTV/r + DSV plus weight-based ribavirin. Five patients experienced virologic failure, four discontinued, and two had missing SVR12 data. Excluding nonvirologic failures, the SVR12 rate was 94.9% (n/N = 94/99). One patient met the primary safety endpoint. OBV/PTV/r + DSV plus low-dose ribavirin offers an alternative option for patients in whom full-dose ribavirin may compromise tolerability, although noninferiority to the weight-based ribavirin regimen was not met.

• Authors: Fred Poordad, Shahriar Sedghi, Paul J Pockros, Natarajan Ravendhran, Robert Reindollar, Michael R Lucey, Michael Epstein, Leslie Bank, David Bernstein, Roger Trinh, Preethi Krishnan, Akshanth R Polepally, Kristina Unnebrink, Marisol Martinez, David R Nelson
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 26 Issue 8 Pg. 1027-1030 (08 2019) ISSN: 1365-2893 [Electronic] England
• PMID: 30980576 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Lactams, Macrocyclic
• Macrocyclic Compounds
• Sulfonamides
• ombitasvir
• Ribavirin
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine
• Anilides (therapeutic use)
• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Cyclopropanes
• Drug Administration Schedule
• Drug Therapy, Combination
• Drug-Related Side Effects and Adverse Reactions
• Female
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Lactams, Macrocyclic
• Macrocyclic Compounds (therapeutic use)
• Male
• Proline (analogs & derivatives)
• Ribavirin (therapeutic use)
• Ritonavir (therapeutic use)
• Sulfonamides (therapeutic use)
• Treatment Outcome
• Uracil (analogs & derivatives, therapeutic use)
• Valine