Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Phase 3 Completed 105 enrolled AbbVie

NaSingle-groupOpen-labelTreatment

Summary

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Timeline

Start: 2015-10-28
Primary completion: 2016-10-07
Completion: 2016-12-28

Outcome

Missed primary endpoint

paper The study did not achieve noninferiority versus the historic SVR12 rate for OBV/PTV/r + DSV plus weight-based ribavirin. PMID 30980576 ↗

Publications

Results Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. 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. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribavirin	Small molecule	600 mg	—
Subject	Ritonavir	Other / unclassified	100 mg	—
Subject	dasabuvir	Small molecule	250 mg	—
Subject	ombitasvir	Small molecule	25 mg	—
Subject	paritaprevir	Small molecule	150 mg	—