Phase 2 Completed N=29 Treatment

A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

Chronic Hepatitis C Infection

Source: ClinicalTrials.gov NCT02356562 ↗

Enrolled (actual)

Serious AEs

6.9%

Results posted

Nov 2017

Primary outcomePrimary: Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment — 95.5 percentage of participants

Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts. Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure. Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment	95.5	—
SECONDARY Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment	85.7	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure	0.0; 14.3	—
SECONDARY Percentage of Participants With Post-Treatment Relapse	4.8; 0.0	—

Eligibility Criteria

Inclusion Criteria

History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
HCV genotype 1 infection
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion Criteria

Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Discontinuation of the prior DAA treatment for reasons other than virologic failure
Confirmed presence of hepatocellular carcinoma
Abnormal lab tests

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Data sourced from ClinicalTrials.gov (NCT02356562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.