A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

AbbVie99 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Cirrhosis Hepatitis C Virus

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvirDRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

RibavirinDRUG

Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * US military veteran currently receiving healthcare through the Veterans Health Administration * Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection * Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease) Exclusion Criteria: * Women who are pregnant or breastfeeding * Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) * Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir * Any current or past clinical evidence of Child-Pugh B or C classification * Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.

Time frame: 12 weeks after the last actual dose of study drug

Secondary Outcomes

Percentage of Participants With Virologic Failure During Treatment

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.

Time frame: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Time frame: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders

Time frame: 12 weeks after the last actual dose of study drug

Data from ClinicalTrials.gov

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