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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02442284

M14-251

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

3-DAA ± RBV for 12 or 24 weeks

Experimental group

Description:

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.

Treatment:

Drug: Ribavirin

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir