A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02442271

M14-225

Details and patient eligibility

About

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
• Males must be surgically sterile or agree to practice acceptable forms of birth control
• Chronic hepatitis C virus (HCV) infection at screening
• Fibrosis stage F3 or greater, documented by acceptable tests
• Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion criteria

• Women who are pregnant or breastfeeding
• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
• Use of contraindicated medications within 2 weeks of dosing
• Clinically significant abnormalities or co-morbidities
• History of solid organ transplant
• Abnormal laboratory tests
• Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

3-DAA ± RBV

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.

Treatment:

Drug: ribavirin

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir