An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

AbbVie

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C; Chronic Hepatitis C Infection

Treatments: Drug: ABT-333; Drug: Ribavirin (RBV); Drug: ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911845

M14-103

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.

Full description

This study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). All participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, HCV RNA, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (PRO) instruments.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile.
• Chronic HCV infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1-infection.
• Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced.
• Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening.

Exclusion criteria

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
• Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
• Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug.
• Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of >3 or Ishak score of > 4.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

ABT-450/r/ABT-267 and ABT-333, plus RBV

Experimental group

Description:

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Treatment:

Drug: ABT-450/r/ABT-267

Drug: Ribavirin (RBV)

Drug: ABT-333