Phase 2
Completed N=38
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
Chronic Hepatitis C Infection · Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01911845 ↗
Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment — 97.4 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment |
97.4 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
— | — |
| SECONDARY Percentage of Participants With Virologic Relapse Post-treatment |
— | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin |
27438.94; 37174.89; 14303.27; 11375.38; 1523.48; 1486.72 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin |
3269.50; 2973.30; 1261.92; 888.70; 102.00; 95.98 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin |
4.38; 6.81; 4.18; 7.01; 4.69; 5.26 | — |
| SECONDARY Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin |
170.01; 458.53; 167.35; 136.87; 33.75; 32.78 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01911845). 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.