Phase 3
Completed N=222
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
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT02442271 ↗
Enrolled (actual)
222
Serious AEs
2.7%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 96.4 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
96.4 | — |
| SECONDARY Percentage of Participants With SVR12 by Fibrosis Stage |
96.6; 96.2 | — |
| SECONDARY Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience |
96.1; 95.5; 100; 100; 97.1; 100 | — |
| SECONDARY Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening |
90.0; 96.7; 85.7; 97.3 | — |
| SECONDARY Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug |
0.5; 0.8; 3.8; 4.2 | — |
| SECONDARY Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug |
-0.5; 1.3; 0.1; 2.1 | — |
| SECONDARY (SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug |
2.4; -0.6; 2.4; 2.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02442271). 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.