Phase 2
Completed N=167
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
Source: ClinicalTrials.gov NCT01466790 ↗Enrolled (actual)
167
Serious AEs
2.4%
Results posted
Oct 2014
Primary outcomePrimary: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) — 19; 14; 26; 13 Participants
Summary
The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) |
19; 14; 26; 13; 28; 16 | — |
| SECONDARY Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT) |
20; 14; 26; 13; 28; 16 | — |
| SECONDARY Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT) |
19; 14; 26; 13; 28; 16 | — |
| SECONDARY Number of Participants With a Sustained Virologic Response (SVR) at Week 48 |
19; 14; 26; 13; 27; 16 | — |
| SECONDARY Number of Participants With Viral Breakthrough |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Inadequate Virologic Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Viral Relapse |
1; 0; 1; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic genotype 1 hepatitis C virus (HCV) infection
- Plasma HCV RNA of more than 10,000 IU/mL at screening
- Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks
- Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV
- Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy
- Patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed Metavir F3 or F4 fibrosis
- Must agree to use 2 forms of effective contraception throughout the study (male and female)
Exclusion Criteria
- Has evidence of hepatic decompensation
- Has any liver disease of non-HCV etiology
- Has an infection/co-infection with non-genotype 1 HCV
- Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)
- Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- Has a history of malignancy within 5 years of the screening visit
Data sourced from ClinicalTrials.gov (NCT01466790). 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.