Phase 3
Completed N=166
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Hepatitis C Infection · Hepatitis C
Source: ClinicalTrials.gov NCT02582632 ↗
Enrolled (actual)
166
Serious AEs
1.2%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 97.6 percentage of participants
◆ Published Evidence
Established
50citations · ~6 / year
Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial.
Summary
This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).
Linked Publications
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Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
97.6 | — |
| SECONDARY Percentage of Participants With On-Treatment Virologic Failure During Treatment Period |
0.6 | — |
| SECONDARY Percentage of Participants With Post-Treatment Relapse12 |
1.2 | — |
| SECONDARY Percentage of Female Participants Responding With SVR12 |
97.9 | — |
| SECONDARY Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 |
98.1 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic HCV infection at Screening.
- Screening laboratory result indicating HCV genotype 1b infection.
- Treatment-naïve and non-cirrhotic.
Exclusion Criteria
- HCV genotype or subtype other than GT1b.
- Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
- Any current or past clinical evidence of cirrhosis.
- Screening laboratory analyses that shows abnormal results.
- Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.
Data sourced from ClinicalTrials.gov (NCT02582632) and the linked publication. 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.