A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (GARNET)

An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

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).

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus; Hepatitis C Infection
• Intervention / Treatment: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Chronic HCV infection at Screening.
2. Screening laboratory result indicating HCV genotype 1b infection.
3. Treatment-naïve and non-cirrhotic.

Exclusion Criteria:

1. HCV genotype or subtype other than GT1b.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
3. Any current or past clinical evidence of cirrhosis.
4. Screening laboratory analyses that shows abnormal results.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir; Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks	Drug: ombitasvir/paritaprevir/ritonavir; Tablet; Other Names: paritaprevir also known as ABT-450; ombitasvir also known as ABT-267; ABT-267/ABT-450/r; Drug: dasabuvir; Tablet; Other Names: ABT-333

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period	On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 8 weeks while on treatment
Percentage of Participants With Post-Treatment Relapse12	Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 12 weeks after last dose of study drug
Percentage of Female Participants Responding With SVR12	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	Baseline and 12 weeks after the last actual dose of study drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population	On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.	Up to 8 weeks while on treatment
Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population	Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 12 weeks after last dose of study drug
Percentage of Female Participants Responding With SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	Baseline and 12 weeks after the last actual dose of study drug

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. 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. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.

Study record dates

Study Major Dates

• Study Start: November 24, 2015
• Primary Completion (ACTUAL): August 24, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (ESTIMATE): October 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Hepatitis C; Interferon-Free; Hepatitis C Virus; Hepatitis C Genotype 1b; Ribavirin-Free
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: M15-684; 2015-003370-33 (EUDRACT_NUMBER)