NCT02582632: GARNET

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

Completed Phase 3 Results posted Last updated 30 July 2021

What this trial tests

Phase 3 trial testing ombitasvir/paritaprevir/ritonavir in Hepatitis C Infection in 166 participants. Completed in 1 December 2016.

Timeline

24 November 2015

Primary endpoint
24 August 2016

1 December 2016

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	24 November 2015
Primary completion	24 August 2016
Estimated completion	1 December 2016

Drugs / interventions tested

• ombitasvir/paritaprevir/ritonavir
• dasabuvir (DASABUVIR) — full drug profile →

Conditions studied

• Hepatitis C Infection — all drugs for Hepatitis C Infection →
• Hepatitis C Virus — all drugs for Hepatitis C Virus →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 100, any sex, with Hepatitis C Infection or Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Primary · 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	97.6	95.3 – 99.9

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period Secondary · Up to 8 weeks while on treatment

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	0.6	0.0 – 1.8

Percentage of Participants With Post-Treatment Relapse12 Secondary · Up to 12 weeks after last dose of study drug

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 t

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	1.2	0.0 – 2.9

Percentage of Female Participants Responding With SVR12 Secondary · 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	97.9	95.0 – 100.0

Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 Secondary · Baseline and 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	98.1	95.9 – 100.0

Percentage of Participants Who Achieve SVR12: mITT-GT Population Secondary · 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	98.2	96.1 – 100.0

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population Secondary · Up to 8 weeks while on treatment

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	0	0.0 – 2.3

Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population Secondary · Up to 12 weeks after last dose of study drug

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 t

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	1.2	0.0 – 3.0

Percentage of Female Participants Responding With SVR12: mITT-GT Population Secondary · 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	97.8	94.9 – 100.0

Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population Secondary · Baseline and 12 weeks after the last actual dose of study drug

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.

Group	Value	95% CI
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	98.7	96.9 – 100.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Serious: 2/166 (1%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Ombitasvir/Paritaprevir/Ri…
GASTROENTERITIS	Infections and infestations	—
SYNCOPE	Nervous system disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Ombitasvir/Paritaprevir/Ri…
HEADACHE	Nervous system disorders	—
FATIGUE	General disorders	—
NASOPHARYNGITIS	Infections and infestations	—
PRURITUS	Skin and subcutaneous tissue disorders	—
NAUSEA	Gastrointestinal disorders	—
ASTHENIA	General disorders	—

Most-reported serious reactions: GASTROENTERITIS, SYNCOPE.

Data from ClinicalTrials.gov NCT02582632 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Welzel TM, Asselah T, Dumas EO, Zeuzem S, et al · · 2017 · cited 36× · PMID 28416221 · DOI 10.1016/s2468-1253(17)30071-7