Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

Phase 3

Completed

Conditions: Hepatitis C Virus (HCV)

Interventions: Drug: Glecaprevir/Pibrentasvir

Registration Number: NCT03212521

Lead Sponsor: AbbVie

Brief Summary: A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

Inclusion Criteria

Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
Does not have current active hepatitis B virus infection defined as:
- positive hepatitis B surface antigen (HBsAg), OR
- hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
Platelets ≥ 150,000 cells/mm³
Albumin ≥ lower limit of normal (LLN)
Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
No past history/evidence of cirrhosis.
No history of hepatocellular carcinoma.
Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glecaprevir/Pibrentasvir	Glecaprevir/Pibrentasvir	Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	12 weeks after the last actual dose of study drug, Week 20	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With On-treatment Virologic Failure	Up to 8 weeks	On-treatment virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or * confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log₁₀ IU/mL above nadir) at any time point during the Treatment Period; or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
Percentage of Participants in the Intention-to-Treat Population With SVR12	12 weeks after the last actual dose of study drug, Week 20	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.
Percentage of Participants With Post-treatment Relapse	From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Trial Locations

Locations (42): Parkway Medical Center /ID# 161261
🇺🇸
Birmingham, Alabama, United States
Arkansas Gastroenterology /ID# 161266
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North Little Rock, Arkansas, United States
UC Davis Medical Center /ID# 161138
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Sacramento, California, United States
Yale University /ID# 161258
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New Haven, Connecticut, United States
Univ Maryland School Medicine /ID# 161157
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Baltimore, Maryland, United States
Digestive Disease Associates - Baltimore /ID# 161260
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Baltimore, Maryland, United States
University of Michigan Hospitals /ID# 161265
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Ann Arbor, Michigan, United States
Northwest Gastroenterology Cli /ID# 161257
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Portland, Oregon, United States
Liver Associates of Texas, P.A /ID# 161262
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Houston, Texas, United States
University of Vermont Medical Center /ID# 161263
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Burlington, Vermont, United States
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Parkway Medical Center /ID# 161261
🇺🇸Birmingham, Alabama, United States