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

AbbVie

Status and phase

Completed

Phase 3

Conditions

Hepatitis C Virus (HCV)

Treatments

Drug: Glecaprevir/Pibrentasvir

Study type

Interventional

Funder types

Industry

Identifiers

NCT03212521

M16-133

2016-004876-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.