Overview

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

Status:
Completed
Trial end date:
2018-08-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
N-Methylaspartate
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.