A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis (EXPEDITION-8)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

Treatments: Drug: Glecaprevir/Pibrentasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03089944

M16-135

2016-004967-38 (EudraCT Number)

Details and patient eligibility

About

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

Enrollment: 343 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
• Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
• Treatment-naive to any approved or investigational anti-HCV medication.
• Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

Exclusion criteria

• Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
• Any current or historical clinical evidence of decompensated cirrhosis.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
• HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
• History of suspected or confirmed hepatocellular carcinoma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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343 participants in 1 patient group

Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

Experimental group

Description:

Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.

Treatment:

Drug: Glecaprevir/Pibrentasvir