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