A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment

The study included a 42-day screening period, a treatment period of either 8, 12, or 16
weeks, and a 24-week post-treatment period. The duration of treatment was determined by
product labeling. Participants received glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg once
daily. Participants who completed or prematurely discontinued the treatment period were
followed for 24 weeks after their last dose of study drug to monitor safety, hepatitis C
virus ribonucleic acid (HCV RNA), and the emergence and persistence of viral substitutions.

Inclusion Criteria:

- Male or female (of non-childbearing potential or using allowed contraceptive methods)
at least 18 years of age time of Screening

- Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV
ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.

- Participant had an estimated glomerular filtration rate (eGFR) less than 45
mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD)
method at Screening according to the following formula: eGFR (mL/min/1.73 m^2 ) = 175
× (Serum Creatinine) ^-1.154 × Age^-0.203 × (0.742 if female) × (1.212 if black), or
were dialysis dependent. Subjects requiring dialysis had to have been receiving
dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis
or peritoneal dialysis.

- Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by
a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging
(MRI) within 3 months prior to Screening or a negative ultrasound at Screening.
Participants who had an ultrasound with results suspicious of HCC followed by a
subsequent negative CT or MRI of the liver were eligible for the study.

Exclusion Criteria:

- Female participants who were pregnant, breastfeeding, or were considering becoming
pregnant during the study or for approximately 30 days after the last dose of study
drug

- Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on
screening tests, defined as:

- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;

- HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in
participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative
HBsAg and Anti-HBsAg), or;

- Positive anti-HIV antibody (Ab).

- Any current or historical clinical evidence of decompensated cirrhosis, including any
current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy
or variceal bleeding; radiographic evidence of small ascites; or prior or current
empiric use of lactulose/rifaximin for neurologic indications. Prophylactic use of
beta blockers was not exclusionary.

- Clinical history of acute renal failure in the 3 months prior to Screening

- History of severe, life-threatening, or other significant sensitivity to any
excipients of the study drugs

- Clinically significant abnormalities or co-morbidities, or recent (within 6 months
prior to study drug administration) alcohol or drug abuse that could preclude
adherence to the protocol in the opinion of the investigator

- Receipt of any investigational or commercially available direct acting anti-HCV agents
other than sofosbuvir