This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of an active drug in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
18 Years and older.
- 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.
- 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
- 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