Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

Launched by ABBVIE · Jul 31, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 1. Positive for anti-HCV Ab (Antibody) and HCV RNA \>1,000 IU/mL at Screening.
• • 2. Screening laboratory result indicating HCV genotype 1 infection.
• • 3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
• • 4. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.
• Exclusion Criteria:
• • 1. Women who are pregnant or breastfeeding.
• • 2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
• • 3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.