A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (TURQUOISE-II)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Compensated Cirrhosis; Chronic Hepatitis C Infection

Treatments: Drug: Ribavirin (RBV); Drug: ABT-450/r/ABT-267, ABT-333

Study type: Interventional

Funder types: Industry

Identifiers

NCT01704755

2012-003088-23 (EudraCT Number)

M13-099

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Full description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Enrollment: 381 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
• Male or female between 18 and 70 years, inclusive, at time of Screening.
• Chronic HCV-infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1-infection.
• Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
• Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion criteria

• Significant liver disease with any cause other than HCV as the primary cause
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
• Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
• Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
• A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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381 participants in 2 patient groups

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

Experimental group

Description:

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Treatment:

Drug: ABT-450/r/ABT-267, ABT-333

Drug: Ribavirin (RBV)

ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

Experimental group

Description:

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Treatment:

Drug: ABT-450/r/ABT-267, ABT-333

Drug: Ribavirin (RBV)