A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Compensated Cirrhosis; Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: Ribavirin (RBV); Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995071

M13-595

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.

Enrollment: 89 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1-infection.
• Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
• Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.

Exclusion criteria

• History of severe, life-threatening or other significant sensitivity to any drug.
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).
• Prior therapy for the treatment of HCV.
• Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
• Any cause of liver disease other than chronic HCV infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 12 patient groups

Arm 1 Non-cirrhotic

Experimental group

Description:

ABT-493 Dose A (100 mg once daily \[QD\]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 2 Non-cirrhotic

Experimental group

Description:

ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 3 Non-cirrhotic

Experimental group

Description:

ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 4 Non-cirrhotic

Experimental group

Description:

ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 5 Compensated cirrhotic

Experimental group

Description:

ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 6 Non-cirrhotic

Experimental group

Description:

ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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

Arm 7 Non-cirrhotic

Experimental group

Description:

ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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

Arm 8 Non-cirrhotic

Experimental group

Description:

ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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

Arm 9 Non-cirrhotic

Experimental group

Description:

ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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

Arm 10 Compensated cirrhotic

Experimental group

Description:

ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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

Arm 11 Non-cirrhotic

Experimental group

Description:

ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

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

Drug: ABT-493

Arm 12 Non-cirrhotic

Experimental group

Description:

ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: ABT-530

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