A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: ABT-530; Drug: Ribavirin (RBV); Drug: ABT-450/ritonavir (r)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068222

M14-213

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Full description

Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
• Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
• Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

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 cirrhosis.
• Any cause of liver disease other than chronic HCV-infection.
• HCV genotype co-infection with any other HCV genotype.
• Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ABT-450/r and ABT-530 plus RBV

Experimental group

Description:

ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Treatment:

Drug: ABT-450/ritonavir (r)

Drug: ABT-530

Drug: Ribavirin (RBV)