A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Genotype 1; Hepatitis C; HCV; Chronic Hepatitis C Infection

Treatments: Drug: Ribavirin; Drug: ABT-072; Drug: ABT-450; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01221298

M12-267

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Full description

This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
• Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
• Treatment naïve male or female between the ages of 18 and 65.
• Females must be postmenopausal for at least 2 years or surgically sterile.
• Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
• Body mass index 18 to < 35 kg/m^2 .

Exclusion criteria

• Significant sensitivity to any drug.
• Use of herbal supplements within 2 weeks prior to study drug dosing.
• Positive screen for certain drugs or alcohol.
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
• Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
• Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
• Abnormal laboratory tests.
• Cirrhosis or extensive bridging fibrosis.
• History of cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

ABT-450/r and ABT-072, plus ribavirin (RBV)

Experimental group

Description:

ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.

Treatment:

Drug: ABT-072

Drug: Ribavirin

Drug: ABT-450

Drug: Ritonavir