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 (prior sponsor, Abbott)11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C HCV Chronic Hepatitis C Infection Hepatitis C Genotype 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).

Time frame: Week 4 through Week 12

Secondary Outcomes

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.

Time frame: Week 2

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).

Time frame: Week 4

Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug.

Time frame: Post-treatment Day 1 to Post-treatment Week 12

Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug.

Time frame: Post-treatment Day 1 to Post-treatment Week 24

Time to Failure to Suppress or Rebound During Treatment

The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA \<LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA \> lower limit of detection (LLOD) for participants who previously achieved HCV RNA \< LLOD.

Time frame: Day 1 through Week 12

Time to Virologic Relapse Through 24 Weeks Post-treatment

Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment.