Clinical trial NCT01458535: A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Official title: An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Keywords: Genotype 1
Genotype 2
Genotype 3
Hepatitis C Virus
ABT-450/r
Ribavirin
ABT-267
Ombitasvir
Paritaprevir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.

Detailed description: This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

Eligibility criteria: Inclusion Criteria:

* Participants who had a body mass index 18 to \< 35 kg/m\^2.
* Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
* Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
* Participants were in a condition of general good health, other than the HCV infection.
* Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

Exclusion Criteria:

* Positive drug screen
* Previous use of anti-HCV agents
* History of cardiac disease
* History of uncontrolled diabetes or diabetes requiring insulin
* Abnormal laboratory results
* Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
* Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.

Primary outcomes:
measure: 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 [(Extended Rapid Virologic Response (eRVR)]
timeFrame: Week 4 through Week 12
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 24
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
timeFrame: Week 2
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: Day 1 through Week 12
measure: Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
timeFrame: Post-treatment Day 1 to Post-treatment Week 48
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Andrew Campbell, MD
role: STUDY_DIRECTOR
References: