A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection

Phase 3

Completed

• Conditions: Chronic Hepatitis C Virus (HCV) Infection
• Interventions: Drug: Placebo for ABT-493/ABT-530; Drug: ABT-493/ABT-530

• Registration Number: NCT02640482
• Lead Sponsor: AbbVie

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Primary Completion: 2016-09
• Disposition First Submitted: 2016-10-21
• Disposition First Submitted QC: 2016-10-21
• Disposition First Posted: 2016-10-24
• Study Completion: 2017-02
• Results First Submitted: 2017-08-17
• Results First Submitted QC: 2017-08-17
• Results First Posted: 2017-09-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection.
• Chronic HCV infection.
• Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy.
• Subject must be non-cirrhotic.

Exclusion Criteria

• History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
• Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
• HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B DB Placebo	Placebo for ABT-493/ABT-530	Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)
Arm A DB Active Drug	ABT-493/ABT-530	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)
Arm B OL Active Drug	ABT-493/ABT-530	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis	12 weeks after the last actual dose of active study drug	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis	12 weeks after the last actual dose of active study drug	SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The secondary efficacy endpoint was the superiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior SOF + RBV ± pegIFN failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks). As pre-specified in the study protocol, the primary outcome measure and the secondary outcome measure are not tested independently from each other. Rather, the two measures are ranked in a fixed sequential testing procedure that only if success was demonstrated for the primary outcome (i.e. non-inferiority test of Arm A SVR12 rate to the standard of care) did we test the first secondary outcome (i.e. superiority test of Arm A SVR12 rate to the standard of care).
Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures	Up to Week 12 post baseline	On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure	12 weeks after the last actual dose of active study drug	SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of active study drug.
Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures	Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection.