A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

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Detailed Description

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This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Conditions

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Chronic Hepatitis C Hepatitis C Virus Genotype 3 Hepatitis C Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Arm B

Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Tablet

Daclatasvir

Intervention Type DRUG

Tablet

Arm C

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Interventions

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ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Intervention Type DRUG

Sofosbuvir

Tablet

Intervention Type DRUG

Daclatasvir

Tablet

Intervention Type DRUG

Other Intervention Names

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ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET Sovaldi Daklinza

Eligibility Criteria

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Inclusion Criteria

* Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
* Screening laboratory result indicating HCV GT3 infection.
* Chronic HCV infection, defined as one of the following:

* Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or
* A liver biopsy consistent with chronic HCV infection; or
* Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
* Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
* Documented as noncirrhotic.

Exclusion Criteria

* Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was 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 have precluded 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 Ab (HIV Ab).
* Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.
* Any cause of liver disease other than chronic HCV infection.
* Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
* History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.
* Previous use of any anti-HCV treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No