Phase 3
N=703
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
Chronic Hepatitis C · Hepatitis C Virus · HCV
Bottom Line
View on ClinicalTrials.gov: NCT02604017 ↗Enrolled (actual)
703
Serious AEs
1.3%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm — 99.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-493/ABT-530 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm |
99.7 | — |
| PRIMARY Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later |
100.0; 100 | — |
| PRIMARY Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants |
99.7; 99.1 | — |
| SECONDARY Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants |
99.7; 99.1 | — |
| SECONDARY Percentage of Participants With SVR12 |
99.7; 99.1 | — |
| SECONDARY Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0; 0.3 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants |
0.0; 0.3 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants |
0.0; 0.0 | — |
Summary
This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
Eligibility Criteria
Inclusion Criteria
- Male or female, at least 18 years of age at time of screening.
- Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
- Chronic HCV infection.
- Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
- Subjects must be non-cirrhotic.
Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:
- HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.
OR
- On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any excipients 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).
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- Chronic HIV type 2 (HIV-2) infection.
Data sourced from ClinicalTrials.gov (NCT02604017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.