Phase 3 Completed N=160 Randomized Treatment

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

HCV · Hepatitis C Infection · Genotype 4

Source: ClinicalTrials.gov NCT02247401 ↗

Enrolled (actual)

160

Serious AEs

2.5%

Results posted

Jul 2017

Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm — 94.0; 96.8; 93.1 percentage of participants

Summary

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm	94.0; 96.8; 93.1	—
PRIMARY Number of Participants With Adverse Events	80; 26; 25	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm	1.0; 3.2; 3.4	—
SECONDARY Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm	3.1; 0.0; 0.0	—

Eligibility Criteria

Inclusion Criteria

Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
Subjects must meet one of the following:
Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion Criteria

Females who are pregnant or breastfeeding
Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
abnormal laboratory tests
self-reports current drinking more than 2 drinks per day
current enrollment in another investigational study
previous treatment with a direct acting antiviral agent (DAA) containing regimen
In substudy 1, evidence of liver cirrhosis
In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02247401). 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. Informational only — not medical advice.