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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Infection; HCV; Genotype 4

Treatments: Drug: 2 DAA; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247401

M14-250

Details and patient eligibility

About

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.

Full description

Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Enrollment: 160 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Arm A

Active Comparator group

Description:

ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.

Treatment:

Drug: 2 DAA

Drug: RBV

Arm B

Active Comparator group

Description:

ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Treatment:

Drug: 2 DAA

Drug: RBV

Arm C

Active Comparator group

Description:

ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Treatment:

Drug: 2 DAA

Drug: RBV