A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection (Turquoise-IV)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus (HCV) Infection

Treatments: Drug: Dasabuvir; Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Ribavirin (RBV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216422

M14-252

Details and patient eligibility

About

This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Full description

The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
• Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
• Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
• Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
• Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.

Exclusion criteria

• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
• Evidence of current or past Child-Pugh B or C classification
• Confirmed presence of hepatocellular carcinoma
• Abnormal laboratory tests
• Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
• Previous treatment with a direct acting antiviral agent (DAA) containing regimen
• History of solid organ transplant.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

Experimental group

Description:

Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: Ombitasvir/Paritaprevir/Ritonavir

Drug: Dasabuvir