A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Compensated Cirrhosis; Chronic Hepatitis C Infection

Treatments: Drug: Dasabuvir; Drug: Ombitasvir/Paritaprevir/Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219503

2014-001953-18 (EudraCT Number)

M14-490

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Full description

This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:

   • Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
   • HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).

2. Screening laboratory result indicating HCV genotype 1b-infection.

3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion criteria

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).

3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)

5. Use of contraindicated medications within 2 weeks of dosing

6. Screening laboratory analyses showing any of the following abnormal laboratory results:

   • Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
   • Albumin < 2.8 g/dL
   • International normalized ratio (INR) > 1.8. Participants with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
   • Hemoglobin < 10 g/dL
   • Platelets < 25,000 cells per mm3
   • Total bilirubin > 3.0 mg/dL

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Experimental group

Description:

Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks

Treatment:

Drug: Ombitasvir/Paritaprevir/Ritonavir

Drug: Dasabuvir