A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Decompensated Cirrhosis; Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: ribavirin; Drug: dasabuvir; Drug: ombitasvir/paritaprevir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219477

M14-227

2014-001477-13 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Enrollment: 36 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.
2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography [CT] scan or magnetic resonance imaging [MRI]).
3. Child-Pugh Score of 7 - 9, inclusive, at time of Screening.

Exclusion criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or 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. Any current or past evidence of Child-Pugh C classification.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 3 patient groups

Group 1: GT1B

Experimental group

Description:

ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants

Treatment:

Drug: ribavirin

Drug: dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir

Group 2: GT1 Non-B

Experimental group

Description:

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

Treatment:

Drug: ribavirin

Drug: dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir

Group 3: GT4

Experimental group

Description:

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Treatment:

Drug: ribavirin

Drug: ombitasvir/paritaprevir/ritonavir