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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-24

Study Completion Date

2017-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: GT1B

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

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

tablet; paritaprevir co-formulated with ritonavir and ombitasvir

dasabuvir

Intervention Type DRUG

tablet

ribavirin

Intervention Type DRUG

tablet

Group 2: GT1 Non-B

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

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

tablet; paritaprevir co-formulated with ritonavir and ombitasvir

dasabuvir

Intervention Type DRUG

tablet

ribavirin

Intervention Type DRUG

tablet

Group 3: GT4

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

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

tablet; paritaprevir co-formulated with ritonavir and ombitasvir

ribavirin

Intervention Type DRUG

tablet

Interventions

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ombitasvir/paritaprevir/ritonavir

tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Intervention Type DRUG

dasabuvir

tablet

Intervention Type DRUG

ribavirin

tablet

Intervention Type DRUG

Other Intervention Names

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ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as norvir ABT-333

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No