Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2016-12-28

Brief Summary

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This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

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Detailed Description

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Conditions

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Hepatitis C Virus (HCV)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3-DAA + RBV 600 mg

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

Tablet

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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Viekira Pak paritaprevir also known as ABT-450 ombitasvir also known as ABT-267 dasabuvir also known as ABT-333

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C virus (HCV) infection
* Non-cirrhotic subjects
* Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
* HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion Criteria

* Pregnant or breastfeeding women
* Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
* HCV genotype of any subtype other than GT1a or unable to subtype
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
* Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No