Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

Study Overview
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Brief Summary
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To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

Official Title
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An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection

Conditions
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Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a

Intervention / Treatment
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* Drug: Ombitasvir/ABT-450/Ritonavir
* Drug: Dasabuvir
* Drug: Ribavirin (RBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening laboratory result indicating HCV genotype 1 (GT1) a infection. Chronic HCV infection. Subjects must be non-cirrhotic. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent. Exclusion Criteria: Women who are pregnant or breastfeeding. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors. History or solid organ transplant. Screening laboratory analysis that shows abnormal results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Ribavirin Full Dose for Last 10 Weeks<br>Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. | Drug: Ombitasvir/ABT-450/Ritonavir<br>* Ombitasvir/ABT-450/ritonavir combination tablets<br>* Other names: ABT-267/ABT-450/ritonavir;Drug: Dasabuvir<br>* Dasabuvir tablets<br>* Other names: ABT-333;Drug: Ribavirin (RBV)<br>* Ribavirin tablets<br>|
| Experimental: Arm B: Ribavirin Full Dose for 12 Weeks<br>Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. | Drug: Ombitasvir/ABT-450/Ritonavir<br>* Ombitasvir/ABT-450/ritonavir combination tablets<br>* Other names: ABT-267/ABT-450/ritonavir;Drug: Dasabuvir<br>* Dasabuvir tablets<br>* Other names: ABT-333;Drug: Ribavirin (RBV)<br>* Ribavirin tablets<br>|
| Experimental: Arm C: Ribavirin Low-dose for 12 Weeks<br>Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. | Drug: Ombitasvir/ABT-450/Ritonavir<br>* Ombitasvir/ABT-450/ritonavir combination tablets<br>* Other names: ABT-267/ABT-450/ritonavir;Drug: Dasabuvir<br>* Dasabuvir tablets<br>* Other names: ABT-333;Drug: Ribavirin (RBV)<br>* Ribavirin tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment | HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm. | From Week 0 to Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment naive, HCV, Interferon free, Hepatitis C Genotype 1a, Chronic Hepatitis C, Hepatitis C