Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C (HCV); Chronic Hepatitis C; Hepatitis C Genotype 1a

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02476617

M14-243

Details and patient eligibility

About

A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

Full description

A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Enrollment: 25 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
2. Chronic HCV infection.
3. Participants must be non-cirrhotic.
4. Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
5. Participants must meet specific human leukocyte antigen (HLA) allele requirements.

Exclusion criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV

Experimental group

Description:

Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)

Treatment:

Drug: dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir

Drug: ribavirin