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

AbbVie

Status and phase: Completed; Phase 2

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

Treatments: Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02493855

M14-242

2014-001478-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
2. Chronic HCV infection.
3. Subjects must be non-cirrhotic.
4. 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

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 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.
5. History or solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Arm A: Ribavirin Full Dose for Last 10 Weeks

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV)

Drug: Dasabuvir

Drug: Ombitasvir/ABT-450/Ritonavir

Arm B: Ribavirin Full Dose for 12 Weeks

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV)

Drug: Dasabuvir

Drug: Ombitasvir/ABT-450/Ritonavir

Arm C: Ribavirin Low-dose for 12 Weeks

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV)

Drug: Dasabuvir

Drug: Ombitasvir/ABT-450/Ritonavir