A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection (Quartz II/III)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Virus Infection

Treatments: Drug: Ribavirin (RBV); Drug: Sofosbuvir; Drug: OBV/PTV/r

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292719

2014-003147-35 (EudraCT Number)

M14-567

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Enrollment: 70 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic HCV infection prior to study enrollment.
2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
3. Absence OR presence of cirrhosis.
4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

Exclusion criteria

1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
3. Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
5. Abnormal lab tests.
6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 6 patient groups

Arm A (genotype [GT]3, noncirrhotic)

Experimental group

Description:

Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.

Treatment:

Drug: OBV/PTV/r

Drug: Sofosbuvir

Arm B (GT3, noncirrhotic)

Experimental group

Description:

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: OBV/PTV/r

Drug: Sofosbuvir

Arm C (GT2, noncirrhotic)

Experimental group

Description:

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: OBV/PTV/r

Drug: Sofosbuvir

Arm D (GT2, noncirrhotic)

Experimental group

Description:

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: OBV/PTV/r

Drug: Sofosbuvir

Arm E (GT3, cirrhotic)

Experimental group

Description:

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: OBV/PTV/r

Drug: Sofosbuvir

Arm F (GT3, noncirrhotic)

Experimental group

Description:

OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.

Treatment:

Drug: OBV/PTV/r

Drug: Sofosbuvir