A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

AbbVie

Status and phase: Completed; Phase 3; Phase 2

Conditions: Compensated Cirrhosis and Non-cirrhotics; Human Immunodeficiency Virus Infection; Hepatitis C Virus Infection; Chronic Hepatitis C

Treatments: Drug: ribavirin; Drug: ABT-333; Drug: ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT01939197

M14-004

2012-005143-24 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment.

Enrollment: 318 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV infection at screening defined as: positive anti-HCV antibodies (Ab) at screening and HCV RNA > 1,000 IU/mL at screening.
• Plasma HIV-1 RNA < 40 copies/mL during screening using Abbott RealTime HIV-1 assay.
• On a stable qualifying HIV-1 antiretroviral therapy regimen.

Exclusion criteria

• Positive test result at screening for hepatitis B surface antigen.
• Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.
• Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.
• Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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318 participants in 12 patient groups

ARM A

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM B

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM C

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM D

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM E

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 for 12 weeks for noncirrhotic (at screening) GT1b-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

ARM F

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

ARM G

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM H

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-experienced participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM I

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for noncirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM J

Experimental group

Description:

ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for cirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: ribavirin

ARM K

Experimental group

Description:

ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ribavirin

ARM L

Experimental group

Description:

ABT-450/r/ABT-267 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ribavirin