A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

NCT ID: NCT01704755

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed Description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Conditions

Chronic Hepatitis C Infection; Compensated Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type: DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet

Ribavirin (RBV)

Intervention Type: DRUG

Capsule

ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type: DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet

Ribavirin (RBV)

Intervention Type: DRUG

Capsule

Interventions

ABT-450/r/ABT-267, ABT-333

Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet

Intervention Type: DRUG

Ribavirin (RBV)

Capsule

Intervention Type: DRUG

Other Intervention Names

Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir

Eligibility Criteria

Inclusion Criteria

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
• Male or female between 18 and 70 years, inclusive, at time of Screening.
• Chronic HCV-infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1-infection.
• Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
• Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria

• Significant liver disease with any cause other than HCV as the primary cause
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
• Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
• Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
• A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Trinh, MD

Role: STUDY_DIRECTOR

AbbVie

References

Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.

Reference Type: BACKGROUND

PMID: 24725237 (View on PubMed)

Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.

Reference Type: DERIVED

PMID: 29377566 (View on PubMed)

Forns X, Poordad F, Pedrosa M, Berenguer M, Wedemeyer H, Ferenci P, Shiffman ML, Fried MW, Lovell S, Trinh R, Lopez-Talavera JC, Everson G. Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia. Liver Int. 2015 Nov;35(11):2358-62. doi: 10.1111/liv.12931. Epub 2015 Sep 6.

Reference Type: DERIVED

PMID: 26248955 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

2012-003088-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-099

Identifier Type: -

Identifier Source: org_study_id