An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

NCT01911845 | Completed Phase 2 Results

• 1 other identifier: M14-103
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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 taking methadone or buprenorphine ± naloxone.

Conditions

Chronic Hepatitis C; Chronic Hepatitis C Infection

Keywords

HCV Genotype 1; Hepatitis Genotype 1; Interferon Free; methadone; HCV; Buprenorphine; Hepatitis C; Viekira Pak; paritaprevir; Viekira; ombitasvir; dasabuvir

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

  The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantification \[\< LLOQ\]) 12 weeks after the last dose of study drug.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (6)

• Percentage of Participants With Virologic Failure During Treatment

  Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

• Percentage of Participants With Virologic Relapse Post-treatment

  From the end of treatment through 12 weeks after the last actual dose of study drug

• Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

  Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

• Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

  Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

  Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Study Arms (1)

ABT-450/r/ABT-267 and ABT-333, plus RBV

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)

Interventions

ABT-450/r/ABT-267 DRUG

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

Also known as: ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir

ABT-450/r/ABT-267 and ABT-333, plus RBV

ABT-333 DRUG

Tablet

Also known as: dasabuvir

ABT-450/r/ABT-267 and ABT-333, plus RBV

Ribavirin (RBV) DRUG

Tablet

ABT-450/r/ABT-267 and ABT-333, plus RBV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile.
• Chronic HCV infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1-infection.
• Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced.
• Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening.

You may not qualify if:

• 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.
• Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug.
• Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of \>3 or Ishak score of \> 4.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Lalezari J, Sullivan JG, Varunok P, Galen E, Kowdley KV, Rustgi V, Aguilar H, Felizarta F, McGovern B, King M, Polepally AR, Cohen DE. Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine. J Hepatol. 2015 Aug;63(2):364-9. doi: 10.1016/j.jhep.2015.03.029. Epub 2015 Apr 1.

  PMID: 25839406 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

paritaprevir; ombitasvir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Dan Cohen, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: July 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: May 30, 2018
• Results First Posted: January 6, 2015

Record last verified: 2015-08