Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

NCT02399345 | Completed Phase 3 Results

• 2 other identifiers: M15-3102014-005280-32
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Conditions

Chronic Hepatitis C Virus (HCV Infection Genotype 1)

Keywords

Treatment naive; Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) 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 quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (2)

• Percentage of Subjects With On-treatment Virologic Failure

  6 weeks

• Percentage of Subjects With Post-treatment Relapse

  Up to 12 weeks after last actual dose of active study drug

Study Arms (1)

Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV

EXPERIMENTAL

Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.

Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir; Drug: sofosbuvir (SOF); Drug: ribavirin (RBV)

Interventions

ombitasvir/paritaprevir/ritonavir, dasabuvir DRUG

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

Also known as: Viekira PAK, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, dasabuvir also known as ABT-333

Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV

sofosbuvir (SOF) DRUG

tablet

Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV

ribavirin (RBV) DRUG

tablet

Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age at time of screening
• Chronic Hepatitis C virus (HCV) infection prior to study enrollment
• Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
• Absence of cirrhosis and advanced bridging fibrosis

You may not qualify if:

• Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
• Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
• Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score \> 2 or an Ishak score \> 3
• Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
• Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related info.

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Viekira Pak; ombitasvir; paritaprevir; dasabuvir; Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; 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)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Eric 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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10