Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania

NCT02807402 | Completed Results

• 1 other identifier: P15-698
• Study Type: observational
• Target: 522
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Paritaprevir; Ombitasvir; Dasabuvir; HCV

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

  Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Secondary Outcomes (20)

• Percentage of Participants Achieving Virological Response at End of Treatment

  End of treatment (week 12 or 24 depending on the treatment regimen)

• Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

• Percentage of Participants With Relapse

  End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

• Percentage of Participants With Breakthrough

  12 or 24 weeks (depending on the treatment regimen)

• Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Study Arms (1)

Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin

Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.

Eligibility Criteria

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

Study Population

Clinical practice patient populations with chronic infection of HCV Genotype 1 (GT1)

You may qualify if:

• Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label
• If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

You may not qualify if:

• None

Sponsors & Collaborators

• AbbVie: lead
• IST GmbH, Germany: collaborator

Related Publications (1)

• Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

  PMID: 30739368 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 21, 2016
• Study Start: July 14, 2016
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08