Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

NCT02615145 | Completed Results

• 1 other identifier: P15-398
• Study Type: observational
• Target: 472
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Dasabuvir; Ombitasvir+Paritaprevir+Ritonavir; Observational Study; Quality of life; Work-ability; Fibrosis; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response (SVR12)

  SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (\< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.

  12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)

Secondary Outcomes (15)

• Percentage of Participants With Virological Response at End of Treatment (EoTR)

  EoT, (treatment period was 12 weeks or 24 weeks)

• Number of Participants With On-Treatment Virological Failure or Relapse

  Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)

• Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)

  Week 4

• Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)

  24 Weeks After EoT (treatment period was 12 or 24 weeks)

• Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)

  48 Weeks After EoT (treatment period was 12 or 24 weeks)

Study Arms (3)

Genotype 1a (G1a) Participants

Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 1b (G1b) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 \[G4\]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 4 (G4) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes 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

Chronic Hepatitis C (CHC)

You may qualify if:

• Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label.
• If RBV is co-administered with the ABBVIE REGIMEN, 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:

• Adolescents; people not treated according to label

Sponsors & Collaborators

• AbbVie: lead

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; Fibrosis

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: November 24, 2015
• First Posted: November 26, 2015
• Study Start: December 3, 2015
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-01