Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

Hoffmann-La Roche21 sites in 1 country991 target enrollmentMay 28, 2012

ConditionsHepatitis C, Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Enrollment: 991
Locations: 21
Primary Endpoint: Percentage of Participants With Sustained Viral Response (SVR) at Week 24
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Registry

clinicaltrials.gov

Start Date

May 28, 2012

End Date

February 10, 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
•Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
•No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
•Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria

•Hepatitis A/B co-infection
•Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
•Pregnant or breast-feeding women

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Viral Response (SVR) at Week 24

Time Frame: Week 24

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

Secondary Outcomes

Percentage of Participants With Extended RVR(Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group)
Time to First Dose Modification of Peginterferon Alfa-2a(Week 48)
Percentage of Participants With End of Treatment Response (EoT)(Week 24)
Treatment Duration(Week 48)
Time to First Dose Modification of Ribavirin(Week 48)
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications(Week 24)
Comparison of SVR at Week 24(Week 24)
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4(Week 4)
Time to First Dose Modification of Telaprevir/Boceprevir(Week 48)
Number of Participants With SVR at Week 24 According to the Demographic Characteristics(Week 24)
Percentage of Participants With Complete Early Virologic Response (cEVR)(Week 12)
Percentage of Participants With Virologic Relapse(Week 72)
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia(Week 48)
Percentage of Participants With Adverse Events (AEs)(Week 48)
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia(Week 48)