An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic

• Study Type: Observational
• Enrollment (Actual): 991

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Haemek Hospital; Gastroenterology
  • Ashkelon, Israel, 78278
    • Barzilai MC; Gastroenterology
  • Beer Sheva, Israel, 84105
    • Soroka Medical Center; Gastroenterology
  • Hadera, Israel, 38100
    • Hillel Yaffe Hospital; Gastroenterology
  • Haifa, Israel, 31096
    • Rambam Medical Center; Gastroenterology - Liver Unit
  • Haifa, Israel, 33394
    • Bnei-Zion Medical Center; Gastroenterology
  • Haifa, Israel, 34362
    • Carmel Hospital; Liver Unit
  • Holon, Israel, 58100
    • Wolfson Hospital; Gastroenterology Unit
  • Jerusalem, Israel, 91031
    • Shaare Zedek Hospital Liver Unit; Liver Unit
  • Jerusalem, Israel, 91120
    • Hadassah Hospital; Liver Unit
  • Kfar Saba, Israel, 44281
    • Meir Medical Center; Liver Unit
  • Nahariya, Israel, 22100
    • Western Galilee Hospital - Nahariya
  • Nazareth, Israel
    • Holy Family Medical Center; Liver Unit
  • Petach Tikva, Israel
    • Hasharon Mc; Gastroenterology
  • Petah Tiqwa, Israel
    • Beilinson-Rabin Liver Unit; Liver Unit
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center; Tel Hashomer
  • Rehovot, Israel, 76100
    • Kaplan Medical Center; Gastroenterology Unit
  • Safed, Israel, 13110
    • Rebecca Sieff Medical Center; Liver Unit
  • Tel Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Center; Liver Unit
  • Tiberias, Israel
    • Poria Hospital; Gastroenterology
  • Zerifin, Israel, 6093000
    • Assaf Harofeh; Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic hepatitis C patients initiating Pegasys-based treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Viral Response (SVR) at 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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of SVR at Week 24	SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.	Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics	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. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.	Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	RVR was defined as HCV-RNA <50 IU/mL by Week 4	Week 4
Percentage of Participants With Extended RVR	Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.	Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR)	Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12	Week 12
Percentage of Participants With End of Treatment Response (EoT)	End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.	Week 24
Percentage of Participants With Virologic Relapse	Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.	Week 72
Treatment Duration	The average amount of time a treatment was prescribed to participants.	Week 48
Time to First Dose Modification of Peginterferon Alfa-2a		Week 48
Time to First Dose Modification of Ribavirin		Week 48
Time to First Dose Modification of Telaprevir/Boceprevir		Week 48
Percentage of Participants With Adverse Events (AEs)	Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.	Week 48
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia		Week 48
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia		Week 48
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications	Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.	Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Clalit Health Services

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2012
• Primary Completion (Actual): February 10, 2016
• Study Completion (Actual): February 10, 2016

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: ML28268

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No