Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

Hepatitis C Clinical Trial

Official title:

A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724464
• Other study ID #: P05209
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 16, 2015
• Start date: December 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who have already begun Summary of Product Characteristics (SmPC)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.

• Participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.

• Participants who have achieved negative HCV RNA at the end of treatment, defined according to genotype (24 weeks for HCV genotypes 2/3 and 48 weeks for genotypes 1/4).

• Participants with diagnosed chronic hepatitis C (CHC) and HCV genotype 1, 2, 3 or 4.

• Participants older than 18 years, regardless of gender or race.

Exclusion Criteria:

• The participant has received treatment for CHC in the past (not treatment-naive).

• The participant has received treatment in the context of a clinical trial in the participating site.

• The participant has been diagnosed with a concomitant infection e.g. with hepatitis B or HIV

• The participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.

• The participant has positive HCV RNA at the end of treatment.

• Pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the SmPC of Rebetol.

• The participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the SmPC.

• The participant has interrupted treatment for any reason.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 µg/kg/week subcutaneously in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.

Drug:
• Rebetol (ribavirin)
Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up	Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Primary	Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up	Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response	SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).	24 weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule	SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.	24 weeks following completion of 24 or 48 weeks of therapy	No