Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Biological: PegIFN-2b; Drug: Ribavirin

Study type: Observational

Funder types: Industry

Identifiers

NCT00724893

P04423

MK-4031-267 (Other Identifier)

Details and patient eligibility

About

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.

Enrollment: 2,430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve patients with chronic hepatitis C
• Adults (>18 years of age)
• Prescribed Pegetron Redipen
• Must meet all requirements for treatment with Pegetron Redipen
• Must be able to obtain reimbursement of medication through private or provincial coverage

Exclusion criteria

• Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
• HIV antibody positive
• Post liver transplant patients
• Any other exclusion criteria as per the product Monograph

Trial design

2,430 participants in 2 patient groups

Stage 1 Participants

Description:

Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.

Treatment:

Drug: Ribavirin

Biological: PegIFN-2b

Stage 2 Participants

Description:

Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.

Treatment:

Drug: Ribavirin

Biological: PegIFN-2b