An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peg-IFN Alfa-2b; Drug: Peg-IFN Alfa-2a; Drug: Boceprevir; Drug: Ribavirin; Drug: Telaprevir

Study type: Observational

Funder types: Industry

Identifiers

NCT01447446

MV25599

Details and patient eligibility

About

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

Enrollment: 4,442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (according to local legislation) participants
• Chronic hepatitis C (HCV)
• Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
• Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion criteria

• Contraindications according to SPC/local labeling
• Treatment started >4 weeks before entering study

Trial design

4,442 participants in 6 patient groups

Dual Therapy: Peg-IFN Alfa-2a + Ribavirin

Description:

Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a \[peg-IFN Alfa-2a\] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Peg-IFN Alfa-2a

Drug: Ribavirin

Dual Therapy: Peg-IFN Alfa-2b + Ribavirin

Description:

Participants with CHC receiving dual therapy (pegylated interferon alfa-2b \[peg-IFN Alfa-2b\] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Peg-IFN Alfa-2b

Drug: Ribavirin

Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin

Description:

Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Boceprevir

Drug: Peg-IFN Alfa-2a

Drug: Ribavirin

Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin

Description:

Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Boceprevir

Drug: Peg-IFN Alfa-2b

Drug: Ribavirin

Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin

Description:

Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Telaprevir

Drug: Peg-IFN Alfa-2a

Drug: Ribavirin

Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin

Description:

Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Treatment:

Drug: Telaprevir

Drug: Peg-IFN Alfa-2b

Drug: Ribavirin