Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427) (APEGIN)

Merck Sharp & Dohme (MSD)

Status

Completed

Conditions

Hepatitis C, Chronic

Hepatitis C

Treatments

Biological: PegIntron (peginterferon alfa-2b; SCH 54031)

Drug: Rebetol (ribavirin; SCH 18908)

Study type

Observational

Funder types

Industry

Identifiers

NCT00724854

001/05

P05427

Details and patient eligibility

About

The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).

Enrollment

1,146 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to participate in the study and sign the Informed Consent Form
Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)
Can be treatment-naïve, have retreatment, or co-infected with HIV
Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit

Exclusion criteria

Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
Prior treatment with PegIntron (combined with ribavirin or not)
History of alcohol abuse in the past 6 months
Decompensated liver disease
Severe heart disease
Decompensated thyroid disorder
Neoplasia
Type 1 diabetes mellitus - uncontrolled or hardly controlled
Seizures - uncontrolled
Primary immune deficiency
Men and women not using appropriate contraceptive methods
Pregnancy or lactation
For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm^3