Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

Merck Sharp & Dohme LLC267 enrolled

Overview

Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Study Type

OBSERVATIONAL

Enrollment

267

Conditions

Hepatitis C, Chronic Hepatitis C

Interventions

PegIntron pen (peginterferon alfa-2b; SCH 54031)BIOLOGICAL

PegIntron administered in accordance with approved labeling.

Rebetol administered in accordance with approved labeling

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment-naïve patients with hepatitis C * Patients treated with PegIntron pen and Rebetol * Patients receiving patient assistance program Exclusion Criteria: * Not applicable

Outcomes

Primary Outcomes

Number of Subjects Who Completed Treatment.

Time frame: Assessed at the end of the 48-week treatment.

Secondary Outcomes

Average Length of Treatment.

Time frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.

Data from ClinicalTrials.gov

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