ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)

Merck Sharp & Dohme LLC902 enrolled

Overview

This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Study Type

OBSERVATIONAL

Enrollment

902

Conditions

Hepatitis C, Chronic

Peginterferon alfa-2bBIOLOGICAL

PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.

RibavirinDRUG

Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC). * Adult patients who are 18 years old or above. * Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records. * Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. * Patients who started treatment for chronic hepatitis C from the year 2008 or later. Exclusion Criteria: * Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form. * Did not start the treatment with peginterferon alfa-2b and ribavirin. * Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.

Outcomes

Primary Outcomes

Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks

The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.

Time frame: First 12 weeks of treatment

Secondary Outcomes

Percent of Participants Who Achieved Rapid Virologic Response (RVR)

RVR was defined as HCV RNA negative after 4 weeks of treatment.

Time frame: Week 4

Percent of Participants Who Achieved Early Virologic Response (EVR)

EVR was defined as HCV RNA negative after 12 weeks of treatment.

Time frame: Week 12