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

Merck Sharp & Dohme LLC1,146 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,146

Conditions

Hepatitis C, Chronic Hepatitis C

Interventions

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

PegIntron administered in accordance with approved labeling

Rebetol (ribavirin; SCH 18908)DRUG

Rebetol administered in accordance with approved labeling

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment

Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.

Time frame: Assessed at Treatment Week 4

Secondary Outcomes

Number of Participants Who Achieved Sustained Virologic Response (SVR)

SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.

Time frame: Assessed at 24 weeks post-treatment

Number of Participants With RVR Who Also Achieved SVR

RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.

Time frame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)

Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR

Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.

Time frame: Treatment Week 48 and Treatment Week 72

Assessment of Baseline Characteristics in Participants With SVR

Baseline characteristics assessed were age, gender, and genotype.

Time frame: 24 Weeks post-treatment

Data from ClinicalTrials.gov

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