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

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
* Drug: Rebetol (ribavirin; SCH 18908)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mono-infected with HCV<br>Participants infected with Hepatitis C Virus (HCV). | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* PegIntron administered in accordance with approved labeling<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* Rebetol administered in accordance with approved labeling<br>* Other names: SCH 18908;|
| Co-infected with HCV and HIV<br>Participants co-infected with HCV and Human Immunodeficiency Virus (HIV). | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* PegIntron administered in accordance with approved labeling<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* Rebetol administered in accordance with approved labeling<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed at Treatment Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. | 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. | 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. | Treatment Week 48 and Treatment Week 72 | 
| Assessment of Baseline Characteristics in Participants With SVR | Baseline characteristics assessed were age, gender, and genotype. | 24 Weeks post-treatment |