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

• Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]
  SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
• Number of Participants With RVR Who Also Achieved SVR [ Time Frame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) ] [ Designated as safety issue: No ]
  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.
• 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 [ Time Frame: Treatment Week 48 and Treatment Week 72 ] [ Designated as safety issue: No ]
  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.
• Assessment of Baseline Characteristics in Participants With SVR [ Time Frame: 24 Weeks post-treatment ] [ Designated as safety issue: No ]
  Baseline characteristics assessed were age, gender, and genotype.

• Sustained virologic response in the 3 study groups [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]
• Assessment of rapid virological response as predictor of sustained virological response in the three study groups [ Time Frame: Assessed at Treatment Week 4 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
• Assessment of response at Weeks 48 or 72 and its relationship with rapid response at Treatment Week 4 for each group of patients [ Time Frame: Assessed at Treatment Week 4 and, depending on the patient's HCV genotype, either at Treatment Week 48 or Treatment Week 72 ] [ Designated as safety issue: No ]
• Assessment of baseline characteristics (gender, age, group and genotype) as predictors of sustained virologic response [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]

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).

Participants infected with Hepatitis C Virus (HCV) who are undergoing treatment with PegIntron and Rebetol in accordance with approved labeling at approximately 60 sites in Brazil. Participants could be treatment-naïve, undergoing re-treatment, or co-infected with Human Immunodeficiency Virus (HIV).

• Hepatitis C, Chronic
• Hepatitis C

• Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
  PegIntron administered in accordance with approved labeling
  Other Name: SCH 54031
• Drug: Rebetol (ribavirin; SCH 18908)
  Rebetol administered in accordance with approved labeling
  Other Name: SCH 18908

• Mono-infected with HCV
  Participants infected with Hepatitis C Virus (HCV).
  Interventions:

  • Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
  • Drug: Rebetol (ribavirin; SCH 18908)
• Co-infected with HCV and HIV
  Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
  Interventions:

  • Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
  • Drug: Rebetol (ribavirin; SCH 18908)

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