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

Completed

• Conditions: Hepatitis C; Hepatitis C, Chronic
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

• Registration Number: NCT00724854
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-12-23
• Results First Submitted QC: 2010-12-23
• Results First Posted: 2011-01-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1146

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Co-infected with HCV and HIV	Rebetol (ribavirin; SCH 18908)	Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
Mono-infected with HCV	PegIntron (peginterferon alfa-2b; SCH 54031)	Participants infected with Hepatitis C Virus (HCV).
Mono-infected with HCV	Rebetol (ribavirin; SCH 18908)	Participants infected with Hepatitis C Virus (HCV).
Co-infected with HCV and HIV	PegIntron (peginterferon alfa-2b; SCH 54031)	Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment	Assessed at Treatment Week 4	Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
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	Treatment Week 48 and Treatment Week 72	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.
Number of Participants Who Achieved Sustained Virologic Response (SVR)	Assessed at 24 weeks post-treatment	SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
Number of Participants With RVR Who Also Achieved SVR	Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (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.
Assessment of Baseline Characteristics in Participants With SVR	24 Weeks post-treatment	Baseline characteristics assessed were age, gender, and genotype.