This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Study Type
OBSERVATIONAL
Enrollment
262
180 micrograms/week sc for 24 weeks
800mg po daily for 24 weeks
Unnamed facility
Vitória, Espírito Santo, Brazil
Unnamed facility
Brasília, Federal District, Brazil
Unnamed facility
São Luís, Maranhão, Brazil
Unnamed facility
Rio de Janeiro, Rio de Janeiro, Brazil
Unnamed facility
Porto Alegre, Rio Grande do Sul, Brazil
Unnamed facility
Porto Alegre, Rio Grande do Sul, Brazil
Unnamed facility
Campinas, São Paulo, Brazil
Unnamed facility
Campinas, São Paulo, Brazil
Unnamed facility
Ribeirão Preto, São Paulo, Brazil
Unnamed facility
Santo André, São Paulo, Brazil
...and 2 more locations
Percentage of Participants With Sustained Virological Response at Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Time frame: At Week 48
Percentage of Participants With Rapid Virological Response at Week 4
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
Time frame: At Week 4
Percentage of Participants With Virological Response at Week 24
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Time frame: At Week 24
Percentage of Participants With Virological Relapse
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Time frame: At week 48
Percentage of Participants With Positive Predictive Value
Positive predictive value is defined as participants with RVR who did not achieve SVR.
Time frame: At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: Up to 48 weeks
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Time frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 48
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