Chronic Hepatitis C Clinical Trial
Official title:
Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4
To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C
virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C
patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD)
180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according
to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200
mg/day, according to body weight).
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to
week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR
= RNA - HCV undetectable at 4 week).
The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin
exposure seems to be crucial to maximize sustained virological response and minimize the
incidence of relapses after treatment discontinuations.
Recent reports showed that it is beneficial to extend the treatment duration in patients
without rapid virological response at 4 weeks (RNA-HCV < 50 UI/ml).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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