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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
2000 mg/day
1000-1200 mg/day
Peginterferon alfa-2a 180 mcg/week
epoetin beta 450 UI/week
Hospital Juan Canalejo
A Coruña, A Coruña, Spain
NOT_YET_RECRUITINGHospital Txagorritxu
Vitoria-Gasteiz, Alava, Spain
NOT_YET_RECRUITINGHospital de Albacete
Albacete, Albacete, Spain
NOT_YET_RECRUITINGHospital General de Elche
Elche, Alicante, Spain
NOT_YET_RECRUITING% patients with RNA-HCV < 50 UI/ml
Time frame: 24 weeks after the end of treatment
% patients with RNA-HCV < 50 UI/ml
Time frame: 4 weeks on treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
NOT_YET_RECRUITINGHospital Santa Creu y Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGHospital Parc Taulí
Sabadell, Barcelona, Spain
NOT_YET_RECRUITINGHospital General de Jerez de la Frontera
Jerez de la Frontera, Cadiz, Spain
NOT_YET_RECRUITINGHospital Marqués de Valdecilla
Santander, Cantabria, Spain
NOT_YET_RECRUITINGHospital General de Fuerteventura
Puerto del Rosario, Fuerteventura, Spain
NOT_YET_RECRUITING...and 30 more locations