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Safety and efficacy of an induction dose of pegylated interferon alpha‐2a on early hepatitis C virus kinetics in HIV/HCV co‐infected patients: the CORAL‐1 multicentre pilot study
Author(s) -
Tural C.,
Solà R.,
Rubio R.,
Santín M.,
Planas R.,
Quereda C.,
Berenguer J.,
MontesRamírez M.,
Clotet B.
Publication year - 2007
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.2007.00860.x
Subject(s) - pegylated interferon , ribavirin , medicine , hepatitis c virus , population , hepatitis c , gastroenterology , human immunodeficiency virus (hiv) , interferon , virus , immunology , environmental health
summary . To evaluate the safety and efficacy of an induction dose of pegylated interferon alpha 2a (IFN‐ α 2a) on the 12‐week hepatitis C virus (HCV) kinetics in human immunodeficiency virus (HIV) patients co‐infected with HCV. One hundred sixteen HIV/HCV co‐infected patients from nine hospitals in Spain were randomized to receive 270 μ g/week of pegylated IFN‐ α 2a for 4 weeks followed by 180 μ g/week for 8 weeks or 180 μ g/week for 12 weeks. Ribavirin was given at a daily dose of 1000 or 1200 mg. The main outcome measure was the percentage of patients achieving an HCV‐RNA below 50 IU/mL or a decrease of 2 or more log 10 at week 12 (early virologic response, EVR). HCV‐RNA was measured at baseline, weekly, for the first 4 weeks and monthly thereafter. We observed no difference in the percentage of patients achieving an EVR between arms (on‐treatment, 74% in both arms; intention‐to‐treat, 70% in the induction arm and 67% in the control arm), nor were there differences in the percentage achieving an undetectable HCV qualitative polymerase chain reaction at any time points or in the decrease in HCV‐RNA from baseline. No differences were found between arms in the percentage of dropouts (8% in the whole study population). Our study failed to find a benefit of an induction dose of 270 μ g/week of pegylated IFN‐ α 2a for 4 weeks on the EVR in co‐infected patients who are treatment naive. Despite the lack of benefit with this regimen, induction therapy with this schedule was safe and well tolerated in co‐infected patients.