Hasson Hamid, Galli Laura, Gallotta Giulia, Neri Valentina, Blanc Perluigi, D'Annunzio Marco, Morsica Giulia, Sollima Salvatore, Merli Marco, Lazzarin Adriano, Uberti-Foppa Caterina
Department of Infectious Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.
New Microbiol. 2012 Oct;35(4):469-74. Epub 2012 Oct 1.
The aim of this randomised, prospective, open-label, multicentre pilot clinical trial was to compare the 48-week toxicity profile of lopinavir/ritonavir (LPV/r) monotherapy with LPV/r-based HAART (KaMon = Kaletra monotherapy) in HIV/HCV patients undergoing HCV treatment. The study involved 30 HIV/HCV co-infected patients naive to anti- HCV therapy. One patient in each arm (6.7%) discontinued anti-HCV therapy because of adverse events. There were no significant between-group differences in terms of the proportion of patients experiencing AEs (p=0.999) or the number of grade 3-4 AEs (p=0.146). No HIV failure was observed. The safety profile of LPV/r monotherapy was similar to that of LPV/r-based HAART, thus encouraging HAART simplification in patients receiving anti-HCV treatment.