title: HAART simplification with lopinavir/ritonavir monotherapy in HIV/HCV co-infected patients starting anti-HCV treatment: a randomised pilot study (KaMon study).
abstract: 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.
authors.affiliation: Department of Infectious Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.
authors.forename: Hamid
authors.initials: H
authors.lastname: Hasson
authors.forename: Laura
authors.initials: L
authors.lastname: Galli
authors.forename: Giulia
authors.initials: G
authors.lastname: Gallotta
authors.forename: Valentina
authors.initials: V
authors.lastname: Neri
authors.forename: Perluigi
authors.initials: P
authors.lastname: Blanc
authors.forename: Marco
authors.initials: M
authors.lastname: D'Annunzio
authors.forename: Giulia
authors.initials: G
authors.lastname: Morsica
authors.forename: Salvatore
authors.initials: S
authors.lastname: Sollima
authors.forename: Marco
authors.initials: M
authors.lastname: Merli
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Caterina
authors.initials: C
authors.lastname: Uberti-Foppa
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D060085:Coinfection / Q000188:drug therapy* / Q000821:virology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology; D016174:Hepacivirus / Q000187:drug effects / Q000502:physiology; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D061466:Lopinavir / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D019438:Ritonavir / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D061466:Lopinavir; D019438:Ritonavir