Real-life effectiveness and safety of lopinavir/ritonavir in HIV-infected adults who experienced prior different antiretroviral treatments

2008 
of results Of the 142 patients enrolled, 47.2% had not received any previous ARV treatment (ARV-naive), 19.0% have not been treated with PI-based regimen (PI-naive), and 31.7% have been exposed to PI-based regimen with the exception of lopinavir/ritonavir (PI-experienced). The mean (SD) age was 44.6 (9.5) years, 123 (86.6%) were male and 109 (76.8%) were Caucasian. The mean (SD) duration of HIV disease was 4.3 (0.7) years. Of the 35 (25.6%) patients discontinued, 13 withdrew due to adverse event (AE). The virologic results after 48 weeks of treatment are available for 106 patients (53 ARV-naive; 19 PI-naive; 34 PI-non-naive). There were 34 (64.2%) ARV-naive, 14 (73.7%) PI-naive, and 22 (64.7%) PI-experienced patients with HIV-RNA viral load 6 protease resistance mutations. At the time of the analysis, there were 171 AEs probably/possibly related to lopinavir/ritonavir reported by 70 out of 142 patients, 29 ARVnaive, 16 PI-naive and 25 PI-experienced patients. Hypercholesterolemia was reported by one ARV-naive and one PI-experienced patient who were not receiving lipid-lowering agents. Of the 17 serious AEs reported by three ARVnaive and four PI-experienced patients, 12 were probably not/not related to study drug and none led to discontinuation.
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