Safety and effectiveness of lopinavir/ritonavir twice-daily in cART naïve patients with HIV-1 infection: Data from POLCA Study Group

BackgroundDespite an increase in number of new drugs in the last few years, the clinical options are limited due to cross resistance and adverse effects of cART. We explored reasons for treatment discontinuation and effectiveness of first-line LPV/r containing regimen.MethodsThe study is a retrospective analysis of data collected in POLCA cohort study. Patients were cART naïve and continued LPV/r based regimen for 24 months. Effectiveness analyses included CD4 count and proportion of patients with durable HIV VL suppression. Safety analyses included changes in selected parameters: metabolic (total cholesterol, LDL, HDL, triglycerides, glucose), hepatic (ALT, AST, GGT, total bilirubin) and renal (creatinine, urea).ResultsThe median CD4 count increased at all time points till 24 months and the largest difference was in group with CD4 < 100 cells/μl at baseline. After 24 months from starting cART 60.8% of patients achieved HIV RNA below 40 copies/ml. Twenty patients (10.6%) developed virological failure.Substantial part of patients had abnormal lipid tests results: TCh, HDL-ch, LDL-ch, TG before starting cART (21%, 29%, 40%, 46%, respectively). An increasing proportion of abnormal results of TCh and TG have been observed during cART with only 41% and 46% of normal results at 24 months. Serum creatinine level was normal in approximately 91% patients at baseline and proportion decreased to 86% between 12 and 24 months of treatment.ConclusionIn POLCA cohort 24 months treatment with LPV/r-based regimen was safe and effective. Gastrointestinal side effects and lipids disorders were quite common but rarely led to treatment discontinuation.