Three-Year Outcome Data of Second-Line Antiretroviral Therapy in Ugandan Adults: Good Virological Response but High Rate of Toxicity

Objective: To evaluate the safety and virological response to lopinavir/ritonavir containing second-line therapy after failing a first line nonnucleoside reverse transcriptase inhibitor NNRTI) based regimen. Design. Prospective 36 months cohort study of patients switched to zidovudine/stavudine plusdidanosine plus lopinavir/ritonavir capsules as second-line regimen. Methodology. Structured interview medical examination and laboratory assessment performed every 6 months. Results. We enrolled 40 patients; 1 died and 3 were lost to follow-up. Median CD4+count at baseline was 108cell/microL median log viral load was 4.8 copies/mL. Sixteen (40%) patients had baseline genotypic resistant test 14 (87%) had lamivudine resistance mutations and all had NNRTIs resistance mutations. At month 36 82% of the patients achieved viral suppression (<400copies/mL) and the median increase in CD4+count was 214 cell/microL (interquartile range: 128-295). Twenty-five patients (62%) experienced at least one adverse event. Conclusions. Our study confirms lopinavir/ritonavir-based second-line regimen but with a high rate of toxicities.