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.


METHODS
Prospective 36 months cohort study of patients switched to zidovudine/stavudine plus didanosine plus lopinavir/ritonavir capsules as second-line regimen.


METHODS
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 108 cell/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 (<400 copies/ 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.
Castelnuovo
Barbara
B
Infectious Diseases Institute, Kampala, Uganda. bcastelnuovo@idi.co.ug
John
Laurence
L
Lutwama
Fred
F
Ronald
Allan
A
Spacek
Lisa A
LA
Bates
Michael
M
Kamya
Moses R
MR
Colebunders
Robert
R
D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006678:HIV / Q000187:drug effects / Q000235:genetics; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007407:Interviews as Topic; D061466:Lopinavir; D008297:Male; D011446:Prospective Studies; D011744:Pyrimidinones / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D019438:Ritonavir / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D018119:Stavudine / Q000494:pharmacology / Q000592:standards* / Q000627:therapeutic use; D016896:Treatment Outcome; D014454:Uganda; D019562:Viral Load; D015215:Zidovudine / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use
D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D011744:Pyrimidinones; D061466:Lopinavir; D015215:Zidovudine; D018119:Stavudine; D016049:Didanosine; D019438:Ritonavir