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Six year safety and efficacy of tenofovir DF (TDF) in combination with lamivudine (3TC) and efavirenz (EFV) in antiretroviral-naïve patients
Presented by Jose Valdez Madruga, Brazil.
Madruga J.V.1, Cassetti I.2, Koenig E.3, Etzel A.4, Zhou Y.5, Cheng A.5, Enejosa J.5, 903E Study Team
1Centro de Referencia e Treinamento DST/AIDS, São Paulo, Brazil, 2Fundacion Centro Estudios Infectologicos, Buenos Aires, Argentina, 3Instituto Dominicano de Estudios Virologicos, Santo Domingo, Dominican Republic, 4Hospital Guilherme Álvaro, Santos, Brazil, 5Gilead Sciences, Foster City, CA, United States
Objectives: Study 903 is a Phase III trial with a 3 year, double-blind phase comparing TDF to d4t in combination with 3TC and EFV. In the study, TDF was associated with durable efficacy, better lipid profiles and less lipodystrophy. Study 903E is the ongoing open-label extension phase evaluating up to 10 year safety and efficacy of a once-daily TDF+3TC+EFV regimen.
Methods: All patients in Argentina, Brazil, and the Dominican Republic who completed the double-blind phase were eligible to roll over to Study 903E and receive a once-daily regimen of open-label TDF+3TC+EFV.
Results: 86 patients (62% male, 70% white, mean age 33 yrs) continued treatment with TDF. At study initiation, mean HIV RNA was 4.9 log10 c/mL and mean CD4 count was 299 cells/mm3. At year 6, 83% (M=F) had HIV RNA <400 c/mL and 80% (M=F) had HIV RNA<50 c/mL; mean CD4 cell increase from baseline (BL) was 413 cells/mm3. 12 patients discontinued study: 1 due to adverse event (elevated amylase/lipase), 3 due to virologic failure. No patient developed K65R mutation. Mean change from BL in glomerular filtration rate (GFR) by Cockcroft-Gault was +7 mL/min. No patient discontinued due to renal adverse events. Decreases in spine and hip bone mineral density (BMD) by dual energy x-ray absorptiometry were seen in the first year and remained stable (mean change from BL at year 6 in BMD was -1.7% in spine and -3.3% in hip). No patient sustained pathologic fractures. Mean limb fat was 8.0 kg at year 2 and increased to 8.8 kg at year 6.
Conclusions: Through 6 years of therapy, the once-daily regimen of TDF+3TC+EFV demonstrated sustained antiretroviral activity with continued immunologic recovery in antiretroviral-naïve patients and was not associated with limb fat loss or progressive bone loss, nor was it associated with declines in estimated GFR.
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