Tenofovir DF (TDF) in Combination with Lamivudine (3TC) and Efavirenz (EFV) in Antiretroviral-Naïve HIV-Infected Patients: a 4-Year Follow-Up
Joel Gallant (Johns Hopkins) reported these study results in a poster at IAS-Rio (July 2005).
Study 903 is a Phase III trial with an ongoing 96-week open-label
extension phase and a completed 144-week randomized, double-blind
phase designed to evaluate TDF compared to stavudine (d4T) in
combination with 3TC and EFV in antiretroviral-naïve patients. Data obtained from patients originally randomized to TDF and participating in 903E were analyzed.
Patient Disposition Through Week 192
--86 patients enrolled in Study 903 open-label extension phase and
continued treatment with TDF
--3 patients discontinued from the study prior to Week 192
- 1 patient discontinued due to adverse event (Grade 3 amylase/
Grade 4 lipase)
- 1 patient discontinued due to pregnancy
- 1 patient withdrew consent
--No patient reported Fanconi syndrome
--No patient discontinued due to renal abnormalities
RESULTS
--Once daily TDF+3TC+EFV demonstrated sustained antiretroviral activity and was well tolerated through 4 years of therapy in antiretroviral-naïve patients (87% <50 copies/ml through wk 192, ITT M=F; mean increase in CD4: +391)
--Limb fat measurement remained stable from Week 96 to Week 192
--Mean decreases from baseline in hip and spine BMD occurred in the first 48 weeks (-3.3%) but after week 48 this analysis reports no further progression.
