14th International AIDS Conference


Barcelona, Spain — July 7-12, 2002
[TITLE:] Efficacy and safety of tenofovir disoproxil fumarate (TDF) versus stavudine (d4T) when used in combination with lamivudine (3TC) and efavirenz (EFV) in HIV-1 infected patients naiuml;ve to antiretroviral therapy (ART): 48-week interim results

[AUTHOR(S):] S Staszewski, J Gallant, A Pozniak3, JMAH Suleiman, E DeJesus, E Koenig, S Coleman, B Lu, AK Cheng

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbOr17

BACKGROUND: TDF is a single tablet, once daily nucleotide analog reverse transcriptase inhibitor with potent activity against wild-type and nucleoside resistant HIV. Prior studies have demonstrated significant anti-HIV activity when TDF was added to stable background ART in treatment-experienced patients. Study 903 was designed to evaluate the efficacy and safety of TDF as part of a fixed ART regimen in antiretroviral naïve patients over a 3-year period.

METHODS: Phase III, multicenter, randomized, double-blind, active-controlled trial in patients with HIV-1 RNA > 5,000 copies/mL with no requirement for entry CD4+ lymphocyte cell count. Patients were randomized to receive either TDF (300mg qd) or d4T (40mg bid or 30mg bid if weight < 60kg) plus 3TC (150mg bid) and EFV (600mg qd). Patients randomized to TDF received d4T placebo bid while those randomized to d4T received TDF placebo once daily.

RESULTS: The intent-to-treat (ITT) population included 600 patients with the following baseline characteristics: mean age 36 years, 76% male, 64% Caucasian, mean HIV-1 RNA 4.9 log10 c/mL; mean CD4 count 279 cells/mm3. Data from a week 48 interim analysis are shown below.

TDF/3TC/EFV d4T/3TC/EFV
(n=299) (n=301) 95% CI*
HIV RNA <400c/mL (ITT)
missing equals failure 87% 87% -6,+5
missing values excluded 95% 96% -4, +2
HIV RNA <50c/mL (ITT)
missing equals failure 82% 81% -6, +6
missing values excluded 90% 89% -4, +5
Mean change in HIV RNA (log10 c/mL) -3.09 -3.09
Mean change CD4 cell count (cell/mm3) +169 +167
Study discontinuation (d/c) 9% 9%
Drug regimen d/c for adverse events 7% 6%
≥ Grade 3 adverse events 19% 17%
≥ Grade 3 laboratory abnormality 29% 32%

*For difference in TDF arm - d4t arm.

CONCLUSIONS: Through 48 weeks, combination therapy with TDF was highly effective and comparable to d4T for safety and efficacy in ART-naïve patients.

Presenting author: S Staszewski

020707
LbOr17

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.