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The Safety and Efficacy of Tenofovir DF (TDF) in
Combination with Lamivudine (3TC) and Efavirenz (EFV) in Antiretroviral-Naive Patients Through Seven Years
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Reported by Jules Levin
IAC Mexico City Aug 3-8, 2008
I Cassetti,1 JVR Madruga,2 A Etzel,3 J Suleiman,4 Y Zhou,5 AK Cheng,5 and J Enejosa5 for the 903E Study Team. 1Fundacion Centro Estudios Infectologicos, Buenos Aires, Argentina; 2Centro de Referencia e Treinamento DST/AIDS, Sao Paulo, Brazil; 3Hospital Guilherme ēlvaro, Santos, Brazil; 4Brasilmed Assistencia Medica e Pesquisas, Sao Paulo, Brazil; 5Gilead Sciences, Inc., Foster City, CA, USA
BACKGROUND
Study 903 is a Phase III trial with an ongoing 336-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-naive patients
METHODS
Study 903 inclusion/exclusion criteria:
- HIV-infected patients naive to antiretroviral treatment, 18-65 years of age, with plasma HIV RNA > 5,000 copies/mL (c/mL)
- No significant laboratory or clinical abnormalities
- No CD4+ cell count criteria Patients in select sites (Argentina, Brazil, and Dominican Republic) rolled-over into
a 7-year (336-week) open-label extension phase (903E)
Data obtained from patients originally randomized to TDF and participating in 903E were analyzed
Patient Disposition Through 7 Years
86 patients enrolled in Study 903 open-label extension phase and continued treatment with TDF
15 patients discontinued from the study prior to Year 7 (Week 336)
--1 patient discontinued due to adverse event (asymptomatic increase in serum amylase/lipase)
--4 patients had virologic failure
--2 patients discontinued due to pregnancy
--8 patients either withdrew consent, were non-compliant or lost to follow-up
--No patient developed Fanconi syndrome
--No patient discontinued due to renal abnormalities
Resistance
4 patients discontinued due to virologic failure
- 2 Wild type genotypes
- 1 T69N, M184V, K103N at Week 240
- 1 M184M/V, K103K/N, V108V/I, P225P/H, T69A/T, K219K/R, K70K/E/G/R at Week 336
-- No K65R
CONCLUSIONS
Through 7 years of therapy in antiretroviral naive patients, TDF+3TC+EFV demonstrated the following:
--Sustained, durable antiretroviral efficacy
--Continued CD4 cell count increases
--No discontinuations due to renal adverse events
--No evidence of clinically relevant bone effects
--Significant increases in limb fat from Years 2 through 7
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