8th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV San Francisco, California - September 24 - 26, 2006

SWITCH FROM STAVUDINE (d4T) TO TENOFOVIR DF (TDF) IN COMBINATION WITH LAMIVUDINE (3TC) AND EFAVIRENZ (EFV) RESULTED IN CONTINUED VIROLOGICAL SUPPRESSION AND IMPROVEMENT IN LIPOATROPHY THROUGH 2 YEARS IN HIV-INFECTED PATIENTS

Antiviral Therapy 2006; 11:L21 (abstract no. 29)

JVR Madruga¹, I Cassetti², JMAH Suleiman³, L Zhong⁴, J Enejosa⁴ and AK Cheng⁴ for the 903E Study Team
¹Centro de Referencia e Treinamento DST/AIDS, Sao Paulo, Brazil; ²Fundacion Centro Estudios Infectologicos, Buenos Aires, Argentina; ³Brasilmed Assistência Médica e Pesquisas, Sao Paulo, Brazil; ⁴Gilead Sciences, Foster City, CA, USA

INTRODUCTION: Studies have demonstrated that switching d4T to TDF can result in improvements in lipid profiles and lipodystrophy.

METHODS: Study 903 is a Phase III trial which began with a 3 year, double-blind phase comparing TDF to d4T with 3TC and EFV in treatment-naïve patients. In the 4 year extension phase (903E), patients switch from twice daily d4T to once-daily TDF in combination with 3TC and EFV.

RESULTS: At time of switch, 100% and 99% of patients (n=85, 60% male, 64% white, mean age 37 yrs, CD4 cell=650) had HIV RNA <400 c/ml and <50 c/ml, respectively. At 2 years post switch, 95% (ITT M=F) had HIV RNA <400 c/ml and 91% (ITT M=F) had HIV RNA <50 c/ml. Mean CD4 cell count increased 118 cells/mm³. No patient discontinued due to adverse events or experienced virological failure. No patient experienced any significant renal toxicity. Decreases from time of switch to year 2 in fasting total cholesterol (Mean change: -23 mg/dl) and triglycerides (-75 mg/dl) were observed. At time of switch, mean limb fat was 4.6 kg but increased significantly to 5.5 kg at 2 years after switch.

CONCLUSIONS: In virologically suppressed patients, switching d4T to TDF in a once-daily regimen containing 3TC and EFV maintains virological suppression and provides continued CD4 cell increases through 2 years. Significant continued improvement in limb fat was observed.

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2006-09-24
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