[NATAP/Rio] Tenofovir Switch: lipoatrophy, bones, lipids

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Switch to TDF: lipoatrophy, bones, lipids

“Improvement in Lipoatrophy and Lipid Abnormalities Following Switch from Stavudine (d4T) to Tenofovir DF (TDF) in Combination with Lamivudine (3TC) and Efavirenz (EFV) in HIV-Infected Patients: a 48-Week Follow-Up from Study 903Eâ€

Reported by Jules Levin

IAS-Rio Poster# TuPe2.2B12

JVR Madruga1, I Cassetti2, JMAH Suleiman3, L Zhong4, J Enejosa4, and A Cheng4 for the 903E Study Team

1Centro de Referencia e Treinamento DST/AIDS, Sao o, Brazil;

2Fundacion Centro Estudios Infectologicos, Buenos Aires, Argentina;

3Instituto de Infectologia Emilio Ribas, Sao o, Brazil;

4Gilead Sciences, City, California, USA

Study 903 initially randomized patients to d4T or tenofovir with 3TC/EFV. Data obtained from patients participating in 903E who substituted d4T

to TDF were analyzed. Switching d4T to TDF resulted in:

--significant decreases in serum triglycerides, cholesterol and LDL-C through Week 48 in Study 903E

--Significant improvement in limb fat was observed 48 weeks after switching d4T to TDF

--No changes in spine BMD and small decreases in hip BMD were seen after switching d4T to TDF

--Virologic suppression was maintained 48 weeks after switching d4T to TDF

Patient Disposition Through Week 192

o 85 patients in the d4T arm substituted d4T to TDF

o 2 patients withdrew consent and discontinued from the study

o No patient discontinued study due to adverse events

Demographic and HIV Characteristics (Prior to Switch)

% Patients with HIV-1 RNA < 50 c/mL

Demographic and HIV Characteristics (Prior to Switch)

Mean Total Limb Fat (Before and After d4T _ TDF

Switch)

Mean % Change in Spine BMD (After d4T to TDF Switch)

Mean % Change in Hip BMD (After d4T to TDF Switch)