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Switch from Stavudine (d4T) to Tenofovir DF (TDF) in Combination with Lamivudine (3TC) and Efavirenz (EFV) Resulted in Continued Virologic Suppression and Improvement in Lipoatrophy Through 2 Years in HIV-Infected Patients
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Reported by Jules Levin
8th International Workshop on Adverse Drug Reactions and
Lipodystrophy in HIV
September 24-26, 2006
San Francisco, California, USA
Poster 29
JVR Madruga,1 I Cassetti,2 JMAH Suleiman,3 L Zhong,4 J Enejosa,4 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 Assistencia Medica e Pesquisas, Sao Paulo, Brazil; 4Gilead Sciences, Inc., Foster City, CA
Use of HAART has been associated with metabolic abnormalities including lipodystrophy especially among patients receiving thymidine analogue-containing HAART1
- Study 903 has shown signifi cantly lower elevations in lipid parameters and higher limb fat in patients treated with TDF compared to d4T2
- Improvement in lipids and lipoatrophy has been observed after switching d4T to TDF3,4
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 192-week (4-year) open-label extension phase (903E)
- Data obtained from patients participating in 903E who substituted d4T to TDF were analyzed
AUTHOR CONCLUSIONS
- Virologic suppression was maintained 2 years after switching d4T to TDF
- No patient experienced virologic failure
- Switching d4T to TDF through 2 years resulted in significant decreases in serum triglycerides and cholesterol
- Significant improvement in limb fat was observed 2 years after switching d4T to TDF
- No changes in spine BMD and small but statistically significant decreases in hip BMD were seen after switching d4T to TDF
- No patient experienced pathologic fractures
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