F8/5 - DYSLIPIDAEMIA IMPROVEMENT IN PATIENTS SWITCHING FROM D4T TO TENOFOVIR (RECOVER STUDY)

9^TH EUROPEAN AIDS CONFERENCE (EACS)
1^st EACS RESISTANCE & PHARMACOLOGY WORKSHOP

October 25 - 29, 2003 Warsaw, Poland

9.2 Disturbances in Lipid and Glucose Metabolism

F8/5 - DYSLIPIDAEMIA IMPROVEMENT IN PATIENTS SWITCHING FROM D4T TO TENOFOVIR (RECOVER STUDY)

Domingo P.¹, Labarga P.², * Llibre J.M.³, Guerrero M.F.⁴, Terrón J.A.⁵, Pérez Elías M.J.⁶, Ruíz Camps M.I.⁷, Moreno S.⁶, Sánchez de la Rosa R.⁸, and the RECOVER study group

(1) Hosp Sant Creu y Sant Pau,² Hosp de San Millán,³ Hosp Sant Jaume de Calella,⁴ Fundación Jiménez Díaz,⁵ Hosp de Jeréz,⁶ Hosp Ramón y Cajal,⁷ Hosp Vall D Hebrón,⁸ Gilead Sciences, SL, Spain

Background: Patients treated with tenofovir have shown a significantly lower trygliceride increase than patients receiving D4T when both were used in combination with lamivudine and efavirenz (study GS903).

Objective: To evaluate the impact on trygliceride levels of switching to tenofovir in patients with hypertrygliceridemia while receiving D4T.

Methods: Prospective, multicenter study. Patients who developed one or more toxic effects that led to substitution of tenofovir for a single NRTI were included. No other discontinuations or substitutions are allowed.

Results: A total of 1300 heavily pretreated (72% were at 3rd line of therapy or higher) and virologically suppressed patients have been recruited. 70% were male and 50% were EVDU. Among patients who switched from d4T to tenofovir, 271 had hypertrygliceridemia and 193 hypercholesterolemia. A third of these patients have reached 12 weeks of therapy with tenofovir, the results are shown in Table I. Trygliceride levels dropped a mean of 179.61 mg/dL (95% IC 125.16-234.05; p<0.001), with 20% returning to normal values. Cholesterol levels have a mean dropped of 34.77 mg/dL ( 95% CI 22.32-47.23; p< 0.001). No virological rebound has been seen after switching to tenofovir.

	Triglicerides (Baseline n=94)	Tryglicerides (Month 3 n=94)	Cholesterol (Baseline n=70)	Cholesterol (Month 3 n=70)
Median	385.5	243.0	255.0	226.0
Range	206-2399 mg/dL	84-812 mg/dL	208-527 mg/dL	154-446 mg/dL

Conclusions: These data suggest that the use of tenofovir should improve the dyslipidaemia associated with D4T based regimens, while maintaining viral suppression. RECOVER study in currently ongoing in 120 Spanish centers, we schedule the follow up to 48 weeks for all patients.

Presenting Author: MD José María Llibre Codina, Hospital Sant Jaume de Calella, Unidad de Enfermedades Infecciosas-VIH, Sant Jaume,209, 08370, Calella/Cataluña, Spain, Phone: +34 937690201

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