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Dyslipidemia Improvement in Patients Switching from D4T to Tenofovir
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Written by Judith Aberg, MD, Washington University, St louis, Missouri and the ACTG
ICAAC 2003, Sept 14-17, Chicago Category Late-Breakers Abstracts Session 184 - Poster Session - Otitis Media Abstract: H-855b
S. MORENO1, P. DOMINGO 2, P. LABARGA 3, J. M. LLIBRE 4, M. FERNÁNDEZ 5, R. PALACIOS 6, M. J. PÉREZ 1, M. I. RUÍZ 7, J. SANTOS 6, M. L. ALVÁREZ 8
1 Hospital Ramón y Cajal, Madrid, Spain, 2 Hospital de Sant Pau, Barcelona, Spain, 3 Hospital San Millán, Logroño, Spain, 4 Hospital de Calella, Barcelona, Spain, 5 Fundación Jiménez Díaz, Madrid, Spain, 6 Hospital Virgen de la Victoria, Málaga, Spain, 7 Hospital Vall D`Hebrón, Barcelona, Spain, 8 Gilead, Madrid, Spain.
Patients receiving tenofovir have shown a significantly lower lipid levels increase than patients receiving D4T when both were used in combination with 3TC and efavirenz in a study reported by Jules Levin during last year’s International AIDS Conference in Barcelona http://www.natap.org/2002/barcelona/day9.htm
Moreno and colleagues sought to evaluate the impact on lipid levels by switching to tenofovir in patients with hyperlipidemia while receiving D4T. They conducted a prospective, multicenter study to identify the most frequently occurring nucleoside associated toxicities causing the nucleoside to be discontinued.
A total of 1350 pretreated (72% on their 3rd line of therapy or higher) and virologically suppressed patients had been recruited. A single nucleoside was switched to tenofovir due to adverse events (d4T 65%, ddI 13%, AZT 6%, 3TC 2% and ddC 1%). Demographics were 70% male and 50% history of intravenous drug use. Mean CD4+T-cell count at baseline (prior to switch) was 529 cells/µl. Lipodystrophy and peripheral neuropathy were the 2 major causes of nucleoside switch (50% and 13% respectively). d4T was the most frequently switched drug (n=886, 65%). Two of the main reasons for d4T substitution by tenofovir was hypertriglyceridemia (271 subjects) and hypercholesterolemia (193 subjects). A third of these patients have reached 12 weeks of follow-up after tenofovir therapy was initiated. For these selected patients the overall median of previous treatment period with d4T was 4 years (range 2-5 years).
Students’t-test was used to detect the between-group differences. Results show that triglyceride levels (n=94) dropped from a mean of 458.11 mg/dl (95% IC 396.73-519.58) at baseline to 278.50 mg/dl (95% IC 248.85-308.15) at 12 weeks (p<0.001). 20% of these patients returned to normal values. Cholesterol levels (n=70) dropped from a mean of 265.73 mg/dl (95% IC 254.98 –276.48) at baseline to 230.96 mg/dl (95% IC 220.26 – 241.66) at 12 weeks (p<0.001). No virological rebound has been seen after switching to tenofovir. No significant changes in CD4 were observed
Their data suggest that the use of tenofovir improves the dyslipidemia associated with D4T-based regimens, while maintaining viral suppression and immunologic recovery. It will be interesting over time to see if the lipodystrophy in this cohort improves as well. Other databases which would be of interest would be those patients who are receiving both d4T and tenofovir to see if the tenofovir counters the lipid elevations associated with d4T. Another possibility would be to look at late intensification with tenofovir in a group of patients with dyslipidemia on antiretroviral therapy. The preliminary data from this cohort are intriguing and further study is warranted.
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