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Metabolic Outcomes from Prospective, Randomized Clinical Trials of Tenofovir DF (TDF) Compared to Thymidine Analog-containing Efavirenz-based Regimens in Antiretroviral-Naive Patients
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Reported by Jules Levin
IAC Mexico City Aug 3-8 2008
RE Campo,1 JE Gallant,2 AL Pozniak,3 E DeJesus,4 Y Zhou,5 AK Cheng,5 and J Enejosa5. 1Univ Miami, Miami, FL; 2Johns Hopkins Univ School of Medicine, Baltimore, MD; 3Chelsea & Westminster Hosp, London, UK; 4Orlando Immunology Center, Orlando, FL; 5Gilead Sciences, Foster City, CA
AUTHOR CONCLUSIONS
Significantly smaller increases in fasting total cholesterol, LDL-C and triglycerides were seen with TDF-containing vs. thymidine analog-containing EFV-based regimens through 144 wks
Higher proportion of patients in thymidine analog group added lipid-lowering agent compared to TDF
Higher proportion of patients on TDF remained within NCEP ATP III guidelines for lipid level goals
Median limb fat was higher in the TDF group compared to the thymidine analog group
Treatment with a thymidine analog was associated with ≥ 20% decrease in limb fat from Wk 96 to Wk 144
BACKGROUND
Metabolic abnormalities have been observed in HIV patients receiving highly active antiretroviral therapy:
--Hypercholesterolemia with or without hypertriglyceridemia
--Morphological changes: limb fat wasting and central fat accumulation
--Drugs within each antiretroviral class have different effects on lipids and fat distribution
--ACTG 5142 demonstrated a lower incidence of lipoatrophy among patients who received efavirenz (EFV)+ lopinavir/ritonavir (LPV/r) or LPV/r plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) compared to EFV+2 NRTIs
--Lipoatrophy in the EFV or LPV/r +NRTI arms was predominantly seen in the stavudine (d4T) or zidovudine (ZDV)-containing regimens
METHODS
We evaluated changes in limb fat (by DEXA) and fasting lipids in patients who
initiated a TDF-containing vs. a thymidine analog-containing regimen (Control) in
Studies 903 and 934
DEXA was performed at Wks 96 and 144, and lipids were obtained at baseline
(BL) and every 12 weeks
Logistic regression analysis was performed to assess factors potentially
associated with a decrease in limb fat of ≥20% from Week 96 to Week 144
Main Inclusion Criteria:
--HIV-1 infected patients naive to antiretroviral treatment
--18-65 years of age
--Plasma HIV RNA > 5,000 copies/mL (Study 903); >10,000 copies/mL (Study 934)
--No CD4+ cell count criteria
--No significant laboratory or clinical abnormalities
RESULTS
Logistic regression analysis was performed to evaluate factors associated with ≥ 20% decrease in limb fat from Wk 96 to Wk 144
--Factors assessed: baseline age, sex, race, weight, HIV-1 RNA, CD4, fasting lipid values and treatment group
In a multivariate analysis, only treatment with thymidine analogs was associated with ≥ 20% decrease in limb fat from Wk 96 to Wk 144
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