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Switching from Combivir (CBV, AZT/3TC) to Truvada (TVD, TDF/FTC) Maintains Viral Suppression, Prevents and Reverses Limb Fat Loss, and Improves Biochemical Parameters: Results of a 48 Week Randomised Study
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Reported by Jules Levin
11th EACS Oct 24-27, 2007 Madrid Spain
M Fisher1, G Moyle2, R Ebrahimi3
Brighton and Sussex University hospitals, UK
Chelsea and Westminster Hospital, London, UK
Gilead sciences Ltd, Cambridge, UK
Note from Jules: patients who switched to tenofovir saw increase in limb fat by DEXA. Patients who remained on AZT saw loss of limb fat. I appears that the longer a patient was on AZT the less gain in limb fat was realized after 48 weeks following the switch. See graphs below
AUTHOR CONCLUSIONS
Switching from Combivirto Truvadain persons receiving EFV:
--Maintains virologicalcontrol
--Improves haemoglobin
--Preserves limb fat and leads to limb fat recovery
--Switching from Combivirto Truvada, even in the absence of clinical lipoatrophy is of benefit to the patient
This supports the recommendation for proactive switching within the EACS 2007 Guidelines
BACKGROUND
Dual nucleosides/tides remain the backbone of HAART regimens
Thymidine analogues (both d4T and AZT) have been associated with lipoatrophy and are less frequently recommended as initial therapy1
Switching from a thymidine analogue to tenofovir in individuals with lipoatrophy is associated with an improvement in limb fat2 and maintenance of virological control2,3
The management of patients currently suppressed on AZT without lipoatrophy is not established
1. European AIDS Clinical Society Guidelines 2007. www.eacs.org
2. Moyle, G, et al; The RAVE Study. AIDS 2006, 20: 2043-2050
3. Martinez E, et al; The BICOMBO study. 4th IAS, 22-25th Jul 2007, Sydney, Australia #WESS102
Results from Studies of Limb Fat Change with Tenofovir-Based Regimens
GS934 (naives)
SWEET Study Design
SWEET = Simplification With Easier Emtricitabine and Tenofovir
Study subjects on stable Combivir plus efavirenz with <50 c/ml were randomized 1:1 to switch the nuke component to Truvada (TDF/FTC) or remain on Combivir, all patients remaining on efavirenz. DEXA sub-study with 100 study patients was performed.
--Undetectable viral load (≦50copies/ml)
--Adequate Baseline Renal (CrCl ≥ 60ml/min) and Hepatic (AST / ALT ≦5 x ULN) function. HBsAg negative
--No known resistance to TDF, FTC, AZT, 3TC or EFV
METHODS
48 week multicentre, prospective, open label, randomised (1:1) study
24 sites in UK and Ireland
-234 subjects enrolled and received at least one dose of study drug
All subjects in specific centres were given the option to participate in the DEXA sub-study at screening
-Subjects in this analysis had paired Baseline and Week 48 assessments
-No requirement for clinical signs of lipoatrophy
Baseline Characteristics*
In DEXA Sub-Study: Median Limb Fat (kg) (IQR): 4.90 (3.41, 7.23) for Truvada; 4.82 (3.95, 6.85) for Combivir. Prior d4T use: 11 (24%) in truvada group; 2 (4%) in Combivir group. Median years of AZT (IQR): 2.9 (2.2, 4.3) in Truvada; 2,9 (1.8, 4.5) in Combivir.
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