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A randomized comparison of continued zidovudine plus lamivudine BID (Combivir, CBV) versus switching to tenofovir DF plus emtricitabine (Truvada, TVD) each plus efavirenz (EFV) in stable HIV infected persons: results of a planned 24 week analysis
Presented by Graeme Moyle, United Kingdom.
Moyle G.1, Fisher M.2, Reilly G.3, and the SWEET Study Group
1Chelsea and Westminster Hospital, London, United Kingdom, 2Brighton and Hove University, Brighton, United Kingdom, 3Glead Sciences, London, United Kingdom
Objectives: In initial therapy comparative data suggests TVD provides similar virological control to CBV but with lower rates of haematological and metabolic AEs. We investigated if these benefits occured when CBV was switched to TVD.
Methods: A 48-week study; 220 subjects with HIV RNA<50copies/ml on BID CBV+EFV>6 months randomized 1:1 to continue this regimen or switch to QD TVD+EFV. The primary endpoint was change in absolute Hb at 24Wks. Secondary endpoints included changes in fasting lipids, absolute Hb at 48Wks, QoL, CD4 and viral load. Morphological assessments by DEXA were planned for baseline and week 48.
Results: 250 subjects were randomized; 234 received at least one dose of study medication, 117 to continue (CBV arm), 117 to switch to TVD (TVD arm). Subjects had received a median 36 months prior CBV, with 86% having received no other prior thymidine analogues. Subjects were well matched for baseline characteristics. At 24 weeks, switch to TVD maintained VL < 50 copies/ml. By ITT Missing = Failure or Switch = Failure analyses rates of viral suppression at week 24 were 89.7% vs. 94.0% for CBV vs. TVD, respectively. (Treatment difference 4.3%, 95% confidence interval (CI) of -2.7% to 11.3%, p = 0.34).
| | Baseline | Wk24 Change from Baseline | | | CBV | TVD | CBV | TVD | TVD vs CBV | | Median CD4 (cells/mm3) | 393 | 415 | 21(p=0.28) | -8(p=0.51) | p=0.20 | | Mean Hb (g/dL) LOCF* | 14.0 | 14.1 | 0.10(p=0.19) | 0.46(p<0.001) | p<0.001 | | Median total cholesterol (mmol/L) | 5.08 | 5.47 | -0.06(p=0.20) | -0.39(p<0.001) | p=0.008 | | Median LDL-c (mmol/L) | 2.99 | 3.25 | -0.09(p=0.093) | -0.10(p=0.013) | p=0.42 | | Median HDL-c (mmol/L) | 1.30 | 1.31 | -0.02(p=0.24) | -0.03(p=0.16) | p=0.82 | | Median Triglycerides (mmol/L) | 1.32 | 1.60 | 0.05(p=0.30) | -0.24(p<0.001) | p<0.001 |
Conclusions: Switching from CBV to TVD in persons receiving EFV provides a simplified QD regimen which maintains virological control and improvements in both Hb levels and key lipid parameters.
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