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Early improvement of limb fat content in patients switching from AZT/3TC to FTC/TDF (TVD): a 24 week interim analysis of the RECOMB trial
Presented by Pedro Ferrer, Spain.
E. Martínez1, E. Ribera2, F. Pulido3, R. Rubio3, E. Negredo4, J. Sanz5, J. Berenguer6, V. Estrada7, M. Larrouse1, A. Curran2, A. Moreno8, M.L. Álvarez8, P. Ferrer8
1Hospital Clinic i Provincial, Unidad de enfermedades infecciosas, Barcelona, Spain, 2Hospital Vall d'Hebron, Unidad de enfermedades infecciosas, Barcelona, Spain, 3Hospital 12 de Octubre, Unidad de VIH, Madrid, Spain, 4Hospital Germans Trias i Pujol, Unidad de VIH, Badalona, Spain, 5Hospital de La Princesa, Unidad de enfermedades infecciosas, Madrid, Spain, 6Hospital Universitario Gregorio Marañón, Unidad de Enfermedades infecciosas, Madrid, Spain, 7Hospital Clínico Universitario San Carlos, Unidad de VIH, Madrid, Spain, 8Gilead Sciences, Medical Department, Madrid, Spain
Background: To compare changes in limb fat (DEXA assessments) after switching from an AZT/3TC backbone to TVD versus maintaining an AZT/3TC regimen.
Methods: 72wk, open-label, randomised; virologically-suppressed HIV-infected patients (<50c/mL) on HAART containing AZT/3TC (plus either an NNRTI or PI) were randomised to either switch their NRTI backbone to TVD or continue current AZT/3TC containing regimen. Stratification was performed by third agent of HAART (NNRTI/PI).
Results: 80 patients included (39TVD; 41AZT/3TC); NNRTI was the third agent in 84% of the patients. Baseline characteristics were well balanced between groups except for the median CD4 count which was higher in the TVD group (655 vs 504 cells/mL;p=0.037). At wk24, VL<50c/mL (ITT;M=F) was 85% (TVD) vs 80% (AZT/3TC), p=0.77 and median increase in CD4 count was +14.5 cells/mL vs -2 cells/mL respectively, p=0.69.
| | Baseline AZT/3TC | Baseline TVD | Wk24 change AZT/3TC | Wk24 change TVD | Wk 24 TVD-AZT/3TC p-value | | Median limb fat (total population; gram | 3582 | 3694 | -59 | +197 | p=0.32 | | Median limb fat (baseline <7.2 Kg); gram AZT/3TC N=29, TVD N=26) | 2918 | 3132 | -97 | +227 | p=0.027 | | Median Hb; g/dL | 14.3 | 14.6 | 0 | +0.7 | p<0.001 | | Median Hematocrit; % | 42 | 42.6 | +0.8 | +2.9 | p=0.002 | | Median Total Cholesterol; mg/dL | 190.5 | 187 | +0.5 | -7.0 | p=0.123 | | Median Total Cholesterol/HDL Ratio | 3.8 | 3.9 | 0 | +0.2 | p=0.22 | | Median LDL-c; mg/dL | 107.5 | 109 | +3 | -11.0 | p=0.049 | | Median HDL-c; mg/dL | 49.5 | 49 | +2 | -3.5 | p=0.003 | | Median TG; mg/dL | 125 | 110 | -7.5 | +17 | p=0.21 |
Conclusions: Through 24wks, switching from a suppressive HAART regimen including AZT/3TC to TVD, maintained efficacy and led to an improvement in limb fat content which was significant in patients with limb fat mass <7.2kg at baseline. Additionally Hb, hematocrit and LDL cholesterol levels were significantly reduced for the TVD group.
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