- Poster presentation
- Open Access
48-week outcomes following switch from AZT/3TC to FTC/TDF (TVD) vs. continuing on AZT/3TC: 48-week interim analysis of the RECOMB trial
© Ribera et al; licensee BioMed Central Ltd. 2008
- Published: 10 November 2008
- Public Health
- Infectious Disease
- Cell Count
- Abdominal Pain
- Interim Analysis
To compare changes in total limb fat by DEXA scan assessment after switching from an AZT/3TC backbone to TVD vs. maintaining an AZT/3TC regimen.
72 weeks, open label, randomised, controlled study. Virologically-suppressed HIV-infected patients (<50 c/mL) on HAART containing AZT/3TC (plus either an NNRTI or a PI) were assigned to either switch their AZT/3TC backbone to TVD or continue current AZT/3TC-containing regimen. Stratification was performed by third agent of HAART (either NNRTI or PI).
Efficacy outcomes at Week 48.
% of Pts with HIV RNA < 50 c/mL (M = F)
Median CD4 count change (cell/mm3)
Week 48 median changes from BL in limb fat, haematology and lipids
TVD arm (BL)
TVD arm (Week 48 – BL)
AZT/3TC arm (BL)
AZT/3TC arm (Week 48 – BL)
Total limb fat (g)
Total Cholesterol (mg/dL)
Five patients discontinued due to an adverse event before week 24; one in the TVD group (upper abdominal pain) and four in AZT/3TC group (two renal cholic, one anaemia, one lactic acidosis). Changes from BL in GFR (CG) were -11.8 for TVD and -3.6 mL/min for AZT/3TC.
Through 48 weeks, switching from a suppressive HAART regimen containing AZT/3TC to TVD, was well tolerated, maintained efficacy and led to a significant improvement in limb fat content. Additionally, haemoglobin and hematocrit significantly improved for patients switched from AZT/3TC to TVD.
This article is published under license to BioMed Central Ltd.