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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
Journal of the International AIDS Society volume 11, Article number: P54 (2008)
Purpose of the study
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).
Summary of results
80 patients included (39 TVD; 41 AZT/3TC). Mean age was 44 years. Patients were predominantly male (81%). The median CD4 cell count at baseline was higher in the TVD vs AZT/3TC arm (655 vs. 504 cel/mm3; p = 0.037). (Tables 1 and 2.)
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.
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Ribera, E., Clotet, B., Martínez, E. et al. 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. JIAS 11, P54 (2008). https://doi.org/10.1186/1758-2652-11-S1-P54
- Public Health
- Infectious Disease
- Cell Count
- Abdominal Pain
- Interim Analysis