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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

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.

Methods

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.)

Table 1 Efficacy outcomes at Week 48.
Table 2 Week 48 median changes from BL in limb fat, haematology and lipids

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.

Conclusion

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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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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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

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P54

Keywords

  • Public Health
  • Infectious Disease
  • Cell Count
  • Abdominal Pain
  • Interim Analysis