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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

  • 1,
  • 2,
  • 3,
  • 4,
  • 5,
  • 6,
  • 7,
  • 7,
  • 3,
  • 1,
  • 2,
  • 8 and
  • 8
Journal of the International AIDS Society200811 (Suppl 1) :P54

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

  • Published:

Keywords

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

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.

 

TVD

AZT/3TC

p-value

% of Pts with HIV RNA < 50 c/mL (M = F)

92%

78%

0.12

Median CD4 count change (cell/mm3)

+60.5

+9

0.079

M = F denotes missing = failure analysis.

Table 2

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)

p-value

Total limb fat (g)

3565

+392

3946

-257

0.001

Hb (g/dL)

14.6

+0.9

14.9

+0.3

0.007

Hematocrit (%)

42.6

+2.7

42.0

+1.0

0.001

Total Cholesterol (mg/dL)

187.0

+4.5

189.0

+1.0

0.97

LDL-c (mg/dL)

109.0

+7.0

107.5

+5.0

0.66

HDL-c (mg/dL)

49.0

-2.0

49.5

+2.0

0.29

TG (mg/dL)

110.0

+1.5

120.0

+4.0

0.96

BL = baseline.

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.

Authors’ Affiliations

(1)
Hospital Vall D'Hebron, Barcelona, Spain
(2)
Hospital Germans Trias i Pujol, Barcelona, Spain
(3)
Hospital Clinic i Provincial, Barcelona, Spain
(4)
Hospital Clínico San Carlos, Madrid, Spain
(5)
Hospital de La Princesa, Madrid, Spain
(6)
Hospital Univ Gregorio Marañón, Madrid, Spain
(7)
Hospital 12 de Octubre, Madrid, Spain
(8)
Medical Department Gilead Sciences, Madrid, Spain

Copyright

© Ribera et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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