Efficacy and safety of tenofovir/emtricitabine compared to abacavir/lamivudine in HIV-1 infected patients in clinical setting. The TEAL study

1758-2652-11-S1-P79 1758-2652 Poster presentation Efficacy and safety of tenofovir/emtricitabine compared to abacavir/lamivudine in HIV-1 infected patients in clinical setting. The TEAL study Eccleston KJ Bambumba A Babu CS Ahmed S Lee V

Central Manchester and Manchester Childrens University Hospitals NHS Trust, Manchester, UK

University Hospitals of South Manchester NHS Trust, Manchester, UK

Journal of the International AIDS Society Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection Meeting abstracts – A single PDF containing all abstracts in this Supplement is available here. http://www.biomedcentral.com/content/pdf/1758-2652-11-S1-info.pdf Ninth International Congress on Drug Therapy in HIV Infection Glasgow, UK

9–13 November 2008

http://www.hivdrugtherapy.org 1758-2652 2008 11 Suppl 1 P79 http://www.jiasociety.org/content/11/S1/P79 10.1186/1758-2652-11-S1-P79 10 11 2008 2008 Eccleston et al; licensee BioMed Central Ltd.

Background

Limited direct comparative data exist between the recommended dual NRTI fixed dose combinations, tenofovir/emtricitabine (Truvada) and abacavir/lamivudine (Kivexa). A recent study (HEAT) evaluated these dual NRTI backbones with a boosted PI. However, there are no data comparing these two formulations when used with other antiretroviral drugs.

Methods

Retrospective study of HIV-1 infected patients in two Genito-Urinary Medicine clinics. Patients taking either Truvada or Kivexa were included. Data including previous treatment, resistance test, HLA B5701 status, pre-treatment CD4 count, plasma viral load, age, ethnicity, renal function, lipid profiles were gathered. Primary endpoint was the proportion of subjects with viral load <50 copies/ml at 48 weeks.

Summary of results

232 patients were included, of which 129 were on Truvada and 103 on Kivexa; 114 were treatment naive. (Tables 1 and 2.)

Table 1

Truvada

Kivexa

p-value

Total number

129

103

Male

119 (92.3%)

96 (93.2%)

0.78

Female

Age (median, IQR)

38 (32.43)

Ethnicity

African

28 (21.7%)

39 (37.9%)

0.001

Causcasian

95 (73.6%)

55 (50.5%)

0.001

Other

6 (4.7%)

12 (11.6%)

0.001

Smoker

51 (42.5%)

31 (30.4%)

0.06

History of cardiovascular event

5 (3.9%)

4 (3.9%)

0.63

Hypertensive

9 (7.0%)

13 (12.6%)

0.14

Diabetic

3 (2.3%)

6 (5.8%)

0.14

HBV co-infected

13 (10.1%)

1 (1.0%)

0.02

HCV co-infected

1 (0.8%)

4 (3.9%)

0.27

AIDS diagnosis

26 (20.2%)

19 (18.5%)

0.74

ART experienced

63 (48.8%)

53 (51.5%)

0.74

Current drug

32 (24.8%)

19 (18.5%)

0.25

NNRTI

97 (75.2%)

84 (81.6%)

Baseline laboratory markers

CD4 (cells/mm3) median

235

228

0.49

Viral load (log copies/ml) median

4.5

3.8

0.07

Cholesterol (mmol/l) median

4.3

4.5

0.05

HDL (mmol/l) median

1.1

1.2

0.52

Triglyceride (mmol/l) median

1.4

1.3

0.59

GFR

110

107

0.14

Table 2

Week 48 results (ITT-E, Missing = excluded).

ARV experienced

ARV naive

Truvada (n = 60)

Kivexa (n = 53)

p-value

Truvada (n = 64)

Kivexa (n = 50)

p-value

Viral load <50 copies/ml

47/49 (95.9%)

35/36 (97.2%)

1.00

56/59 (94.9%)

29/33 (87.9%)

0.22

Median CD4 increase (cells/mm3)

0.36

208

170

0.59

Withdrawn due to adverse events

Suspected ABC HSR

Proximal renal tubular dysfunction

Virological failure

Conclusion

Truvada was non-inferior to Kivexa in this cohort. However, virological failure was observed in three patients when Kivexa was used with an NNRTI. Median CD4 increase was greater in Truvada arm at 48 weeks but this was not statistically significant. Further data will be presented at the meeting.