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  • Open Access

Efficacy and safety of an antiretroviral regimen containing etravirine plus raltegravir in HIV-1 treatment-experienced patients failing darunavir

  • 1,
  • 1,
  • 1,
  • 2,
  • 1 and
  • 1
Journal of the International AIDS Society200811 (Suppl 1) :P38

https://doi.org/10.1186/1758-2652-11-S1-P38

  • Published:

Keywords

  • Atazanavir
  • Foscarnet
  • Darunavir
  • Raltegravir
  • Etravirine

Purpose of the study

To evaluate the efficacy of raltegravir (RAL) and etravirine (ETV) in addition to a background optimised treatment in patients (pts) with persistent viremia while on darunavir (DRV) and multidrug resistant virus.

Methods

Prospective, pilot, open-label, single arm study evaluating pts with at least 3-drug class exposure, plasma HIV-RNA (VL) >1000 c/ml while on a DRV-containing regimen. Pts were given RAL and ETV in addition to optimized background therapy (OBT). Primary end-point was the proportion of pts with a VL<40 c/ml at week 24.

Summary of results

Overall, 20 pts were enrolled. Baseline characteristics were as follows: median duration of prior ARV therapy 13 years [range: 6–20], median VL of 4.6 log10 [3.36–5.56], and median CD4 count of 254 cells/mm3 [63–833]. Eleven pts (55%) had prior enfuvirtide and four prior foscarnet. Excluding RAL and ETV, GSS was 0 for two pts, one for 11 (58%) pts, two for five (25%) pts and 3 for one pt. Fourteen pts (74%) had a virus with 1 NNRTI resistance mutation (median: 1 [0–3]), 14 (73%) were resistant to DRV, four (21%) had intermediate DRV sensitivity. The median number of antiretroviral drugs in the OBR was five [3–7], five (25%) received atazanavir and nine (45%) enfuvirtide.

At week 24, the proportion of patients with VL< 40 c/ml was 65% and the proportion <400 copies/ml 100%. The median decrease in viral load was -2.56 log10 [-3.78 – -1.01] at week 4, -2.87 log10 [-3.78 – -1.01] at week 12 and -2.90 log10 [-3.78 – -1.76] at week 24. The median increase in CD4 was + 80 [-29 – +485] cells/mm3 at week 24. At week 4, the median RAL Cmin in nine pts was 134 ng/ml [44–379], ETV: 374 ng/ml [86–785] and DRV: 3487 ng/ml [1442–4603]. Resistance testing was successful in 3/7 patients between 40 and 400 c/ml: none had RAL-associated mutations.

Conclusion

An unexpectedly high rate of virological success was observed in this pilot study of patients with very limited treatment options except RAL and ETV while failing darunavir.

Authors’ Affiliations

(1)
Pitié-Salpétrière, Paris, France
(2)
Bichat Claude Bernard, Paris, France

Copyright

© Canestri et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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