13th Annual Conference of the British HIV Association 29 March–1 April 2007, Brighton, UK

WEEK 48 ANTIRETROVIRAL (ARV) RESPONSE TO DARUNAVIR (TMC114)/RITONAVIR AND ETRAVIRINE (TMC125) COMBINATION IN PATIENTS WITH HIGH-LEVEL VIRAL RESISTANCE

HIV Med 2007; 8(Suppl. 1):10 (abstract no. P2)

Marta Boffito¹, Alan Winston¹, Akil Jackson¹, Carl Fletcher¹, Anton Pozniak¹, Mark Nelson¹, Graeme Moyle¹, Richard Hoetelmans², Diego Miralles² and Brian Gazzard^1
1Chelsea and Westminster Hospital, London, UK, ²Tibotec BVBA, Mechelen, Belgium

BACKGROUND: The protease inhibitor darunavir has been recently approved for the treatment of HIV and etravirine is an investigational NNRTI. They have shown activity in naïve and experienced patients. We previously showed the absence of a clinically significant drug interaction between the two agents. We here present week 48 responses in 11 HIV-infected patients with high level viral resistance.

METHODS: Multi-class experienced patients with documented three-class resistance were enrolled to investigate the pharmacokinetics, safety, and efficacy of darunavir/r 600/100 mg twice daily and etravirine 200 mg twice daily (new formulation) plus NRTI with or without enfuvirtide (ENF). Genotype and phenotype testing, safety, and efficacy parameters were assessed at baseline and over the study period.

RESULTS: Eleven patients completed the 48-week study; median (range) baseline characteristics included age 45 (39–57) years; CD4 100 (3–490) c/mm³; log₁₀ viral load 4.9 (3.9–5.5); number of mutations (IAS, October 2005) for protease inhibitors, primary 4 (0–5), and resistance associated 11 (2–13), for NRTI 7 (2–9), and for NNRTI 2 (0–6). Of 11 patients, six had prior exposure to tipranavir and to ENF; only three used ENF for the first time. At week 48, patients had achieved at least a 2.2 log₁₀ decrease in HIV RNA (median –2.7); all but two patients had viral loads <50 copies/mL; the two detectable viral loads were low: 166 and 465 copies/mL. Median CD4 increase was 118 c/mm³.No serious adverse events or grade 3/4 changes in laboratory safety parameters were reported.

CONCLUSION: The combination was well tolerated and showed impressive efficacy over 48 weeks against three-class resistant HIV. Further studies of this combination are ongoing.

2007-03-29
P2

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