Less Drugs for more Safety, Convenience and Sustainability: the Italian experiences Roma, Istituto Superiore Sanità 10-11 marzo 2011 Switch e strategie.

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Less Drugs for more Safety, Convenience and Sustainability: the Italian experiences Roma, Istituto Superiore Sanità marzo 2011 Switch e strategie di mantenimento: i nuovi paradigmi nellesperienza Silvia Nozza italiana

Randomized, multicenter, comparative open-labeled study. Proof-of-concept. 60 HIV-infected Treatment-Naive Subjects. AIM OF THE STUDY To evaluate virologic efficacy of Maraviroc associated to Kaletra in HIV-Infected Treatment-Naive Subjects. Studio VEMAN

Elegible subjects Trofile R5 Randomization 1:1 Truvada + Kaletra Maraviroc 150 mg QD Kaletra

Virological results p= pts in MVC-KAL 19 pts in TDF/FTC-kAL

Immunological results p=0.056

Only pts infected with R5 virus. Low flexibility; could be a switch regimen? Flexibility

3/41 (7%) pts stopped therapy at W12 due to diarrhea No significant increase in AST, ALT, CPK, cholesterol, tryglicerides and glycaemia in both groups. Safety

At week % pts with undetectable viral load. 20 pts (10 in group MVC and 10 in group TDF/FTC) reached W96; they are still undetectable Durability