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Methods Observational study to analyse immune and virological response, and incidence of adverse events during raltegravir therapy. Transaminase elevation(TE) was scored according to increase in ALT value 2.6–5× upper normal limit (toxicity grade 2), 5.1–10× upper normal limit (toxicity grade 3) and >10× upper normal limit (toxicity grade 4). To avoid bias related to patients with high baseline serum ALT and AST levels, TE was defined by increase in ALT value 2.6–3.5× (toxicity grade 2), 3.6–5× (toxicity grade 3), and >5× (toxicity grade 4) the baseline value. Metabolic and renal profile were assessed at baseline, after 1 month and every 3 months. 103 HIV+ patients have been enrolled; 37 patients were HCV or HBV co-infected. CDC group was 50C, 34B and 19A. Previous therapeutic mean lines was 9.1; mean mutations were 5.5 for NRTI and 8.6 for PI.

Raltegravir therapy in HIV multi-experience patients: safety and efficacy