Cause and effect relationship of drug adverse events: Our experience using protease inhibitors of HIV [Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV]

Purpose: To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events. Materials and Method: Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm. Results: Since the beginning of the study 1207 patients have been enrolled. Average time of observation is 10.7 months. To date, 784 adverse events have been observed, distributed as follows: excluded 3.8%, improbable 18.5%, possible 41.3%, probable 30.1%, and highly probable 6.3%. Saquinavir shows a statistically significant difference in the rate of non-correlated events with respect to other groups. Conclusions: Over 20% of adverse events during PI treatment are shown to be non-correlated to these drugs. Saquinavir shows the highest rate of non-correlated events.