[Safety profile of rilpivirine: general and neuropsychiatric tolerability, safety in patients with hepatitis B or C viruses, and lipid profile].

Currently available data on the safety and tolerability of rilpivirine come from the product information document, a phase IIb, dose-finding clinical trial (TMC278-C204), the phase III ECHO and THRIVE clinical trials, and the preliminary data from the STaR and SPIRIT clinical trials, with a total of 1,728 patients. The comparator has usually been efavirenz. All studies have found a lower incidence and severity of neuropsychiatric adverse effects, a better lipid profile, and a lower number of patients with subclinical transaminase elevation in patients treated with rilpivirine. However, because of the relatively low number of patients coinfected with hepatitis B or C virus, definitive conclusions cannot be drawn. Similarly, experience in patients with mild or moderate liver failure is limited and there are no safety data in patients with advanced liver failure.