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On March 25, 2011, the FDA approved a 400-mg extended-release tablet formulation of nevirapine that can be dosed once daily. The approval is based on 48-week results from a manufacturer-sponsored trial in which treatment-naive patients received the new formulation once daily or the standard tablet (200 mg) twice daily as part of combination therapy; efficacy and tolerability were equivalent between the groups (Abstract THLBB202, AIDS 2010). Preliminary results from another trial (also manufacturer-sponsored) support the safety of switching patients who are virologically suppressed on twice-daily nevirapine to the once-daily formulation.
Patients starting once-daily nevirapine should receive the 200-mg tablet once daily for 14 days first, to …