“…This last FDA statement does not seem well substantiated, since the large majority of studies were conducted on pregnant women (5-7) (while the advisory included all women, regardless of pregnancy) (14), and it was stated that single-dose nevirapine was less toxic than b.i.d. administration, while the large 2NN study demonstrated a slight increased toxicity just for once-daily nevirapine administration (19), other non-comparative surveys failed in retrieving reduced hepatotoxicity with once-daily nevirapine (1), a very recent Cochrane review (17) underlined a possible increased toxicity when nevirapine is delivered once daily (17), and also pharmacokinetic studies disclosed greater Cmin/Cmax nevirapine values when this drug is administered once daily (8). Later, a large retrospective study published in the year 2006 and regarding 197 pregnant women exposed to nevirapine for at least 7 days, disclosed a 5.6% overall rate of toxicity, no fatalities, and especially no serious hepatotoxicity save one case of grade-4 cholestasis (possibly attributable to underlying conditions) (6).…”