Substitution of nevirapine because of efavirenz toxicity in AIDS clinical trials group A5095

Abstract

In AIDS Clinical Trials Group A5095, 9% of participants who experienced an adverse event related to efavirenz substituted nevirapine. Most adverse events resolved; 15 participants ultimately discontinued nevirapine therapy. Grade 3/4 hepatotoxicity was observed in 14% of individuals who substituted nevirapine, compared with 6% who continued efavirenz therapy. Substitution of nevirapine because of efavirenz toxicity was generally safe and efficacious. Clinical trials registration. NCT00013520 .

Conflict of interest statement

Potential conflicts of interest. D.R.K. has served as a consultant for and has received speaker’s fees and research support from Boehringer-Ingelheim, Bristol-Myers Squibb, and GlaxoSmithKline. R.M.G. has received research grants (awarded to Cornell University) from Merck and has served as an ad hoc consultant to Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, and Merck. All other authors: no conflicts.

Figures

Figure 1

Toxicity management strategy. CNS, central nervous system; EFV, efavirenz; NVP, nevirapine; SS, skin symptoms. *EFV strategy included participants who continued to receive EFV for 30 days after the initial targeted toxicity; participants may have made a subsequent switch to NVP after 30 days. **NVP strategy included participants who switched to NVP within 30 days after the initial targeted toxicity. ***Temporarily discontinued antiretroviral therapy within 4 weeks after targeted adverse event.