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Randomized Controlled Trial
. 2010 Mar 1;50(5):787-91.
doi: 10.1086/650539.

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

Jeffrey T Schouten  1 , Amy Krambrink, Heather J Ribaudo, Anne Kmack, Nancy Webb, Cecilia Shikuma, Daniel R Kuritzkes, Roy M Gulick
Affiliations
Randomized Controlled Trial

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

Jeffrey T Schouten et al. Clin Infect Dis. .

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 .

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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
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.
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Comment in

  • Switching from efavirenz to nevirapine.
    Gelinck LB, Burger DM. Gelinck LB, et al. Clin Infect Dis. 2010 Aug 1;51(3):365; author reply 365-6. doi: 10.1086/654803. Clin Infect Dis. 2010. PMID: 20578877 No abstract available.

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References

    1. Mehta U, Maartens G. Is it safe to switch between efavirenz and nevirapine in the event of toxicity? Lancet Infect Dis. 2007;7:733–738. - PubMed
    1. Ward DJ, Curtin JM. Switch from efavirenz to nevirapine associated with resolution of efavirenz-related neuropsychiatric adverse events and improvement in lipid profiles. AIDS Patient Care STDS. 2006;20(8):542–548. - PubMed
    1. FDA public health advisory for nevirapine (Viramune) [Accessed 12 October 2009]. Last updated 30 April 2009. http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051674.htm.
    1. Ena J, Leach A, Nguyen P. Switching from suppressive protease inhibitor-based regimens to nevirapine-based regimens: a meta-analysis of randomized controlled trials. HIV Medicine. 2008;9:747–756. - PubMed
    1. Kesselring AM, Wit FW, Sabin CA, et al. Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy. AIDS. 2009;23(13):1689–1699. - PubMed

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