Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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 .

PubMed Disclaimer

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.
See this image and copyright information in PMC

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.

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

Publication types

Associated data