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Tenofovir DF Plus Lamivudine or Emtricitabine for Nonoccupational Postexposure Prophylaxis (NPEP) in a Boston Community Health Center

Mayer, Kenneth H MD*†; Mimiaga, Matthew J ScD, MPH*‡; Cohen, Daniel MD*; Grasso, Chris MPH*; Bill, Ronn AS*; VanDerwarker, Rodney BA; Fisher, Alvan MD

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 1st, 2008 - Volume 47 - Issue 4 - p 494-499
doi: 10.1097/QAI.0b013e318162afcb
Epidemiology and Social Science

Background: Nonoccupational postexposure prophylaxis (NPEP) has been used to decrease HIV transmission after high-risk exposures. However, suboptimal adherence in completing the recommended 28-day course has resulted in prophylaxis failures. Fenway Community Health, the largest center caring for HIV-infected and high-risk men who have sex with men (MSM) in New England, began an NPEP program in 1997, initially using zidovudine-based regimens.

Methods: Two phase 4 studies, using tenofovir DF regimens combined with either lamivudine or emtricitabine, were conducted. This paper evaluates the experience of those who used tenofovir-based NPEP regimens, comparing the subjects to historical controls who used zidovudine-containing regimens.

Results: Between May 2004 and March 2005, 44 individuals who presented after high-risk sexual exposure were prescribed tenofovir DF/lamivudine for NPEP. Between March 2005 and March 2006, 68 individuals with 72 high-risk experiences received tenofovir DF/emtricitabine, and were compared to122 historical controls who were prescribed 126 courses of zidovudine plus lamivudine between January 2000 and May 2004. Seventy-two percent of those who took tenofovir DF and emtricitabine, and 87.5% of the participants who took tenofovir DF and lamivudine, for NPEP completed their regimens as prescribed, whereas only 42.1% of those who took zidovudine plus lamivudine did so (P < 0.0001). Participants who took tenofovir DF-containing regimens were more likely to report diarrhea or abdominal discomfort; patients who took zidovudine-containing regimens were more likely to report nausea and vomiting, which was often severe enough to lead to product discontinuation.

Conclusions: Tenofovir DF-containing regimens for NPEP are generally well tolerated with high completion rates. Tolerability and adherence compared favorably to zidovudine-containing regimens used previously. Tenofovir DF-containing regimens should be considered for PEP to enhance adherence and regimen completion.

From the *Fenway Institute, Fenway Community Health, Boston, MA; †Brown University/the Miriam Hospital, Providence, RI; ‡Harvard University School of Public Health, Boston, MA; §Boston University School of Public Health, Boston, MA; and ∥Gilead Sciences, Foster City, CA.

Received for publication April 25, 2007; accepted November 19, 2007.

Dr. Alvan Fisher is deceased.

Supported by educational grants from Gilead Sciences and the Lifespan/Tufts/Brown Center for AIDS Research, a National Institutes of Health-funded program (#P30 AI42853). The authors did not have any other conflicts of interest.

Correspondence to: Kenneth H. Mayer, MD, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02906 (e-mail: Kenneth_Mayer@Brown.edu).

© 2008 Lippincott Williams & Wilkins, Inc.