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.
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.
Authors: David V Glidden; K Rivet Amico; Albert Y Liu; Sybil G Hosek; Peter L Anderson; Susan P Buchbinder; Vanessa McMahan; Kenneth H Mayer; Burns David; Mauro Schechter; Beatriz Grinsztejn; Juan Guanira; Robert M Grant Journal: Clin Infect Dis Date: 2016-01-20 Impact factor: 9.079
Authors: Robert M Grant; Javier R Lama; Peter L Anderson; Vanessa McMahan; Albert Y Liu; Lorena Vargas; Pedro Goicochea; Martín Casapía; Juan Vicente Guanira-Carranza; Maria E Ramirez-Cardich; Orlando Montoya-Herrera; Telmo Fernández; Valdilea G Veloso; Susan P Buchbinder; Suwat Chariyalertsak; Mauro Schechter; Linda-Gail Bekker; Kenneth H Mayer; Esper Georges Kallás; K Rivet Amico; Kathleen Mulligan; Lane R Bushman; Robert J Hance; Carmela Ganoza; Patricia Defechereux; Brian Postle; Furong Wang; J Jeff McConnell; Jia-Hua Zheng; Jeanny Lee; James F Rooney; Howard S Jaffe; Ana I Martinez; David N Burns; David V Glidden Journal: N Engl J Med Date: 2010-11-23 Impact factor: 91.245
Authors: Allan E Rodríguez; Amanda D Castel; Carrigan L Parish; Sarah Willis; Daniel J Feaster; Michael Kharfen; Gabriel A Cardenas; Kira Villamizar; Michael Kolber; Liliana Vázquez-Rivera; Lisa R Metsch Journal: J Acquir Immune Defic Syndr Date: 2013-11-01 Impact factor: 3.731