Mayer Kenneth H, Mimiaga Matthew J, Cohen Daniel, Grasso Chris, Bill Ronn, Van Derwarker Rodney, Fisher Alvan
Fenway Institute, Fenway Community Health, Boston, MA, USA.
J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):494-9. doi: 10.1097/QAI.0b013e318162afcb.
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.
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.
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.
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.
非职业性暴露后预防(NPEP)已被用于降低高危暴露后HIV的传播。然而,在完成推荐的28天疗程中依从性欠佳导致了预防失败。芬威社区健康中心是新英格兰地区为感染HIV及高危男男性行为者(MSM)提供护理的最大中心,于1997年启动了一项NPEP项目,最初使用基于齐多夫定的方案。
开展了两项4期研究,采用替诺福韦酯方案联合拉米夫定或恩曲他滨。本文评估了使用基于替诺福韦的NPEP方案者的经历,并将这些受试者与使用含齐多夫定方案的历史对照进行比较。
2004年5月至2005年3月期间,44名在高危性暴露后前来就诊的个体被开具替诺福韦酯/拉米夫定用于NPEP。2005年3月至2006年3月期间,68名有72次高危经历的个体接受了替诺福韦酯/恩曲他滨治疗,并与122名历史对照进行比较,这些对照在2000年1月至2004年5月期间被开具了126疗程的齐多夫定加拉米夫定。接受替诺福韦酯和恩曲他滨进行NPEP的患者中,72%按规定完成了疗程,接受替诺福韦酯和拉米夫定的参与者中这一比例为87.5%,而接受齐多夫定加拉米夫定的患者中只有42.1%完成了疗程(P<0.0001)。接受含替诺福韦酯方案治疗的参与者更有可能报告腹泻或腹部不适;接受含齐多夫定方案治疗的患者更有可能报告恶心和呕吐,其严重程度往往足以导致停药。
含替诺福韦酯的NPEP方案总体耐受性良好,完成率高。与先前使用的含齐多夫定方案相比,耐受性和依从性更佳。对于暴露后预防,应考虑使用含替诺福韦酯的方案以提高依从性和疗程完成率。