MMWR Morb Mortal Wkly Rep. 2012 Aug 10;61(31):586-9.
In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009. Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population. Those recommendations remain valid for MSM, including MSM who also have sex with women. Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM. This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.
2009 年，美国估计有 48100 例新的人类免疫缺陷病毒（HIV）感染。其中，27%发生在异性恋男女中，他们没有注射毒品，64%发生在与男性发生性关系的男性（MSM）中，包括 3%的男性同时注射毒品。2011 年 1 月，在 iPrEx 试验中发布了每日口服替诺福韦酯 300mg（TDF）/恩曲他滨 200mg（FTC）（Truvada，吉利德科学公司）作为抗逆转录病毒暴露前预防（PrEP）以降低 MSM 中 HIV 感染风险的安全性和有效性证据后，疾病预防控制中心发布了临时指南，提供了有关在该人群中使用 PrEP 的信息和重要的初步注意事项。这些建议仍然适用于 MSM，包括也与女性发生性关系的 MSM。自 2011 年 1 月以来，关于 PrEP 在异性恋男性和女性中的研究数据已经可用，并且 2012 年 7 月 16 日，美国食品和药物管理局（FDA）批准了一项用于减少包括异性恋者和 MSM 在内的成年人通过性感染 HIV 风险的标签指示。本临时指南考虑了新信息，并解决了以前 MSM 使用 PrEP 临时指南中未讨论的异性恋活跃成年人在非常高的性 HIV 感染风险下的怀孕和安全性问题。
