Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000

In September 2000, two instances of life-threatening hepatotoxicity were reported in health-care workers taking nevirapine (NVP) for postexposure prophylaxis (PEP) after occupational human immunodeficiency virus (HIV) exposure. In one case, a 43-year-old female health-care worker required liver transplantation after developing fulminant hepatitis and end-stage hepatic failure while taking NVP, zidovudine, and lamivudine as PEP following a needlestick injury (1). In the second case, a 38-year-old male physician was hospitalized with life-threatening fulminant hepatitis while taking NVP, zidovudine, and lamivudine as PEP following a mucous membrane exposure. To characterize NVP-associated PEP toxicity, CDC and the Food and Drug Administration (FDA) reviewed MedWatch reports of serious adverse events in persons taking NVP for PEP received by FDA (Figure 1). This report summarizes the results of that analysis and indicates that healthy persons taking abbreviated 4-week NVP regimens for PEP are at risk for serious adverse events. Clinicians should use recommended PEP guidelines and dosing instructions to reduce the risk for serious adverse events.     

Human immunodeficiency virus postexposure prophylaxis for occupational exposure in a medical school hospital in Thailand

This is a retrospective review of occupational exposure to human immunodeficiency virus (HIV) and subsequent postexposure prophylaxis (PEP) among healthcare workers (HCWs) in King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. From January 2002 to December 2004, data were collected from incident reports, the hospital's infectious diseases unit and the emergency department. There were 315 reported episodes of occupational exposure among 306 HCWs. Nurses (34.0%) were the HCWs most frequently exposed and percutaneous injury (91.4%) was the most common type of exposure. One-third of the source patients tested were infected with HIV. PEP was initiated following 200 (63.5%) of the 315 exposures and was started within 24h in >95% of cases. The most commonly prescribed PEP regimen was zidovudine, lamivudine and nelfinavir. Fifty-six percent of HCWs given PEP completed a four-week course but the remainder discontinued PEP prematurely due to side-effects, or after negative results from the source, or following informed risk reassessment or from their own accord. No exposed HCW acquired HIV during the study period. Appropriate counselling and careful risk assessment are important in achieving effective HIV PEP among HCWs.     

Effect of zidovudine postexposure prophylaxis on the development of HIV-specific cytotoxic T-lymphocyte responses in HIV-exposed healthcare workers.

We evaluated the effects of zidovudine postexposure prophylaxis (PEP) on the development of human immunodeficiency virus (HIV) envelope-specific cytotoxic T-lymphocyte responses in 20 healthcare workers with occupational exposures to HIV. Seven healthcare workers were treated with zidovudine PEP. Only 1 of 7 treated, versus 6 of 13 not treated, developed an HIV envelope-specific cytotoxic T-lymphocyte response. These data suggest that zidovudine abrogated HIV-specific cytotoxic T-lymphocyte responses. HIV-specific cytotoxic T-lymphocyte responses may be useful as a surrogate marker of HIV replication in the evaluation of new regimens for PEP of occupational HIV exposures.     

Experience of healthcare workers taking postexposure prophylaxis after occupational HIV exposures: findings of the HIV Postexposure Prophylaxis Registry.

OBJECTIVE: To collect information about the safety of taking antiretroviral drugs for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). DESIGN: A voluntary, confidential registry. SETTING: Hospital occupational health clinics, emergency departments, private physician offices, and health departments in the United States. RESULTS: 492 healthcare workers (HCWs) who had occupational exposures to HIV, were prescribed HIV PEP, and agreed to be enrolled in the registry by their healthcare providers were prospectively enrolled in the registry. Three hundred eight (63%) of 492 of the PEP regimens prescribed for these HCWs consisted of at least three antiretroviral agents. Of the 449 HCWs for whom 6-week follow-up was available, 195 (43%) completed the PEP regimen as initially prescribed. Forty-four percent (n=197) of HCWs discontinued all PEP drugs and did not complete a PEP regimen. Thirteen percent (n=57) discontinued > or =1 drug or modified drug dosage or added a drug but did complete a course of PEP Among the 254 HCWs who modified or discontinued the PEP regimen, the two most common reasons for doing so were because of adverse effects attributed to PEP (54%) and because the source-patient turned out to be HIV-negative (38%). Overall, 340 (76%) HCWs with 6-week follow-up reported some symptoms while on PEP: nausea (57%), fatigue or malaise (38%), headache (18%), vomiting (16%), diarrhea (14%), and myalgias or arthralgias (6%). The median time from start of PEP to onset of each of the five most frequently reported symptoms was 3 to 4 days. Only 37 (8%) HCWs with 6-week follow-up were reported to have laboratory abnormalities; review of the reported abnormalities revealed that most were unremarkable. Serious adverse events were reported to the registry for 6 HCWs; all but one event resolved by the 6-month follow-up visit. Fewer side effects were reported by HCWs taking two-drug PEP regimens than by HCWs taking three-drug PEP regimens. CONCLUSIONS: Side effects from HIV PEP were very common but were rarely severe or serious. The nature and frequency of HIV PEP toxicity were consistent with information already available on the use of these antiretroviral agents. Clinicians prescribing HIV PEP need to counsel HCWs about PEP side effects and should know how to manage PEP toxicity when it arises.     

广东省艾滋病病毒职业性暴露应急系统响应情况分析

目的建立艾滋病病毒(HIV)职业性暴露应急系统,分析应急响应情况。方法回顾性收集和分析2002~2004年报告的广东省各地HIV职业性暴露个案。结果2002~2004年共报告152例HIV职业性暴露个案,其中医务人员占74.34%,干警占13.82%。29.61%是皮肤黏膜接触性暴露,70.39%是创伤性暴露。暴露级别中,一级暴露占57.24%,二级暴露占35.53%,三级暴露占7.24%。94.74%的暴露者进行了暴露后应急局部处理。发生暴露后,只有38.16%的暴露者采用了合理的处理方案。104例(68.42%)进行了预防性服药,但其中仅有27.88%(29/104)的人采用合理的服药方案。48例(31.58%)未进行预防性服药,但其中仅有60.42%(29/48)的人是真正无需预防性服药者。92例暴露者经12个月的随访未发现有感染HIV者。结论广东省HIV职业性暴露应急系统能有效地响应全省HIV职业性暴露事件,但仍需加强对职业性暴露后应急处理技术的知识培训。     

护理人员HIV职业暴露及感染HIV原因分析

目的分析护理人员HIV职业暴露后感染情况及部分感染HIV护理人员情况,为预防护理人员发生HIV感染提供依据。方法对某院2004年1月—2015年6月发生的HIV职业暴露的护理人员,及2001年1月—2015年12月在该院住院、门诊咨询或院外会诊的抗HIV阳性的护理人员及其配偶的HIV感染情况进行分析。结果 76例护理人员HIV职业暴露进行规范化处理及随访后均未发生HIV感染。13例感染HIV的护理人员中既往可能职业暴露感染3例,二十世纪九十年代输血感染5例,性传播感染4例(其中男护士同性性行为感染2例),感染途径不明1例;发生二次传播2例;目前存活9例。感染者多得到有效治疗并改为从事后勤工作。结论护理人员常发生HIV职业暴露,可能职业暴露感染均发生在未实施规范化管理的情况下,实施规范化管理可避免HIV职业暴露感染的发生。性传播(包括男男同性性行为)已成为护理人员感染HIV的重要途径。     

云南省德宏州2010-2015年艾滋病病毒职业暴露状况分析

目的 了解云南省德宏州艾滋病病毒（human immunodeficiency virus,HIV）职业暴露发生、暴露后预防以及预后随访现状,为开展和加强HIV职业暴露防护工作提供依据。方法 对德宏州2010-2015年上报的所有HIV职业暴露者的个案登记记录进行汇总和统计分析。结果 2010-2015年期间,德宏州共报告323例,均未发现HIV抗体阳转者。其中220人（68.11%）为女性,229人（70.90%）年龄小于35岁,209人（64.71%）为医务人员。暴露方式以针刺或锐器刺伤为主,占72.14%（233/323）;暴露发生地点以医疗单位为主,占82.66%（267/323）;发生职业暴露后,323人立即对皮肤或粘膜进行清洗或消毒处理,279人在职业暴露后采用了预防性用药,156人完成了28 d的暴露后预防（post-exposure prophylaxis,PEP）疗程,6年HIV职业暴露人数变化浮动较大。结论 坚持"普遍性防护原则"、暴露后立即采取应急措施、暴露评估后尽早接受PEP有益于避免和降低职业暴露者感染HIV的风险。     

Occupational exposure to HIV and post-exposure prophylaxis in healthcare workers

Healthcare workers are at risk of occupationally acquired HIV infection primarily due to percutaneous exposure to HIV infected blood. The average risk of HIV transmission after such exposure is approximately 0.3%. There is evidence of higher risk for exposures involving an increased volume of blood (deep injury, injury with a device visibly contaminated with source patient's blood and a procedure which involved a needle placed in the source patient's artery or vein) and exposures to source patients with a high viral load. Triple therapy with two nucleoside analogues (zidovudine, lamivudine) and a protease inhibitor (indinavir) is now widely used for post-exposure prophylaxis following occupational exposure to HIV. Most of the evidence for the efficacy of prophylaxis is based on zidovudine monotherapy. Little is known about the long-term toxicity of these drugs in non-infected individuals. Their use in these circumstances requires careful assessment of possible risks and benefits.     

HIV postexposure prophylaxis: Who should get it?

In most cases, HIV postexposure prophylaxis (PEP) is given only to healthcare workers if the settings make exposure to HIV-infected persons likely. Otherwise, it is usually deemed unnecessary. However, a decision for or against PEP is complicated. Occupational and nonoccupational exposure to HIV can produce fear, anxiety, and stress. Information on the exposure risk is frequently incomplete, the risk of infection is usually low, the degree of protection offered by PEP is not fully defined, and the potential for side effects from the medications is significant. This article distills the Centers for Disease Control and Prevention's most recent guidance on HIV PEP.     

Post-Exposure Prophylaxis of HIV Infection in Healthcare Workers: Recommendations for the European Setting

The European Commission funded a project for the standardisation of the management of occupational exposures to HIV/blood-borne infections and antiretroviral post-exposure prophylaxis (PEP) in Europe. Within this project, the following recommendations and rationale were formulated by experts representative of participating countries. Based on assessment of the exposure, material, and source characteristics, PEP should be started as soon as possible with any triple combination of antiretrovirals approved for the treatment of HIV-infected patients; initiation is discouraged after 72 hours Rapid HIV testing of the source could reduce inappropriate PEP. HIV testing should be performed at baseline, 4, 12, and 24 weeks, with additional clinical and laboratory monitoring of adverse reactions and potential toxicity at week 1 and 2. HIV resistance tests in the source and direct virus assays in the exposed HCW are not recommended routinely. These easy-to-use recommendations seek to maximise PEP effect while minimising its toxicity and inappropriate use.     

Occupational Exposure to Human Immunodeficiency Virus in Health Care Providers: A Retrospective Analysis

Objectives:

To determine the population at risk, risk factors, and outcome of occupational exposure to blood and body fluids in health care providers.

Materials and Methods:

Retrospective review of two and half year data of ongoing surveillance of occupational exposure to blood and body fluids in a tertiary care hospital.

Results:

103 Health Care Providers (HCP) reported an occupational exposure to blood and body fluids during the period under review. These comprised 72 (69.9%) doctors, 20 (19.4%) nursing personnel, and 11 (10.6%) cleaning staff. Of the doctors, 65% were interns. 53.4% HCP had work experience of less than one year. Circumstances of exposure included clinical procedures (48%), sweeping/handling used sharps (29%), recapping (16%), and surgery (6.9%). 74.3% of the exposures were due to non-compliance with universal precautions and were thus preventable. The device most frequently implicated in causing injury was hollow bore needle (n=85, 82.5%). Human Immunodeficiency Virus (HIV) status of the source was positive in 6.8% cases, negative in 53.4% cases, and unknown in remaining 39.8% cases. Postexposure prophylaxis (PEP) was indicated in 100 (97.08%) cases and was initiated within 2 h of exposure in 26.8% HCP. In 23.2% HCP, PEP initiation was delayed beyond 72 h of exposure due to late reporting. Thirteen HCP received expanded and the remaining received basic regime. Of the 82 HCP followed up, 15 completed the full course, while 55 stopped PEP after the first dose due to negative source status. Twelve HCP with exposure to blood of unknown HIV status discontinued PEP despite counseling. Complete follow-up for seroconversion was very poor among the HCP. HIV status at 6 month of exposure is not known for any HCP.

Conclusions:

Failure to follow universal precautions including improper disposal of waste was responsible for majority of occupational exposures. HCP need to be sensitized regarding hospital waste management, management of occupational exposure, need for PEP, and continued follow-up.     

One-year study of occupational human immunodeficiency virus postexposure prophylaxis

A 12-month experience with human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) in a tertiary care center was evaluated for timeliness of treatment and adherence to treatment recommendations. Forty-six health care workers were started on HIV PEP. Risk status of the source patient, rather than type of exposure, was a significant determinant for both initiating and completing treatment. Of those exposed to HIV-positive sources, 79% completed the full 28 days of therapy. Only 22% of all health care workers who started PEP discontinued treatment because of adverse effects. Excluding three cases with significant delays in reporting and one in which treatment was controversial, the mean time from exposure to first dose of PEP was 1 hour and 46 minutes. The use of a defined treatment protocol, with supporting educational material and PEP medication immediately available, is an effective way of managing HIV exposures.     

云南省5年HIV职业暴露因素分析

[目的]分析艾滋病病毒（HIV）职业暴露现状,探讨职业暴露后应急预防处理方法。[方法]对云南省2005年～2010年报告的由于职业因素引起的HIV暴露案例进行分析。[结果]2005年～2010年共发生职业暴露1138人,包括医护人员和公安司法人员;暴露类型主要包括针刺伤647例（56．9％）、血液接触皮肤粘膜305例（26．8％）和抓伤96例（8．4％）。974（85．6％）人实施暴露后预防（PEP）,采用基本用药程序或强化用药程序进行干预治疗,所有病例随访未发现HIV抗体阳转者。[结论]HIV职业暴露后感染的危险度较低,但是应严格遵守安全防护措施,暴露后及时使用预防用药,可有效阻断发生艾滋病职业暴露后感染。     

Pregnancy outcome among working women

The influence of occupational factors on the outcome of pregnancy was investigated in a prospective study of 3901 women who worked during their pregnancy and received prenatal care in Orebro County from October 1980 to June 1983. Data on occupational factors, social circumstances, and life-style factors were obtained from questionnaires. There were no significant differences in the incidence of adverse pregnancy outcome (spontaneous abortion, perinatal death, birth defects, or low birthweight) between the nine occupational categories used when nonoccupational factors were accounted for. No increased risk was found for exposure to organic solvents, but the adjusted risk ratio of adverse outcome was 1.28 (95% CI 0.91-1.80) for "other chemical exposures." The work conditions in this county have been generally favorable in recent years, and the results therefore cannot be generalized to conditions with higher exposures. Methodological problems such as misclassification of exposure and the possible bias resulting from different rates of legal abortions among occupational groups are discussed.     

Current Practice of HIV Postexposure Prophylaxis Treatment for Sexual Assault Patients in an Emergency Department

BackgroundComprehensive data that address current HIV nonoccupational postexposure prophylaxis (nPEP) practices in the emergency care of sexual assault patients are limited. The U.S. Centers for Disease Control and Prevention released HIV nPEP guidelines in 2005 and updated guidelines for Sexually Transmitted Disease Treatment in 2006 and 2010, each of which support providing nPEP to sexual assault patients. This study examined the offer, acceptance, and adherence rates of nPEP among sexual assault patients treated at an emergency department (ED).MethodsWe conducted a retrospective review between January 1, 2008, and December 31, 2011, of women, aged 16 years and older, treated for sexual assault in an academic ED that participates in the sexual assault nurse examiner program.FindingsOne hundred seventy-one female patients were treated in the ED for 179 sexual assault events. nPEP was not indicated in 19 cases and was offered to all 138 of patients for whom nPEP was appropriate. Five patient cases that exceeded the 72-hour exposure window were offered nPEP. Of the 143 patient cases offered nPEP, 124 (86.7%) initiated nPEP. Of the 124 who accepted PEP, 34 (27.4%) had documented completion of the 28-day course.ConclusionsnPEP was offered in all 138 cases where patients were eligible for treatment. Of patients who accepted nPEP, a minority are documented to have completed a course of treatment. Systems to improve postassault follow-up care should be considered.     

2000-2017年国际HIV暴露后预防研究热点的文献计量分析

目的 从文献计量分析角度对国际HIV暴露后预防（post-exposure prophylaxis,PEP）的发文量、研究热点及其变化趋势等方面进行分析和研究,旨在为我国相关研究开展及防治条例制订提供参考依据。方法 利用CiteSpace 5.1软件对Web of Science核心合集数据库收录的2000－2017年间所有PEP相关文献进行可视化分析。结果 国际上PEP相关研究发文量平均增速为10.78%,2016年发文量达到顶峰（34篇）,近年相关研究热点从预防HIV职业暴露向MSM等高危人群的HIV非职业暴露后阻断转移,聚类分析显示PEP研究热点主要集中于强化干预减少HIV感染风险、全球HIV PEP的形势、德国-奥地利预防指南3个领域。结论 近年高危人群尤其MSM人群的HIV非职业暴露后预防日益受到国际关注,相关研究主要集中于提高PEP在MSM人群中的知晓和使用度以及服药过程中的依从性等方面。在我国MSM人群HIV疫情较为严峻且未得到有效控制的背景下应加强PEP对MSM人群HIV感染风险的评估和探索,以便为医务人员实施HIV非职业暴露阻断及相关部门制定PEP用药指南提供参考依据。     

A ‘morning-after’ pill for HIV? Social representations of post-exposure prophylaxis for HIV in the British print media

Post-exposure prophylaxis (PEP) is a biomedical approach to HIV prevention that is administered after a potential exposure to the virus. Although it was originally approved in the UK for occupational exposure to HIV among healthcare workers, PEP has remained a controversial method of preventing HIV infection following sexual exposure. To examine emerging social representations of PEP, we undertook a qualitative thematic analysis of 72 articles published in UK newspapers between 1997 and 2015. We focused on print media, as they still reflect broader societal debates, set the agenda for wider discussions in other media and contribute to shaping public perceptions and policy priorities. Our findings show that there were two major social representations of the use of PEP for HIV prevention amongst gay and bisexual men: a positive social representation of PEP as a relatively straightforward solution, where PEP is metaphorically framed as the ‘morning-after pill’, and a more negative social representation of PEP as posing risks and yielding uncertain outcomes. We also found a third social representation for the use of PEP amongst public health care workers, where PEP is represented as needed and deserved. The positive representation generally consisted of anecdotal statements, while the negative representation was substantiated by ‘expert’ and layperson voices, rendering the latter more akin to a hegemonic representation of PEP. We generally found a lack of technical information in all newspapers, and an information gap that might inhibit informed discussion and lead to entrenching polarised social representations and to the stigmatisation of some users of PEP.     

Knowledge of Treatment to Reduce Perinatal Human Immunodeficiency Virus (HIV) Transmission and Likelihood of Testing for HIV: Results from Two Surveys of Women of Childbearing Age

Objective: To determine whether knowledge of zidovudine treatment to reduce the risk of mother-to-child transmission of HIV increases the likelihood of HIV testing among women of childbearing age at increased risk for HIV infection. Method: Data from two samples were analyzed. The Young Women Survey was a population-based, door-to-door survey of 2,545 women aged 18 to 29 years who were living in lower-income neighborhoods. For the Perinatal Survey, women receiving prenatal care or who had delivered within the previous six months (N = 850) were recruited at randomly selected sites. Most (71.2%) of these participants were covered by public payment sources for their prenatal care. Data were collected within California counties with high rates of HIV among newborns, high rates of HIV among female clients of alternative test sites, and high rates of AIDS among female injection drug users. Most participants from both surveys were women of color. Results: Participants who knew about zidovudine therapy for HIV-positive pregnant women were more likely to have had an HIV test, regardless of race/ethnicity, age, education, or number of previous births. The majority of women (79.3%) from both samples stated that they were more likely to take a test for HIV knowing about zidovudine treatment. Conclusions: HIV educators should include information on zidovudine therapy in campaigns designed to promote HIV testing among women. Prenatal care providers should incorporate a brief discussion about the benefits of zidovudine treatment when providing HIV counseling to patients.