杀菌剂将能预防爱滋病及性病


  Oct. 12, 2005 (旧金山) - 一项于美国感染疾病学会第43届年会上所提出的简报指出,目前正在进行的杀菌剂研究显示,杀菌剂在预防爱滋病和其它性病上成效卓著。
  
  宾州匹茨堡大学Sharon Hillier博士向与会人士表示,杀菌剂是尚待开发的领域,,并反驳杀菌剂的效果被许多人视为「盲目的猜测」。
  
  然而,对Hillier博士而言,正在进行研究的局部杀菌剂,在将来会有进一步的研究,对疫苗来说是有效的替代策略,她并补充道,疫苗永远无法提供全方位的保护作用。
  
  第二代的杀菌剂之中正在进行研究的是反转录酶抑制剂,象是局部使用的tenofovir凝胶。
  
  Hillier医师表示,局部使用的tenofovir凝胶,其优势在于原先即是用来治疗爱滋病,带来局部及全身性低量毒性,而在动物研究中已显示具有部份的保护作用。
  
  由美国卫生署所赞助的第二阶段研究(HPTN 059),目前正召募妇女参与实验,以评估其安全性及阴道用杀菌剂1%的tenofovir凝胶之效果为何;实验组的使用方法为每天擦或是在性行为前擦两种,而对照组为使用安慰剂型凝胶,两组皆使用超过24周。
  
  迄今,该研究已被位于印度浦那及纽约的国际级医药审查理事会所核可,两个地点都将以100名参与实验的女性为目标,预计于2005年十月开始进行;研究将进行超过六个月,追踪观察则会延续到下个阶段的六个月。
  
  由研究所提出的关键议题之一,为女性能否接受每日剂量?Hillier医师表示,那真是大问题。
  
  美国纽约市哥伦比亚大学梅尔曼公共卫生学院感染病流行病学研究中心副主任Jessica Justman医师附和;她虽为Hillier医师的同事,却持不同意见,她以警告的口吻提出意见,Justman医师强调,要是女性及其伴侣并不想使用局部杀菌剂,那么它的效果是零;然而,许多女性向她表示,她们会想要用杀菌剂,前提是安全且有效的;她指出,我真的认为女性对于能自主控制的事,感到兴奋。
  
  需要进行更深入研究的议题是,局部使用的tenofovir凝胶会不会产生抗药性;Justman医师表示,仍有数个问题尚待解答,举例来说,是否杀菌剂的成份改变了抗药性的风险?全身性吸收和抗药性的形成之间有何关联?
  
  Hillier医师特别感到兴奋的是,另一项正在商品化的第二代剂型UC-781,UC-781已经显示出具有对不同型态的细胞和病毒株有著保护作用;这个剂型甚至对具抗药性的病毒也有效,Hillier医师表示,这确实是希望之光。
  
  此外,标准的新型杀菌剂将结合商品化药品,以产生复合机转的药效为目标;Hillier医师表示,未来的趋势是新药品能同时治疗爱滋病和性病(如疱疹)。
  
  美国感染疾病学会(Infectious Disease Society of America,IDSA)第43届年会:第1213号摘要。发表于2005年10月8日。

Microbicides Show Promise for<

By
Medscape Medical News

Oct. 12, 2005 (San Francisco) — Microbicides currently under investigation are showing promise for protecting again HIV and other sexually transmitted diseases, according to a presentation here at the Infectious Disease Society of America 43rd annual meeting.

"Microbicides is an area that is underrecognized," Sharon Hillier, PhD, from the University of Pittsburgh in Pennsylvania, told meeting attendees, adding that many people think that microbicides are really "shots in the dark."

For Dr. Hillier, however, topical microbicides currently under investigation and several lined up for future study may provide an effective complementary strategy to vaccines, which, she added, will never be fully protective in and of themselves.

Among the second-generation microbicides currently under investigation are the reverse transcriptase inhibitors, such as topical tenofovir.

The advantage of topical tenofovir, said Dr. Hillier, is that it has known activity for treatment of HIV, has a low level of local and systemic toxicity, and has been shown in animal studies to be partially protective. A National Institutes of Health–funded phase II study (HPTN 059) is currently enrolling women to evaluate the safety and acceptability of vaginal microbicide 1% tenofovir gel (either daily dosing or prior to sexual activity) compared with placebo over 24 weeks, she said.

To date, the study has been approved by the international review board in Pune, India, and New York, and each site will have a target enrollment of 100 women, expected to begin in October 2005. Enrollment will take place over six months, with follow-up to extend another six months.

One of the key issues that will be addressed by that study is whether daily dosing is acceptable to women. "That is a big question," Dr. Hillier said.

Jessica Justman, MD, associate director of the Center for Infectious Disease Epidemiologic Research at the Mailman School of Public Health, Columbia University, in New York City, agreed. Speaking with the caveat that she is a colleague of Dr. Hillier and therefore may be biased, Dr. Justman emphasized that a topical microbicide is of no use if women and their partners are not willing to use it. However, many women have told her that they would use a microbicide if it was safe and effective. "I really think that women are excited about something they can control themselves," she said.

An issue that needs further study is how topical tenofovir may affect resistance. A number of questions remain unanswered, Dr. Justman said. For example, will the microbicide formulation alter the risk of resistance? What is the relationship between systemic absorption and the development of resistance?

Another second-generation agent in the pipeline that Dr. Hillier finds particularly exciting is UC-781, which has been shown to have protective activity against different cell types and virus strains. "This agent even works against resistant virus," said Dr. Hillier. "This is a real ray of hope."

In addition, new microbicides on the horizon will combine products to target multiple mechanisms of action. "The exciting trend moving forward is coming products to target both HIV and STDs, such as herpes," Dr. Hillier said.

IDSA 43rd Annual Meeting: Abstract 1213. Presented Oct. 8, 2005.

Reviewed by Gary D. Vogin, MD

    
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