N Engl J Med. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

[Giuseppe]

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men (N Engl J Med., abstract, edited)


[Source: The New England Journal of Medicine, full text: <cite cite="http://www.nejm.org/doi/full/10.1056/NEJMoa1011205?query=OF">Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men ? NEJM</cite>. Abstract, edited.]

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Robert M. Grant, M.D., M.P.H., Javier R. Lama, M.D., M.P.H., Peter L. Anderson, Pharm.D., Vanessa McMahan, B.S., Albert Y. Liu, M.D., M.P.H., Lorena Vargas, Pedro Goicochea, M.Sc., Mart?n Casap?a, M.D., M.P.H., Juan Vicente Guanira-Carranza, M.D., M.P.H., Maria E. Ramirez-Cardich, M.D., Orlando Montoya-Herrera, M.Sc., Telmo Fern?ndez, M.D., Valdilea G. Veloso, M.D., Ph.D., Susan P. Buchbinder, M.D., Suwat Chariyalertsak, M.D., Dr.P.H., Mauro Schechter, M.D., Ph.D., Linda-Gail Bekker, M.B., Ch.B., Ph.D., Kenneth H. Mayer, M.D., Esper Georges Kall?s, M.D., Ph.D., K. Rivet Amico, Ph.D., Kathleen Mulligan, Ph.D., Lane R. Bushman, B.Chem., Robert J. Hance, A.A., Carmela Ganoza, M.D., Patricia Defechereux, Ph.D., Brian Postle, B.S., Furong Wang, M.D., J. Jeff McConnell, M.A., Jia-Hua Zheng, Ph.D., Jeanny Lee, B.S., James F. Rooney, M.D., Howard S. Jaffe, M.D., Ana I. Martinez, R.Ph., David N. Burns, M.D., M.P.H., and David V. Glidden, Ph.D. for the iPrEx Study Team

November 23, 2010 (10.1056/NEJMoa1011205)


Abstract

Background
Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

Methods
We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC?TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.

Results
The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC?TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC?TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC?TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

Conclusions
Oral FTC?TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.)

-
------

 

[Gert van der Hoek]

Re: N Engl J Med. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Use of HIV Medications Reduces Risk of HIV Infection in Uninfected People, Study Suggests

ScienceDaily (Nov. 23, 2010) — In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill (95% CI 15.4 to 62.6%; P=0.005).

The study, reported in the New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

ScienceDaily

 

[Gert van der Hoek]

Re: N Engl J Med. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

SOUTH AFRICA: HIV prevention drugs raise more questions than answers


JOHANNESBURG, 29 November 2010 (PlusNews) - Recent studies have shown that antiretroviral [ARV] drugs can reduce the risk of HIV-infection but for researchers and governments - the research raises more questions than answers about its implementation.

The New England Journal of Medicine recently published the results of a study to use antiretrovirals as pre-exposure prophylaxis (PrEP) to prevent HIV infection among men who have sex with men (MSM).

The iPrEx results come four months after Centre for the AIDS Programme of Research in South Africa (CAPRISA) researchers announced their tenofovir-based vaginal gel reduced HIV infections by 39 percent in study participants.

The result will be increased pressure on high HIV-prevalence countries such as South Africa to roll out prevention methods, according to Helen Rees, director of the Wits Institute for Sexual and Reproductive Health, HIV and Related Diseases.

Speaking at a debate on PrEP held by Johannesburg?s University of the Witwatersrand on 25 November, Rees cautioned that while more research was needed, South Africa had to start thinking about how, when and to whom PrEP would be given.

- snip -

Private sector may be first out of the gate

While Pillay stressed that it was too early for the government to adopt a formal position on PrEP, Morris said this might not stop an informal private sector roll-out.

?After the publication of the iPrEx results, a doctor is perfectly justified in prescribing tenofovir to a high-risk [HIV-negative] gay man in his office and I?m sure that is going to happen,? she told IRIN/PlusNews.

Jonathan Berger, a researcher with the human rights organization Section27, said that without public sector provision, socio-economics would largely determine who would benefit.

?This is going to become an access issue because for those in the private sector with money, they?ll be able to get access ? those in the public sector will have to wait for the policies to be implemented,? he added. ?It?s really going to become a question of the haves and the have-nots. For me, it?s not really a question of whether we implement but when and how.?

Further research raises ethical questions

Read more:

Plusnews