FDA ASKED TO APPROVE NEW HIV PREVENTION METHOD, PRE-EXPOSURE PROPHYLAXIS (PrEP)

 

For Immediate Release                          Contact

December 15, 2011                                  Mark Aurigemma; 646-270-9451; mark@aucomm.net

                        Pedro Goicochea; 415-490-8350; pgoicochea@gladstone.ucsf.edu                                                                                                      

 

FDA ASKED TO APPROVE NEW HIV PREVENTION METHOD, PRE-EXPOSURE PROPHYLAXIS (PrEP)

 

An application from Gilead Sciences, Inc. has been filed with the U.S. Food and Drug Administration toapprove an HIV antiretroviral therapy to reduce the risk of HIV infection among uninfected men who have sex with men (MSM) and heterosexual women and men. The application to approve the new HIV prevention method called pre-exposure prophylaxis, or PrEP, is based partly on data from the Global iPrEx study, the first human efficacy study to prove that PrEP reduces HIV infection risk inpeople (http://www.iprexnews.com).

 

The PrEP drug is a single-tablet once-daily combination of emtricitabine (FTC 200 mg) and tenofovir (TDF 300 mg), marketed under the brand name Truvada®. The iPrEx study found that MSM who were prescribed a single daily FTC/TDF tablet experienced an average of44% fewer HIV infections than those who received a placebo pill. Among a study sub-set those who took the tablet frequently enough for drug to be detected in their bodies, the rate of protection against HIVinfection was more than 90%. All participants in the iPrEx study received condoms and comprehensive HIV prevention support. The HIV prevention benefits of PrEP were in addition to the benefits obtained from other prevention methods.

 

iPrEx study results were first reported in the New England Journal of Medicine in November, 2010 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1011205).

 

Data supporting the use of PrEP to reduce HIV infection risk in heterosexual men and women were provided by the Partners PrEP study, which involved 4758 HIV serodiscordant couples (couples in which one partner is HIV-infected and the other is not) at nine trial sites in Kenya and Uganda. Both the iPrEx and Partners PrEP studies found that PrEP is safe, with very low levels of sideeffects and limited risk of HIV drug resistance.

 

“With 2.6 million new HIV infections occurring each year, and fewer than half of people with HIV receiving treatment, the world needs new and effective HIV prevention strategies,” said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. “Men who have sex with men have borne an enormous burden in this epidemic, and have also beenconsistently at the head of efforts to help reverse it. The 2,499 men and transgender women who participated in the iPrEx study Brazil, Ecuador, Peru, South Africa, Thailand and the United States have made an historic contribution to the effort to help end this epidemic.”

 

“The data are clearly strong enough to warrant FDA approval of Truvada for HIV prevention,” said Dana Van Gorder, Executive Director of the AIDS advocacy group Project Inform. “The decision about whether to approve Truvada for prevention should be made with compassion, based on science rather than ideology, and without judgment regarding the behaviors of people at risk for HIV. We firmly believe in the right of people at risk of becoming infected with HIV to choose PrEP, which has been shown to be effective when used with condoms, as an additional method of HIV prevention.”

An Open Label Extension of the iPrEx study (iPrEx OLE; http://www.iprexole.com/index.html) is currently underway at 11 clinical trials sites in the United States, Peru, Ecuador, Brazil, South Africa and Thailand. iPrEx OLE is designed to provide additional information about the safety of PrEP and the behavior of people taking PrEP over a longer term.

 

The iPrEx study was sponsored by the U.S. National Institutes of Health (NIH) through a grant to the Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco. Additional support for iPrEx was provided by the Bill & Melinda Gates Foundation.

# # #

 

Mark Aurigemma

mark@aucomm.net

212.600.1960 (office)

646.270.9451 (mobile)

OHCHR: Discriminatory Laws and Practices & Acts of Violence Against Individuals Based on their Sexual Orientation & Gender Identity

The United Nations has produced its first ever report on LGBT rights. The UN Human Rights Council requested the High Commissioner for Human Rights, Navi Pillay, to prepare the report in a resolution in June of this year.

That resolution was led by South Africa and the brave Cameroonian lawyer and LGBT rights defender Alice N’Kom said:

“I am so proud that this breakthrough was initiated by an African country, and that South Africa is standing up for human rights. Not only were they leaders at the United Nations in pushing for the passage of this historic resolution on LGBT rights, they are also setting an example for all African countries and sending a simple message : homophobia is not an African value.”

The pro-LGBT Ugandan Anglican Bishop Christopher Senyonjo said:

“They have created an “indaba” – a listening process that is familiar to Africans. They have provided the safety for many thousands of people to open deep wounds again and share their stories, experiences and aspirations.  Their courage is to be commended in the hope the next generation may not have to suffer the indignities of our blood-stained past.”

“This work represents the possibility that we can to learn to respect each other, regardless of sexual orientation or gender identity.  We can learn to forgive each other for our complicity in silence or for acts of violence in word and deed against LGBT people.”

“There is another African tradition whereby the spilling of the blood of another is regarded as a major taboo and should be avoided by all faithful people. The spilling of blood caused by homophobia should become our global taboo. This report is a small step towards new possibilities and hopes.”

The findings of the report are due to be presented and discussed by governments at the Human Rights Council in March 2012.

Among its most important recommendations is a call for the decriminalization of same-sex relations between consenting adults. It also notes the particular experiences of lesbians and other women who suffer violence, killings, rape and abuse, often at the hands of family and community. The report includes a call for protection and recognition of the self-identified gender of trans persons.

On refugees and asylum seekers:

• The UN urges governments to recognize persecution based on sexual orientation and gender identity as grounds for refugee status, and to train asylum adjudicators and government officials to be sensitive to the unique challenges faced by LGBTI refugees.
• The report recognizes the extreme vulnerability of LGBTI refugees at risk of violence both before they flee their homelands, and during the refugee status determination and resettlement process. It also calls for a more consistent approach for safeguarding the human rights of LGBTI refugees.
• The report urges governments not to return LGBTI refugees to countries they have fled where their freedom will be threatened because of their sexual orientation or gender identity.

Jessica Stern, Acting Executive Director of The International Gay and Lesbian Human Rights Commission said;

“The report is a tribute to all of the activists who have fought for recognition of homophobic violence and transphobic discrimination over decades, often in the face of extreme hostility. It will serve as an invaluable aid to each one of us who seeks to advance LGBT rights – not only at the United Nations but in cities and towns around the world.”

The release of Pillay’s report follows another landmark at the United Nations, which was the 10 December international consultation organised by UNESCO to address bullying against LGBT students in educational institutions. This took place in Rio de Janeiro, Brazil and brought together experts from UN agencies, NGOs, ministries of education and academia from more than 25 countries around the world.

All participants of the consultation agreed on a joint statement. Chinese and African representatives at the event noted the importance of both sharing experience as well as evidence gathering to develop a “solid foundation when approaching schools and policy-makers.”OHCHR: Discriminatory Laws and Practices and Acts of Violence Against Individuals Based on their Sexual Ori…

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