Wednesday, October 19, 2011

HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

[Press Release - October 18, 2011]

Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges FDA and Gilead to start the review process that could allow safe and appropriate approved PrEP use as a public health intervention, and not to delay review because of distinct questions about the safety and efficacy of PrEP in heterosexual populations.

[The letter is available online here. LifeLube's mother - AIDS Foundation of Chicago - is a signatory.]

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone.

Advocates assert that the need for new HIV prevention strategies for MSM is urgent. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the United States. CDC logged an estimated 34% increase in HIV infections in young gay men between 2006 and 2009, and a 48% HIV increase among young black/African American gay men over the same period.

“We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men,” said Phill Wilson, executive director of the Black AIDS Institute. “We’ve had evidence of PrEP’s effectiveness in MSM for almost a year now. It’s time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. Prompt FDA review will help ensure that appropriate guidelines for PrEP use are established that can reduce HIV infections and safeguard public health.”

Data on PrEP in heterosexuals raise important but unique questions that may require further study. Two major trials in Africa found that PrEP reduces HIV infection risk in heterosexual men and women substantially. But two other studies present conflicting information about how PrEP works in heterosexuals. Critical and necessary efforts to understand how PrEP interacts with hormonal contraception, or how PrEP may impact pregnancy, however, should not delay access to a potentially lifesaving form of HIV prevention for MSM.

Before the results of the heterosexual PrEP studies were announced, the FDA and Gilead Sciences, the maker of the drugs, were reported to be ready to move quickly to consider approval of PrEP for those MSM who could benefit from the approach. Recent signs indicate, however, that FDA review of PrEP for this population may not start until the agency acquires more data on PrEP among heterosexuals—despite the urgent need for new HIV prevention strategies for MSM, and the fact that PrEP data in MSM were announced nearly one year ago.

“The FDA and Gilead Sciences should move quickly to ensure a thorough review of PrEP for MSM now, while they both work simultaneously and swiftly to thoroughly address questions and concerns about PrEP among heterosexual populations,” said Mitchell Warren, executive director of AVAC “Prompt FDA review of PrEP in MSM is the right thing to do for public health. In the midst of a growing HIV epidemic, HIV prevention delayed is HIV prevention denied.”

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

select key words

2007 National HIV Prevention Conference 2009 National LGBTI Health Summit 2011 LGBTI Health Summit 2012 Gay Men's Health Summit 2012 International AIDS Conference abstinence only ACT Up activism advocacy Africa african-american aging issues AIDS AIDS Foundation of Chicago anal cancer anal carcinoma anal health anal sex andrew's anus athlete ball scene bareback porn barebacking bathhouses bears big bold and beautiful Bisexual Bisexual Health Summit bisexuality black gay men black msm blood ban blood donor body image bottom Brian Mustanski BUTT Center on Halsted Charles Stephens Chicago Chicago Black Gay Men's Caucus Chicago Task Force on LGBT Substance Use and Abuse Chris Bartlett chubby chaser circumcision civil rights civil union Coaching with Jake communication community organizing condoms Congress crystal meth dating dating and mating with alan irgang David Halperin David Munar depression disclosure discrimination domestic violence don't ask don't tell douche downlow Dr. James Holsinger Dr. Jesus Ramirez-Valles Dr. Rafael Diaz Dr. Ron Stall drag queen Ed Negron emotional health ENDA Eric Rofes exercise Feast of Fun Feel the love... female condom fitness Friday is for Faeries FTM gay culture gay identity gay latino gay male sex gay marriage gay men gay men of color gay men's health Gay Men's Health Summit 2010 gay pride gay rights gay rugby gay sex gay youth gender harm reduction hate crime HCV health care health care reform health insurance hepatitis C HIV HIV care HIV drugs HIV negative HIV positive HIV prevention HIV stigma HIV strategic plan HIV testing hiv vaccine HIV/AIDS homophobia homosexuality hottie hotties how are you healthy? Howard Brown Health Center HPV human rights humor hunk Illinois IML immigration International AIDS Conference international mr. leather internet intimacy IRMA Jim Pickett leather community leathersex Leon Liberman LGBT LGBT adoption LGBT culture LGBT health LGBT rights LGBT seniors LGBT youth LGBTI community LGBTI culture LGBTI health LGBTI rights LGBTI spirituality LGV LifeLube LifeLube forum LifeLube poll LifeLube subscription lifelube survey Lorenzo Herrera y Lozano love lube lubricant Lymphogranuloma Venereum masturbation mental health microbicides middle Monday Morning Perk-Up MRSA MSM music National AIDS Strategy National Gay Men's Health Summit negotiated safety nutrition One Fey's Tale oral sex Peter Pointers physical health Pistol Pete pleasure PnP podcast policy politics poppers porn post-exposure prophylaxis PrEP President Barack Obama Presidential Campaign prevention Project CRYSP prostate prostate cancer public health public sex venues queer identity racism Radical Faerie recovery rectal microbicides relationships religion research safe sex semen Senator Barack Obama sero-adaptation sero-sorting seroguessing sex sexual abuse sexual addiction sexual health sexual orientation Sister Glo Sisters of Perpetual Indulgence smoking social marketing spirituality STD stigma stonewall riots substance abuse treatment substance use suicide super-bug superinfection Susan Kingston Swiss declaration syphilis Ted Kerr Test Positive Aware Network testicle self-examination testicular cancer testing The "Work-In" The 2009 Gay Men's Health Agenda Tony Valenzuela top Trans and Intersex Association trans group blog Trans Gynecology Access Program transgender transgender day of remembrance transgendered transmen transphobia transsexual Trevor Hoppe universal health care unsafe sex vaccines video violence viral load Who's That Queer Woof Wednesday writers yoga You Tube youtube