UPDATED NUMBER - 116 Leading HIV/AIDS groups (and allied orgs) endorse CDC HIV PrEP Guidelines

[May 20 update: The current list of sign ons has gone up to 116 - and the list below the letter reflects the new number. Organizations - and now individuals as well - are invited to sign on here.]

 

PrEP is a powerful, additional tool in the AIDS response

Thursday, May 15, 2014 — A group of 69 82 116 leading HIV/AIDS and health organizations HIV/AIDS and health organizations and allies today reiterated their strong support for oral pre-exposure prophylaxis (PrEP) as an important HIV prevention strategy for men and women at risk of HIV infection. The diverse group of advocates, researchers and service providers hailed new HIV PrEP guidelines from the US Centers for Disease Control and Prevention (CDC) as a science-driven, public health approach to what remains a major health crisis in the United States.

The guidelines come almost two years after the US Food and Drug Administration (FDA) approved the oral drug Truvada (TDF/FTC) for HIV prevention following an extensive review of data from multiple, multinational clinical trials of PrEP among men and women with different risks for HIV infection. In the time since FDA approval, the CDC has reviewed additional data and sought input from a range of experts and community members to develop these new guidelines.

The guidelines provide critical information to help healthcare providers and patients evaluate the suitability of oral PrEP as an HIV prevention option and ensure that those who choose PrEP have the support – including ongoing monitoring, counseling, adherence support and frequent HIV and STD testing – necessary for PrEP to be effective.

The group strongly condemns the harmful misrepresentations of the facts and anti-scientific approach to PrEP adopted by the AIDS Healthcare Foundation and its president Michael Weinstein. Weinstein continues to make assertions that are not grounded in scientific evidence. We reject statements from all quarters that add to the deep stigma attached to HIV and that erect barriers between people and what they can use to support their health.

Weinstein’s statement that widespread use of PrEP will be accompanied by “a shift to condomless sex” is not based on evidence. In fact, initial studies suggest the opposite, and Weinstein’s assertion underestimates the capacity of informed individuals to make decisions about their health and sex lives. We all must do more to reinvigorate the approach to correct and consistent condom use and underscore that PrEP and condoms are complimentary interventions to the prevention of all STDs, including HIV. But Weinstein's statements fail to recognize that many adults – in the United States and across the world – have not been using condoms consistently or correctly for a host of reasons. PrEP now provides an additional option that also provides significant protection against HIV.

The current scientific evidence clearly indicates that PrEP, when taken daily as directed, can reduce the risk of HIV infection by more than 90 percent. CDC’s PrEP guidelines, like public health guidelines aimed at helping prevent other diseases, outline the support needed to help patients adhere to the daily dosing. The idea of taking a daily pill for prevention is not new: millions of women have successfully taken contraceptive pills to prevent unintended pregnancy, and men and women are able to take a variety of medications to treat or prevent a range of health issues.

The CDC PrEP guidelines underscore that PrEP is not for everyone. Neither CDC nor any of our organizations are advocating for indiscriminate use of PrEP. Neither is anyone suggesting that oral PrEP is a replacement for condoms; rather it is an additional option from which individuals should be able to choose.

PrEP has the potential to help many individuals in the US and around the world protect themselves from HIV. Failure to strategically, effectively and responsibly implement this scientifically sound strategy as part of comprehensive prevention and treatment programs in our fight against HIV would be a true catastrophe. We support the CDC guidelines, and, more importantly, we support the right of informed adults to choose the most appropriate mix of HIV prevention options for their lives as part of truly comprehensive approaches to testing, treatment, care and prevention.

Organizational sign ons: (updated May 20)

30 for 30 Campaign
ACT UP New York
AIDS Action Baltimore
AIDS Action Coalition
AIDS Action Committee
AIDS Alabama
AIDS Alliance for Women, Infants, Children, Youth & Families
AIDS Arms
AIDS Community Research Initiative of America (ACRIA)
AIDS Foundation of Chicago
AIDS Research Consortium of Atlanta
AIDS Resource Center of Wisconsin
AIDS Resource Center Ohio
AIDS Treatment News
AIDS United
American Sexual Health Association
amfAR: The Foundation for AIDS Research
Amida Care
ANAC
Asian & Pacific Islander Wellness Center
ASPIRA Association
Association of Nurses in AIDS Care
AVAC
Bay Area Perinatal AIDS Center (BAPAC)
Between the Lines Newspaper
Black AIDS Institute
BOOM!Health
Cascade AIDS Project
Center for Health & Gender Equity (CHANGE)
Center for HIV Educational Studies and Training (CHEST), Hunter College, CUNY
Chicago Center for HIV Elimination
Chicago House and Social Service Agency
Chicago Women's AIDS Project
Community Access National Network-CANN
Delaware HIV Consortium
East Bay AIDS Center
End AIDS Now!
Equality Michigan
FHI 360
Friends For Life, Memphis
GAT Portugal
Gay City Health Project
Gay Men's Health Crisis (GMHC)
Georgia Equality
Harlem United Community AIDS Center
Harm Reduction Coalition
HealthHIV
Hispanic AIDS Forum
HIV Medicine Association (HIVMA)
HIV Prevention Justice Alliance
House of Joe
Housing Works
Howard Brown Health Center
Hyacinth AIDS Foundation
Inova Juniper Program
International Rectal Microbicide Advocates (IRMA)
IV-CHARIS
Justice Resource Institute (JRI)
L.A. Gay and Lesbian Center
Lambda Legal
Lansing Area AIDS Network
Latinos Salud
Legacy Community Health Services
Lifelong
Long Beach AIDS Foundation, Inc.
Los Angeles County PrEP Workgroup
Los Angeles County Public Health Social Justice Caucus
Louisiana AIDS Advocacy Network
Maritime Life Precious Foundation
Minnesota AIDS Project
Mr Friendly
Multicultural AIDS Coalition
Nashville CARES
National Alliance of State & Territorial AIDS Directors (NASTAD)
National Association of County and City Health Officials
National Association of Social Workers
National Black Leadership Commission on AIDS, Inc.
National Coalition of STD Directors (NCSD)
National Female Condom Coalition
National Minority AIDS Council (NMAC)
National Women's Health Network
NO/AIDS Task Force
Ohio AIDS Coalition
Pediatric AIDS Chicago Prevention Initiative
Positive Women's Network- USA
PrEP for New York City Task Force
Prepolicious.org
Program for Wellness Restoration
Project Inform
Project PrEPare
Puerto Rican Cultural Center-Vida/SIDA
San Francisco AIDS Foundation
Scott A. Kramer, LCSW
SisterLove
Skills4
Sociologists AIDS Network
Southern AIDS Coalition
Southern HIV/AIDS Strategy Initiative
St. Louis Community PrEP Implementation Project (C-PIP)
START at Westminster
Tennessee Association of People With AIDS
Test Positive Aware Network
The AIDS Institute
The Network for Multidisciplinary Studies on ARV-based HIV Prevention (NEMUS)
The Stigma Project
The Well Project
The Women's Collective
Treatment Access Expansion Project
Treatment Action Group
Urban Coalition for HIV/AIDS Prevention Services (UCHAPS)
US Women & PrEP Working Group
Valley AIDS Information Network Inc.
VOCAL-NY
Whitman-Walker Health
Women With a Vision
Woodhull Sexual Freedom Alliance

CDC/U.S. Public Health Service Release Cinical Guidelines on PrEP for HIV Prevention

This is MAJOR.

Click here for the full guidelines.

CDC's press release (text below)

New guidelines recommend daily HIV prevention pill for those at substantial risk
Could have significant impact on the U.S. epidemic if targeted and used as directed

Health care providers should consider advising the use of anti-HIV drugs by uninfected patients who are at substantial risk of infection, according to new clinical guidelines.

PrEP, or pre-exposure prophylaxis, could reduce HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90 percent. Inconsistent use results in much lower levels of protection. 

“HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States,” said CDC Director Tom Frieden, M.D., M.P.H. “PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.”

The guidelines were developed by CDC in partnership with other federal health agencies, public health experts and community leaders.

The guidelines say PrEP should be considered for HIV-uninfected patients with any of the following indications:

•         Anyone who is in an ongoing sexual relationship with an HIV-infected partner.

•         A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.

•         A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative.

•         Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

“While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today,” said Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.  “These guidelines represent an important step toward fully realizing the promise of PrEP.  We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances.”

The guidelines offer providers specific advice on how to give people the support they need to take their pills regularly. Given the need for high adherence and the lack of complete protection from HIV with PrEP or any other single strategy, the guidelines encourage providers to promote and support its use in combination with condoms and other proven risk-reduction strategies.  Accompanying the guidelines is a supplement that includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.

The guidelines build on interim guidance issued by CDC following the release of research findings on PrEP for men who have sex with men (MSM), heterosexuals, and people who inject drugs.  In 2012, the U.S. Food and Drug Administration (FDA) approved the drug combination of 300 milligrams tenofovir disoproxil fumarate and 200 milligrams emtricitabine (TDF/FTC) for use as PrEP in combination with safer sex practices.

Consistent with FDA labeling, the guidelines stress the importance of HIV testing before PrEP is prescribed and at three-month intervals while a patient is using PrEP.  Regular testing ensures that anyone on PrEP who becomes infected with HIV discontinues PrEP use in order to minimize the risk that the virus could become resistant to the drugs.  Such patients then can begin receiving HIV treatment.

“PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing,” said Dawn K. Smith, M.D., M.P.H., the epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the development of the guidelines.  “Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection.”

In addition to providing guidelines and tools to assist providers in effectively prescribing and supporting PrEP use, CDC and other organizations are conducting pilot implementation studies and demonstration projects throughout the country.  These projects aim to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection.

The guidelines were announced today in CDC’s Morbidity and Mortality Weekly Report.  The 67-page guidelines and 44-page clinical providers’ supplement are published in full here.