Feds Approve Broad New Clinical Guidance On PrEP

Michigan LGBT And HIV Leaders Praise New Guidance

By Todd Heywood

comprehensive clinical guidance

On May 14 the CDC released a comprehensive clinical guidance for use of the anti-HIV drug Truvada in preventing new HIV infections. The new guidance is the most comprehensive clinical guidance issued by a government agency since the FDA approved the drug for prevention in July of 2012.


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The new guidance says PrEP (which stands for Pre-Exposure Prophylaxis) should be considered for HIV-uninfected persons who fit any of the follow risk categories: are in an ongoing sexual relationship with HIV-infected partner; a gay, bisexual or other man who has sex with men or a transgender woman who has had sex without a condom or has been diagnosed with a sexual transmitted infection in the previous six months and is not in a mutually monogamous relationship with a partner who recently tested negative for HIV; a heterosexual man or woman who does not always use condoms and is not in a mutually monogamous relationship with a person who has recently tested HIV-negative; anyone who has injected illicit drugs and shared equipment or has been in treatment for injection drug use in the past six months.

The guidance was developed through a partnership between the CDC, other federal health authorities, public health agencies, health experts and community leaders.

"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," a press release from the CDC quoted Jonathan Mermin, M.D., M.P.H., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention as saying. "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."

Mermin was not alone his assessment of the importance of the new guidance.

"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, in a press release. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the US."

New Guidances Praised

LGBT and HIV service organizations in Michigan are praising the new guidance.

Bryan Victor, victim advocate at Equality Michigan and the organizations point person on HIV issues, praised the new guidance as "welcome" and "an incredibly important tool."

"Both public and private health insurers have already opened a pathway to PrEP use by offering coverage of the drug. We now need health care professionals - and primary care providers in particular - to take these CDC guidelines seriously and begin prescribing PrEP when clinically indicated," Victor said in a press statement emailed to the organization's membership. "Transgender women, gay men and bisexual men deserve access to the full range of options that will allow them to have safe and fulfilling sex. Equality Michigan will continue to work with our partners throughout Michigan to make PrEP as accessible as possible."

In Lansing, Jake Distel, executive director of Lansing Area AIDS Network, said the guidance was welcome, but noted there remained structural issues to accessing the prevention pill.

"There seems to be no conformity relative to the prescribing of PrEP, nor access to the regimen, through either specialty providers (Infectious Disease Clinics), local health departments or primary care providers," Distel said. "This appears to be true not only in Michigan but in other states across the country. LAAN case managers report, for example, that the agency has been advised that there are no protocols or guidances in place under which to comfortably prescribe and provide access to PrEP. This is unfortunate."

He said the staff at LAAN is keenly aware of people living with HIV who are in serodiscordant relationships - that's where one partner is HIV-positive and the other is HIV-negative - and the lack of conformity hampers attempts by these couples to access the prevention regime.

Distel noted the new guidance should "alter past processes and decisions" related to PrEP. At the very least, he said, the new guidance should foster a discussion among local and state partners on the prevention.

On The Ground In Michigan

Unfortunately, the federal guidance may not translate to on the ground support in Michigan. The Michigan Department of Community Health has previously declined to issue guidance on PrEP. The agency said as recently as last week, while the science behind the intervention is interesting, officials are still waiting for more information before committing to PrEP. MDCH officials now say they are reviewing their options on communicating PrEP guidance to providers and stakeholders in the state.

The department had similar problems several years ago when an investigation revealed the agency had no set guidance for prescribe post-exposure prophylaxis (n-PEP) for persons who may have been exposed to HIV as a result of sexual activity, sexual assault or drug use. The lack of state guidance and policy resulted in a mishmash of scenarios across the state. Where in the state someone lived often dictated whether or not a person would be prescribed the drugs.

In n-PEP, a physician prescribes a person exposed to HIV a month long course of anti-HIV medications in order to prevent infections. The regiment must be started within 72 hours of exposure to be effective.

After the news reports on the lack of policy came out, it took the health agency 18 months to issue a state guidance on the intervention, and the new guidance was similar to federal guidance on the drug intervention.

Ironically, despite the state's refusal to promote the intervention, which can be more than 90 percent effective in preventing new infections if used daily, the Medicaid program will pay for the drug for low-income residents who are prescribed the prevention intervention. The cost of the drug is about $12,000 a year and requires routine blood work to monitor HIV status as well as the function of internal organs to detect any possible side effects from the drugs.

Angela Minicuci, spokesperson for MDCH, issued a press statement saying they will follow the CDC guidance: "PrEP is an important tool in the prevention of HIV and the CDC guidance in support of PrEP is a major step forward. MDCH will follow the CDC guidance on PrEP and the prevention and treatment of HIV. As we are still reviewing the recommendation, we will be determining how this information will be distributed. On a cautionary note, PrEP does not prevent bacterial sexually transmitted diseases, such as syphilis, gonorrhea and chlamydia. Condoms reduce the risk of HIV and STDs so we will continue to recommend those as well."

CDC press release: http://www.cdc.gov/nchhstp/newsroom/2014/PrEP-Guidelines-Press-Release.html

Federal Guidance: http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf

Link to the supplement for the guidelines: http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf


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