Advances in HIV Prevention that Work!

PrEP and Its Impact in Prevention Care

Over the last five years, increasingly convincing evidence has shown that HIV-negative individuals can take HIV treatment drugs to avoid becoming infected, even if they come into contact with the virus. This practice is called PrEP (pre-exposure prophylaxis), and it promises to radically change the way we think about HIV prevention.

The latest major study was published on September 1, 2015, by researchers with Kaiser Permanente in California.[1] After tracking 657 participants with access to PrEP for two and half years, they found no new cases of HIV, though they found reduced condom use and an increase in other sexually transmitted infections among the study participants. The research was a "real-world study", which examines how people use a treatment in their own lives outside of controlled, clinical trials settings. Real-world studies are undertaken after a drug's efficacy is proven in clinical trials to see if its efficacy is maintained outside the clinical setting.

At present, the only HIV treatment approved by the FDA as PrEP is Truvada. Truvada is a well-tolerated and widely used HIV treatment drug that the FDA approved for PrEP in July 2012 on the basis of findings in earlier international clinical trials showing that when Truvada was taken daily, as prescribed, it prevented infection in more than 92% of subjects.[2] At present, more HIV treatment drugs are in clinical trials - in all 13 different drugs, including four different combinations of Tenofovir, one of the main components of Truvada. While Truvada is a daily treatment, the other drugs are being tested in other dosing patterns and with other delivery systems, including vaginal gels, tablets, rings and film; rectal gel; thin film polymer; nano fiber; and long-acting injectable. The last method, long-acting injectable, is taken once every three months to prevent HIV infection.

Since PrEP involves prescribing treatment drugs to individuals who are not already infected or sick, there has been some debate as to whether or not PrEP would be covered by insurers. However, most of the evidence to date shows that private insurers and Medicaid will pay for PrEP. The New York State Department of Health AIDS Institute provides a regularly updated guide to payment options for PrEP in New York State, which includes payment assistance from the drug's manufacturer.

As PrEP has become a more prominent prevention tool, practitioners have debated whether it should be prescribed by HIV specialists or other providers, including general practitioners. HIV specialists know more about PrEP -- given its history as an HIV treatment -- but they tend to see only those who are already infected. HIV-negative individuals who would be good candidates for PrEP tend to go to general practitioners. The most recent pharmacy survey available from Truvada's manufacturer shows that PrEP is being widely prescribed across medical disciplines, with the following five accounting for most prescriptions: internal medicine (19% of prescriptions between 2012 and 2014), family practice (18%), infectious diseases (11%), nurse practitioners (10%), and physician assistants (10%).[3] A recent study by a multidisciplinary team from New York[JG1] examined provider attitudes on prescribing PrEP and concluded that while there is much to be done in training providers on PrEP implementation, ultimately PrEP should be available in multiple settings, including emergency rooms, with HIV specialists, and with general practitioners.[4]

Health care reform provides a further impetus for increasing access to PrEP, including the integration of HIV care and primary care, as well as the integration of behavioral and primary care. Thus, providers across several disciplines will need to learn as much about PrEP as possible. Fortunately, there are resources available to help providers and patients learn about PrEP and the patients it is most likely to benefit. These include the AIDS.gov PrEP page, the U.S. Public Health Service's clinical practice guideline for PrEPAVAC's continuously updated compendium of PrEP research and consumer-friendly resources, the World Health Organization, and other public resources such as those provided by Project Inform, including brochures and informative videos. 

 

--------------------------------------------------------------

[1] Volk JE, Marcus JL, Phengrasamy T, Blechinger D, Nguyen DP, Follansbee S, and Hare CB. 

No New HIV Infections with Increasing Use of HIV Preexposure Prophylaxis in a Clinical Practice Setting. Clin Infect Dis. (2015) doi: 10.1093/cid/civ778.  First published online: September 1, 2015.

[2] Grant RM, et al. Preexposure chemo-prophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine 2010;363(27):2587-99.

[3] Flash C, Landovitz R, Mera Giler R, et al. Two years of Truvada for pre-exposure prophylaxis utilization in the US (Abstracts of the HIV Drug Therapy Glasgow Congress 2014). J Int AIDS Soc. 2014;17(suppl 3):19730.

[4] Hoffman S, Guidry JA, Collier KL, Mantell JE, Boccher-Lattimore D, Kaighobadi F, Sandfort TGM. 

A Clinical Home for Preexposure Prophylaxis: Diverse Health Care Providers' Perspectives on the ''Purview Paradox." Journal of the International Association of Providers of AIDS Care 2015 Aug 20; pii: 2325957415600798 (E-pub ahead of print).