Pre-Exposure Prophylaxis (PrEP) Health Department Issues for Consideration June 2014 The National HIV/AIDS Strategy (NHAS) highlights that current approaches to preventing HIV must be coupled with research on new and innovative prevention methods that can have a long-term impact. Such strategies include pre-exposure prophylaxis (PrEP), the use of antiretroviral (ARV) therapy by high-risk, uninfected individuals. PrEP has the potential to have a significant effect on helping to stabilize if not decrease the HIV transmission rates for particular populations including HIV-negative gay and bisexual men, other men who have sex with men (MSM), transgender women, and people who inject drugs. In 2010, initial data from the Global iPrEx study demonstrated that there is proven effectiveness in a PrEP regimen of tenofovir/emtricitabine (TDF/FTC, brand name Truvada) among gay and bisexual men, other MSMs and transgender women. CDC TDF 2 study also demonstrated efficacy of Truvada and Partners PrEP demonstrated efficacy of Truvada, as well as tenofovir (TDF, brand name Viread) among sero-discordant heterosexual couples. Truvada was approved for as the first ARV to be labeled for PrEP use in July 2012 by the U.S. Food and Drug Administration (FDA). In June 2013, the release of the Bangkok Tenofovir Study demonstrated efficacy for the use of Truvada for PrEP among people who inject drugs. Following the release of this research, the U.S. Centers for Disease Prevention and Control (CDC) released treatment guidelines in May 2014 for any HIV uninfected person at substantial risk for HIV through sexual or injection drug related transmissions. Additional demonstration projects are underway, such as iPrEx OLE (Open Label Extension), around the world to examine the adaptability outside of carefully controlled research studies (e.g., real world situations) related to the safety and efficacy of Truvada as PrEP in particular to use among gay and bisexual men, other MSMs and transgender women. Some of these additional studies are examining sexual event based dosing versus daily dosing options. There is also a need for continued research assessing long term effects of ARVs on HIV-negative individuals, as well as the cost effectiveness of these approaches and the overall benefit to prevention efforts and health care. Despite the clinical evidence showing the effectiveness of this new intervention to prevent HIV infection, health departments (HD) face a number of significant issue to address when incorporating this intervention into their HIV prevention plans. Issues for Consideration Concept versus Product: PrEP is the concept of using antiretroviral (ARV) medications for pre-exposure prophylaxis to prevent HIV infection among uninfected individuals. The use of a medication is not

independent. PrEP, as an effective intervention, needs to include behavioral counseling and regular routine HIV testing. Truvada is currently the only medication or product approved for PrEP, as a once daily oral medication. There are numerous clinical trials around the globe studying the use of other oral ARVs (e.g., Selezentry [Maraviroc]), other drug formulations (e.g., long lasting injectables), as well as other modalities (e.g., microbicides and vaccines) to determine the efficacy of these products. It is likely that there will be a variety of products available for PrEP in the foreseeable future. Identifying the Right Community: HDs should identify and strategically target populations that have higher prevalence rates or may have elevated risk due to personal circumstances. Not every person who is engaging in sexual activity or injection drug use is at risk for HIV. Other factors must be considered when offering or evaluating a potential PrEP user. Who are potential users of PrEP?  HIV uninfected persons: o With a sexual partner known to be HIV infected o With frequent partner change or concurrency o With partner(s) at high risk of HIV infection (e.g., people who inject drugs, nonmonogamous individuals and sex workers) o With other evidence of risk (e.g