Preexposure Prophylaxis: Adapting HIV Prevention Models to Achieve Worldwide Access

The efficacy of Truvada as a means of preexposure prophylaxis (PrEP) for individuals at high risk for HIV infection is well established with the first comprehensive guidelines for administration of PrEP developed and published by the Centers for Disease Control and Prevention in 2014.¹ The availability of PrEP as a biomedical mechanism for HIV prevention is considered a “game changer” in HIV prevention efforts, much as the widespread availability of highly active antiretroviral therapy (HAART—more commonly referred to as “ART”) was considered for HIV treatment in 1996. However, many of the questions that followed this breakthrough in HIV treatment are now being put forth regarding PrEP. How much does it cost? Who should pay for it? Will there be disparities in access to PrEP in the United States and how will we overcome these disparities? How can we afford to pay for PrEP when many people around the world still do not have access to ART?

ENHANCING ACCESS TO PREEXPOSURE PROPHYLAXIS

Where will the resources come from to support the use of PrEP in low- and middle-income countries? This question was very much on the minds of clinicians and advocates at the introduction of ART in the mid to late 1990s. How would a daily regimen of expensive HIV medications (three of them!) needed to treat individuals for years and possibly decades be affordable for the millions of HIV-infected persons in less developed nations, many of which have per capita health spending the equivalent of a few hundred US dollars per year or less?

Through cross-sectorial advocacy and lobbying efforts, the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched in 2003.² Although not perfect, the PEPFAR program has played a key role in extending the reach of ART to millions of HIV-positive persons in more than 60 countries. More recently, the PEPFAR DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe)³ initiative has launched efforts to provide PrEP in 10 sub-Saharan African countries to prevent HIV infections in adolescent girls and young women. However, models to broaden scale-up and rapid access to PrEP in other key populations are still necessary.

In the United States, the Ryan White HIV/AIDS Program, through the AIDS Drug Assistance Program (ADAP), has provided ART for low-income individuals, helping to provide lifesaving treatment to hundreds of thousands of individuals. Administered by the states, ADAP has played a crucial role in reducing socioeconomic disparities in access to HIV medications for those with limited or no health insurance. Although Truvada for PrEP cannot be purchased through ADAP, some states have adapted the ADAP model for access to medications, resulting in several PrEP drug assistance programs around the country. First launched in Washington State, the PrEP drug assistance program was a key strategy in the state’s efforts to decrease the number of incident HIV infections by reducing cost barriers to PrEP. This program has served as a model for other states and was later implemented in Massachusetts and New York. But it bears noting that the success of these programs relies on campaigns that raise awareness not only of PrEP but also of mechanisms for enhancing access to PrEP among PrEP users and health care providers.

A similar strategy should be pursued globally, particularly in low- and middle-income countries, for increasing access to PrEP to those most at risk for HIV. Infrastructure in place for supply chain management of highly active antiretroviral therapy can and should be extended to include PrEP. Although funds may or may not be used to purchase PrEP, the same strategies for negotiating reduced pricing by purchasing in bulk as was done for ART may also be used to purchase PrEP in bulk. An example of this is in Brazil, a middle-income country. Recent published findings indicated that there were high rates of adherence to PrEP among men who have sex with men and transgender women taking part in a PrEP demonstration program in that country.⁴ Subsequently, on May 24, 2017, the Brazilian government announced a plan to provide PrEP for free to approximately 7000 high-risk individuals across the country.⁵

Although middle-income countries, such as Brazil, may be willing and able to make this commitment, it is less likely that low-income countries will be able to do so. Because of this, PEPFAR should continue to consider and recommend the use of PrEP for various groups, such as pregnant women, men who have sex with men, high-risk heterosexuals, and other high-risk populations. With a patchwork approach to PrEP similar to that used with ART, access to PrEP can be greatly expanded and can make a significant difference in reducing the global burden of HIV.

MODELS TO SUPPORT ACCESS

With more widespread use of PrEP and ART, questions arise regarding the meaning of “safer sex.” in this issue of AJPH, Calabrese et al. look at how provider biases may affect their ability to effectively counsel patients using PrEP about the risks involved in stopping the use of condoms (p. 1572). With respect to supporting providers who prescribe PrEP, Greene recommends provider education and other means for supporting expanded prescriptions of PrEP (p. 1580). Provider education as a means of expanding access to PrEP can also have multiple benefits: it increases access to and utilization of routine HIV and other sexually transmitted infections testing and a range of primary and preventative health care services—screenings and services that may otherwise be missed or ignored.

In addition, Samandari et al., from the Centers for Disease Control and Prevention, advocate increasing the use of PrEP as part of a comprehensive HIV prevention strategy (p. 1577). Even as a game changer, PrEP should be considered only one tool in an arsenal of comprehensive HIV prevention and education programming. An important consideration, especially as we grapple with minimizing disparities in access and use of PrEP, is recognizing that the prevention paradigms of the early HIV/AIDS era will need to be modified to meet the needs and challenges of a new generation of individuals currently at risk for HIV.

PrEP has become an important part of the more recent HIV prevention programs, especially those that focus increasingly on biomedical prevention technologies; therefore, it necessitates an increase in the role of clinical providers in treating HIV and preventing new infections. Thus, the most likely path to expanding this model and achieving access to PrEP worldwide is to use the institutional pathways and funding mechanisms that have supported global efforts to expand access to HIV treatment.