Is HIV PrEP at a Tipping Point?: A Top HIV Clinical Development of 2016

Top 10 Clinical Developments of 2016
1. Donald Trump6. Return of the Antibodies
2. Switch Frenzy7. Is an Unexpected Low HIV RNA Level Real?
3. 2-Drug ART8. Dolutegravir and the Central Nervous System
4. Is HIV PrEP at a Tipping Point?9. TAF in Hepatitis B
5. Start ART Now10. New HIV infections in U.S. Are Down -- a Bit

Tenofovir/emtricitabine (TDF/FTC, Truvada) was approved for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection way back in 2012 -- the year Mitt Romney challenged President Obama's re-election. Although that may seem like a billion years ago, it wasn't, and since then, the uptake of PrEP has been steadily increasing. As reported at the 2016 International AIDS Conference by the Centers for Disease Control and Prevention (CDC), about 80,000 people were prescribed PrEP from 2012-2015. However, the CDC estimates there are 1.2 million people in the U.S. whose risk for HIV makes them candidates for PrEP (including 490,000 men who have sex with men (MSM), 115,000 people who inject drugs and 624,000 heterosexual men and women). Moreover, 76% of these PrEP users were men. Other data suggest that only a fraction of those prescribed PrEP is not white or male.

Given disparities in access to medical care and HIV-prevention messaging, it may not be a surprising that white men were most likely to adopt PrEP. While PrEP uptake in this population is a good thing, those who can most benefit from PrEP are not receiving it. Recent modeling performed by the CDC estimates the lifetime risk of HIV infection to be 1 in 20 for African-American men and 1 in 48 for African-American women and Hispanic men. Bad, but it gets worse. MSM had an astounding 1 in 6 risk and this jumped to a mind boggling 1 in 2 for African-American MSM.

The Bottom Line

PrEP is an effective and important tool in our shallow HIV prevention toolbox. Real-world studies have shown that it works. However, a number of studies show that there is incredibly limited awareness of the existence of PrEP among people who are candidates for it and among health care providers.

It should take nothing more than the risk faced by MSM, particularly MSM of color, to justify a massive push to get PrEP to all who can benefit from it, regardless of who they are, where they live or how much they make. Certainly, PrEP in its current incarnation is not perfect. For now, it is still a pill that needs to be taken most every day. The TDF component can drop bone density a few percentage points, and PrEP does not protect against other major sexually transmitted infections (STI). Recent data show that, among adolescent MSM, adherence to PrEP is pitiful. However, it still saves lives and money.

What do we need to do stop PrEP from being a best-kept secret from those who are at risk and the primary care providers who care for them? As a provider who has become evangelical about PrEP, I believe what is needed to make it as accessible as oral contraceptives is exposure and action:

  • Marketing: Few successful medications market themselves. The manufactures of TDF/FTC have belated realized this and are finally launching a full-court marketing press, including detailing the drug to clinicians and in direct-to-consumer advertising -- especially in cities and regions where HIV incidence rates are high.
  • Public Funding for Non-Drug PrEP Costs: Although the cost of TDF/FTC for PrEP is often covered by insurance or, for those who qualify, the manufacturer support program, many of the other costs associated with PrEP, such as clinic visits and STI testing, are not covered. This can be a tragic deal-breaker. Expanded access to PrEP needs to happen in places where people can get affordable health care, including federally qualified health centers, community health centers and health departments. An STI clinic that is not providing PrEP or at least offering a referral to a PrEP clinic is falling short of its mission.
  • Don't Ignore Injectors: PrEP works not just for prevention of HIV acquisition via sex; injection drug users can also be protected. However, little attention is paid to this group. If we do not want another Scott County, Indiana, PrEP education and provision needs to be folded into other efforts that target the opioid epidemic in rural America. Needle exchange and opioid substitution sites have to be added as venues where PrEP can be accessed.
  • Primary Care Must Get on Board: Not just the manufacturer of PrEP needed to be convinced to jump-start efforts to get PrEP out there. Health care providers too must be accepting that their patients have sex, that sexual health is part of general health and thus should be discussed, and that PrEP is a biological intervention proven to prevent HIV and should be prescribed. By them. To their patients. The mindset among primary care regarding HIV prevention must change. Moralizing by providers about condoms, promiscuity and gay sex will lead to people becoming infected and some dying. Primary care associations, medical, family practice and OB/GYN residencies need to immediately include education and training about how to take a sexual history and about prescribing PrEP for those at risk. There are excellent resources for learning efficient techniques to ask about sexual health. The Ask, Screen, Intervene (ASI) training developed by the CDC, the Health Resources and Services Administration, the National Institutes of Health and the HIV Medicine Association provides excellent guidance. Prescribing PrEP is about as complicated as prescribing oral contraceptives and is a whole lot easier than treating Lyme Disease. So, to the primary care docs reading this who are not prescribing PrEP, please start doing so.
  • Community Advocates Must Get on Board: Last, the same community advocates who advocate for fair drug pricing and defend studies such as the START trial need to have skin in the PrEP game -- and many do. These are the people that can best push to make PrEP better known and accepted by those at risk for HIV infection. Community voices must be heard by those who are reluctant to provide PrEP.

During the past year, an undercurrent of progress has been made. Stakeholders have started to mobilize to spread the word about PrEP. The first PrEP-related advertising has launched. My prediction is that PrEP will take off and the steep climb in uptake will be one of the top stories of 2017. Let's all help to make it so.

What are some other top clinical developments of 2016? Read more of Dr. Wohl's picks.

David Alain Wohl, M.D., is a professor in the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, director of the North Carolina AIDS Training and Education Center and site leader of the University of North Carolina Chapel Hill AIDS Clinical Research Site.