States Late to Adopt PrEP Risk Falling Further Behind

Two oral combination medications for preexposure prophylaxis (PrEP) against HIV are approved for use in the United States. Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved in 2012, following a 2004 indication for antiretroviral treatment for HIV-1 infection,¹ and Descovy (emtricitabine/tenofovir alafenamide) was approved in 2019.²

Despite PrEP’s availability, however, and evidence that it is highly effective when taken as prescribed—up to 74% among injection drug users and 99% overall³—new evidence in Open Forum Infectious Diseases shows uptake continues to vary widely among all states plus Washington, DC, and that the gap between states considered early adopters of PrEP compared with late adopters is large and continuing to widen.⁴

“The low PrEP uptake that we found is concerning because it means that people are not benefiting from an HIV-prevention medication that has been approved and available for almost a decade,” said senior author Kathleen McManus, MD, an infectious diseases physician at the University of Virginia School of Medicine, in a press release announcing the findings of a retrospective analysis. “The United States needs innovative interventions at the federal, state and clinic level in order to get PrEP to people who are at high risk of getting HIV.”⁵

Conducted prior to the US government’s mandate that most health insurers provide no-cost coverage of PrEP, including co-pays, co-insurance, and deductibles related to clinic visits and laboratory tests⁶—which can quickly add up in light of the CDC’s recommendation that those on PrEP be tested for HIV prior to starting the preventive regimen and every 3 months while on it, to continue their PrEP prescriptions⁷—the study from McManus and her team investigated PrEP uptake and use from 2014 through 2018.

There was a 2-fold impetus behind their investigation: First, suboptimal uptake levels are evident, especially among the most high-risk groups and in the South region of the United States, where more than half of new HIV infections occur every year.⁸ Second, PrEP is highlighted as an important component of the US government’s plan, Ending the HIV Epidemic in the US.⁹

“Our team had seen data on how many people were estimated to need HIV prevention or PrEP in each state, and how many people were estimated to be on PrEP in each state, but we hadn't seen anything that put the two together,” McManus said in an interview with The American Journal of Managed Care® (AJMC®). “And so we wanted to estimate PrEP uptake on a state level, track that over time and try to understand if all states were progressing at the same rate.”

A similar investigation of 2012-2019 data from Kaiser Permanente Northern California evaluated PrEP use as well, also finding disparities related to care delivery gaps and patient population concentrations. For example, African American and Latinx individuals were less likely to both initiate PrEP and to even receive a prescription for it vs White patients, while overall, women, persons living in lower socioeconomic status areas, and those with substance use disorders were more likely to not receive a PrEP prescription and to discontinue the treatment when they were prescribed PrEP.¹⁰

For their investigation, McManus et al gleaned publicly available data on PrEP prescriptions from AidsVu.org for 2014 through 2018, because those were the years with the pertinent data when she and her team conducted the study, while PrEP indication data came from the CDC. States were classified into 2 categories⁴:

• Early adopters of PrEP usage had a top-10 ranking for initial uptake in 2014
• Late adopters of PrEP usage had a bottom-10 ranking for initial uptake in 2014

Their investigation found that the states considered early PrEP adopters went on to have continued gains—for every 5% of baseline usage, there was a 1.2% increase in uptake the following year, McManus told AJMC®—and that the states considered late PrEP adopters continued to fall behind, so that starting the study period as an early-adopting state meant a greater likelihood of having greater PrEP uptake at the end of the study period. This despite median uptake rising overall from 1.9% to 9.6%.⁴

“We have this medication that can prevent HIV, and only 20% of people who could benefit are getting it,” McManus said.

States in the Northeast came out on top overall, with a 16.6% jump in PrEP uptake for the study years, followed by the Midwest, which has a 9.2% gain. The South and West regions finished the study years at the bottom, with 7.1% and 7.0% gains, respectively.⁴

Among the states, Wyoming had the lowest uptake at the beginning and end of the study, although it’s numbers still improved slightly overall: from 0.4% in 2014 to 2.4% in 2018.⁵ The situation is especially dire in Virginia, however, which despite having an overall exponential increase of 405%—from 1.8% to 7.3%—still dropped 11 places in state ranking, from 32 to 43.

Massachusetts, meanwhile, had the highest initial uptake rate of 8.3% in 2014, ultimately finishing with 23.1% and placing it firmly in second place behind New York, which started the study period at 5.9% but finished with 29.7%. These states had the highest PrEP uptake rates for the duration of the study, with the former holding the #1 spot for 2014 and 2015 prior to being overtaken by New York for 2016 through 2018.⁴

For the 9 states, along with Washington, DC, considered early adopters of PrEP at the start of the study—Connecticut, Illinois, Iowa, Kansas, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island—just 3 had maintained their standing throughout the years analyzed. In addition to Massachusetts and New York, Connecticut ended the study period in fourth, after starting in third. In contrast, for the 10 states considered late adopters of PrEP at the start of the study—Alaska, Hawaii, Idaho, Indiana, Kentucky, Montana, Oklahoma, Tennessee, Vermont, and Wyoming—only Oklahoma and Tennessee improved their uptake enough to move out of the bottom 10. Oklahoma ended ranked 38 after starting in 46 and Tennessee finished ranked 41 after starting at 45.

The average uptake difference between the 2 state groups had also nearly quadrupled from the beginning of the study to the end. In 2014, 3.2 percentage points separated early- and late-adopting states compared with 12.0 percentage points in 2018.⁴

“Being one of the 10 earlier adopting states as opposed to being one of the 10 late-adopting states in 2014 was associated with increased PrEP uptake in 2018,” the authors wrote. “Underperforming states are not catching up.”

There are several potential reasons for the disparate uptake rates among the states, they note, and these include lack of access to providers, clinics that provide PrEP being few and far between, and social and health policy interventions that hinder access to PrEP. For this last reason especially, previous research shows strict prior authorization requirements may be a principal roadblock.

Among qualified health plans from 2019 that were offered through the Health Insurance Marketplace, despite 18.9% overall having PA requirements for PrEP that contained tenofovir disoproxil fumarate and emtricitabine, the regional rates varied widely. In the Northeast, just 2.3% of plans had PA requirements compared with 37.3% in the South.¹¹

When asked what circumstances solutions must address to overcome disparities between high- and low-uptake regions, McManus stated needs in several areas. “Clinicians need to be thinking about ways to improve uptake of PrEP and discussing PrEP with more patients. We also need to work on reducing HIV stigma so that we can talk more freely about HIV and prevention, and people need to have a good estimation of their personal risk of acquiring PrEP.”

Ultimately, however, the best solution may lie with policy and innovation at the federal, state, and clinic levels, especially those that align with Ending the Epidemic goals, and translating successful interventions for PrEP in early-adopting states to late-adopting states, McManus and her fellow investigators concluded.

“Best practices of PrEP early-adopter states should be identified and disseminated to states with lower PrEP uptake alongside necessary material support,” they said, while still emphasizing the need for research on policy proposals.

“I think on the national level, it's not good to see these worsening disparities,” McManus added. “And if we want to end the HIV epidemic, I think the federal and the state governments have a role to play.”

References

1. U.S. Food and Drug Administration approves Gilead’s Truvada for reducing the risk of acquiring HIV. Press release. Gilead Sciences. July 16, 2012. Accessed September 6, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2012/7/us-food-and-drug-administration-approves-gileads-truvada-for-reducing-the-risk-of-acquiring-hiv

2. U.S. Food and Drug Administration approves Descovy for HIV pre-exposure prophylaxis (PrEP). Press release.Gilead Sciences. October 3, 2019. Accessed September 6, 2021.https://www.gilead.com/news-and-press/press-room/press-releases/2019/10/us-food-and-drug-administration-approves-descovy-for-hiv-preexposure-prophylaxis-prep

3. PrEP effectiveness. CDC. Accessed September 6, 2021. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html

4. Powers SD, Rogawski McQuade ET, Killelea A, Horn T, McManus KA. Worsening disparities in state-level uptake of human immunodeficiency virus preexposure prophylaxis, 2014–2018. Open Forum Infect Dis. 2021;8(7):1-6. doi:10.1093/ofid/ofab293

5. In HIV prevention, worsening disparities among states. Press release. UVA Health. August 12, 2021. Accessed September 6, 2021. https://newsroom.uvahealth.com/2021/08/12/hiv-prevention-worsening-disparities-among-states/

6. Ryan B. PrEP, the HIV prevention pill, must now be totally free under almost all insurance plans. NBC News. Published July 20, 2021. Updated July 21, 2021. Accessed September 15, 2021. https://www.nbcnews.com/nbc-out/out-health-and-wellness/prep-hiv-prevention-pill-must-now-totally-free-almost-insurance-plans-rcna1470?

7. Pre-exposure prophylaxis (PrEP) care system. CDC. Accessed September 15, 2021. https://www.cdc.gov/hiv/effective-interventions/prevent/prep/index.html

8. Sullivan PS, Mena L, Elopre L, Siegler AJ. Implementation strategies to increase PrEP uptake in the South. Curr HIV/AIDS Rep. 2019;16(4):259-269. doi:10.1007/s11904-019-00447-4

9. What Is Ending the HIV Epidemic in the U.S.? Updated June 2, 2021. Accessed September 15, 2021. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

10. Hojilla JC, Hurley LB, Marcus JL, et al. Characterization of HIV preexposure prophylaxis use behaviors and HIV incidence among US adults in an integrated health care system. JAMA Netw Open. Published online August 26, 2021. doi:10.1001/jamanetworkopen.2021.22692

11. McManus KA, Powers S, Killelea A, Tello-Trillo S, McQuade ER. Regional disparities in qualified health plans' prior authorization requirements for HIV pre-exposure prophylaxis in the United States. JAMA Netw Open. Published online June 3, 2020. doi:10.1001/jamanetworkopen.2020.7445