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Improving PrEP access, use crucial in combating HIV epidemic
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Pre-exposure prophylaxis, or PrEP, is an essential part of ending the HIV epidemic; however, less than one in four Americans out of approximately one million who are at considerable risk for acquiring HIV are taking the treatment.
Healio spoke with Douglas Krakower, MD, assistant professor of medicine in the division of infectious diseases at Beth Israel Deaconess Medical Center and research scientist at The Fenway Institute, about increasing the use of PrEP, potential downsides to the medication, a newly approved drug to reduce HIV infection and the future of HIV prevention.
Increasing access, use of PrEP
Men who have sex with men, transgender individuals, people with HIV-infected sexual partners and people who inject drugs are the populations most heavily impacted by HIV in the United States and the most likely to benefit from PrEP, according to Krakower. Because of this, the CDC recommends that these populations be offered PrEP as an HIV prevention option.
“There may be individuals who don’t fit into the categories outlined in the CDC guidelines who would also be good candidates for a discussion about PrEP,” Krakower said. “In the ideal world, clinicians would engage in nonjudgemental conversations about HIV risk with all of their patients as a way to identify the broadest set of people who may benefit from using PrEP.”
However, many barriers stand in the way of comprehensive conversations about sexual health care in routine practice among clinicians and patients, including time constraints, competing preventive health priorities and a lack of training among health care providers on how to engage in HIV risk assessments, he said.
“Additionally, there are many gaps in terms of awareness of PrEP among people in the U.S. who are most likely to benefit from it,” Krakower said.
While knowledge and use of PrEP has increased among some populations, such as subgroups of MSM in urban areas, other populations of MSM – including racial and ethnic minorities – have lower awareness and use of PrEP, he said. Transgender individuals and people who inject drugs also have low rates of PrEP use, he said.
“The data on the effectiveness and safety of PrEP are robust,” Krakower said.
When taken daily, PrEP is 99% effective at reducing the risk for HIV infection; however, its efficacy is reduced if it is not taken regularly, or if people discontinue its use while still being at risk for HIV acquisition.
So, it is important for at risk patients to be aware of the benefits of PrEP and use it consistently. However, despite CDC guidance that individuals at increased risk be tested for HIV at least annually, about half of MSM and people who inject drugs in the United States who were unaware of their HIV infection reported not being offered testing in the past year although they had visited a clinician.
Another recent study led by CDC researchers showed that two-thirds of patients newly diagnosed with HIV had missed opportunities for PrEP. These patients had a mean of 6.9 recent health care visits prior to being diagnosed.
“It’s important to try to improve awareness and access by providing information in health care settings and community settings,” Krakower said. “Efforts to engage clinicians in conversations with their patients about sexual health, substance misuse and PrEP is a really important step. This might include providing clinicians with new training to help them feel more comfortable in assessing HIV risk in care settings and providing them with decision support tools that can help them identify candidates for PrEP more effectively.”
For instance, EHRs provide an opportunity to identify patients at increased risk for HIV acquisition, he said. Data from EHRs can be used by clinicians to help decide which patients are most likely to benefit from discussions about sexual health and PrEP, he added.
“In terms of engaging patient communities, partnerships amongst health care organizations, public health authorities and community-based organizations could offer great benefit regarding disseminating information about PrEP in the communities that are most likely to derive benefit,” Krakower said. “All of this work has begun and hopefully there will be more resources invested in supporting community-based conversations in the coming years.”
Lack of financial assistance and insurance coverage, as well as the stigma associated with PrEP, are significant barriers that hinder PrEP access that must be addressed, he said.
“I’m hopeful that in the next few years, we will see increasing public health and clinical partnerships to improve awareness and access to PrEP,” Krakower said.
Drawbacks to PrEP
For patients who are at increased risk for HIV acquisition, PrEP is greatly beneficial with few drawbacks, according to Krakower.
The potential downsides of PrEP include the inconvenience of taking a pill every day and having to frequently follow-up with health care providers, he said.
“On the other hand, some people draw benefits from taking a daily pill because they feel protected and empowered and that can offer benefits in terms of their sexual well-being and their overall health,” Krakower said.
In rare instances, PrEP has been linked to toxicities, including decreased renal function and lower bone mineral density, he said. These side effects are probably more common among patients with other risk factors such as preexisting chronic kidney disease, he noted.
“For most otherwise healthy people, PrEP can be used with relatively no downsides in terms of medication-related toxicities,” Krakower said.
The cost of PrEP may be an obstacle for some patients, especially those who are underinsured, have high deductible health care plans or challenges with copays, he said.
Moreover, while use of PrEP prevents HIV, it does not protect against STIs, so there has been concern that if HIV prevention strategies, particularly PrEP, result in reduced condom use and increased numbers of sexual partners, then there might be increased transmission of non-HIV STIs. A recent study found truth to such concerns, indicating that use of PrEP was linked to an increased incidence of STIs.
Even with these potential unintended consequences of PrEP, the USPSTF issued tenofovir disoproxil fumarate with emtricitabine (Truvada; TDF/FTC; Gilead) a grade A recommendation for use to prevent HIV, indicating that the net benefits considerably outweigh the possible harms, according to Krakower. “Guidelines do not recommend that clinicians withhold contraception from patients who might benefit from its use out of concern that these patients might decrease their condom use. Similarly, clinicians who prescribe PrEP to their patients are helping them to lead healthier sex lives and clinicians can use the follow-up visits for PrEP to provide frequent STI counseling, screening and treatment.”
New option for HIV prevention
For several years, TDF/FTC was the only FDA approved and CDC recommended option for PrEP, according to Krakower.
However, in October 2019, the FDA approved tenofovir alafenamide with emtricitabine (Descovy; TAF/FTC; Gilead) as an additional option to prevent HIV. The approval was based on the results from the DISCOVER study that revealed that TAF/FTC was noninferior to TDF/FTC as daily PrEP among MSM and transgender women.
“The new approval of TAF/FTC for PrEP has rapidly generated much controversy” because DISCOVER excluded important populations, such as cisgender women and youth, Krakower said.
“Many advocates and clinicians are rightly upset that the study did not include cisgender women and other priority populations,” he added.
The chair of the FDA’s Antimicrobial Drugs Advisory Committee even stated that they “failed women.”
Because of this, the FDA has called for a study involving cisgender women; however, Krakower noted that data from a new trial may take several years to accrue, which has led to even more frustration and criticism.
Of note, TAF/FTC did not demonstrate superior efficacy over TDF/FTC, he said. While safety outcomes were similar between the two treatments, renal and bone biomarkers favored TAF/FTC and weight gain and dyslipidemia favored TDF/FTC, he said. Safety differences were not clinically significant overall, he noted.
“Given years of data for TDF/FTC in multiple important populations and an excellent safety record as PrEP, this agent should remain the first-line treatment for most individuals, except perhaps MSM and transgender women at high risk for, or with preexisting, renal or bone disease,” Krakower said. “Ideally, clinicians and patients would engage in shared decision making about the right PrEP option for each individual.”
Developments on the horizon
The field of PrEP is a rapidly changing and there are several exciting developments in the works, according to Krakower.
Clinical studies are currently underway to evaluate new modalities of PrEP delivery, including long-acting injectable PrEP agents, and studies have already demonstrated the efficacy of intervaginal rings that elute antiretroviral medications, he said.
Monoclonal antibodies and long acting implants are also being studied as PrEP, he said. In fact, early-phase clinical trials suggested that a subdermal implant containing islatravir, a novel antiviral agent, could potentially protect against HIV for 1 year.
“It’s likely that there will be an increasing number of diverse PrEP modalities in the future, which will hopefully provide a chance for individuals to identify PrEP options that work best for them as opposed to a one size fits all approach,” Krakower said. “The analogy here is contraception, where there are pills, injectable or subcutaneous options and a whole host of individualized approaches that make it attractive and patient centered.”
References:
HIV.gov. Ending the HIV Epidemic. Available at: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview. Accessed on November 8, 2019.
CDC. Pre-exposure prophylaxis for HIV prevention in the United States – 2017 update: A clinical practice guideline. Available at: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Accessed on October 30, 2019.
CDC. Pre-exposure prophylaxis (PrEP). Available at: https://www.cdc.gov/hiv/risk/prep/index.html. Accessed October 30, 2019.
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FDA. FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic. Accessed October 29, 2019.
Hare CB, et al. Abstract 104LB. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2019; Seattle.
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Matthews RP, et al. First-in-human trial of MK-8591-eluting implants demonstrates concentrations suitable for HIV prophylaxis for at least one year. Presented at: IAS Conference on HIV Science; July 21-25, 2019; Mexico City.
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