PAIN AND ADDICTION SUMMIT

Join us for this full-day conference that brings professionals together for a day of sharing expertise and learning from each other about opportunities to approach the treatment of pain and substance use disorder.

FRIDAY, APRIL 28

8 A.M. – 5 P.M. NOW HELD AT WILKES UNIVERSITY

KEYNOTE SPEAKER

Cost is $130 for the whole day and 6 hours of continuing education or $75 for half day, 3 hours of continuing education.

Up to six hours of continuing education credit available. Register online: wilkes.edu/addiciton or call 570-408-4460

For too many years, the mainstay of HIV prevention counseling consisted of advising patients to use condoms consistently, maintain a mutually monogamous sexual relationship with one partner, or avoid sex entirely. Condoms have been recommended for STI prevention for decades, but they are not without their drawbacks: they break, expire, limit pleasure, and aren’t always there when you need them. There is also data that suggests that, among heterosexual and same-gender-loving people alike, condoms signify a lack of trust and can be a barrier to intimacy. It’s no wonder, then, that the United States saw nearly 35,000 new HIV infections in 2019. (That number trended slightly lower in 2020, but the dip may reflect decreased access to testing and case surveillance during the SARS-CoV-2 pandemic.)

While it is certainly worth celebrating that we have come a long way from the peak of 100,000 new HIV infections annually in the mid-1980s, HIV incidence remains unacceptably high. In 2019 the United States launched Ending the HIV Epidemic in the U.S. with the goal of reducing new HIV infections by 90% by 2030, with an interim goal of 75%, or 10,000 new infections, by 2025. We are not currently on track, but we could be, thanks to a revolution in HIV prevention. In the same way that the birth control pill fundamentally changed contraception, PrEP has been a game-changer for reducing the spread of HIV. PrEP has the potential to dramatically change the landscape of the HIV epidemic – but only if people take it.

What is PrEP? In essence, PrEP – or Pre-Exposure Prophylaxis, also known as biomedical HIV prevention – refers to the use of antiviral medication to reduce the risk of HIV infection before exposure by preventing the virus from entering cells and establishing an infection. We might also consider PrEP as “proactive, responsible, empowered pleasure,” suggests PrEP activist Damon Jacobs, founder of the evidence-informed volunteer-run Facebook page PrEP Facts. Being on PrEP means not having to worry about becoming infected with HIV if a condom breaks or slips off, or if a partner refuses to wear one. It puts the control in the hands of anyone who wants to take charge of their own HIV protection, without having to depend on their partner.

PrEP should be considered for anyone who is concerned about exposure to HIV through sex or shared injection drug equipment. Despite popular misconceptions, PrEP is not exclusively for men who are gay, bisexual, or have sex with men. While most efforts to publicize PrEP have been focused on the populations most vulnerable to HIV – primarily young gay and bisexual men of color – 22% of new HIV diagnoses in 2020 – over 6,000 cases – were in people who reported heterosexual contact. Of that 22%, the majority of cases – over 4,500 – were in women.

Proxies for HIV risk such as a recent STI should always prompt an offer of HIV testing and a conversation about HIV prevention. However, because patients may not always reveal every detail about their sexual lives to their primary care providers, providers should feel comfortable discussing and offering PrEP to anyone who is sexually active or using injection drugs, regardless of the number or frequency of sex or drug-using partners they report. One option for opening the conversation: “I’d like to talk to you about PrEP, because I want to make sure you know about all your options for preventing HIV and keeping yourself healthy.”

The FDA has approved three PrEP regimens: two are oral daily tablets and the third is an intramuscular injection given every two months. Both oral medications are pills that contain a combination of two known HIV medications. The first regimen to receive approval was the fixed-dose combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (TDF-FTC, brand name: Truvada®). The second was emtricitabine 200 mg and tenofovir alafenamide 25 mg (TAF-FTC, brand name: Descovy®). Both are meant to be taken by mouth once daily. The third regimen, cabotegravir 200 mg (brand name: Apretude) is given via intramuscular injection every two months. Of the three, TAF-FTC is not approved for people at risk from vaginal receptive sex due to those populations having been excluded from the initial clinical trials, although additional studies are ongoing.

The evidence for PrEP has been accumulating for years, resulting in an “A” rating from the U.S. Preventive Services Task Force in 2019. From as far back as 2010, clinical trials of TDF-FTC have consistently shown that the key to PrEP’s power is adherence. The better the adherence, the stronger the protection, with daily dosing (i.e., 7 doses weekly) resulting in 99% risk reduction for HIV acquisition from sex and 74% from injection drug use. TDF-FTC has been FDA-approved since 2012 for men who have sex with men, for women including transgender women, and for men who have sex with women. TAF-FTC was approved for PrEP in 2019 and injectable cabotegravir was approved in December of 2021. Oral PrEP is recommended for adolescents at risk of HIV infection, as long as they weigh at least 77 pounds. (Studies of injectable cabotegravir in adolescents are underway.) The latest CDC guidelines for the use of PrEP are available for download; see the resources list following this article.

As a preventive health strategy, PrEP sits comfortably within the purview of primary care. A referral is not required because patients trust and prefer their primary care providers and may be put off or unnecessarily delayed by having to wait for a specialty appointment. Initiating PrEP requires labbased HIV testing to establish that there is no current HIV infection, STI screening, and, depending on the formulation under consideration, completing basic lab studies such as creatinine clearance and hepatitis B status. There are a few considerations of which prescribers need to be aware, including potential medication interactions and medical contraindications, but these are no more complex than managing other chronic conditions frequently encountered in primary care. For clinicians interested in building PrEP into their practice, the National Clinician Consultation Center offers free guidance and advice on all aspects of PrEP initiation and maintenance. Phone consultations are available at 855-448-7737 (1-855-HIV-PrEP) or clinicians can submit a case online (see Resources, below).

Under federal law, almost all insurers, including Medicare and Medicaid, are required to cover all the costs of oral PrEP (TDF-FTC and TAF-FTC), including quarterly office visits and lab tests, with no charge for copayments, coinsurance or annual deductibles. The federal government’s Ready, Set, PrEP program makes oral PrEP medication available for those without insurance. TDF-FTC is available as a generic formulation for as low as $30 per month. In addition, the manufacturers of the brand-name medications, Gilead (Descovy®) and Viiv (Apretude), have patient assistance programs for the uninsured and for those whose insurance has high out-of-pocket costs.

PrEP has the potential to radically retool HIV prevention and bend the curve of the HIV epidemic, but it will require a concerted effort on the part of health care providers across the spectrum of care to make sure all our patients know about it and can access it. For more information, and to get started, see the resource list below, or contact your local health department.

ADDITIONAL RESOURCES:

CDC Clinical Practice Guideline (December, 2021): https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prepguidelines-2021.pdf

CDC Clinician Resources: https://www.cdc.gov/hiv/ clinicians/prevention/prep.html

National Clinician Consultation Center: https://nccc.ucsf.edu/clinician-consultation/ prep-pre-exposure-prophylaxis/

Ready, Set, PrEP (federal patient assistance program): https://www.hiv.gov/federal-response/ ending-the-hiv-epidemic/prep-program

ViiV Connect (patient assistance program for A pretude): https://www.viivconnect.com/

Advancing Access (patient assistance program for Descovy®): https://www.gileadadvancingaccess.com/