Jeanine P. Abrons, PharmD, MS, FAPhA
Jennifer S. Bhuiyan, PharmD, MPH
Axel A. Vazquez Deida, PharmD, BCIDP, AAHIVP
Kristy M. Shaeer, PharmD, MPH, BCIDP, AAHIVP
Kyle J. Wilby, BSP, ACPR, PharmD, PhD
At the end of this case, students will be able to:
- Discuss the opportunity for enhanced promotion and use of preexposure prophylaxis
- Describe and apply current recommendations for the use of preexposure prophylaxis
- Identify counseling and monitoring parameters for patients taking preexposure prophylaxis
Although significant progress has been made towards decreasing the morbidity and mortality associated with human immunodeficiency virus (HIV) infection, the HIV epidemic remains a major public health challenge.1 In 2018, an estimated 1.2 million people were living with HIV in the United States. Of these, approximately 38,000 received new diagnoses, and an estimated 161,800 people were living with undiagnosed HIV.2 People living with HIV, especially those unaware of their diagnosis or those unable to access healthcare services, may unknowingly engage in practices that increase the risk of HIV transmission to others. In 2015, approximately 1.1 million adults in the U.S. were considered at risk of becoming infected with HIV and met an indication for preexposure prophylaxis (PrEP). Yet in 2016, only about 78,000 persons filled a prescription for PrEP in the United States.3 Pharmacists have demonstrated great success with screening, initiating, and monitoring patients taking PrEP, demonstrating their potential role in this public health initiative.4-5
PrEP has been demonstrated to be a highly effective option for preventing the acquisition of HIV.6-10. In 2012, the Food and Drug Administration (FDA) approved the oral tablet combination of tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) (Truvada®) as the first medication indicated for PrEP for at-risk adults and adolescents weighing at least 35 kg. In 2019, the FDA approved the second PrEP oral tablet combination of FTC and tenofovir alafenamide (TAF) (Descovy®) for at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.
The Centers for Disease Control and Prevention (CDC) and the US Public Health Service (USPHS) recommend daily oral PrEP with Truvada® for sexually active adult men who have sex with men (MSM), adult persons who inject drugs (PWID), and heterosexually active men and women at substantial risk for HIV infection.11 The US Preventive Services Task Force (USPSTF) states that activities that constitute a substantial risk for HIV acquisition include having a serodiscordant sex partner (e.g., in a sexual relationship with a partner living with HIV), inconsistent use of condoms during receptive or insertive anal sex or with a partner whose HIV status is unknown and is at high risk (i.e., a PWID, a person who has a high number of sex partners, a person who engages in transactional sex or is trafficked for sex work, etc.), or having a sexually transmitted infection (STI) within the past six months. In addition, the USPSTF states that sharing used drug injection equipment represents a high-risk activity for PWID.12
Unfortunately, long-term use of Truvada® can cause serious adverse effects such as osteomalacia and renal injury, both of which are due to the TDF component of this PrEP regimen. Therefore, the 2020 recommendations by the US Panel of the International Antiviral Society state that Descovy® is a good option for individuals at risk for kidney dysfunction, osteopenia, or osteoporosis.13 Through either community practice or collaborative, direct clinical care, pharmacists can screen patients and assess PrEP eligibility prior to initiation and conduct follow-up monitoring of PrEP use to ensure the effectiveness and safety of the prophylaxis regimen.
CC: “I don’t want to get HIV.”
Patient: TC (he/him) is a 23-year-old gay cis-male living in Denver. He relocated from Brazil to the United States three years ago but moved to Denver one year ago. He overstayed his visa conditions to find steady employment and apply for graduate school. He does not have plans to return to Brazil and is picking up shift work in the local area ski resorts as much as he can for the time being.
HPI: TC’s friend recently started Truvada® for PrEP and encouraged him to do the same. TC was previously in a monogamous long-term relationship of one year of duration but has been single since moving to Denver. He is ‘out’ to friends and family and primarily meets partners online. Over the past three months, he has had six sexual partners and is currently not in a committed relationship. He is sexually active and participates in both insertive and receptive oral and anal intercourse. He prefers to have sex with condoms but admits that he cannot always afford to, or his partners may request that they do not use them. He states he likely has unprotected anal sex about 50% of the time and unprotected oral sex 100% of the time.
- Shoulder injury (three months ago from skiing)
- Pharyngeal gonorrhea (successfully treated one month ago)
- Family is in Brazil and is overall in good health
- Father: 51 years old; HTN
- Mother: 50 years old; rheumatoid arthritis
- Does not use tobacco or illicit substances
- Smokes cannabis approximately once weekly
- Drinks approximately ten alcoholic drinks weekly
- Ibuprofen 200 mg four times a day as needed
- Currently uses 3-4 days a week for shoulder and finds it effective
- Acetaminophen 500 mg four times a day as needed
- Currently uses 1-2 days a week for shoulder and finds it effective
- Vaccinations up to date (including Hepatitis A and B), but has not received the human papillomavirus (HPV) vaccine
- BP (sitting) 118/74 mmHg
- HR 74 bpm
- RR 16/min
- Temp 98.1°F
Relevant laboratory results From yesterday:
|HIV immunoassay||Negative||SCr||0.87 mg/dL|
|HBsAg||Negative||WBC||8.8 x 103/uL|
|anti-HBs||Positive||Neutrophils||6.5 x 103/uL|
|anti-HCs||Negative||RBC||4.6 x 106/uL|
|Gonorrhea and chlamydia PCR (specimen: urine)||Negative||Hgb||15.0 g/dL|
|Gonorrhea and chlamydia PCR (specimen: rectal swab)||Negative||Platelets||350 x 103/uL|
|Gonorrhea and chlamydia PCR (specimen: pharyngeal swab)||Negative|
- General: pleasant 23-year-old male
- CNS: alert, oriented, not confused
- HEENT: WNL
- Resp: no evidence of cough, no dyspnea, or wheeze
- GI: no nausea/vomiting, states one regular bowel movement daily
- GU: no blood in urine, no genital pain, pruritus, swelling, or discharge
- MSK: decreased range of motion to the right shoulder
- Skin: WNL
Surgical history: None
SDH: TC is currently not regularly employed but awaiting the next ski season to find more consistent shift work. He is presently picking up short-term cash jobs within hospitality. He is living with his friend but only minimally contributes to rent. He speaks English at a conversational level and is natively fluent in Portuguese. He studied exercise physiology at a university in São Paulo. He would like to apply to a PhD program in this field once he has money to do so.
Because TC’s visa is no longer valid, he currently does not have legal immigration status in the United States and is not eligible to receive health insurance. He pays cash for medications at his local pharmacy and receives his primary care medical services at a nearby federally-qualified community health center at no cost. Although he is currently living with a friend, he meets the federal definition of sheltered homelessness because he cannot afford the cost of housing.
Additional context: Based on your state’s laws and the training you have acquired, you can assess TC for his suitability PrEP and prescriber it for him if you deem it to be an appropriate choice.
1. Who should be assessed for the suitability of PrEP? What patient-specific risk factors may support its use in a given patient?
2. What are the current FDA-approved regimens for pre-exposure prophylaxis (PrEP)? How do indications for use differ between the two regimens? Which regimen do you recommend and prescribe for TC?
3. What monitoring is needed for patients receiving PrEP?
4. After reviewing TC’s medication list, what would you advise him regarding potential drug interactions with PrEP?
5. You tell an old pharmacy school classmate about your unique collaborative community pharmacy practice which includes pharmacist-run services, such as PrEP. She tells you she is surprised you are offering PrEP services since she believes that “it just facilitates and promotes irresponsible sexual behaviors.” How would you respond to her stigmatizing beliefs about PrEP?
6. TC is unable to afford to pay cash for his PrEP prescription. What are some ways he may be able to obtain PrEP?
7. TC states that he is worried he may get tired of taking daily oral PrEP. Are there non-oral PrEP options?
8. What medication adherence and harm reduction strategies can you recommend for TC?
Pharmacists continue to play a large role in HIV in the community practice setting and beyond.14 Pharmacists can identify HIV risk factors, screen for patient eligibility for PrEP therapy, recommend, and in this case, initiate an appropriate PrEP regimen, screen for drug interactions, counsel patients on adherence to PrEP, improve access to PrEP for patients who are underinsured or uninsured, address PrEP-related stigma. Primary prevention of HIV involves screening individuals for HIV and providing comprehensive sex education on ways to avert acquisition of the virus, prevention counseling, easy access to condoms, lubricants, HIV screening, etc. Secondary prevention of HIV includes education of people living with HIV on ways to reduce transmission to their partner(s), engaging and encouraging those who are HIV positive to decrease risky behaviors (e.g., sex, illicit substances, etc.), and offering antiretroviral adherence counseling. One specific strategy used for education is the CDC campaign “U=U” (undetectable = un-transmittable),15 which means if a patient has an undetectable HIV viral load, that their virus is fully suppressed and the risk of HIV transmission to a partner reduced almost to zero. Key in this messaging is the benefit in maintaining a continuously suppressed viral load by taking antiretrovirals consistently and as prescribed. Finally, tertiary prevention focuses on the patients living with HIV, continuously improving their duration and quality of life, and reducing morbidity and mortality associated with the virus.
Patient Approaches and Opportunities
In addition to PrEP, pharmacists can offer patients other HIV prevention services, including HIV management via pharmacotherapy, monitoring and counseling, HIV testing, post-exposure prophylaxis (PEP), and harm reduction education and tools.15 Harm reduction is defined as “a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use.”16 Pharmacists in various practice settings can offer patients harm reduction services to prevent HIV, including education on safe substance use, and access to sterile syringes and condoms.
It is important for pharmacists, pharmacy students, and other healthcare practitioners to avoid stigmatizing language while providing PrEP services to patients. Our choice of language and words has an impact. We can either empower or stigmatize people living with HIV.17 It is important for healthcare professionals to recognize how the social determinants of health (in this case, insurance, housing, or immigration status) can affect patient accessibility to PrEP services. Additionally, healthcare professionals providing PrEP services must routinely assess patients taking PrEP for adherence and need, as well as screen patients for STIs, changes in kidney function, risk factors (e.g., injection drug use, condom-less sex, etc.), and pregnancy status as indicated.11
Related chapters of interest:
- HIV and hepatitis C co-infection: a double-edged sword
- Harm reduction for people who use drugs: A life-saving opportunity
- A stigma that undermines care: opioid use disorder and treatment considerations
- Journal articles and guidelines:
- Centers for Disease Control and Prevention: US Public Health Service: Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: clinical providers’ supplement. 2018. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-provider-supplement-2017.pdf
- US Preventive Services Task Force. Preexposure prophylaxis for the prevention of HIV Infection: U.S. Preventive Services Task Force recommendation statement. JAMA 2019;321(22):2203-13.
- Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA 2020;324(16):1651-69.
- Bosh KA, Johnson AS, Hernandez AL, et al. Vital signs: deaths among persons with diagnosed HIV infection, United States, 2010-2018. MMWR Morb Mortal Wkly Rep 2020;69(46):1717-1724.
- Centers for Disease Control and Prevention. HIV surveillance report: diagnoses of HIV infection in the United States and dependent areas, 2018 (updated). Volume 31. Published May 2020. . Accessed January 26, 2021.
- Huang YA, Zhu W, Smith DK, et al. HIV preexposure prophylaxis, by race and ethnicity – United States, 2014-2016. MMWR Morb Mortal Wkly Rep 2018;67(41):1147-50.
- Tung EL, Thomas A, Eichner A, Shalit P. Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care. Sex Health 2018;15(6):556-561.
- Havens JP, Scarsi KK, Sayles H, Klepser DG, Swindells S, Bares SH. Acceptability and feasibility of a pharmacist-led HIV pre-exposure prophylaxis (PrEP) program in the Midwestern United States. Open Forum Infect Dis 2019;6(10):ofz365.
- Grant RM, Lama JR, Anderson PL, et al. iPrEx study team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363:2587-99.
- Baeten JM, Donnell D, Ndase P, et al. Partners PrEP study team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367:399-410.
- Thigpen MC, Kebaabetswe PM, Paxton LA, et al. TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012;367:423-434.
- Choopanya K, Martin M, Suntharasamai P, et al.; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2013;381(9883):2083-2090.
- Mayer KH, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs. emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet 2020;396(10246):239-254.
- Centers for Disease Control and Prevention: U.S. Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States – 2017 Update: a clinical practice guideline. Published March 2018. . Accessed January 25, 2021.
- U.S. Preventive Services Task Force. Preexposure prophylaxis for the prevention of HIV infection: U.S. Preventive Services Task Force recommendation statement. JAMA 2019;321(22):2203-2213.
- Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society-USA Panel. JAMA 2020;324(16):1651-1669.
- Hubbard DM, Byrd KK, Johnston M, Gaines M. Roles for pharmacists in the “Ending the HIV epidemic: a plan for America” initiative. Pub Health Rep 2020;135(5):547-554.
- Prevention Access Campaign. Undetectable = Untransmittable. . Accessed June 1, 2021.
- National Harm Reduction Coalition. Principles of harm reduction. . Accessed April 29, 2021.
- Lynn V, Giwa-Onaiwu M, Gallagher B, Wojiechowicz V. HIV #LanguageMatters: addressing stigma by using preferred language. . Accessed March 12, 2021.