When taken daily, PrEP is highly effective for preventing HIV from sex or injection drug use.
HIV weakens a person’s immune system by specifically attacking the CD4 cells, which are often called T cells. HIV can destroy so many cells over time that the body cannot fight off infections over time, leading to AIDS if left untreated.
The damage to the immune system makes the person more likely to contract opportunistic infections and other infection-related cancers before eventually succumbing to those complications. There is no effective cure that currently exists, but the disease can be controlled with proper medical care.1
HIV continues to be a serious health issue for parts of the world, including the United States. At the end of 2018, an estimated 1.2 million people aged 13 years and older had HIV in the United States, including an estimated 161,800 (14%) of people whose infections had not been diagnosed. In 2018, 37,968 people received an HIV diagnosis in the United States and dependent areas.2
Access to treatment is essential in reducing transmission. People with HIV who take their medication as prescribed and have an undetectable viral load can stay healthy and have effectively no risk of transmitting HIV to an HIV-negative partner through sex.
HIV-negative people can also decrease their risk for HIV. Pre-exposure prophylaxis (PrEP) is an HIV prevention approach in which people at risk for HIV (current HIV-negative individuals) take daily medicine to prevent it.
PrEP can stop HIV from taking hold and spreading throughout the body and reduce the risk of becoming infected if exposed to the virus. When taken daily, PrEP is highly effective for preventing HIV from sex or injection drug use. It is even more effective when combined with condoms and other prevention tools; however, it is much less effective when not taken consistently.3
The CDC classifies HIV diagnoses into 6 transmission categories: male-to-male sexual contact (MSM), injection drug use, male-to-male sexual contact and injection drug use, heterosexual contact, mother-to-child (perinatal) transmission, and other (includes blood transfusions and unknown causes).2 Gay, bisexual, and other men who reported MSM are the population most affected by HIV accounting for 69% of the new HIV diagnoses in 2018. Heterosexuals accounted for 24% of the new diagnoses during that year and people who inject drugs (PWID) accounted for 7%.4
PrEP should be considered for people without HIV who are at risk for getting the virus from sex or injection drug use. The federal guidelines recommend that PrEP be considered for HIV-negative individuals who:
Have had anal or vaginal sex in the past 6 months and:
PrEP is also recommended for people who injects drugs and
PrEP should also be considered for people who have been prescribed non-occupational post-exposure prophylaxis (PEP) and
PrEP can also be an option for couples getting pregnant who have a partner with HIV as it can help protect the mother and baby from getting HIV during conception, pregnancy, or while breastfeeding.3 As long as the risk exists for the individual, adherence to the daily PrEP regimen should be maintained.
There are 2 agents currently FDA-approved for PrEP, Truvada [Tenofovir disoproxil fumarate 300 mg & Emtricitabine 200 mg (F/TDF)] and Descovy [Tenofovir alafenamide 25 mg & Emtricitabine 200 mg (F/TAF)]. Both were shown to be safe and highly effective in clinical trials.5,6
Tenofovir disoproxil fumarate 300 mg + Emtricitabine 200 mg (F/TDF)
Tenofovir alafenamide 25 mg + Emtricitabine 200 mg (F/TAF)
1 tablet PO QD
Unless using a PrEP 2-1-1 schedule
1 tablet PO QD
Alternative dosing (2-1-1 schedule)
Note: while there is substantial published data supporting this strategy, it has not been reviewed by the FDA or recommended by the CDC. The International AIDS Society of the US (IAS-USA), World Health Organization (WHO), and European AIDS Clinical Society (EACS) all endorse the option of this dosing strategy
2-1-1 for MSM with anal exposures only:
2 tablets 2-24 hours before anal sex
(24 hours before for optimal protection)
For a detailed 2-1-1 guide, click on this link.7
Descovy has not been evaluated using a PrEP 2-1-1 schedule
Approved for use for all adults and adolescents ≥35 kg with indications for PrEP.
Approved for use for adults and adolescents ≥35 kg at risk for sexually acquired HIV, excluding individuals at risk from receptive vaginal/front hole sex and injection drug use only.
Generally safe and well tolerated
Estimated GFR or CrCl by serum labs should be ≥60 mL/min (Cockcroft-Gault) to safely use Truvada
Estimated GFRF or CrCl by serum labs should be ≥30 mL/min (Cockcroft-Gault) to safely use Descovy
Time to Protection
Time to maximum protection varies by site of exposure:
If there are no contraindications and the patient wants to use PrEP, it can be initiated.
Same-day PrEP prescriptions are encouraged when possible. A prescription should be written and PrEP started on the same day a patient comes in for consultation when:
If it has been more than 2 weeks since baseline labs were obtained, repeat an HIV test and start PrEP the same-day while awaiting results of the repeat HIV test.
Comments and rationale
HIV antigen/antibody or antibody-only test:
Rapid HIV Ab test, or fourth generation (Quest #91431) or HIV RNA PCR (Quest #40085)
Consider testing for acute HIV infections in all patients who are initiating PrEP with either an individual HIV RNA, a pooled HIV RNA or a fourth generation combined HIV Ag/Ab assay, especially if they have had a high-risk exposure in the prior month. Test for acute HIV infection in all patients with symptoms concerning for acute HIV infection.
If the patient has acute or chronic HIV infection, they must receive 3 active HIV medications for treatment and risk resistance if taking only PrEP.
CrCl should be ≥60 mL/min (Cockcroft-Gault) to safely use Truvada or ≥30 mL/min to safely use Descovy.
Hepatitis B (HBV) serologic screening (surface antigen)
Truvada is active against HBV. Patients with chronic HBV can use Truvada for PrEP, but should have liver function tests monitored regularly during PrEP use and after discontinuing PrEP, and should be cautioned that hepatitis can flare if Truvada is discontinued. Patients who are HBsAg negative should be offered HBV vaccination if not previously infected or immunized.
Hepatitis C (HCV) antibody
Determine baseline HCV infection status and obtain repeat testing at least yearly among MSM, PWID, and others with ongoing risks of exposure.
STIs (based on patient sexual practices)
Test patients on PrEP for syphilis and for urethral, rectal, and pharyngeal gonorrhea (GC) and chlamydia (CT) based on reported exposure routes (not based on gender/sexuality) every 3 months. Consider using self-collected swabs for GC/CT testing. Consider offering the human papillomavirus (HPV) and hepatitis A virus (HAV) vaccines if not previously vaccinated.
Pregnancy test (when appropriate)
People who can become pregnant (reproductive-age cisgender women, some transgender men and non-binary people) should receive a pregnancy test and have contraception plans reviewed. In patients trying to conceive, PrEP should be coordinated with prenatal care with attention to the partner’s reproductive and breastfeeding plans. Descovy is not approved for use as PrEP in this population. Perinatal HIV/AIDS consultation is available 24/7 at 888-448-8765.
Ongoing monitoring and support for patients using PrEP
Monitoring recommendations are currently identical for Truvada and Descovy as well as for people using 2-1-1 dosing.
30 days after initiation
In-person follow-up visit highly recommended for patients 24 years old and under or those who may have difficulties with adherence.
A phone call is a reasonable alternative for other patients.
Prescribe additional 60-day supply with no refills
Every 3 months
Every 12 months or more often based on assessed risk
Positive HIV test while on PrEP
California Senate Bill 159 (CA SB 159)10
Bill 159, approved in California in October 2019, eliminates mandatory doctor visits and bars insurance companies from requiring prior authorization for the drugs necessary for PrEP and PEP. The bill, as it relates to PrEP and pharmacy, would authorize a pharmacist to furnish PrEP and PEP in specified amounts and would require a pharmacist to furnish those drugs if certain conditions are met, including that the pharmacist determines the patient meets the clinical criteria for PrEP or PEP consistent with federal guidelines.
It would require a pharmacist to complete a training program approved by the board before furnishing PrEP or PEP. The bill will be implemented in July.
A key difference from the allowances of this bill and standard PrEP provider care is that the trained pharmacist is only allowed to dispense at least a 30-day supply up to a 60-day supply (if the screening conditions are met) so as to direct the patient to their PrEP prescriber for additional monitoring and prescription refills.
The pharmacist may not furnish a 60-day supply of PrEP to a single patient more than once every 2 years, unless directed otherwise by a prescriber. The bill also requires the pharmacists be trained on the different coverage options for PrEP.
PrEP Coverage Options
Many private insurers cover PrEP but may require prior authorization (PA). PAs for Truvada will no longer be allowable after July 2020. Approval for coverage typically requires documentation of all of the following:
Adolescents covered on their parents’ plan can keep their information confidential by signing up at myhealthinfo.org. Medi-Cal (California Medicaid) does not require a PA for PrEP. Have the pharmacy bill to the State Medi-Cal HIV carve-out instead of the managed care plan to help ensure Medi-Cal coverage.
The Gilead Advancing Access PrEP medication assistance program will provide monthly Truvada or Descovy deliveries to the patient or clinic at no cost for those without prescription coverage and who meet income guidelines (500% FPL).
The Ending the HIV Epidemic: Ready, Set, PrEP program (getyourprep.com) provides monthly Truvada or Descovy deliveries to the patient or clinic at no cost for those without prescription coverage, regardless of income, for up to 200,000 patients per year. Patients must provide proof of lack of prescription coverage, a recent negative HIV test result, and a current prescription for PrEP. State programs for PrEP are also available to assist with cost and access.
Telehealth and Further Direction
Numerous barriers prevent access to PrEP. Individual awareness of HIV risk and willingness to take PrEP, geographic distance to care, provider awareness of PrEP, and willingness to prescribe, cost or insurance access, and adherence all present as obstacles along the PrEP continuum of care.
Stigma also prevents HIV preventative care for many. For example, fewer than 50% of MSM disclose their sexual orientation to their primary care provider (PCP) due to discomfort in healthcare settings and fear of judgement. Novel technology-based strategies can be employed as attempts to circumvent these barriers and scale-up PrEP coverage for at-risk populations.12
Provider-to-patient telehealth modalities provide a function of remote PrEP prescribing and are designed to overcome geographic barriers, connect at-risk persons directly to PrEP-trained providers, and may reduce barriers, such as fear of discrimination.
Many of the following programs allow patients to use self-testing/self-collection kits for HIV and other STIs to send in for screening. Examples include:
Provider-to-provider telehealth modalities function as distance mentorship and clinical consultation for community PrEP prescribers via videoconference with infectious disease specialists plus a multidisciplinary support team and are designed to build capacity of primary care providers to prescribe PrEP.
An example of this type of modality is the Mountain West AIDS Education and Training Center Extension for Community Healthcare Outcomes program, which offers quarterly PrEP didactics and case-based discussion via videoconference, connecting community PrEP providers in 6 states with University of Washington specialists, including ID providers as well as pharmacy, psychiatry, and social work experts.
Store-and-forward consults (e-Consults) serve as electronic healthcare record (EHR)-based specialist consultation without a face-to-face visit and are designed to reduce barriers to access to PrEP specialists, support prescribing, and build capacity of non-specialists to prescribe PrEP.
The Veteran’s Health Administration has a well-established e-Consult system to support PCPs in PrEP prescribing and the University of Washington recently introduced infectious disease e-Consults, including an option for PrEP prescribing guidance.
The outcomes data for all of these modalities are currently limited but show promise. Technology-based interventions can address gaps in the PrEP care continuum.
As the programs continue to evolve, opportunities can present themselves for pharmacists to take an active role in PrEP care. Novel funding sources for the programs—as well as advocacy to change laws and regulations to better support and reimburse such models and support collaborative practice pharmacist prescribing—must occur so they can be implemented in regions with the greatest need for PrEP.
About the AuthorsJennifer Nguyen is a PharmD candidate at Marshall B. Ketchum University’s College of Pharmacy, anticipated to graduate in spring 2021.
Jonathan Ogurchak, PharmD, CSP, is the co-founder and CEO of STACK, a pharmacy compliance management software, and serves as preceptor for a virtual Advanced Pharmacy Practice Experiential Rotation for specialty pharmacy, during which this article was composed.