Intended for healthcare professionals

Practice 10-Minute Consultation

HIV prevention with postexposure prophylaxis-in-pocket (PIP)

BMJ 2023; 382 doi: https://doi.org/10.1136/bmj-2023-076016 (Published 02 August 2023) Cite this as: BMJ 2023;382:e076016
  1. Maxime J Billick, general internist and infectious diseases fellow12,
  2. Jordana Sheps, family physician and sexual health physician3,
  3. Isaac I Bogoch, general internist and an infectious diseases consultant and scientist124
  1. 1Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  2. 2Division of Infectious Diseases, University of Toronto, Toronto, Ontario, Canada
  3. 3Department of Family Medicine, Women’s College Hospital, Toronto, Ontario, Canada
  4. 4Divisions of Infectious Diseases, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada
  1. Correspondence to: I I Bogoch Isaac.bogoch{at}uhn.ca

What you need to know

  • Postexposure prophylaxis-in-pocket (PIP) is an HIV prevention strategy that may be particularly suitable for people who have only a low number of high risk, often unanticipated, HIV exposures per year (such as 0-4 per year)

  • Prescribing postexposure PIP involves proactively providing 28 days of guideline-approved HIV postexposure prophylaxis so that people may self initiate medications after a potential HIV exposure

  • Evaluate HIV risk at follow-up visits as people may change their preferred HIV prevention modality (for example, between postexposure and pre-exposure prophylaxis) as their needs and circumstances evolve

Patient 1: A 47 year old man taking HIV pre-exposure prophylaxis presents to a primary care clinic for a routine follow-up visit. He is considering entering a monogamous relationship with a male partner, but is uncertain if he may have “very infrequent” sex with other partners. He is wondering whether to discontinue pre-exposure prophylaxis.

Patient 2: A 36 year old woman who engages in sex work presents to a sexual health clinic for symptoms of a sexually transmitted infection. She routinely uses condoms but says that this infection was acquired in the context of non-consensual condomless sexual activity at work.

Patient 3: A 68 year old man who identifies as bisexual presents to an HIV clinic after initiating a postexposure prophylaxis starter pack in an emergency department. He sought urgent care because, although he ensures condoms are worn almost all of the time, he was having receptive anal intercourse with a person of unknown HIV serostatus whom he met on a dating app and the condom broke.

Patient 4: A 25 year old woman presents for follow-up to a general infectious disease clinic for evaluation of a skin and soft tissue infection. She uses drugs intravenously. She tells you she almost never shares injection paraphernalia but ran out of supplies and shared paraphernalia with a friend, whose HIV status is unknown.

Postexposure prophylaxis-in-pocket (PIP) is an HIV prevention modality for individuals with infrequent, often unanticipated, high risk HIV exposures whose needs may not be met by daily or event-driven HIV pre-exposure prophylaxis or routine HIV postexposure prophylaxis. The patients described in the vignettes above were all prescribed postexposure PIP.

Despite the general population’s increasing familiarity with pre-exposure and postexposure prophylaxis (box 1), there remain knowledge gaps, gaps in care, and barriers to HIV prevention, including cost, pill burden, stigma, and wait times for both urgent and non-urgent care.789 PIP can mitigate many of these barriers for individuals with a low frequency of high risk exposures, which are often unanticipated (as shown in the clinical vignettes), by prospectively identifying those who have few (such as 0-4) potential HIV exposures per year and providing them with a full 28-day course of HIV postexposure prophylaxis before an exposure occurs.1011 Those using PIP are counselled on when to self initiate medications after a potential exposure and how to follow up with care within the first week of antiretroviral drug use on a less urgent basis.91011 This approach provides people with agency and empowerment over their HIV prevention and lowers barriers to accessing pharmacotherapy as they may self initiate antiretroviral drugs immediately.91011 PIP also avoids potentially long and stressful visits an emergency department, which are a barrier to routine access to postexposure prophylaxis after unanticipated HIV exposure.78 As PIP involves identifying those who may require antiretroviral drugs before an HIV exposure occurs, it allows for referrals to social workers or community based healthcare practitioners to help navigate potential challenges accessing medications.1011

Box 1

Use of pre-exposure and postexposure prophylaxis

Pre-exposure and postexposure prophylaxis are well established methods of preventing HIV infection with antiretroviral drugs.12345 Pre-exposure prophylaxis typically consists of taking tenofovir disoproxil fumarate and emtricitabine either daily or in an event-driven (“on demand”) manner for anticipated HIV exposures, such as sex and sharing of injection drug paraphernalia with those of unknown HIV serostatus and people living with known HIV infection and detectable virus.1 Event-driven pre-exposure prophylaxis is best for HIV exposures that can be anticipated and are relatively frequent.14 Injectable pre-exposure prophylaxis is also increasingly available.

Conversely, postexposure prophylaxis involves the initiation of antiretroviral drugs after a potential exposure to HIV, and typically consists of three medications and a 28 day treatment course that must be initiated within 72 hours of an exposure.235 In care models across most high, middle, and low income countries, this requires a person to overcome several barriers—including those related to knowledge gaps, stigma, and finance—to present to an emergency department or urgent care centre for assessment and to obtain a prescription on a semi-urgent basis.256

RETURN TO TEXT

In this article, we outline an assessment approach to potential PIP candidates, steps for PIP initiation, monitoring of patients using PIP, and when to consider transitioning from PIP to another HIV prevention modality, such as pre-exposure prophylaxis. There are growing real world data on the effectiveness and safety of PIP, though the current evidence base is largely restricted to small, retrospective cohorts and none linked to HIV seroconversion. We make the following recommendations based on our clinical experience as well as breadth of evidence supporting effectiveness of postexposure prophylaxis.

What you should cover

Based on a patient’s medical history, risk profile, and support systems, assist them in choosing what their best HIV prevention strategy may be, including postexposure-prophylaxis-in-pocket (PIP), daily or on-demand pre-exposure prophylaxis, injectable pre-exposure prophylaxis, or routine postexposure prophylaxis. Counsel patients that any decision can be changed based on their evolving HIV risk or personal preference, and that you can support them with such changes.

Views and knowledge

Many individuals who initiate PIP transition from either postexposure or pre-exposure prophylaxis care, based on their current or projected HIV risk and their preference over other HIV prevention modalities.1011 Therefore, we recommend starting the first visit with open questions to determine what brings the patient to care and what they know about different prevention modalities.

  • What is the patient’s understanding of HIV infection, HIV prevention, and what are the options available?

  • What is their past medical history, including use of postexposure or pre-exposure prophylaxis and prior sexually transmitted infections, to help gauge current and past HIV risk?

  • Do they have conditions that may impair the absorption of oral medications (such as gastric bypass surgery, short gut syndrome, etc)?

Medical history

Clarify the patient’s past medical history and use of prescribed and over-the-counter medications, including the use of medications that have potential to interact with antiretroviral drugs.

  • Does the patient have a history of renal disease, metabolic bone disease, or liver disease? These conditions do not necessarily prohibit the use of PIP, but medications may need to be adjusted based on creatinine clearance or degree of hepatic impairment (measured via Child-Pugh class).12 A history of hepatitis B is important given that medications used for HIV treatment and prevention (such as tenofovir) also treat hepatitis B, and discontinuing such medications may lead to a hepatitis B virus rebound.12

  • Anti-epileptic medications such as phenytoin or carbamazepine can decrease serum concentration of antiretroviral drugs such as bictegravir and dolutegravir.

  • Rifamycin based medications decrease serum concentrations of commonly used antiretroviral drugs such as bictegravir, dolutegravir, and tenofovir.

  • St John’s wort will decrease serum concentrations of bictegravir, dolutegravir, and tenofovir.4

Consultation with a pharmacist or advanced HIV care practitioner may be warranted if the patient has a history of any of the above conditions or is taking the above medications and is not able to discontinue them from a safety perspective.

Risk factors

Clarify risk factors for HIV acquisition, including those related to sex or drug use, and the frequency of potential HIV exposures. Based on limited, retrospective cohort data, we consider patients who have up to four exposures per year as potential candidates for PIP use.1011 In our experience, most individuals using PIP as their primary HIV prevention modality have one to two exposures per year; some individuals report up to four exposures per year but do not want to use pre-exposure prophylaxis because of perceived pill burden or side effects of the medications.

  • Does the patient engage with insertive or receptive vaginal or anal sex with those of known HIV seropositive status who are not virologically suppressed, or with those of unknown HIV serostatus? Elucidate the use (and frequency) of barrier protection such as condoms. Also inquire about “chemsex,” the use of drugs to enhance sex, which may result in decreased use of barrier protection.

  • Ask about the potential for unanticipated HIV exposures, including condoms breaking, instances of not using condoms, sexual assault, inability to negotiate consistent condom use with a partner, or sharing injection drug paraphernalia.

Barriers to care

Evaluate barriers to care, including access to a general practitioner, shame and stigma surrounding HIV prevention care, access to urgent care and emergency departments (stigma, proximity, work hours, language, etc), and potential for sexual violence. As insurance and drug coverage for HIV prevention care differs between different settings and countries, referral to social work services or community partnerships may facilitate financial assistance to access medications or to support with insurance preauthorisation.

What you should do

Individuals with up to four potential HIV exposures per year who think that PIP is their preferred HIV prevention option should undergo baseline testing, counselling, and follow-up.1011

Baseline investigations

Before prescribing PIP and based on postexposure prophylaxis guidance234513:

  • Perform a full blood count, serum creatinine test, and liver enzyme testing

  • Screen for sexually transmitted infections, including syphilis, chlamydia, and gonorrhoea (in the pharynx, rectum, and urine)

  • Screen for HIV infection

  • Screen for hepatitis A, B, and C and ensure vaccination to hepatitis A and B if non-immune1234514

  • Pregnancy testing (beta HCG) if appropriate.

Prescribing medications

We prescribe local, guideline-approved postexposure prophylaxis regimens for PIP234:

  • For example, for those who were assigned male at birth, we recommend prescribing co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (BIC/FTC/TAF) as it is a once-daily pill

  • For patients who were born female and are of childbearing age, we recommend prescribing dolutegravir 50 mg plus co-formulated tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg or co-formulated tenofovir alafenamide 25 mg and emtricitabine 200 mg (DTG + TDF/FTC, or TAF/FTC) once daily, due to the improved safety profile in those of childbearing potential.

All prescriptions are for 28 days, occasionally with refills, context depending. We remind people that these medications are typically well tolerated, but short term side effects such as nausea, diarrhoea, and headache may occur. These are typically mild and self resolve.34

Patient counselling

We recommend counselling those starting PIP that it is important to:

  • Fill prescriptions and have tablets ready to use in a safe place to help reduce the time to initiation should a potential HIV exposure occur

  • Self initiate medications as soon as possible, and within 72 hours of a potential HIV exposure

  • Follow up in clinic within seven days of a potential exposure to conduct baseline screening for HIV and sexually transmitted infections, and to be referred to appropriate care based on the exposure (for example, psychosocial support in the context of sexual assault).

This approach prioritises flexibility and timely access to essential medications without the initial barrier of first seeking urgent and immediate healthcare for routine postexposure prophylaxis, which often requires lengthy wait times and discussing challenging topics with unfamiliar healthcare providers.

Follow up

We follow up with patients using PIP every five or six months, or sooner if they have a potential HIV exposure. At follow-up visits we recommend:

  • Asking about HIV risk factors and the frequency of potential exposures

  • Asking whether PIP was used and, if so, if it was initiated within 72 hours of potential exposure

  • Determining if PIP is currently the most appropriate HIV prevention modality, or if the patient is better served by daily, on demand, or injectable pre-exposure prophylaxis

  • Screening patients for HIV infection, syphilis, hepatitis C, chlamydia, and gonorrhoea (urine, pharynx, rectum).

We use these visits as opportunities to accommodate other sexual health needs, such as consideration of doxycycline for sexually transmitted infection postexposure prophylaxis,15 and vaccination for mpox (formerly monkeypox) and human papilloma virus, where appropriate.15 If patients still have no more than four potential exposures per year and are amenable to PIP, we recommend continuing with this approach and refilling medications if necessary. We transition some to pre-exposure prophylaxis if they experience frequent exposures or prefer that alternative.

Patients’ perspectives

• “I feel tremendous relief knowing that I can start my HIV prevention medications any time I choose. I once had to go to the hospital for postexposure prophylaxis. I remember having to wait a long time and then having an uncomfortable conversation with a doctor in a rather public setting about my exposure. PIP allows me to bypass the hospital and take ownership over my health.”

• “I was on pre-exposure prophylaxis for a while but was only rarely having sex without a condom. I have an unexpected situation happen probably only one or two times a year, when a condom breaks or isn’t used. PIP seemed like a good choice for me because I don’t have to take a daily pill like with pre-exposure prophylaxis, and I can start the medications whenever I need to.”

How patients were involved in the creation of this article

Patients were interviewed regarding their experience using PIP and other HIV prevention modalities, highlighting their perceived benefits and drawbacks, and focusing on anxiety related to risk of HIV acquisition and sexual behaviours. Their involvement also helped frame and contexualise use of PIP from a patient’s view.

Education into practice

  • Think about the patients you care for who take pre-exposure prophylaxis and postexposure prophylaxis. How might you introduce the concept of PIP for patients with less frequent and often unanticipated HIV exposures?

  • In patients who are eligible and want to try PIP, how you would provide access to medications in your clinical setting?

How this article was created

We searched PubMed for “HIV post-exposure prophylaxis,” “HIV PEP,” “on-demand PEP,” “PEP-in-pocket,” “self-initiated PEP,” “self-start HIV postexposure prophylaxis,” and “PEPSE.” Relevant articles were reviewed. We also sought input from patients currently using PIP as their primary HIV prevention modality.

Acknowledgments

We thank all the patients who discussed their personal HIV prevention journey for this article, and who shared their views on PIP.

Footnotes

  • This is part of a series of occasional articles on common problems in primary care. The BMJ welcomes contributions from GPs.

  • Contributors: IIB and MJB conceived the article and are guarantors. All authors conducted the literature review. All authors wrote, reviewed, and revised the article and created the boxes. IIB was the contact for patient involvement.

  • Competing interests: The BMJ has judged that the authors have no disqualifying financial ties to commercial companies that are relevant to this paper. The authors declare the following other interests: IIB has consulted to BlueDot, a social benefit corporation that tracks emerging infectious diseases, and to the NHL Players’ Association.

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