PREP

An Overview of PrEP, Including its Efficacy, Indications, Monitoring Requirements, and Potential Side Effects.

To learn more about Philadelphia’s TelePrEP program, text“PrEP” to (215) 709-7826
or visit
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In order to keep up with the ever-changing landscape of HIV prevention, it is vital for physicians to stay updated and equipped with the latest advancements in this field. One such advancement is the use of Pre-Exposure Prophylaxis (PrEP), which has become a critical tool in preventing the transmission of HIV. PrEP involves prescribing antiretroviral medications to sexually active individuals who wish to reduce their risk of HIV infection. By following an oral or long-acting injectable regimen, PrEP has been proven to greatly decrease HIV acquisition. This booklet aims to provide physicians with a high-level overview of Prep, including its efficacy, indications, monitoring requirements, and potential side effects. By incorporating PrEP into your clinical practice, you can make substantial strides towards reducing the incidence of HIV and improving the overall health outcomes of your patients and our community.

What is PrEP?

  • PrEP, short for pre-exposure prophylaxis, is medicine that lowers the risk of acquiring HIV through sexual activity or injection drug use.
  • When taken as prescribed, PrEP proves to be highly effective in preventing HIV transmission.
  • Currently there are three FDA-approved PrEP medications available: two in oral form and one as a long-acting injectable:
    1. Truvada® (Tenofovir Dixoproxil Fumarate and Emtricitabine – TDF/FTC): This daily oral PrEP is recommended for all adults and adolescents weighing at least 77 pounds. It significantly reduces the risk of HIV transmission through both sexual contact and injection drug use.
    2. Descovy® (Tenofovir Alafenamide and Emtricitabine – TAF/FTC): Daily oral PrEP recommended to substantially lower the risk of HIV acquisition through sexual activity in adults and adolescents weighing at least 77 pounds. However, it is not recommended for individuals at risk of acquiring HIV through receptive frontal sex.
    3. Apretude® (Cabotegravir – CAB): A long-acting injectable PrEP that is recommended for all adults and adolescents weighing at least 77 pounds. It is an effective option to reduce the risk of HIV transmission through sexual contact or injection drug use. Apretude® can be beneficial for individuals who struggle with adhering to daily oral PrEP, prefer receiving injections every two months over taking oral medication, or have severe kidney disease preventing the use of oral PrEP drugs.

PrEP Effectiveness

Oral PrEP Effectiveness

  • When taken as prescribed, oral PrEP can be up to 99% effective at preventing HIV in men who have sex with men (MSM), and heterosexual men and women.
  • Oral PrEP is effective up to 84% in people who inject drugs (PWID).
  • Oral PrEP reaches maximum protection from HIV for receptive anal sex (bottoming) at about 7 days of daily use.
  • For receptive vaginal sex and injection drug use, PrEP reaches maximum protection at about 21 days of daily use.
  • Please note, Descovy has not had any trials for vaginal sex. This is an important consideration for cis-women and trans-men.

Long-acting (Injectable) PrEP Effectiveness

  • Adhering to a bimonthly injection schedule is crucial to maintain protective levels of medication.
  • Clinical trials have documented instances of HIV infections occurring among individuals who delayed their bimonthly injections for several months.
  • Currently, there is a lack of available data to estimate the timeframe required for achieving optimal drug levels associated with protection against HIV acquisition when using the injectable PrEP (CAB).

Truvada and Descovy at a Glance

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Injectable PrEP (Cabotegravir) Dosing

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On-Demand PrEP

On-Demand PrEP or PrEP 2-1-1 is a non-daily PrEP dosing strategy that has been studied with Truvada and has been shown to be effective at preventing HIV transmission
in MSM.

  • PrEP 2-1-1 can prevent HIV transmission during anal sex.
  • PrEP medication absorbs slower into vaginal tissue than anal tissue, so PrEP 2-1-1 is not an effective option for vaginal sex.
  • PrEP 2-1-1 can be an option for people who have less frequent anal sex or for people who are unable or prefer not to take daily or injectable PrEP.

On-Demand PrEP Dosing

  • Two pills between 2 and 24 hours before sex. Taking the pills closer to 24 hours before sex is better but can be taken up to 2 hours before sex.
  • After sex, one pill 24 hours after the first pills, and one pill again 24 hours after that.

Please note that On-Demand PrEP has not been FDA approved and is not recommended by CDC. Daily PrEP has extensive clinical trial data on safety and efficacy and is the only dosing strategy recommended by the CDC.

How PrEP Works

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PrEP Delivery System

The PrEP delivery system encompasses two fundamental models: the PrEP clinical care model and the public health collaborative model.

PrEP Clinical Care Model

Within the PrEP clinical care model, the process involves:

  • Identifying and engaging patients in need of PrEP;
  • Conducting essential examinations and laboratory assessments;
  • Prescribing PrEP to eligible patients, and subsequently; and
  • Maintaining patient oversight with follow-up appointments and prescription renewals for as long as the patient needs PrEP.

See graphic at right.

Public Health Collaborative Model

  • The Public health collaborative model describes how health departments fund, guide, and lead collaborative planning and delivery of health protective measures—like PrEP.
  • A public health model for prevention using PrEP encompasses cooperation between national, state, and local levels of public health in conjunction with clinical and non-clinical community-based organizations (CBOs) to guarantee that PrEP is readily accessible, available, and culturally acceptable.

The Essential Elements and Flow of PrEP Care in a Clinic

Graphic

PrEP Continuum

The PrEP Continuum mirrors the HIV Continuum of Care, albeit with a focus on HIV-negative individuals. It serves as a tool for monitoring efforts aimed at raising awareness, utilization, and adherence to PrEP among individuals who are at risk of contracting HIV.

The PrEP Continuum consists of four parts:

  • Awareness of PrEP
  • Discussing PrEP with a medical provider in
    the past year
  • PrEP usage in the past year
  • PrEP adherence in the past year

Continuum of PrEP Awareness and Usage

Bar Graph

Navigating Conversations About PrEP

  • Discussions concerning PrEP between healthcare providers and patients should be regarded as an ongoing and evolving process.
  • A patient might initially dismiss a provider’s mention of PrEP if they do not perceive its relevance at that moment, and providers may hesitate to reintroduce the topic. However, individuals may go through phases where their risk for HIV acquisition fluctuates.
  • Data from interviews conducted through the
    Philadelphia Department of Public Health’s Demonstrated Expanded Interventional Surveillance program (DExIS) revealed that 50% of recently diagnosed individuals believed it was somewhat or very improbable that they would acquire HIV.
    • Primary care providers who participated in DExIS found that they had greater success initiating PrEP conversations with patients when they recognized that an individual’s perception of risk is shaped by their life experiences.
  • To navigate these intricacies effectively, it is recommended for providers to establish trust and rapport with their patients over time, making it more comfortable to revisit discussions about PrEP regularly.
  • Additionally, it is important for providers to address stigma and patients’ potential underestimation of their own risk.

PrEP Indications

The following are clinical indications for PrEP, provided by the CDC’s Clinical Practice Guidelines for PrEP for the Prevention of HIV.

Indications for PrEP in Sexually Active Persons

  • In 2021, MSM accounted for 56% of newly diagnosed HIV infections in Philadelphia and heterosexuals accounted for 17% of newly
    diagnosed HIV infections.
  • The following are PrEP indications in sexually active persons:
    • Sexually active adults and adolescents at risk of HIV acquisition
    • Anal or vaginal sex in the past 6 months
    • HIV positive sex partner with unknown or detectable viral load
    • One or more sex partner with unknown HIV status
    • Any sex partners without condoms in the past 6 months
    • A bacterial STI (syphilis, gonorrhea, or chlamydia) diagnosed or reported in the last 6 months

PrEP should be discussed with everyone who is sexually active and prescribed if requested, even if sexual history shows no indications.

Indications for PrEP in People who Inject Drugs (PWID)

  • In 2021, PWID accounted for 12% of newly diagnosed HIV infections in Philadelphia.
  • The following are PrEP indications in PWID:
    • Adults or adolescents at risk of HIV acquisition through injection drug use
    • Any injection drug use in the past 6 months
    • Sharing of injection or drug preparation equipment in the past 6 months

PrEP should be discussed with every person who injects drugs and should be prescribed if requested.

Do not withhold PrEP from candidates who:

  • Are pregnant or planning a pregnancy
  • Use other risk-reduction practices inconsistently, including condoms
  • Report substance use
  • Have mental health disorders, including those with serious persistent mental illness
  • Report intimate partner violence
  • Have unstable housing or limited social support
  • Recently were diagnosed with an STI
  • Request PrEP even if they have a partner living with HIV with an undetectable viral load.
  • Disclose that they are not currently sexually active, as their sexual practices are subject to change over time.

Philadelphia Estimates

Philadelphia estimates of adults with indications for PrEP by race/ethnicity and transmission category and modes of transmission of newly diagnosed HIV infection in Philadelphia provided by the Philadelphia Department of Public Health’s 2021 Annual HIV Surveillance Report.

Estimate of Adults with indications for PrEP in Philadelphia, 2022

  • There were 266,303 people in Philadelphia are estimated to be at risk for acquiring HIV in 2022.
  • Among these, 8,750 had an indication for PrEP.
  • The greatest overall number and proportion of persons with an indication for PrEP was among MSM.

Prescribing PrEP

In 2022, the Philadelphia Department of Public Health launched an innovative initiative known as TelePrEP.

What is TelePrEP?

  • TelePrEP is a program designed to offer convenient online PrEP services and medication delivery to residents of Philadelphia, all within the comfort of their homes.
  • The array of services encompasses:
    • Virtual appointments with PrEP providers
    • At-home lab work
    • Complimentary delivery of PrEP medications

For individuals transitioning from PEP to PrEP, consider the following indicators.

Transitioning from PEP to PrEP

  • Individuals who are considered candidates for PrEP after PEP, are:
    • Individuals who request PrEP and may have experienced an HIV exposure incident due to sexual activity or injection. Drug use within the preceding 72 hours.
  • Individuals who have undergone multiple rounds of PEP within a relatively short time frame, such as more than twice in the past 6 months.

Paying for PrEP

Ensure that patients are aware of these options to access PrEP without financial barriers.

Insurance and Medicaid Coverage:

  • Most insurance plans and Medicaid programs include coverage for PrEP.
  • Under the Affordable Care Act, PrEP is typically available free of charge under nearly all health insurance plans.
  • This means patients will not incur any expenses for PrEP medication or the necessary clinic visits and lab tests to maintain their prescription.

Access without Insurance or Medicaid:

  • If an individual has no insurance or Medicaid coverage, there are alternative programs that offer PrEP at no cost or reduced rates:
    • Ready, Set, PrEP: Provides free PrEP medication to eligible individuals
    • Co-pay Assistance Programs: These programs reduce the cost of PrEP medications, with eligibility not based on income
    • ViiVConnect: Offers a program to assist with covering the expenses of PrEP shots
    • Gilead Advancing Access Program: Assists in paying for Truvada and Descovy

Additional Resources

Downloadable PDFs

  • Download the PrEP book as a PDF
  • Truvada and Descovy at a Glance
  • Injectable PrEP (Cabotegravir) Dosing

Resources and Links

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