PEP: Provider FAQs

PEP is short for post-exposure prophylaxis. It is the use of antiretroviral medication to prevent acquisition of HIV infection among HIV-negative people who report a specific high-risk exposure to HIV. Such an exposure typically involves direct contact to potentially infectious body fluids or secretions, either through sex or sharing injection equipment with someone who has or might have HIV.

Exposure to HIV is a medical emergency, because HIV establishes infection very quickly, often within 24 to 36 hours after exposure [1-3]. Many providers attempt to expedite the provision of the first dose of PEP while they conduct baseline evaluation (including laboratory testing). Therefore, many clinics prioritize patients requiring PEP to minimize wait time prior to their first dose of emergency medication.

What are the guidelines for prescribing PEP? +

New York State (NYS) Guidelines for prescribing PEP are available from the HIV Clinical Resource, a body convened by the New York State AIDS Institute. There are separate guidelines for adults, [4] children outside the perinatal period [5]. and victims of sexual assault [6].

National guidelines from the Centers for Disease Control (CDC) were last published in January 2005 [7] . 

Find both sets of guidelines on nyc.gov by searching “HIV PrEP and PEP.”

Hide

Which types of exposure warrant PEP? +

Based on the NYS Guidelines, the following exposures to HIV within 36 hours but not beyond 72 hours may warrant PEP:

  • Receptive and insertive anal intercourse
  • Receptive and insertive vaginal intercourse
  • Sharing of injection equipment
  • Injuries with exposure to blood or other potentially infected, including needlesticks with a hollow-bore needle, human bites and accidents

Certain exposures may warrant PEP on a case-by-case basis. These include:

  • Oral-vaginal contact (receptive and insertive)
  • Oral-anal contact (receptive and insertive)
  • Receptive and insertive penile-oral contact with or without ejaculation

The factors that increase risk of the above exposures include:

  • The source person is known to be HIV-infected, especially if the person has a high viral load
  • The oral mucosa not intact (e.g., oral lesion, gingivitis, wounds)
  • The exposure was bloody or involved visibly bloody fluids
  • The patient (or the source) had genital ulcer disease or other sexually transmitted infections (STIs) at the time of exposure

Hide

Who can prescribe PEP? +

Any licensed prescriber in New York State can prescribe PEP. Emergency medicine physicians are among the most frequent prescribers of PEP given the need for immediate treatment after exposure. Clinicians working in ambulatory care practices can also ensure that their non-HIV-infected patients who report risk behavior are aware of PEP and know how to access it after-hours.
If questions arise, clinicians should consult the PEPLine:

New York State Clinician Education Initiative’s CEI Line
1-866-637-2342 (9 a.m. to 2 a.m./Seven (7) days per week)

Hide

What is the recommended PEP regimen? +

The preferred PEP regimen is:

Tenofovir 300mg PO qd + Emtricitabine 200mg PO qd*
PLUS
Raltegravir 400mg PO bid or Dolutegravir 50mg PO daily

*Lamivudine 300 mg PO qd may be substituted for emtricitabine. However, a fixed-dose combination is available when tenofovir is used with emtricitabine (Truvada 1 PO qd).

This regimen is preferred because of its excellent side effect profile and limited drug-drug interactions. Limited resistance has been described to the integrase inhibitor class of antiretrovirals, which includes raltegravir (Isentress) and dolutegravir (Tivicay).

Alternative regimens may be used in the setting of potential HIV resistance, toxicity risks, clinician preference, or constraints on the availability of particular agents. Many clinicians successfully use elvitegravir as an integrase inhibitor in place of raltegravir or dolutegravir. Stribild is a once-a-day, fixed-dose combination of elvitegravir, tenofovir disoproxil fumarate and emtricitabine, with cobicistat as a pharmacokinetic enhancer. This substitution facilitates adherence since it is administered as one tablet, once daily (versus the preferred PEP regimens shown above, which involve taking more than one tablet, possibly twice a day).

Recently, fixed-dose combinations similar to Truvada and Stribild have been approved for HIV treatment (Descovy and Genvoya, respectively), both of which include a novel, tenofovir pro-drug (tenofovir alafenamide) in addition to other medications. However, data are not available to support their routine use as PEP.

Hide

What is the evidence base for PEP? +

PEP was first attempted for HIV prevention in the 1980s among health care workers who experienced occupational exposures. At that time, only AZT (zidovudine) was available. Anecdotal evidence of success began to accumulate, leading to the first formal study of PEP effectiveness, a case-control study of occupational exposures. This study demonstrated an 81% reduction in HIV infection in those who received AZT alone compared with those who did not receive any treatment [8] . PEP was only proposed for non-occupational exposures (“nPEP”) more recently.

The additional evidence supporting PEP includes:

  • Its biologic plausibility (based on animal studies) [1, 2] ;
  • The efficacy of antiretrovirals post-partum in reduction of mother-to-child transmission [3] ;
  • Observational studies (such as data from existing PEP for non-occupational exposure programs). [9]

Hide

Is PEP safe? +

The current preferred regimen is generally safe and well-tolerated [11, 12] . Patients usually experience only mild side effects on the preferred PEP regimen. Most importantly, PEP is only taken for 28 days. In almost all cases, the benefits of HIV prevention outweigh any other risks posed by the medication.

Hide

Who is not eligible for PEP? +

There are few absolute contraindications to the recommended PEP regimen. All medications in this regimen have minimal drug-drug interactions. In almost all cases, the first dose of a PEP regimen should be given and then further consultation obtained, such as the CEI Line (1-866-637-2342).

In the case of pregnancy in the exposed person, expert consultation should be sought. In general, however, PEP is indicated at any time during pregnancy when a significant exposure has occurred, despite a theoretical risk to the woman and the fetus. The recommended PEP regimen remains the same.

In people with compromised renal function (creatinine clearance <50mL/min), the dose of TDF-FTC must be adjusted. (See appendix of guidelines.)

Hide

Can adolescents take PEP? +

PEP has been used safely among adolescents. As with every patient, but especially with younger adolescents:

  • Carefully weigh the potential benefits and risks, including acquiring HIV infection.
  • Make clear that the efficacy of PEP is highly dependent on strict adherence to medication.
  • Refer to institutional policy or consult with the institution’s legal department about consent to care for adolescents under 18 years of age according to NYS law. It is critical that the initiation of PEP not be delayed while awaiting administrative guidance, given the time-limited efficacy of this intervention.

Per NYS guidelines, when parental or legal guardian consent cannot be obtained to initiate HIV PEP in a minor, PEP should be prescribed given the emergency nature of the indication. Parental/legal guardian consent is strongly recommended, but not mandatory, to continue PEP beyond the first few hours/days. As with other treatment in NYS, emancipated minors, married minors and minors who are parents may provide consent for medical care and treatment [5].

Please refer to the separate NYS guidelines for PEP in children beyond the perinatal period [5].

Hide

What baseline assessment is required for individuals beginning PEP? +

NYS Guidelines and CDC Guidelines recommend the following baseline screening within 3 days of initiating PEP:

  • HIV test (At baseline, rapid testing is acceptable, but whenever possible, exposed persons should be tested with laboratory-based HIV antibody (Ab) and antigen (Ag) combination test (preferred) or antibody test (alternative if Ab/Ag combination test not available)]. All lab-based testing has a higher sensitivity than point-of-care/rapid tests.
  • Pregnancy test (if applicable)
  • AST and ALT
  • BUN/Creatinine
  • STI screening
  • Hepatitis B and C testing

[Note: That the first dose of PEP should always be expedited; testing can wait until after PEP has been initiated.]

Hide

What additional support is required for patients on PEP? +

Providers should maintain contact with their patients on PEP, either by telephone or in a clinic visit for the entire duration of PEP. This is both to ensure adherence and to facilitate follow-up HIV testing at 30 and 90 days. Patients should be counselled to take measures that reduce the risk of transmission during the 12-week follow-up period, such as using condoms consistently, avoiding pregnancy/breastfeeding, avoiding needle-sharing and refraining from donating blood, plasma, organs, tissue or sperm.

Hide

Will PEP be covered by my patients’ health insurance? +

In New York State, PEP is generally covered by insurance, including Medicaid.

The programs below provide assistance to appropriate patients who are uninsured or underinsured, or who need financial assistance to pay for the medicine and co-pays.

Providers can assist their patients by:

  • Applying for assistance with medication co-pay if the patient is insured; or
  • Applying for complete coverage of the medication if the patient does not have insurance or needs financial assistance. Those earning <500% of the federal poverty level (in 2017, $60,300 for an individual living alone) are eligible. 

The paperwork must be signed and submitted by a licensed clinical provider.

  • Gilead Advancing Access Program: Assists with coverage of Truvada (a fixed-dose combination of tenofovir disoproxil fumarate 300 mg + emtricitabine 200 mg) and of Stribild (a fixed-dose combination of tenofovir disoproxil fumarate 300 mg + emtricitabine 200 mg + cobicistat 150 mg +elvitegravir 150 mg). For more information and the form (PDF), visit The Gilead Advancing Access.
  • Merck Patient Assistance Program and Savings Card: Assists with coverage of Isentress (raltegravir 400 mg). For more information and the form (PDF), visit Isentress.
  • ViiV Healthcare Patient Assistance Program and Patient Savings Card: Assists with coverage of Tivicay (dolutegravir 50 mg). For more information, visit ViiV Connect or ViiV Healthcare Support Card
  • NYC’s Programs: In New York City, uninsured patients with appropriate exposures can receive PEP (and PrEP) free at clinics that provide PEP to uninsured persons. To get started on PEP right away, patients can call the NYC PEP Hotline at (844) 3-PEPNYC (844-373-7692). The Hotline is available 24/7 and can connect patients with a clinic that has expertise in providing PEP. If calling after hours, the Hotline can get patients a PEP starter pack through a pharmacy and connect patients with a clinic for the rest of PEP.

Hide

Other resources

Please visit patient resources on PrEP and PEP. For more information, go to nyc.gov and search "HIV PrEP and PEP" or contact us at PrEPandPEP@health.nyc.gov.

References

  1. Tsai CC, Follis KE, Sabo A, et al. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl)adenine. Science 1995 Nov 17;270(5239):1197-9.
  2. Otten RA, Smith DK, Adams DR, et al. Efficacy of postexposure prophylaxis after intravaginal exposure of pig-tailed macaques to a human-derived retrovirus (human immunodeficiency virus type 2). J Virol 2000 Oct;74(20):9771-5.
  3. Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. The New England journal of medicine 1998 Nov 12;339(20):1409-14.
  4. New York State Department of Health AIDS Institute. Guidance for the Use of Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission. 2014.
  5. New York State Department of Health AIDS Institute. Guidance for the Use of HIV Post-Exposure Prophylaxis for Children Beyond the Perinatal Period. 2014. http://www.hivguidelines.org/wp-content/uploads/2013/10/hiv-post-exposure-prophylaxis-for-children-beyond-the-perinatal-period.pdf
  6. New York State Department of Health AIDS Institute. HIV Prophylaxis for Victims of Sexual Assault. 2014. http://www.hivguidelines.org/wp-content/uploads/2014/10/hiv-prophylaxis-for-victims-of-sexual-assault.pdf
  7. Centers for Disease Control and Prevention (CDC), Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV---­­­­­­United States, 2016. Atlanta, GA: US Department of Health and Human Services, CDC; 2016: available at Centers for Disease Control and Prevention
  8. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. The New England journal of medicine 1997 Nov 20;337(21):1485-90.
  9. Schechter M, do Lago RF, Mendelsohn AB, et al. Praca Onze Study Team. Behavioral impact, acceptability, and HIV incidence among homosexual men with access to postexposure chemoprophylaxis for HIV. J Acquir Immun Defic Syndr. 2004 Apr 15;35(15):519-25.
  10. Michelle E.R, Torsten B.N, Jeffrey N.M, et al. Seroconversion following Nonoccupational Postexposure Prophylaxis against HIV. Clinical Infectious Diseases. 2005: 1507.
  11. Mayer KH, Mimiaga MJ, Gelman M, Grasso C. Raltegravir, tenofovir DF, and emtricitabine for postexposure prophylaxis to prevent the sexual transmission of HIV: safety, tolerability, and adherence. J Acquir Immune Defic Syndr 2012 Apr 1;59(4):354-9.
  12. McAllister J, Read P, McNulty A, Tong WW, Ingersoll A, Carr A. Raltegravir-emtricitabine-tenofovir as HIV nonoccupational post-exposure prophylaxis in men who have sex with men: safety, tolerability and adherence. HIV medicine 2014 Jan;15(1):13-22.