Pre-Exposure Prophylaxis (PrEP), Non-Occupational Post-Exposure Prophylaxis (nPEP) & Occupational PEP (oPEP)

(See the Guidelines listed below for persons with decreased renal function (CrCL < 60 mL/min), pregnant women, and children.)

Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis, (September 2013) at https://www.jstor.org/stable/10.1086/672271, the New York State Department of Health AIDS Institute occupational post-exposure prophylaxis guidelines (June 2020) at https://www.hivguidelines.org/pep-for-hiv-prevention/, and CDC. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV—United States, 2016. Available at https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf. All accessed October 1, 2020.

Note: If the source is known to be infected with HIV, the healthcare provider should attempt to get a history of antiretroviral use, resistance and most recent viral load from the source patient or his/her provider to guide the choice of nPEP medications. The clinician is encouraged to consult an expert in PEP management when choosing a regimen for an exposed pregnant women or in cases of exposures to virus known or suspected to be resistant to one or more antiretroviral agents. The National Clinician Consultation Center provides timely answers for urgent exposure management and PEP. Visit https://nccc.ucsf.edu/clinician-consultation/pep-post-exposure-prophylaxis/ for more information. See the online PEP Quick Guide (https://nccc.ucsf.edu/clinical-resources/pep-resources/pep-quick-guide/) for urgent PEP decision making.

Preferred oPEP Regimens

• Tenofovir disoproxil fumarate/emtricitabine 300/200mg (Truvada) po once daily PLUS [raltegravir (Isentress) 400 mg po twice daily OR dolutegravir⁷ (Tivicay) 50 mg po once daily]⁸

Alternative oPEP Regimens

• For alternative oPEP regimens see New York State Department of Health AIDS Institute occupational post-exposure prophylaxis guidelines
  (June 2020) at https://www.hivguidelines.org/pep-for-hiv-prevention/pep/#tab_7_0

Preferred nPEP Regimens

• Tenofovir disoproxil fumarate/emtricitabine 300/200 mg (Truvada) po once daily PLUS [raltegravir (Isentress) 400 mg po twice daily OR dolutegravir⁷ (Tivicay) 50 mg po once daily]

Alternative nPEP Regimens

• For alternative nPEP regimens see CDC. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV—United States, 2016. Available at https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf.

NOTES: Some pharmacies may not “break” their bottles of ARVs which typically come in a 30-day supply. Consider ordering a complete 30-day supply to assure PEP is started in a timely manner.

7. Individuals with childbearing potential should be warned of small risk of teratogenicity with dolutegravir in the 1st trimester of pregnancy. Contraception should be used while taking dolutegravir. Raltegravir is considered safe in pregnancy and in women of child-bearing potential. See https://www.hivguidelines.org/antiretroviral-therapy/resources-care-providers/#tab_4.

8. USPHS Guidelines list only the raltegravir regimen as preferred for oPEP.

NOTES: Baseline testing is recommended for all source and exposed persons. Follow up testing of the exposed person should be determined based on presence or absence of HIV, HBV or HCV in the source person. See sections on HBV, HCV, and HIV of this resource for additional details including PEP.

Source

Baseline: HIV Ag/Ab⁹, hepatitis B surface antigen¹⁰, HCV RNA¹¹ (for sexual exposures, also test for STIs¹²)

Exposed Persons

Baseline: HIV Ag/Ab⁹, hepatitis B serology¹³, HCV Ab¹⁴, pregnancy test (if indicated)¹⁵, BUN, serum creatinine¹⁶, AST/ALT¹⁶ (for sexual exposures, also test for STIs¹¹)

2 weeks: oPEP: AST/ALT, BUN, creatinine, CBC ¹⁶

4-6 weeks: HIV Ag/Ab¹⁹, pregnancy test¹⁵, BUN, serum creatinine¹⁶, AST/ALT¹⁶ , hepatitis C RNA¹ (for sexual exposures test for syphilis and, if indicated, gonorrhea/chamydia (if not provided presumptive treatment at baseline or if symptomatic))

3 months: HIV Ag/Ab⁹

6 months: HIV Ag/Ab test^9,18, hepatitis B serology^{13, 19} , HCV Ab with reflex to HCV RNA

9. For HIV testing, rapid testing of source patient facilitates decision making. Ag/Ab or Ab tests can be used. Use of oral test is not recommended. If using Ag/Ab test, can consider discontinuing HIV testing at 3-4 months. Obtain HIV viral load and HIV genotype if exposed person determined to have HIV infection at any visit. Follow-up HIV testing should be done even if the exposed person declines PEP.

10. If exposed person has completed Hep B vaccination series with subsequent documented anti-HBs > or = 10 mIU/mL, testing source patient for HBsAg is not necessary.

11. Can consider hepatitis C antibody (HCV Ab) with reflex to HCV RNA

12. Test all sites of exposure for gonorrhea, chlamydia, and syphilis

13. Hepatitis B serology: HBsAg, quantitative HBsAb, HBcAb Total or IgG

14. If positive, reflex to HCV RNA viral load. If viral load positive, refer to care for pre-existing chronic HCV infection.

15. Woman of reproductive age, not using effective contraception, with vaginal exposure to semen

16. If prescribed PEP. oPEP guidelines recommend repeating at 2 weeks and also recommend CBC even though current preferred oPEP regimens are not associated with hematologic toxicity. Further testing may be indicated if abnormalities are detected.

17. If positive, refer to care for Hepatitis C infection.

18. Delayed HIV seroconversion has been seen in persons who simultaneously acquire HIV and HCV infection. The oPEP guidelines recommend HCP who acquire HCV after exposure to a source coinfected with HIV and HCV undergo repeat HIV Ag/Ab testing at 12 months.

19. If susceptible to HBV at baseline. See Post-Exposure Prophylaxis for HBV section for testing following vaccination.

Refer to Appendix B of the Adult/Adolescent Antiretroviral Guidelines for a complete and updated source for antiretroviral medications to include: dosing, renal or hepatic insufficiency dosage adjustments, side effects, drug interactions, and warnings/contraindications.

Dolutegravir (DTG, Tivicay)

• Usual Adult Dosage Forms: 50 mg tab
• Important Points:
  • Take with or without food
  • Take 2 hrs before or 6 hrs after certain medications (e.g. cation-containing antacids or laxatives, sucralfate, oral iron or calcium supplements, multivitamins with minerals) containing polyvalent cations (e.g. Mg, Al, Fe, Ca). DTG may be taken with calcium or iron supplements if taken together with food.
  • Adverse Effects: headache and insomnia most common. Hypersensitivity reaction including rash, constitutional symptoms and organ dysfunction (e.g. liver injury) have been reported.
  • Individuals with childbearing potential should be warned of small risk of teratogenicity with DTG in the 1st trimester of pregnancy. Contraception should be used while taking DTG.

Raltegravir (RAL, Isentress)

• Usual Adult Dosage Forms: 400 mg tab, 100 mg chewable tabs
• Important Points:
  • Take with or without food
  • Avoid Al or Mg-containing antacids. No separation needed when given with CaCO³ antacids. Take 2 hrs before or 6 hrs after other medications (e.g., cation-containing antacids or laxatives, sucralfate, oral iron or calcium supplements, multivitamins with minerals) containing polyvalent cations (e.g. Mg, Al, Fe, Ca).
  • Adverse effects: diarrhea, nausea, headache, and pyrexia; ↑ ALT, AST, creatine phosphokinase; myopathy and rhabdomyolysis have been reported, rare severe skin reactions (SJS/TEN) and systemic hypersensitivity reaction with rash, and constitutional symptoms +/- hepatitis

Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC, Truvada)

• Usual Adult Dosage Forms: TDF 300mg /FTC 200 mg tab
• Important Points:
  • Take with or without food
  • Abrupt withdrawal can cause chronic active HBV flares
  • Do not use for PEP in pts with estimated CrCL < 60 mL/min
  • Adverse effects: flatulence, headache, renal insufficiency, Fanconi Syndrome (rare), ↓ PO4, ↑ pigmentation of palms/soles (> in black and Hispanic pts)

Clinical Consultation Center

National HIV Clinician Consultation Center

Visit nccc.ucsf.edu for additional details including online resources, phone numbers and hours of operation.

Clinical consultation topics:

• HIV/AIDS Management
• Perinatal HIV/AIDS
• Hepatitis C Management
• Substance Use Management
• PrEP: Pre-Exposure Prophylaxis
• PEP: Post-Exposure Prophylaxis

Report Adverse Events and Pregnancy Exposures

FDA MedWatch:

Report unusual or severe toxicity to antiretrovirals
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
800.FDA.1088 (332.1088)

Antiretroviral Pregnancy Registry:

A voluntary prospective, exposure-registration, observational study designed to collect and evaluate data on the outcomes of pregnancy exposures to antiretroviral products.
www.apregistry.com
800.258.4263