What are the guidelines for Pre-Exposure Prophylaxis (PrEP) initiation?

Guidelines for Pre-Exposure Prophylaxis (PrEP) Initiation

PrEP should be initiated for individuals at high risk of HIV infection, including men who have sex with men (MSM), transgender women (TGW), heterosexual serodiscordant couples, people who inject drugs, and at-risk heterosexual men and women, using daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as the standard regimen. 1

Populations Recommended for PrEP

• Strong recommendation with high-quality evidence for:

  • Men who have sex with men (MSM) and transgender women (TGW) 1
  • Heterosexual serodiscordant couples (where one partner is HIV-positive) 1

• Weak recommendation with high-quality evidence for:

  • People who inject drugs (PWID) 1

• Weak recommendation with moderate-quality evidence for:

  • At-risk heterosexual men and women 1

Risk Assessment Criteria

• For MSM and TGW, consider PrEP if there has been at least one episode of condomless anal intercourse (regardless of insertion or reception) in the past six months 1

• For all populations, PrEP should be prioritized for individuals in communities with HIV incidence of three per 100 person-years or higher 1

• Daily dosing is especially important for women, as tenofovir concentrates at 10-fold lower levels in vaginal tissue than in rectal tissue 2

Pre-Initiation Testing Requirements

• HIV testing (preferably using rapid antibody or rapid antigen-antibody test) to confirm HIV-negative status 1, 2

• Serum creatinine level to assess renal function 2

• Hepatitis B surface antigen and hepatitis C IgG antibody testing 2

• Genital and non-genital testing for sexually transmitted infections (STIs) 2

• Pregnancy testing for individuals of childbearing potential 2

PrEP Regimens

• Standard daily regimen: TDF 300mg/FTC 200mg taken orally once daily 1, 2

• Event-driven regimen (for MSM and likely TGW only): High-quality evidence supports this dosing strategy for these specific populations 1

Monitoring and Follow-up

• PrEP prescriptions should not exceed 90 days without interval testing for HIV infection 2

• Quarterly monitoring should include:

  • HIV antibody and antigen testing 2
  • Estimated creatinine clearance rate 2
  • STI testing (gonorrhea, chlamydia, syphilis) 2
  • Pregnancy testing when applicable 2

Important Considerations

• PrEP is most effective when combined with other prevention strategies, including risk-reduction counseling and consistent condom use 3

• Unlike condoms, PrEP does not prevent other sexually transmitted infections 2

• Regular adherence monitoring is critical for maintaining efficacy, particularly for women who require consistent daily dosing due to pharmacokinetic differences in tissue drug concentrations 2, 4

• For individuals with ongoing risk, consider PrEP as part of a comprehensive prevention approach that includes regular HIV testing and risk reduction counseling 5, 3

Potential Side Effects to Monitor

• Gastrointestinal effects (mild to moderate nausea, vomiting, diarrhea) are most common 4

• Regular monitoring of liver enzymes, renal function, and bone mineral density is recommended 4

• Overall, PrEP has demonstrated a favorable safety profile in clinical trials, with most side effects being mild and transient 4, 6