What is the recommended regimen for prescribing Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV)?

Recommended Regimen for HIV Pre-Exposure Prophylaxis (PrEP)

Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) once daily is the recommended oral PrEP regimen for all populations at risk of HIV infection. 1

Patient Selection for PrEP

PrEP should be discussed with all sexually active adults and adolescents and individuals who inject drugs. High-risk populations who should be offered PrEP include:

• Men who have sex with men (MSM), especially those who do not use condoms
• Transgender individuals
• People from or whose partners are from areas with high HIV prevalence (≥3%)
• Individuals who have traded sex for money, goods, or services
• People with multiple sexual partners
• Individuals with history of sexually transmitted infections (STIs)
• People who have been incarcerated or have partners who have been incarcerated
• Individuals who share injection drug equipment 1

PrEP Regimen Options

Standard Daily Oral PrEP

• First-line regimen: TDF/FTC (Truvada) once daily 1
  • For MSM: Double dose (2 tablets) on first day, then once daily dosing 1
  • For all others: Once daily dosing with maximum protection achieved in approximately 7 days 1

Alternative Regimens

1. For MSM only: 2-1-1 (on-demand) dosing 1

   • Double dose (2 tablets) 2-24 hours before sex
   • Single dose 24 hours after first dose
   • Single dose 24 hours after second dose
   • Continue daily dosing until 48 hours after last sexual contact

2. For MSM with kidney dysfunction: TAF/FTC once daily 1

   • Recommended for MSM with creatinine clearance 30-60 mL/min
   • Also recommended for those with history of osteopenia/osteoporosis

3. Injectable cabotegravir: Administered every 8 weeks (pending regulatory approval) 1

   • For cisgender men and transgender women who have sex with men

Pre-Initiation Evaluation

Before starting PrEP, the following tests are required:

• Combined HIV antibody and antigen testing (HIV RNA if acute HIV suspected) 1
• Serum creatinine level 1
• Hepatitis B surface antigen 1
• Hepatitis C antibody 1
• Hepatitis A antibody (for MSM and people who inject drugs) 1
• STI screening (gonorrhea and chlamydia at all potential exposure sites) 1

Monitoring During PrEP

• At 1 month: HIV antibody/antigen test 1
• Quarterly:
  • HIV antibody/antigen test 1
  • STI screening 1
• Every 6 months:
  • Creatinine level 1
  • More frequent monitoring for patients >50 years or with comorbidities 1

Duration and Discontinuation

• For MSM: Continue TDF/FTC for 2 days after last at-risk exposure 1
• For others: Continue TDF/FTC for 7 days after last at-risk exposure 1

Special Considerations

Pregnancy and Breastfeeding

• Daily TDF/FTC is recommended for at-risk individuals who are pregnant or breastfeeding 1

Hepatitis B Infection

• Careful monitoring of HBV infection and liver function is recommended after discontinuation of TDF/FTC in patients with active HBV infection 1
• Discontinuation could lead to acute HBV flares or hepatic decompensation 1

Common Pitfalls to Avoid

1. Starting PrEP in patients with undiagnosed HIV infection

   • Always confirm HIV-negative status before initiating PrEP 1
   • Use HIV RNA testing if acute infection is suspected 1

2. Inadequate adherence monitoring

   • Efficacy is highly dependent on adherence
   • Address barriers to adherence at each visit 1

3. Inappropriate regimen selection

   • TAF/FTC is not recommended for individuals at risk through vaginal sex 1
   • 2-1-1 dosing is only recommended for MSM 1

4. Inadequate STI screening

   • Regular STI screening is essential as PrEP does not prevent other STIs 1

5. Prescribing without regular follow-up

   • PrEP prescriptions should not exceed 90 days without interval HIV testing 1

By following these evidence-based recommendations, healthcare providers can effectively prescribe PrEP to reduce HIV transmission risk while monitoring for safety and efficacy.