HIV Pre-Exposure Prophylaxis (PrEP) Recommendations
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is the recommended oral PrEP regimen for all populations at risk for HIV infection, with specific dosing strategies tailored to different risk groups. 1, 2
First-Line PrEP Options by Population
For Men Who Have Sex with Men (MSM):
- Daily oral TDF/FTC (Truvada) is recommended with a double dose (2 tablets) on the first day to achieve faster protective drug levels 1, 2
- The 2-1-1 (on-demand) dosing schedule is an effective alternative to daily dosing specifically for MSM 1, 2
- This requires a double dose 2-24 hours before sexual activity, followed by single doses 24 and 48 hours after the first dose 1
- For MSM with kidney dysfunction (creatinine clearance 30-60 mL/min), osteopenia, or osteoporosis, daily tenofovir alafenamide/emtricitabine (TAF/FTC, Descovy) is recommended 1, 3
For Women and Heterosexual Men:
- Daily TDF/FTC is recommended with no loading dose 4, 2
- Daily dosing is critical for women as tenofovir concentrates at 10-fold lower levels in vaginal tissue than in rectal tissue 4
- On-demand (2-1-1) dosing is NOT recommended for women due to inadequate drug concentrations in vaginal tissues 4, 3
- TAF/FTC (Descovy) is NOT currently recommended for cisgender women or prevention of HIV-1 infection from receptive vaginal sex 3
For People Who Inject Drugs:
- Daily TDF/FTC is recommended 2
- Additional harm reduction interventions such as opioid substitution therapy and needle exchange services should be used when available 1
Pre-Initiation Assessment
Before starting PrEP, the following tests are essential 1, 2:
- Combined HIV antibody and antigen testing (with HIV RNA testing if acute infection is suspected)
- Serum creatinine level and estimated creatinine clearance
- Hepatitis B surface antigen
- Hepatitis C IgG antibody
- Genital and non-genital testing for sexually transmitted infections (gonorrhea, chlamydia)
- Pregnancy testing for individuals of childbearing potential 4
Monitoring During PrEP Use
Regular monitoring should include 1, 4, 2:
- HIV testing at 1 month after initiation and every 3 months thereafter
- STI screening every 3 months
- Creatinine assessment at first quarterly visit and annually thereafter (more frequent for those with risk factors for kidney disease)
- Pregnancy testing as needed for individuals of childbearing potential
Important Clinical Considerations
- PrEP prescriptions should not exceed 90 days without interval testing for HIV infection 4
- PrEP does not prevent other sexually transmitted infections; condoms are still recommended 1, 4
- Adherence is crucial for effectiveness - daily dosing is particularly important for women 4, 5
- Acute HIV infection must be ruled out before initiating PrEP to prevent development of drug resistance 2, 6
- For patients with chronic hepatitis B, discontinuation of PrEP may cause hepatitis flares 2
- Injectable cabotegravir every 8 weeks is a newer option for cisgender men and transgender women who have sex with men, pending wider regulatory approval and availability 1, 2
Population-Specific Efficacy Data
- TDF/FTC has demonstrated efficacy across multiple populations when used as prescribed:
- TAF/FTC has demonstrated non-inferior efficacy to TDF/FTC for HIV prevention in MSM and transgender women, with more favorable effects on bone mineral density and renal safety 8, 9
PrEP is a highly effective HIV prevention strategy when prescribed appropriately and taken consistently, with options that can be tailored to specific populations and individual risk factors.