What are the steps to start PrEP for HIV prevention?

How to Start PrEP for HIV Prevention

Initiate PrEP as soon as feasible once the patient has chosen to use it, after confirming HIV-negative status with combined antibody/antigen testing. 1

Step 1: Confirm Eligibility and HIV-Negative Status

• Perform combined HIV antibody and antigen testing to confirm HIV-negative status before prescribing any PrEP medication 1
• If the test was performed within 7 days of the visit and is negative, PrEP can be initiated same-day 1
• If no recent test is available, perform a rapid point-of-care test at the visit and start PrEP only if negative; however, also send a laboratory-based combined antibody/antigen test 1
• If acute HIV infection is suspected (fever, headache, muscle soreness, sore throat, rash, swollen lymph nodes), perform HIV RNA testing and withhold PrEP until results confirm negative status 1
• Confirm the patient is 18 years or older (current FDA approval age) 1

Step 2: Complete Baseline Laboratory Testing

Before initiating PrEP, obtain the following tests (though they need not delay same-day initiation): 1

• Serum creatinine and estimated creatinine clearance 1
• Hepatitis B surface antigen (HBsAg) 1
• Hepatitis C antibody (test annually thereafter, or every 3-6 months for people who inject drugs or MSM who use drugs during sex) 1
• Hepatitis A antibody for MSM and people who inject drugs if not known to be immune 1
• Genital and nongenital STI testing (gonorrhea and chlamydia by NAAT, syphilis serology) 1
• Pregnancy test for women and assess pregnancy plans 1

Step 3: Assess Medical History and Contraindications

• Obtain complete medical history including chronic kidney disease, osteoporosis/osteopenia, viral hepatitis, and STI history 1
• TDF-based PrEP is contraindicated if creatinine clearance is below 60 mL/min 1, 2
• TDF-based PrEP is not recommended for patients with pre-existing osteopenia or osteoporosis 3
• Assess for substance use (methamphetamine, GHB/GBL) 1
• Review co-medications for potential drug-drug interactions 1

Step 4: Provide Comprehensive Counseling

The Centers for Disease Control and Prevention requires that counseling must emphasize: 4

• Adherence to daily medication is the single most critical factor determining PrEP efficacy 4
• PrEP is not 100% effective against HIV infection 1, 4
• PrEP does not prevent other STIs; condoms and risk-reduction counseling remain essential 1, 4
• Patients must return for HIV testing every 2-3 months while on PrEP 4
• For women: determine pregnancy status and plans at every visit 4

Step 5: Select and Prescribe PrEP Regimen

For Most Patients:

• Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) once daily is the recommended first-line oral PrEP 1

For MSM Specifically:

• Start with a double dose (2 tablets) on the first day, then one tablet daily 1
• On-demand (2-1-1) dosing is an alternative: 2 tablets 2-24 hours before sex, then 1 tablet at 24 hours after the first dose, then 1 tablet at 48 hours after the first dose, continuing until 48 hours after last intercourse 1

For MSM with Kidney Dysfunction, Osteopenia, or Osteoporosis:

• Tenofovir alafenamide/emtricitabine (TAF/FTC) daily is recommended instead of TDF/FTC 1, 3

Prescribing Details:

• Prescribe no more than 30 days initially, then 90-day supplies thereafter 1
• Never prescribe more than 90 days without interval HIV testing 1

Step 6: Schedule Follow-Up Monitoring

At 1 Month After Initiation:

• Combined HIV antibody and antigen test 1
• Assess adverse effects and support adherence 1

Every 3 Months (Quarterly):

• Combined HIV antibody and antigen test (mandatory) 1
• STI screening (gonorrhea, chlamydia, syphilis) 1
• Assess risk behaviors, adherence, and willingness to continue PrEP 1

Renal Monitoring:

• Calculate creatinine clearance at first quarterly visit, then annually 1
• For patients over age 50, with baseline creatinine clearance <90 mL/min, or with diabetes/hypertension, monitor every 3-6 months 1

Hepatitis C Monitoring:

• Test annually (or every 3-6 months for high-risk individuals) 1

Special Circumstances

Recent High-Risk Exposure (Within 72 Hours):

• Prescribe 3-drug PEP for 28 days, then transition seamlessly to 2-drug PrEP 1
• Perform combined HIV antibody/antigen testing and HIV RNA testing at conclusion of PEP 1

Exposure Reported >72 Hours Ago:

• Initiate PrEP immediately according to standard protocol 1

Common Pitfalls to Avoid

• Never initiate PrEP without confirming HIV-negative status 4
• Do not prescribe TDF-based PrEP if creatinine clearance is <60 mL/min 1, 2, 4
• Do not prescribe TDF-based PrEP to patients with pre-existing osteoporosis or osteopenia without considering TAF/FTC alternative 3
• Do not delay PrEP initiation for baseline lab results if HIV testing is negative and no acute HIV symptoms are present 1, 4
• Do not prescribe more than 90 days without confirming continued HIV-negative status 1, 4
• Do not use TDF/lamivudine, TAF/emtricitabine alone, or TDF alone for PrEP (only TDF/FTC or TAF/FTC are approved) 1