Initial Visit, Dosing, and Follow-up image

Initial Visit, Dosing, and Follow-up

Review the latest recommendations with

David Malebranche, MD, MPH and Ariel Watriss, MSN, NP-C

Dr. Malebranche (he/him/his), an internal medicine specialist with expertise in sexual health and HIV/STI prevention and treatment, is a clinician at the AIDS Healthcare Foundation Health Care Center in midtown Atlanta

Ariel Watriss (she/her/hers) is a college health nurse practitioner at Tufts University in Boston, and a renowned sexual health clinician and educator

SUMMARY:

The initial visit for HIV PrEP will establish the start of the patient’s PrEP experience. It is a blend of education, clinical care, and establishing a new health practice for the patient

Initial Visit: What to Include

The initial visit needs to include both a comprehensive history of the patient, their sexual history, eligibility for PrEP as well as laboratory workup prior to initiation

Sexual Health History and Comprehensive Screening

  • A comprehensive sexual health history review and review of eligibility for PrEP includes
    • Gender and number of sexual partners
    • Specific sexual behaviors (oral, vaginal, anal)
    • HIV-status of sexual partners
    • Condom use practices
    • Substance use/abuse screening
    • History of sexually transmitted infections (STI)
  • Confirmation of HIV negative status (see lab tests below)
  • Assessment for acute HIV
    • A patient’s HIV negative status must be confirmed in the context of recent sexual or other possible exposure contexts in the preceding 30 days
    • If there is concern for acute HIV and someone has an initial negative HIV Ag/Ab, that may require HIV RNA testing before initiating PrEP
  • Symptoms of acute HIV may include:
    • Fever
    • Pharyngitis
    • Lymphadenopathy
    • Many other symptoms (diarrhea, headache, flu-like symptoms) or NONE AT ALL
  • Assessment for medical cautions or contraindications include
    • Hepatitis B, renal or hepatic insufficiency
  • Discussion with patients of potential, yet rare side effects, including:
    • Truvada (F/TDF 200mg/300mg): worsening renal function including kidney failure, bone thinning
    • Descovy (F/TAF 200mg/25mg): elevated cholesterol levels, weight gain
  • Other sexual health needs including STI testing or contraception, as needed

Laboratory Tests and Other Diagnostic Procedures

Initiation of Oral PrEP

  • HIV testing | must be performed and results must be negative within one week before starting PrEP to document that patients do not have HIV
    • 4th generation HIV Ag/Ab serologic testing is preferred over either oral/fingerstick rapid Ab or serologic Ab testing
  • Renal function
    • Truvada (F/FTC) | eCrCl should be documented at >60 ml/min prior to starting PrEP
    • Descovy (F/TAF) | eCrCl should be >30 ml/min
  • Hepatitis B surface antigen should be documented negative before initiating PrEP
    • Both medications are active against Hepatitis B
    • If an individual taking HIV PrEP also has chronic active Hepatitis B and suddenly stops PrEP, they could experience a symptomatic acute Hepatitis B flare
    • Exhibit caution and educate patients about this dynamic if they have chronic active Hepatitis B
  • Urine Pregnancy Test (UPT) for individuals who may become pregnant
  • Sexually Transmitted Infection (STI) testing
    • At initial screening and semi-annual visits (or more frequently as per clinical assessment)
    • Gonorrhea and Chlamydia testing
      • Oral, pharyngeal, and anal NAAT for men who have sex with men and transgender women
      • Vaginal NAAT for cis gendered women
    • Syphilis screening
      • Treponemal IgG cascade
      • RPR
  • Hepatitis C antibody screening for PWID and MSM

Initiation of intramuscular PrEP

  • Administration of cabotegravir 600mg via one 3mL intramuscular injection in the gluteal muscle
    • Can consider trial of cabotegravir 30mg daily for four weeks prior to initiation of IM injections if patients are anxious about side effects
  • Initiation of cabotegravir requires a second dose 4 weeks after the first dose (one month follow up visit) and every 8 weeks after with HIV testing at visits
  • Schedule is initial administration (month 0), one month after initiation (month 1), then every 8 weeks afterwards (month 3, 5, 7, etc.)
    • Follow-up visit one month after initial injection should include second dose and HIV Ag/Ab test and HIV-1 RNA assay with subsequent 2-month intervals
  • The following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use:
    • Creatinine or eCrCl
    • hepatitis B serology
    • lipid panels
    • liver function tests

Medication choices and dosing

  • The two current choices for oral PrEP are F/TDF 200/300 (Truvada) and F/TAF 200/25 (Descovy)
    • Only F/TDF (Truvada) is FDA-approved for cis women engaging in vaginal sex
    • Both are FDA-approved for men who have sex with men and transgender women
    • Both are fixed-dose, daily tablets that can be taken with or without food
  • Prescriptions can be written either as 30 days with 2 refills or as a 90-day course depending on insurance coverage allowance
  • Cabotegravir is now FDA-approved, administered at month 0, month 1, then every 2 months (8 weeks) afterwards starting from month 3, 5, 7, etc.

Ongoing monitoring

The current recommendations for ongoing care for oral PrEP include:

  • In-person or telehealth follow up visit every 3 months
  • Prescription refills every 3 months
  • HIV test every 3 months (typically done as part of refill of prescription on the same timeline and can be administered as at-home testing)
  • Renal and hepatic labs every 6 months
  • UPT as indicated
  • STI testing as directed by sexual health review done at each follow up visit.
  • Assessment of sexual and general health needs
  • Review of any new medications and medical updates

Similar recommendations apply to intramuscular PrEP, with timing intervals every 2 months but would not require renal or hepatic lab results at initiation or during follow-up

Learn More – Primary Sources

PrEP Provider Toolkit

ACHA Guidelines: HIV Pre-Exposure Prophylaxis

Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

David Malebranche, MD, MPH serves on the PrEP speakers bureau for Gilead Sciences, Inc 

Ariel Watriss, MSN, NP-C has no relevant financial relationships to disclose