CDC PrEP recommendations

PrEP is short for pre-exposure prophylaxis. PrEP is used by people without HIV who are at risk of being exposed to HIV through sexual contact or injection drug use. Two medications have been approved for use as PrEP by the FDA. Each consists of two drugs combined in a single oral tablet taken daily:

• Emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (F/TDF – brand name Truvada®)
• Emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (F/TAF – brand name Descovy®)

These medications are approved to prevent HIV infection in adults and adolescents weighing at least 35 kg (77 lb) as follows:

• Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all persons at risk through sex or injection drug use.
• Daily oral PrEP with F/TAF is recommended to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex. F/TAF has not yet been studied for HIV prevention for receptive vaginal sex.

Indications

PrEP is indicated for people at risk for acquiring HIV:

• Sexually active gay and bisexual men without HIV
• Sexually active heterosexual men and women without HIV
• Sexually active transgender persons without HIV
• Persons without HIV who inject drugs
• Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report continued risk behavior, or who have used multiple courses of PEP

Contraindications for PrEP

• People with HIV. Individuals must be confirmed as HIV-negative before initiating PrEP. Excluding persons with acute HIV infection is critically important, as there is a risk of developing resistant HIV if they are inadvertently started on PrEP. F/TDF and F/TAF are appropriate components of a regimen to treat HIV but must be combined with additional antiretrovirals to provide effective treatment.
• People with renal insufficiency. Providers should confirm that the patient’s estimated creatinine clearance is ≥60 mL/minute (Cockcroft-Gault formula) before initiating F/TDF as PrEP, or ≥30 mL/minute before initiating F/TAF as PrEP.

Efficacy of PrEP

HIV testing is required

It is necessary to confirm that patients do not have HIV infection when they start taking PrEP.  While antigen/antibody tests are preferred, at a minimum, clinicians should document a negative antibody test result within the week before initiating (or re-initiating) PrEP medications. The required HIV testing can be accomplished by (1) drawing blood and sending the specimen to a laboratory for testing or (2) performing a rapid, point-of-care FDA-approved fingerstick blood test. Oral rapid tests should not be used to screen for HIV infection when considering PrEP use because they can be less sensitive than blood tests.[12] A listing of FDA-approved HIV tests, specimen requirements, and time to detection of HIV infection are available online at: www.cdc.gov/hiv/testing/laboratorytests.html