CDC Interim Guidance on PrEP Use
MSM: Following the publication of the iPrEx trial results, CDC published interim clinical guidance for physicians electing to provide PrEP for HIV prevention among MSM in January 2011. CDC guidance stressed the importance of targeting PrEP to MSM at very high risk for HIV acquisition; delivering PrEP as part of a comprehensive set of prevention services; providing counseling regarding risk reduction and the importance of PrEP medication adherence; ensuring MSM who are prescribed PrEP are confirmed to be HIV negative prior to use; and providing regular monitoring of HIV status, side effects, adherence, and risk behaviors.
Heterosexuals: Following the publication of final results from the TDF2 and Partners PrEP trials, in August 2012 CDC published interim guidance to help clinicians safely and effectively provide PrEP for heterosexually-active adults. This guidance included recommendations similar to those for MSM, as well as new recommendations relevant to women who may become pregnant while taking PrEP and to couples in which one partner is HIV-positive and the other is HIV-negative.
CDC is also leading the development of comprehensive U.S. Public Health Service (PHS) guidelines on the use of PrEP for the prevention of sexually-acquired HIV infection. These guidelines will include more detailed recommendations for PrEP use with adults at very high risk for HIV infection, including MSM as well as heterosexually-active men and women. They are being developed in partnership with other PHS agencies and will incorporate input from providers, HIV prevention partners, and affected communities. The guidelines will be updated as information from additional trials and studies about factors affecting efficacy and safety for all transmission risk groups becomes available.
|CDC Interim Guidance on HIV Pre-Exposure Prophylaxis|
Recommendations in black apply to both adult MSM and heterosexually-active men and women; items in blue are specific to heterosexual women.
Before Initiating PrEP
- Document negative HIV antibody test immediately before starting PrEP medication.
- Test for acute HIV infection if patient has symptoms consistent with acute HIV infection or reports unprotected sex with an HIV-positive person in the preceding month.
- Determine if women are planning to become pregnant, are currently pregnant, or are breastfeeding.
- Confirm that patient is at ongoing, very high risk for acquiring HIV infection.
- If any sexual partner is known to be HIV-infected, determine whether receiving antiretroviral therapy; assist with linkage to care if not in care or not receiving antiretroviral therapy.
- Confirm that calculated creatinine clearance is ≥60 mL per minute (Cockcroft-Gault formula).
Other recommended actions:
- Screen for hepatitis B infection; vaccinate against hepatitis B if susceptible, or treat if active infection exists, regardless of decision regarding prescribing PrEP.
- Screen and treat as needed for sexually transmitted infections (STIs).
- Disclose to women that safety for infants exposed during pregnancy is not fully assessed but no harm has been reported.
- Do not prescribe PrEP to women who are breastfeeding.
Beginning PrEP Medication Regimen
- Prescribe tenofovir disoproxil fumarate 300 mg (TDF) plus emtricitabine 200 mg (FTC) (i.e., one Truvada [Gilead Sciences] tablet) daily.
- In general, prescribe no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV-uninfected. For women, ensure that pregnancy test is negative or, if pregnant, that the patient has been informed about use during pregnancy.
- If active hepatitis B infection is diagnosed, consider using TDF/FTC, which may serve as both treatment of active hepatitis B infection and HIV prevention.
- Provide risk-reduction and PrEP medication-adherence counseling and condoms.
Follow-Up While PrEP Medication Is Being Taken
- Every 2-3 months, perform an HIV antibody test (or fourth generation antibody/antigen test) and document negative result.
- At each follow-up visit for women, conduct a pregnancy test and document results; if pregnant, discuss continued use of PrEP with patient and prenatal-care provider.
- Evaluate and support PrEP medication adherence at each follow-up visit, more often if inconsistent adherence is identified.
- Every 2-3 months, assess risk behaviors and provide risk-reduction counseling and condoms. Assess STI symptoms and, if present, test and treat for STIs as needed.
- Every 6 months, test for bacterial STIs even if asymptomatic, and treat as needed.
- Three months after initiation, then every six months while on PrEP medication, check serum creatinine and calculate creatinine clearance.
On Discontinuing PrEP (at Patient Request, for Safety Concerns or If HIV Infection Is Acquired)
- Perform HIV test(s) to confirm whether HIV infection has occurred.
- If HIV positive, order and document results of resistance testing, establish linkage to HIV care.
- If HIV negative, establish linkage to risk reduction support services as indicated.
- If active hepatitis B is diagnosed at initiation of PrEP, consider appropriate medication for continued treatment of hepatitis B infection.
- If pregnant, inform prenatal-care provider of TDF/FTC use in early pregnancy and coordinate care to maintain HIV prevention during pregnancy and breastfeeding.
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