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Monitoring patients during administration of oral pre-exposure prophylaxis (PrEP) against HIV

Monitoring patients during administration of oral pre-exposure prophylaxis (PrEP) against HIV
One month after starting PrEP:
  • Evaluate and support PrEP medication adherence*
  • Assess risk behaviors and provide risk-reduction counseling and condoms
  • Evaluate for side effects
Three months after starting PrEP:
  • Evaluate and support PrEP medication adherence*
  • Perform an HIV test
  • Assess risk behaviors and provide risk-reduction counseling and condoms
  • Check serum creatinine in all patientsΔ
  • Test for STIs among individuals with high-risk sexual behaviors, even if patient is asymptomatic
  • Assess pregnancy status for patients who could become pregnant§
Every three months thereafter:¥
  • Evaluate and support PrEP medication adherence*
  • Perform an HIV test
  • Assess risk behaviors and provide risk-reduction counseling and condoms
  • Monitor creatinine in patients at risk for renal disease,Δ all others should have creatinine checked every six months
  • Test for STIs among individuals with high-risk sexual behaviors, even if patient is asymptomatic
  • Assess pregnancy status for patients who could become pregnant§
On discontinuing PrEP†,** (at patient request, for safety concerns):
  • Perform HIV test(s) to determine whether HIV infection has occurred¶,¶¶
  • If the patient has chronic HBV infection, the decision to switch to an alternative agent or to monitor for HBV flare should be discussed with a provider experienced in the management of HBV
This table addresses monitoring in patients receiving oral PrEP. Detailed information on monitoring persons receiving injectable cabotegravir for PrEP can be found on the CDC website.

FTC: emtricitabine; HBV: hepatitis B virus; HCV: hepatitis C virus; HIV: human immunodeficiency virus; MSM: men who have sex with men; PrEP: pre-exposure prophylaxis; STI: sexually transmitted infection; TDF: tenofovir disoproxil fumarate.

* Adherence should be assessed at each follow-up visit, and more often if inconsistent adherence is identified.

¶ Patients should have plasma HIV testing, preferably with a fourth generation antigen/antibody test. Additional testing for HIV RNA may be needed if the patient has signs or symptoms suggestive of acute HIV infection, or has an indeterminate antigen/antibody test. If HIV-positive, order and document results of resistance testing and establish immediate linkage to HIV care. Dual therapy with TDF-FTC should not be continued. Refer to the topics that discuss acute HIV infection for more information on the clinical manifestations and diagnosis of acute HIV.

Δ Discontinue PrEP if estimated glomerular filtration rate <60 mL/minute/1.73 m2, or if there is evidence of moderate or severe proximal tubular dysfunction or Fanconi syndrome. Refer to the topic that discusses administration of PrEP for an approach to patients who develop worsening renal function on TDF-FTC.

◊ STI screening should include serum testing for syphilis and screening for gonorrhea and chlamydia at mucosal sites with potential exposures (eg, throat, rectum, urogenital). Refer to the topic that discusses screening for STIs within UpToDate.

§ PrEP can be used in pregnancy after an informed decision is made. Refer to the topic that discusses how to identify candidates for PrEP for a more detailed discussion of PrEP during pregnancy.

¥ In addition to the routine monitoring that is performed at three-month intervals, HCV testing should be performed every 6 to 12 months in people who inject drugs and MSM who engage in high-risk behaviors.

‡ Risk factors for renal disease include hypertension, diabetes, proteinuria, and prior history of renal insufficiency. For such patients, we obtain a urinalysis every six months in addition to monitoring the creatinine. More frequent monitoring may be required for those who develop abnormal findings.

† We generally continue PrEP for one month after the last high-risk exposure, unless PrEP is being discontinued because of toxicity.

** Some patients may discontinue PrEP temporarily. It is important that clinicians educate patients to reinitiate PrEP before they begin to engage in high-risk behaviors. When a patient wishes to resume PrEP, we repeat the same evaluation as in those who are initiating PrEP for the first time.

¶¶ If HIV-negative, establish linkage to risk-reduction support services as indicated.
References:
  1. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2017 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf (Accessed on March 12, 2019).
  2. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2018 Recommendations of the International Antiviral Society-USA Panel. JAMA 2018; 320:379.
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