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Routine monitoring for patients on a stable PrEP regimen*

Routine monitoring for patients on a stable PrEP regimen*
What to monitor Frequency for patients receiving TDF-FTC or TAF-FTC Frequency for patients receiving cabotegravir LA
  • Perform an HIV test
Every 3 months Every 2 months
  • Evaluate and support PrEP medication adherence
Every 3 months Every 2 months
  • Assess for side effects
Every 3 months Every 2 months
  • Assess risk behaviors and provide risk-reduction counseling and condoms
Every 3 months Every 2 months
  • Assess pregnancy status for patients who could become pregnantΔ
Every 3 months Every 2 months
  • Test for STIs among individuals with high-risk sexual behaviors, even if patient is asymptomatic

MSM and transgender women: Every 3 months

All others: Every 6 months

MSM and transgender women: Every 4 months

All others: Every 6 months
  • Serum creatinine

Persons at risk for renal disease§¥: Every 6 months

All others: Every 12 months
Routine monitoring not needed
  • HCV testing
MSM, transgender women, persons who inject drugs: Every 12 months MSM, transgender women, persons who inject drugs: Every 12 months
  • Lipids and weight
Persons on TAF-FTC: Every 12 months Routine monitoring not needed
This table addresses routine monitoring in patients on a stable PrEP regimen. Additional information on monitoring (eg, the first month after antiviral therapy is started, when therapy is discontinued) and management of adverse outcomes are discussed in the UpToDate topic review on PrEP.

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

* For persons who are asymptomatic, routine monitoring can occur in conjunction with scheduled follow-up visits. Additional monitoring should be performed if there are specific concerns (eg, inconsistent adherence is identified, person has signs or symptoms of an STI or acute HIV infection).

¶ Patients receiving oral PrEP should have plasma HIV testing with a fourth-generation antigen/antibody test. We obtain RNA testing if the patient has signs or symptoms suggestive of acute HIV infection or has an indeterminate antigen/antibody test, although some experts recommend HIV RNA testing for monitoring all patients on oral PrEP.

For patients receiving cabotegravir LA, our approach is generally consistent with the United States Centers for Disease Control and Prevention (CDC), which recommends that HIV RNA testing be performed in addition to an antigen/antibody test to monitor for HIV. However, this many not always be feasible (eg, due to cost or availability). In these settings, an antigen/antibody test alone is reasonable for those who have not missed doses and are without evidence of acute HIV infection. If testing is consistent with new HIV infection, clinicians should order and document results of resistance testing and establish immediate linkage to HIV care. PrEP regimens are not sufficient for treatment of HIV.

Δ Oral PrEP can be used in pregnancy after an informed decision is made. Refer to the UpToDate topic that discusses PrEP for information on regimen selection.

◊ 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.

§ Discontinue oral PrEP if there is evidence of moderate or severe proximal tubular dysfunction or Fanconi syndrome. In other settings the approach must be individualized. As an example, TDF-FTC should be discontinued in persons whose estimated glomerular filtration rate falls below 60 mL/minute/1.73 m2 but switching to TAF-FTC or cabotegravir LA may be reasonable.

¥ The United States CDC states risk factors for renal disease include age 50 and older and/or having an estimated creatinine clearance <90 mL/minute. We also consider hypertension, diabetes, proteinuria, and prior history of renal insufficiency as risk factors for renal disease. 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.
Reference:
  1. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Centers for Disease Control and Prevention. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf (Accessed on August 26, 2022).
  2. Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the International Antiviral Society-USA Panel. JAMA 2023; 329:63.
  3. Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach. World Health Organization 2021. https://www.who.int/publications/i/item/9789240031593 (Accessed on May 24, 2022).
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