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Indications
Clinicians should recommend PrEP for individuals, including adolescents, who do not have but are at risk of acquiring HIV. (A1) Clinicians should prescribe PrEP for any individual who self-identifies as being at risk of acquiring HIV. (A*) For patients who are completing a course of nPEP and remain at risk for HIV, clinicians should recommend initiation of PrEP immediately after completion of nPEP. (A3)
Contraindications to PrEP
Clinicians should not prescribe oral or injectable PrEP for any patient with a documented HIV diagnosis; none of the available PrEP regimens are adequate ART regimens for HIV treatment. (A1) Clinicians should recommend or refer individuals with confirmed HIV for immediate initiation of a fully suppressive ART regimen. (A1) Clinicians should not initiate TDF/FTC as PrEP for any individual with a confirmed CrCl <60 mL/min and should discontinue it in patients with a confirmed CrCl <50 mL/min; in such cases, TDF/FTC as PrEP is contraindicated. (A1) Clinicians should not prescribe TAF/FTC as PrEP for any individual with a confirmed CrCl <30 mL/min; in such cases, TAF/FTC as PrEP is contraindicated. (A1)
Choice of Regimen
Clinicians should engage in shared decision-making with PrEP candidates to identify an optimal and safe regimen and dosing strategy based on patient preference, clinical considerations, and individual patient factors. (A3) If daily dosing is a barrier to adherence or if episodic dosing is preferred, clinicians should inform candidates about dosing and adherence requirements for available PrEP regimens and engage them in informed, shared decision-making regarding the choice of regimen. (A3)
TDF/FTC
TAF/FTC
Clinicians should recommend TAF/FTC as the preferred oral PrEP regimen for cisgender MSM and transgender women with preexisting renal disease or osteoporosis. (A1) Clinicians should not recommend TAF/FTC for protection against HIV exposure through receptive vaginal sex. (A1)
Patients With HBV Infection
Clinicians should discuss daily TDF/FTC or TAF/FTC as the preferred regimens for patients with HBV infection who require treatment. (A2†) Clinicians should closely monitor patients with chronic HBV infection for a potential viral rebound when PrEP with TDF/FTC or TAF/FTC is discontinued and develop an alternative treatment plan if necessary. (A2)
CAB LA
Clinicians should recommend CAB LA as a preferred PrEP regimen for protection against HIV through sexual exposure for individuals who are willing to receive regular IM injections and have no contraindications or barriers to its use. (A1) An oral CAB lead-in is optional before initiation of CAB LA injections; if challenges to adhering to daily oral medication have been identified, clinicians should engage patients in shared decision-making to weigh the risk of HIV acquisition against the benefit of an oral CAB lead-in. (A3) If a patient at ongoing risk of HIV acquisition discontinues CAB LA injections, the clinician should recommend an oral PrEP regimen to be started 2 months after the last injection and continued for at least 1 year to prevent potential acquisition of INSTI-resistant HIV. (A3) Given the current lack of safety data on CAB LA during pregnancy, clinicians should engage pregnant patients and those planning to conceive in shared decision-making regarding the options of continuing CAB LA or switching to daily oral TDF/FTC. (A3)
Laboratory Testing Before PrEP Initiation
Before prescribing PrEP, clinicians should assess all candidates for:
Clinicians should perform baseline laboratory testing as recommended in . Clinicians should recommend same-day PrEP initiation pending laboratory test results in candidates for whom there are no signs or symptoms of acute HIV infection, no history of renal disease, and no concern for HIV exposure in the previous 72 hours requiring PEP. (A2) For same-day initiation of PrEP, clinicians should obtain a rapid HIV test and order a laboratory-based HIV-1/2 Ag/Ab combination immunoassay and an HIV RNA test for all candidates (A3) and ensure that HIV test results are available and acted upon within 7 days of initiation. (A3)
If same-day initiation is not an option, clinicians should repeat lab-based HIV-1/2 Ag/Ab and HIV RNA testing if more than 1 week has lapsed since HIV testing was performed (A3) and should ensure that the HIV test results are available and acted upon within 7 days of initiation. (A3) If a patient has been exposed to HIV within the previous 72 hours, the clinician should recommend PEP before PrEP (A1). Clinicians should not wait to initiate PrEP in individuals who may be in the window period for seroconversion when an HIV test cannot detect infection; doing so risks additional exposures and significant delays in PrEP (A*). If a patient has a positive HIV test result within 1 week after oral PrEP initiation, the clinician should intensify the PrEP regimen to fully suppressive ART and refer the patient to an experienced HIV care provider for ongoing care. (A3) If a patient has a positive HIV test result after receiving the first CAB LA injection, the clinician should consult with an experienced HIV care provider to identify the best strategy for ART intensification. (A1) To consult an expert, call the NYSDOH AI CEI Line at 1-866-637-2342. Clinicians should repeat HIV testing 1 month after PrEP initiation in patients who report a risk exposure in the 30 days before initiation of PrEP. (A2†)
HIV Testing
For any patient who reports an exposure to HIV that occurred in the 30 days before PrEP initiation, clinicians should repeat HIV testing 30 days after the patient starts PrEP. (A2†) Clinicians should perform an FDA-approved plasma or serum HIV-1/2 Ag/Ab combination immunoassay every 3 months in patients taking oral PrEP. (A3) Clinicians should perform an HIV-1/2 Ag/Ab combination immunoassay and HIV RNA test in patients who report missing PrEP doses during times of sexual activity and possible HIV exposure. (A3) For patients receiving CAB LA, clinicians should perform an HIV-1/2 Ag/Ab combination immunoassay and HIV RNA test at every injection visit; if the patient completed an oral CAB lead-in, the clinician should perform an HIV-1/2 Ag/Ab combination immunoassay and HIV RNA test upon completion. (A2) Regardless of the PrEP regimen used, clinicians should perform an HIV-1/2 Ag/Ab combination immunoassay and HIV RNA test whenever there has been an interruption in PrEP of >1 week with a risk of exposure during that time off PrEP. (A3)
Renal Function Testing
Clinicians should perform renal function testing (serum creatinine level and calculated CrCl) as recommended in . Clinicians should discontinue daily TDF/FTC as PrEP if a patient develops a confirmed CrCl <50 mL/min and consider alternative options; see discussion in text for options for patients with reduced renal function. (A3) Clinicians should discontinue TAF/FTC as PrEP if a patient develops a confirmed calculated CrCl <30 mL/min. (A3) Clinicians should perform urinalysis at baseline and annually to assess urine glucose and protein in patients taking tenofovir-based oral PrEP. (B3)
STI Screening
At every visit, a care team member should assess patients for signs and symptoms of STIs, including syphilis and gonococcal and chlamydial infections, as part of a sexual history, perform testing as indicated, and treat STIs empirically based on symptoms while test results are pending. (A2†) Clinicians should perform routine STI screening as recommended in .
HCV Screening
Pregnancy Screening
Suspected Acute HIV
For patients with any symptoms of acute retroviral illness and for whom acute HIV is suspected, clinicians should perform a plasma HIV RNA test in conjunction with a laboratory-based HIV-1/2 Ag/Ab combination immunoassay. (A2)
In the case of a reactive HIV-1/2 Ag/Ab combination immunoassay result and an HIV RNA test result that indicates the virus at any level, a diagnosis of HIV can be made, and the clinician should initiate treatment. (A1) In the case of a nonreactive HIV-1/2 Ag/Ab combination immunoassay result and an HIV RNA level ≥200 copies/mL, the clinician can make a presumptive diagnosis of acute HIV infection and should proceed with treatment as outlined below. (A3) Clinicians should inform patients with suspected acute HIV about the increased risk of transmitting HIV during acute HIV infection and advise them to refrain from sexual activity or use condoms to minimize the risk of transmitting HIV to a partner without HIV until acute infection is ruled out. (A2)
Asymptomatic Patients With a Reactive HIV Screening Test Result While Using PrEP
Clinicians should assess for dosing interruption of any duration and identify any access or adherence barriers (A3); potential risk exposures since the previous HIV test (A*); and signs and symptoms of acute HIV since the last visit (A2). If supplemental laboratory testing confirms HIV, the clinician should perform quantitative HIV RNA testing (if not already obtained) to measure viral load, order ART initiation laboratory testing, perform genotypic resistance testing, and initiate ART as outlined below. (A2)
Ambiguous HIV Test Results
TDF/FTC, TAF/FTC, or CAB LA used as PrEP may alter viral load and immune response and cause ambiguous HIV test results when following the current CDC/APHL HIV testing algorithm.
Clinicians should consider a reactive HIV-1/2 Ag/Ab combination immunoassay result with a positive qualitative HIV RNA or a quantitative HIV RNA of any level a positive HIV test result. (A2) In the case of an ambiguous HIV test results (a reactive HIV-1/2 Ag/Ab combination immunoassay result and a negative HIV RNA test result, or a nonreactive HIV-1/2 Ag/Ab combination immunoassay result and an HIV RNA level <200 copies/mL), the clinician should repeat HIV diagnostic testing to either exclude a false-positive result or identify a true-positive result with a blunted viral response due to the presence of antiretroviral agents as PrEP. (A3) In the case of continued ambiguous HIV test results, the clinician should continue PrEP or intensify to a fully suppressive ART regimen, and consult with an experienced HIV and PrEP care provider for guidance on appropriate next steps. (A3) To consult an expert, call the NYSDOH AI CEI Line at 1-866-637-2342.
ART Selection for a Positive or Ambiguous HIV Test Result
For patients taking TDF/FTC or TAF/FTC as PrEP, clinicians should add a third antiretroviral agent with a high resistance barrier, such as DRV/COBI, DTG, or BIC (available as TAF/FTC/BIC) while awaiting resistance test results. (A2) For patients receiving CAB LA, clinicians should initiate ART with a non–INSTI-based regimen while awaiting resistance test results. (A2)
Discontinuing PrEP
Clinicians should discontinue PrEP in any patient with a confirmed positive HIV test result (see recommendations in guideline section Managing a Positive HIV Test Result). (A1) Clinicians should discontinue PrEP if a patient does not adhere to HIV testing requirements despite repeated efforts at engagement in care. (A3) Clinicians should discontinue TDF/FTC as PrEP in patients who develop a confirmed calculated CrCl <50 mL/min. (A2) For patients who develop kidney dysfunction and must discontinue TDF/FTC but wish to continue with PrEP, clinicians should switch their regimen to CAB LA or to TAF/FTC if CrCl is ≥30 mL/min (for MSM and transgender women only). (A3) Clinicians should closely monitor patients with chronic HBV infection for a potential viral rebound when PrEP with TDF/FTC or TAF/FTC is discontinued and develop an alternative treatment plan if necessary. (A2)
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