Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

Prior treatment

• Currently using an essential product or medication that interacts with the study drug such as the following:
  • other antiretroviral agent other than F/TDF (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents)
  • agents with known nephrotoxic potential:
  • aminoglycoside antibiotics (including gentamicin)
  • IV amphotericin B
  • cidofovir
  • cisplatin
  • foscarnet
  • IV pentamidine
  • IV vancomycin
  • oral or IV gancyclovir
  • other agents with significant nephrotoxic potential
  • \- drugs that slow renal excretion
  • probenecid
  • \- immune system modulators
  • systemic chemotherapeutic agents (i.e. cancer treatment medications)
  • ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
  • interleukin-2 (IL-2)
  • interferon (alpha, beta, or gamma)
  • \- other agent known to have a significant interaction with TDF, TAF, or FTC
  • the following table includes medications/herbal supplements to be excluded or should be used with caution while participants are taking study drugs due to potential drug-drug interactions with F/TAF.

Other illness

• Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
• Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
  • gastrointestinal condition that would impair absorption of study drugs
  • known condition of reduced bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture
  • neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP
  • tubular or glomerular kidney disease that could be exacerbated by tenofovir
  • other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP
• Suspected sensitivity or allergy to the study drug or any of its components
• Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives

Other

• Unable to give informed consent
• Proteinuria 2+ or greater by urine dipstick
• Pregnancy (if applicable)

• Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth
• Age 18 years or older
• Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF
• Negative for HIV infection
• Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula in the past 30 days