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FDA: PrEP indication updated to include adolescents at risk of HIV infection

  • inconsistent or no condom use.
  • diagnosis of sexually transmitted infections.
  • exchange of sex for commodities (such as money, food, shelter, or drugs).
  • use of illicit drugs or alcohol dependence.
  • incarceration.
  • partner(s) of unknown HIV-1 status with any of the factors listed above.

Dosage and administration

2.1 Testing prior to initiation of Truvada for treatment of HIV-1 infection or for HIV-1 PrEP

Prior to or when initiating Truvada, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].

Prior to initiation and during use of Truvada, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus