INDICATION & LIMITATION OF USE

DESCOVY® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use: DESCOVY FOR PrEP® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Please see below for Important Safety Information for DESCOVY.

Initiating PrEP: Get started with DESCOVY®

Implementation fits within the paradigm of preventive health in primary care

Before starting DESCOVY FOR PrEP®

Screen for HIV and HBV1

  • DESCOVY FOR PrEP must be prescribed only to individuals confirmed to be HIV negative
  • Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1
  • Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present, unless negative HIV status is confirmed by a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection
  • If screening or symptoms consistent with acute HIV-1 infection indicate an individual may have become HIV-positive while taking DESCOVY FOR PrEP, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Test and monitor for chronic HBV and, if negative, consider vaccination

Counsel individuals on the importance of daily dosing1

  • Individuals should strictly adhere to the recommended DESCOVY FOR PrEP dosing schedule
  • The effectiveness of DESCOVY FOR PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence
  • Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Confirm estimated CrCl is ≥30 mL/min1

  • DESCOVY FOR PrEP is not recommended in individuals with CrCl <30 mL/min
  • Assess serum creatinine, estimated CrCl, urine glucose, and urine protein prior to or when initiating
  • In individuals with chronic kidney disease, assess serum phosphorus

Prescribe DESCOVY FOR PrEP to individuals at risk of HIV, as appropriate, as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).

Continuing DESCOVY and follow-up visits

Here’s a brief overview of what you need to do during follow-up visits for appropriate individuals continuing on DESCOVY FOR PrEP:

Consider starting DESCOVY FOR PrEP, as appropriate.

CrCl=creatinine clearance; FDA=US Food and Drug Administration; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; HBV=hepatitis B virus; STI=sexually transmitted infection.