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:
Confirm HIV-negative status at least every 3 MONTHS and upon diagnosis of an STI1
Screen for STIs in appropriate anatomical sites every 3 MONTHS2
Asymptomatic STIs may go undiagnosed without routine screening
During follow-up visits with individuals using DESCOVY FOR PrEP1:
- Reassess HIV risk.
- Counsel individuals on the importance of adherence to daily dosing and safer sex practices to reduce the risk of STIs.
- Monitor renal function: Assess serum creatinine, estimated CrCl, urine glucose, and urine protein on a clinically appropriate schedule.
