Descovy for PrEP
What lab tests are needed for PrEP?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
DESCOVY for PrEP® (emtricitabine and tenofovir alafenamide)
What lab tests are needed for PrEP?
This information is provided in response to your question. It is not treatment advice on how to use DESCOVY for PrEP. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the DESCOVY Patient Information for more details, including approved use(s) and important warnings. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_patient_pi.pdf
The short answer1
Before you start taking DESCOVY for PrEP you need:
- an HIV-1 test
- a hepatitis B virus, or HBV, test
- a test to check your kidney health.
While you are taking DESCOVY for PrEP, your doctor will need to do the tests in the table below to monitor your health.
What tests should I have? | How often do I need to repeat them? | |
|
and
and
and
| |
| Regularly | |
Kidney health | Regularly | |
Please talk to your doctor for advice on how often you need to repeat these tests.
What is the most important information I should know about DESCOVY for PrEP?1
Some medications have important warnings that are designed to alert you of serious or life-threatening risks that come with taking the medication.
DESCOVY for PrEP has an important warning for: Worsening of hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before or when you start treatment with DESCOVY. If you have HBV infection and take DESCOVY, your HBV may get worse (flare-up) if you stop taking DESCOVY. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
- Do not run out of DESCOVY. Refill your prescription or talk to your healthcare provider before your DESCOVY is all gone.
- Do not stop taking DESCOVY without first talking to your healthcare provider.
- If you stop taking DESCOVY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DESCOVY.
Who is DESCOVY for PrEP for?1
- DESCOVY for PrEP is a once-daily prescription medicine used to reduce the risk of getting HIV-1 infection in adults and teenagers who weigh at least 77 pounds (35 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
- It is not known if DESCOVY for PrEP is effective in reducing the risk of getting HIV-1 from certain types of sex.
- DESCOVY for PrEP is not for use in people born female (assigned female at birth) who are at risk of getting HIV-1 from vaginal sex, because its effectiveness has not been studied.
| You must be HIV-negative before you start and while taking DESCOVY for PrEP. Do not take DESCOVY for HIV-1 PrEP if you already have HIV-1 infection or you do not know your HIV-1 infection status. |
| Talk to a healthcare provider about your risk of getting HIV and if DESCOVY for PrEP is right for you. If you do not have a healthcare provider, the PrEP Locator website (https://www.PrEPLocator.org) can help you find a healthcare provider in your area who has experience prescribing PrEP medications. |
What should I do before taking DESCOVY for PrEP?1
Before you start DESCOVY for PrEP, there are several tests that your doctor will do to check your health. Please talk openly with your doctor about your sexual health.
HIV-1 Test
| DESCOVY for PrEP can only help to reduce the risk of getting HIV-1 if you are HIV-negative. You must be confirmed to be HIV-negative before you start taking DESCOVY for PrEP. |
|
|
HBV Test
| Your doctor will test you for HBV before you start taking DESCOVY for PrEP. If you have HBV and take DESCOVY for PrEP, your HBV may flare up if you stop taking it.
|
| If you have HBV and stop taking DESCOVY for PrEP, your doctor will need to do blood tests regularly for several months to check your HBV. |
Kidney health tests
Your doctor should do blood and urine tests to check how well your kidneys work. |
What should I do while taking DESCOVY for PrEP?1
While you are taking DESCOVY for PrEP, there are several tests that your doctor will do to check your health. Exactly how often these tests need to be repeated may depend on your health and your circumstances. Please talk openly with your doctor about your sexual health. Your doctor will be able to advise you when and how often you need these tests.
HIV-1 test
| You must stay HIV-negative to keep taking DESCOVY for PrEP. While taking DESCOVY for PrEP, you should have an HIV test:
|
| Your doctor can talk with you about all the ways to help reduce the risk of getting HIV.
|
STI tests
| While you are taking DESCOVY for PrEP, you should have regular STI tests. Having certain STIs can make it easier for you to get HIV-1.
|
| Please speak to your doctor for more information about all the ways to help reduce the risk of getting STIs and how often you should be tested. |
Kidney health tests
Your doctor should do blood and urine tests to check how well your kidneys are working while you are taking DESCOVY for PrEP.
|
Glossary
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Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
AIDS (acquired immunodeficiency syndrome): most advanced stage of HIV infection.
HBV (hepatitis B virus) infection: a type of virus (HBV) that can cause serious liver infection.
HIV (Human Immunodeficiency Virus): HIV (human immunodeficiency virus) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome).
Pre-exposure prophylaxis (PrEP): means routinely taking prescription medicine before you're exposed to HIV to help reduce your chances of getting it.
Sexually transmitted infection (STI): A sexually transmitted infection which can be spread through skin-to-skin contact and body fluids during oral, vaginal, and anal sex.
References
- Enclosed. Gilead Sciences, Inc., DESCOVY® (emtricitabine/tenofovir alafenamide) tablets, for oral use. U.S. Prescribing Information. Foster City, CA.
More information about DESCOVY
If you would like more detailed information about DESCOVY, please visit:
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for DESCOVY. It will tell you about the uses, warnings, and other important safety information about DESCOVY.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for DESCOVY. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of DESCOVY in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your HCP.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
Data Privacy
The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.
It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact privacy@gilead.com.
DESCOVY, DESCOVY for PrEP, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.
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