All people featured on this page are actor portrayals.
All people featured on this page are actor portrayals.
Nearly 100% of people stayed HIV negative on YEZTUGO® in two global studies.
They included over 12,000 people*
Both studies were randomized, double-blinded, and included a wide range of people across many ages, genders, and backgrounds. All participants were sexually active with a male partner or partners. The studies looked at how well YEZTUGO could prevent HIV compared to a daily PrEP pill (FTC/TDF).†
*Not all participants were given a study drug.
†FTC/TDF=emtricitabine/tenofovir disoproxil fumarate.
The studies:
Purpose 1
included around 2100 young cisgender women and adolescent girls who received YEZTUGO, including those who became pregnant or started breastfeeding,‡ in South Africa and Uganda.
‡People were allowed to stay in the study and continue treatment if they became pregnant or started lactating.
Purpose 2
included around 2100 cisgender men, transgender
men and women, and nonbinary people who received YEZTUGO in multiple countries around the world.
The studies:
Purpose 1
included around 2100 young cisgender women and adolescent girls who received YEZTUGO, including those who became pregnant or started breastfeeding, ‡ in South Africa and Uganda.
Purpose 2
included around 2100 cisgender men, transgender men and women, and nonbinary people who received YEZTUGO in multiple countries around the world.
‡People were allowed to stay in the study and continue treatment if they became pregnant or started lactating.
Results at 1 year§:
Purpose 1
100%
of people remained HIV negative while on YEZTUGO,
compared with
98.5% on a daily PrEP pill (FTC/TDF).
Purpose 1:That means 0 out of 2134 people got HIV while taking YEZTUGO
compared to 16 out of 1068 people on a daily PrEP pill (FTC/TDF).
Purpose 2
99.9%
of people remained HIV negative while on YEZTUGO,
compared with
99.2% on a daily PrEP pill (FTC/TDF).
Purpose 2: That means 2 out of 2179 people got HIV while taking YEZTUGO
compared to 9 out of 1086 people on a daily pill (FTC/TDF).
§Researchers looked at how well YEZTUGO worked in a planned early analysis once 50% of the people had been in the study for a year.
The results were so strong the researchers stopped the first part of the study and offered everyone the option to switch to YEZTUGO.
Each study showed
of people stayed HIV negative while taking YEZTUGO.
Each study showed
of people stayed HIV negative while taking YEZTUGO.
Purpose 1: 0 out of 2134 people got HIV while taking YEZTUGO compared to 16 out of 1068 people on a daily PrEP pill (FTC/TDF)
Purpose 2: 2 out of 2179 people got HIV while taking YEZTUGO compared to 9 out of 1086 people on a daily PrEP pill (FTC/TDF)
§Researchers looked at how well YEZTUGO worked in a planned early analysis once 50% of the people had been in the trial for a year. The results were so strong the researchers stopped the first part of the study and offered everyone the option to switch to YEZTUGO.
Learn more about possible side effects
See side effect informationTalk to a healthcare provider to see if YEZTUGO is right for you.
YEZTUGO is a prescription medicine used as HIV-1 PrEP (pre-exposure prophylaxis) to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds. You must be HIV negative before and while receiving YEZTUGO.
YEZTUGO is a prescription medicine used as HIV-1 PrEP (pre-exposure prophylaxis) to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds. You must be HIV negative before and while receiving YEZTUGO.
Important Safety Information
What is the most important information I should know about YEZTUGO?
Before and while receiving YEZTUGO:
Tap for Important Safety Information, including an important warning on the risk of drug resistance if you become HIV positive and only take YEZTUGO.
- You must be HIV negative before you start and while receiving YEZTUGO. Get an HIV test before starting, before each injection, and when your healthcare provider tells you. If you think you were exposed to HIV while receiving YEZTUGO, talk to your healthcare provider as you may need an HIV test.
- Some HIV tests may not detect HIV in a person who recently acquired HIV. Tell your healthcare provider if you had a flu-like illness within the last month before starting or while receiving YEZTUGO. Symptoms of new HIV infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting or diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
- YEZTUGO does not prevent other sexually transmitted infections (STIs). Get tested for other STIs and practice safer sex by using condoms to reduce the risk of getting STIs.
- YEZTUGO is not approved to treat HIV. You must immediately take other medicines if you get HIV. If you have HIV and only receive YEZTUGO, your HIV may become harder to treat.
- Follow the YEZTUGO dosing schedule, which includes returning to a healthcare provider for your scheduled injections every 6 months. Missing scheduled injections or tablets can increase your chances of getting HIV.
- To further help reduce your risk of getting HIV:
- Know your HIV status and the HIV status of your partner(s). If they are living with HIV, your risk of getting HIV is lower if they are taking effective HIV treatment.
- Talk to your healthcare provider about all the ways to help reduce the risk of getting HIV.
Who should not receive or take YEZTUGO?
- Do not receive YEZTUGO if you already have HIV or do not know your HIV status. If you have HIV, you will need to take other medicines to treat it. YEZTUGO is not approved to treat HIV and is only for reducing the risk of getting HIV before you get it.
What are the possible side effects of YEZTUGO?
- The most common side effects of YEZTUGO are injection site reactions, headache, and nausea. These are not the only possible side effects.
- Reactions at the injection site may include a lump or bump, pain, skin hardening, swelling, itching, redness, bruising, or warmth.
- Rarely, if YEZTUGO is injected incorrectly, serious injection site reactions, like severe damage of the skin or open sores, can occur.
- Tell your healthcare provider if you have any injection site reactions or other side effects that bother you or don’t go away.
What should I tell my healthcare provider before receiving YEZTUGO?
- All your medical conditions.
- If you are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant while or after receiving YEZTUGO.
- If you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby while you are receiving YEZTUGO.
- All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. YEZTUGO can remain in your body for up to 9 months after your last injection and can affect other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.