TRUVADA for PrEP was studied in 2 separate clinical trials.

The first study followed adult HIV negative men and transgender women who have sex with men and are at high risk for getting HIV. The second study followed adult male-female partners where one partner was HIV positive and the other was not.

During the studies, all participants were told to use safer sex practices, including condoms. They also received monthly HIV testing and counseling. In the end, it was determined that TRUVADA for PrEP helped reduce the chances of HIV infection in both groups that were studied compared to those taking a placebo (sugar pill).

Clinical studies showed that TRUVADA for PrEP works better when taken every day as directed.

After the initial studies were completed and the results were known, researchers conducted further analysis and looked at a sample of people who were assigned to take TRUVADA® in the studies. They wanted to know if people who had TRUVADA in their body were better protected against HIV than those who did not.

In both studies, people with TRUVADA in their body* were less likely to get HIV. But keep in mind that this kind of analysis, called a "post-hoc analysis," should be interpreted with caution because it was not one of the original goals of either study.

STUDY 1

Men who have sex with men and transgender women who have sex with men:

  • Number of people who were assigned to take TRUVADA: 1,251
  • Number of people who took a placebo (sugar pill): 1,248

STUDY 2

Couples (male/female) where one partner has HIV and the other does not:

  • Number of people who were assigned to take TRUVADA: 1,583
  • Number of people who took a placebo (sugar pill): 1,586
 

When taken every day as one part of a 
complete HIV prevention plan, TRUVADA for PrEP is recommended by the Centers for Disease Control and Prevention (CDC).

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Important Safety Information

What is the most important information I should know about TRUVADA for PrEP?

Before and while taking TRUVADA for PrEP:

  • You must be HIV negative before you start and while taking TRUVADA for PrEP. Do not take TRUVADA to reduce the risk of getting HIV-1 unless you are confirmed to be HIV negative.
    • Get tested for HIV-1 immediately before and at least every 3 months while taking TRUVADA.
    • If you think you were exposed to HIV-1, tell your healthcare provider right away. They may do more tests to confirm that you are still HIV negative.
  • Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. Tell your healthcare provider if you had a flu-like illness within the last month before starting or at any time while taking TRUVADA.
    • Symptoms of new HIV-1 infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting, diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
  • TRUVADA by itself is not a complete treatment for HIV-1. Do not take TRUVADA for PrEP unless you are confirmed to be HIV-1 negative.
  • To further help reduce your risk of getting HIV-1:
    • Do not miss any doses of TRUVADA. Missing doses may increase your risk of getting HIV-1 infection.
    • Know your HIV status and the HIV status of your partners. If your partner is living with HIV, your risk of getting HIV is lower if your partner consistently takes HIV treatment every day.
    • Get tested for other sexually transmitted infections. Some STIs make it easier for HIV-1 to infect you.
    • Talk to your healthcare provider about all the ways to help reduce HIV risk.
  • If you do become HIV-1 positive, you need more medicine than TRUVADA alone to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only TRUVADA, your HIV-1 may become harder to treat now and in the future.

TRUVADA can cause serious side effects:

  • Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have HBV and stop taking TRUVADA, your HBV may suddenly get worse. Do not stop taking TRUVADA without first talking to your healthcare provider, as they will need to monitor your health.

Who should not take TRUVADA for PrEP?

Do not take TRUVADA for PrEP if you:

  • Already have HIV-1 infection or if you do not know your HIV-1 status. If you have HIV-1, you need to take other medicines with TRUVADA to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only TRUVADA, your HIV-1 may become harder to treat now and over time.

What are the other possible side effects of TRUVADA for PrEP?

Serious side effects of TRUVADA may also include:

  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before and during treatment with TRUVADA. If you develop kidney problems, your healthcare provider may tell you to stop taking TRUVADA.
  • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
  • Bone problems, including bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may do tests to check your bones.

Common side effects in people taking TRUVADA for PrEP are headache, stomach-area (abdomen) pain, and decreased weight. Tell your healthcare provider if you have any side effects that bother you or do not go away.

What should I tell my healthcare provider before taking TRUVADA for PrEP?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, or liver problems, including hepatitis.
  • If you are pregnant or plan to become pregnant. It is not known if TRUVADA can harm your unborn baby. If you become pregnant while taking TRUVADA for PrEP, tell your healthcare provider.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you think you may have recently become infected with HIV. HIV can be passed to the baby in breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding while taking TRUVADA for PrEP.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRUVADA may interact with other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • If you take certain other medicines with TRUVADA, your healthcare provider may need to check you more often or change your dose. These medicines include certain medicines to treat hepatitis B or C infection.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.1-800-FDA-1088.

What is TRUVADA for PrEP?

TRUVADA for PrEP (pre-exposure prophylaxis) is a once-daily prescription medicine for adults and adolescents at risk of HIV who weigh at least 77 pounds. It helps lower the chance of getting HIV through sex. You must be HIV negative before and while taking TRUVADA for PrEP.

To help determine if TRUVADA for PrEP may be an option for you, talk openly with your healthcare provider about your risk for HIV-1.

Please see Important Facts about TRUVADA for PrEP, including important warnings.

Important Safety Information

What is the most important information I should know about TRUVADA for PrEP?

Before and while taking TRUVADA for PrEP:

  • You must be HIV negative before you start and while taking TRUVADA for PrEP. Do not take TRUVADA to reduce the risk of getting HIV-1 unless you are confirmed to be HIV negative.