Is ODEFSEY Right for you?

Whether you're starting treatment or replacing your current HIV-1 treatment, ODEFSEY® can help you reach important HIV-1 health goals.

Starting or replacing your HIV-1 treatment is an important decision. Your healthcare provider should always work with you to decide if changing your medicine makes sense.

Reaching Undetectable

For people new to treatment

Decrease viral load

ODEFSEY can help reduce the amount of HIV-1 in your blood (viral load) to reach an undetectable level. Being "undetectable" means that the amount of virus in your blood is below the level that can be measured in a lab test (less than 50 copies/mL).

Increase CD4 T-cell count

ODEFSEY can also help increase the number of CD4 T-cells in your blood. T-cells are important because they help your body fight infection and improve your immune system.

Staying Undetectable

For people replacing their current HIV-1 treatment

ODEFSEY can help you stay undetectable and maintain your CD4 T-cell count. Before taking ODEFSEY, your healthcare provider must determine that you meet certain requirements, such as being undetectable for 6 months or more on your current treatment.

Before taking ODEFSEY, tell your healthcare provider if you:

  • have or have had any kidney, bone, mental health (depression or suicidal thoughts), or liver problems, including hepatitis virus (HBV) infection.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if ODEFSEY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking ODEFSEY.
  • are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

Avoid doing things that can spread HIV-1 infection to other people.

  • Do not share personal items that can have blood or body fluids on them, like needles, other injection equipment, razor blades, or toothbrushes.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Starting or replacing your HIV-1 treatment is an important decision. Your healthcare provider should always work with you to decide if changing your medicine makes sense.

Important Safety Information

What is the most important information I should know about ODEFSEY®?

ODEFSEY may cause serious side effects:

Who should not take ODEFSEY?

Do not take ODEFSEY if you take:

What are the other possible side effects of ODEFSEY?

Serious side effects of ODEFSEY may also include:

The most common side effects of rilpivirine, one of the medicines in ODEFSEY, are depression, trouble sleeping (insomnia), and headache.

The most common side effect of emtricitabine and tenofovir alafenamide, two of the medicines in ODEFSEY, is nausea.

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 ODEFSEY?

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call .

What is ODEFSEY?

ODEFSEY is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older. It can either be used in people who are starting HIV-1 treatment, have never taken HIV-1 medicines before, and have an amount of HIV-1 in their blood ("viral load") that is no more than 100,000 copies/mL; or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. ODEFSEY combines 3 medicines into 1 pill taken once a day with a meal. ODEFSEY is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

ODEFSEY does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking ODEFSEY. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Please see Important Facts about ODEFSEY, including important warnings.