Odefsey (Emtricitabine/Rilpivirine/Tenofovir Alafenamide) for HIV

What Members Say Top Tips Side Effects Copay Help FAQs

Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children weighing at least 25 kilograms.

What Members Say

MHT logo These insights are based on 150 comments about Odefsey from myHIVteam members. These are the experiences of a small number of people and are not meant to be medical advice.

Benefits:

Once-daily dosing feels simple and easy to fit into a routine.
The tablet feels small and easier to swallow than older HIV medicines.
Long-term use can feel manageable with few or no side effects.

Considerations:

Odefsey must be taken with a meal, which can complicate timing.
Sleep problems, including insomnia or vivid dreams, can occur.
Mood changes, anxiety, or depression need prompt medical attention.

How Odefsey Works and How It’s Taken

Odefsey is an antiretroviral medicine used to treat HIV-1. Its medicines block reverse transcriptase, an enzyme HIV needs to make more copies of itself.

Doctors prescribe Odefsey in adults and children who weigh at least 25 kilograms. It may be used as a first HIV treatment in people who have not taken HIV medicines before and have an HIV-1 viral load of 100,000 copies per milliliter or less.

Odefsey may also replace a stable HIV treatment in people whose viral load has been below 50 copies per milliliter for at least six months. They must have no history of treatment failure and no known resistance to the medicines in Odefsey.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Odefsey is taken as one tablet by mouth once daily with a meal.

Typical Dosing for HIV

The recommended dose is one tablet once daily with a meal for adults and children who weigh at least 25 kilograms and have creatinine clearance of at least 30 milliliters per minute.

For people receiving chronic hemodialysis, Odefsey should be taken after dialysis on dialysis days.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Top Advice From Members on Odefsey

MHT logo These insights are based on 150 comments about Odefsey from myHIVteam members.

Members who use Odefsey often say it helps to stay in close contact with your HIV care team, especially when you are switching medications or noticing side effects. Many members also mention the importance of taking Odefsey consistently, planning around meals, and keeping up with lab work and follow-up visits.

1

Plan ahead to take Odefsey with food.
“Odefsey must be taken with food, so I find myself having to take my meds with my lunch. Being out and around it is difficult to plan lunch and dinner when not home.”
2

Keep taking it regularly and avoid missed doses.
“It’s easy to miss a dose. My husband died in October. Even with the best intentions of taking the medicine every day, I have missed a number of doses and I have a once-a-day pill — Odefsey.”
3

Let your doctor know if cost or coverage becomes a problem.
“So I went to renew my script for Odefsey, which has kept me undetectable for four and a half years. It had always been a $0 copay. This time they decided to charge me, but my doctor is going to look into it.”

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Odefsey Side Effects

In clinical studies of Odefsey, the most common side effects occurred in about 2 percent of people. These include:

Headache
Sleep disturbances (problems sleeping)

Serious Side Effects and Warnings

Odefsey can cause serious side effects that may require immediate medical attention. These include:

Worsening of hepatitis B after stopping Odefsey — A hepatitis B flare can lead to serious liver problems, including liver failure, in people who have both HIV-1 and hepatitis B.
Severe skin and allergic reactions — These reactions can include drug reaction with eosinophilia and systemic symptoms, or DRESS, which is a serious drug reaction that can include rash, fever, swelling, blisters, eye irritation, mouth sores, or organ problems like liver injury.
Liver problems — Liver injury may be more likely in people with hepatitis B or hepatitis C.
Depressive disorders — New or worsening depression, mood changes, or suicidal thoughts or actions can occur.
New or worsening kidney problems — These problems can include serious kidney injury, such as Fanconi syndrome, a kidney condition that can affect how your body handles minerals and other substances.
Lactic acidosis with severe liver enlargement and fatty liver — This serious buildup of lactic acid in the blood can happen with some HIV medicines.
Immune reconstitution syndrome — Immune system changes after starting HIV treatment can cause inflammation and symptoms from hidden infections, and sometimes autoimmune conditions.

Get medical help right away if you think you are having a serious reaction. If you or someone you know needs help, you can contact the 988 Suicide & Crisis Lifeline by calling or texting 988 or by using the online chat.

How To Save on Odefsey

Gilead Sciences, Inc, the manufacturer of Odefsey, offers the Gilead Advancing Access Co-pay Savings Program. Eligible people with commercial insurance may pay as little as $0 per prescription. If you have government insurance or no insurance, the program also provides information about other financial assistance options that may be available.

The Gilead Advancing Access Program also offers help understanding insurance coverage, addressing coverage denials, exploring payment assistance options, and navigating appeals.

To learn more, visit the Gilead Advancing Access Program or call 800-226-2056.

What To Know Before Taking Odefsey

Before starting Odefsey, your healthcare provider will test you for hepatitis B virus infection.

Your healthcare provider will also check your kidney function before or when you start Odefsey and during treatment. Tests include serum creatinine, estimated creatinine clearance, urine glucose, and urine protein. If you have chronic kidney disease, your serum phosphorus should also be checked.

Before receiving Odefsey, tell your healthcare provider if you:

Have or have had liver problems
Have kidney problems
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed
Have any allergies to emtricitabine/rilpivirine/tenofovir alafenamide or any ingredients in Odefsey

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not take Odefsey with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone for more than a single dose, St. John’s wort, or proton pump inhibitors such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole.

Do not stop taking Odefsey or let your supply run out without first talking with your healthcare provider. If treatment is stopped, the amount of HIV-1 in your blood may increase and the virus may become harder to treat.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Odefsey, talk with your doctor about the risks and benefits.

A pregnancy exposure registry monitors pregnancy outcomes in people exposed to Odefsey. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry or calling 800-258-4263.

If you are breastfeeding or plan to breastfeed, talk with your healthcare provider about the risks. HIV-1 may pass to a baby who does not have HIV-1. The virus may become harder to treat if the baby has HIV-1, and the baby may have side effects from Odefsey.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Odefsey for HIV?

In adults with HIV who were already virally suppressed and switched to Odefsey, 90 percent to 94 percent had HIV-1 RNA below 50 copies per milliliter at week 48, depending on the study.

The effectiveness of Odefsey for people starting HIV treatment was also supported by studies of its individual components. In one study of emtricitabine and tenofovir alafenamide used with two other HIV medicines, 92 percent of adults had HIV-1 RNA below 50 copies per milliliter at week 48.

In another supporting study of adults with certain levels of kidney function, 95 percent had HIV-1 RNA below 50 copies per milliliter at week 24. Most people in this study were already virally suppressed before switching treatment.

How long does Odefsey take to work for HIV?

Clinical studies measured HIV-1 RNA at set times, including week 24 and week 48. It does not say exactly how long it will take an individual person to respond to treatment.

Can Odefsey cause depression or mood changes in people with HIV?

Yes. Depression and mood changes have been reported with rilpivirine, one of the medicines in Odefsey. People with severe symptoms of depression should be evaluated promptly.

A healthcare provider can help determine whether the symptoms may be related to Odefsey and whether the benefits of continuing treatment outweigh the risks.