Odefsey is a combination medication that contains rilpivirine, emtricitabine and tenofovir alafenamide. It is used as a standalone antiretroviral therapy (ART) regimen for HIV-1 in individuals who have never taken any other HIV medicines before and have a viral load (amount of virus in the blood) of less than 100,000 copies per mL.
Individuals taking Odefsey should be at least 77 pounds (35 kg). Odefsey may be used in individuals who are replacing a stable ART regimen, have not had any previous treatment failures, and who have had a viral load of 50 copies per mL or less on a stable ART regimen for at least six months.
Although it is not a cure for HIV, when taken as directed, it allows for the virus to be suppressed. This prevents further transmission of HIV and allows an individual’s immune system to improve through increasing CD4 cell counts and decreasing viral load.
What are the ingredients in Odefsey?
The main ingredients in Odefsey are rilpivirine, emtricitabine, and tenofovir alafenamide. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), while emtricitabine, and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs).
How does Odefsey work?
Odefsey is a combination of two NRTI medications and one NNRTI medication. Both types of drugs stop the reverse transcription step of the HIV life cycle. Normally, HIV uses its reverse transcriptase enzyme to build a strand of DNA from its original RNA form. In order to do this, it uses genetic building blocks called nucleosides that come from the host cell. These nucleosides are strung together one at a time, like beads on a string, to create the final DNA product.
NRTIs act as nucleoside mimics that stop the DNA-building process. NRTIs look like normal nucleosides, except they’re missing a special chemical group on one side. Without this group, the reverse transcriptase enzyme is unable to attach more nucleosides to the chain after them.
NNRTIs bind to the reverse transcriptase enzyme itself to stop the DNA-building process. When an NNRTI binds to reverse transcriptase, the enzyme is unable to attach more nucleosides to the chain. Both of these mechanisms block the full string of DNA from being formed, preventing HIV RNA from making it all the way through the reverse transcription process and into host DNA for further replication.
Possible side effects
The most common side effects of Odefsey include, but are not limited to:
- Insomnia
- Headache
These are not all the possible side effects of Odefsey. Talk to your doctor about what to expect when taking Odefsey. You also should call your doctor if you have any changes that concern you when taking Odefsey.
Things to consider
Odefsey has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because of the possibility of serious side effects as described below.
As with any medication, there are several very rare but serious risks that need to be considered before taking Odefsey. Your healthcare provider can help determine what issues you may be at risk for and help determine what treatment options are the safest for you. It’s also important to remember that the risk of one or more of these issues occurring is low, and the benefits of treating the virus often greatly outweigh the risks.
Several of these rare but serious side effects of Odefsey include liver issues and an increase of lactic acid in the blood (lactic acidosis). Signs of liver issues include, but are not limited to:
- Dark-colored urine
- Loss of appetite
- Nausea
- Yellowing of the whites of the eyes or skin
- Light-colored bowel movements
- Pain or tenderness on the right side of your stomach
Signs of lactic acidosis include, but are not limited to:
- Trouble breathing
- Feeling cold, especially in the limbs
- Dizziness or lightheadedness
- Feeling tired or weak
- Muscle pain
- Nausea and vomiting
- Irregular or fast heartbeat
If you have hepatitis B virus and start taking Odefsey, your hepatitis B may get worse. Odefsey may also cause new or worsening kidney issues. This includes an increased risk of kidney failure. Your healthcare provider will need to monitor your kidney function before you start and while taking Odefsey. Serious psychiatric issues such as depression or mood changes may occur. Contact your healthcare provider as soon as possible if you experience these or any suicidal thoughts or ideations.
Before starting Odefsey, tell your doctor if you:
- Have or previously had hepatitis B virus
- Have or previously had hepatitis C virus
- Have a history of liver or kidney problems
- Have a history of a mental health condition, depression, or suicidal thoughts
- Are pregnant or planning to become pregnant
- Are breastfeeding or planning to breastfeed
- Are taking any over-the-counter vitamins, supplements, medicines, or herbal remedies
- Are on any other medications or are about to start any other medications, including hormonal birth control or medications for hepatitis viruses
There are many medications that cannot be taken with Odefsey. It is important to tell your doctor about any and all medications you are taking to ensure you are taking Odefsey safely.
Certain antacids, laxatives, and supplements containing aluminum, magnesium, iron, or calcium may interfere with the absorption of Odefsey.
Avoid taking certain medications together with Odefsey, as it may reduce the effectiveness of the treatment and potentially lead to drug resistance. These medications include carbamazepine, high-dose systemic dexamethasone, oxcarbazepine, phenobarbital, phenytoin, proton pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), rifampin, rifapentine, and St. John's wort. It's important to consult with your doctor to determine suitable alternatives if you need to take any of these medications.
Rarely, skin rashes or allergic reactions may occur with Odefsey and may be serious. Alert your healthcare provider if you notice any of the following:
- Skin blisters
- Mouth sores
- Swelling of the lips, mouth, face, or throat
- Pain on right side of the stomach
- Fever
- Trouble breathing or swallowing
- Dark-colored urine
- Redness or swelling of the eyes
Odefsey may cause a condition called IRIS (immune reconstitution inflammatory syndrome). IRIS occurs when an individual’s immune system gets stronger after being weak and responds aggressively to previously hidden infections. This heightened response may make the person fighting the infection feel worse. Alert your healthcare provider immediately if you begin to have new symptoms after taking Odefsey. These are not all the possible side effects of Odefsey. Patients should talk to their doctor about what to expect with treatment with Odefsey.