Odefsey

HIV-1 Treatment

Odefsey is used to treat HIV-1 infection in adults and pediatric patients who weigh at least 35 kg (about 77 pounds). It is prescribed for specific situations based on a patient's treatment history and viral load:

• Initial Treatment: It may be used in people who have never received antiretroviral therapy before and have a viral load (HIV-1 RNA) of 100,000 copies/mL or less.
• Stable Switch: It may be used to replace a current, stable HIV treatment regimen in people who are virologically suppressed (viral load less than 50 copies/mL) and have been on their current regimen for at least six months. This switch is only appropriate for those with no history of treatment failure and no known resistance to the individual components of Odefsey.

Odefsey is intended to be used alone as a complete regimen and should not be taken with other antiretroviral medications. While the medication helps manage HIV by decreasing the amount of virus in the body and supporting the immune system, it is not a cure for HIV infection or AIDS.

Mechanism of Action

Odefsey contains three active ingredients: emtricitabine, rilpivirine, and tenofovir alafenamide. These drugs belong to two classes of antiretroviral medications known as nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).

The primary goal of these medications is to stop HIV from making copies of itself. To multiply, HIV must convert its genetic material (RNA) into DNA using an enzyme called reverse transcriptase. Odefsey interferes with this process in two ways:

• Blocking the building process: Emtricitabine and tenofovir alafenamide act as faulty building blocks. When the virus tries to use them to build its DNA, the process is interrupted, and the DNA chain cannot be completed.
• Disabling the enzyme: Rilpivirine binds directly to the reverse transcriptase enzyme, physically preventing it from working.

By interfering with this replication process, Odefsey reduces the viral load, which is the amount of HIV in the blood. This allows the immune system, specifically CD4 cells, to recover and better protect the body against infections. While Odefsey helps manage HIV, it is not a cure for the virus.

Common Side Effects

The most frequently reported side effects of Odefsey are generally mild. They include:

• Headache
• Nausea
• Difficulty sleeping (insomnia)
• Tiredness
• Stomach pain or diarrhea
• Dizziness
• Rash

Serious Side Effects

Some side effects can be severe and may require medical intervention. Contact a healthcare provider immediately if you experience:

• Liver problems: Symptoms include yellowing of the skin or eyes, dark-colored urine, or pain in the upper stomach area.
• Kidney problems: This medication can cause new or worsening kidney impairment.
• Mental health issues: Severe depression, anxiety, or suicidal thoughts have been reported.
• Lactic acidosis: A serious condition where too much lactic acid builds up in the blood, causing muscle pain, weakness, or a fast heartbeat.
• Immune system changes: Also known as immune reconstitution syndrome, this occurs when the immune system gets stronger and reacts to previous or hidden infections.
• Bone density changes: Some patients may experience thinning of the bones (bone loss).
• Severe allergic reactions: Signs include a severe rash, swelling of the face or throat, and difficulty breathing.

Severe Acute Exacerbation of Hepatitis B

Patients with both HIV-1 and hepatitis B virus (HBV) may experience severe, acute worsening of hepatitis B after stopping Odefsey. Liver function should be monitored closely for several months in patients who discontinue this medication. In some cases, starting anti-hepatitis B treatment may be necessary.

Drug Interactions

Odefsey should not be taken with certain other medications because they can significantly decrease the levels of rilpivirine in the blood, potentially leading to treatment failure. These include:

• Proton pump inhibitors (such as omeprazole, lansoprazole, or esomeprazole)
• Certain seizure medications (such as carbamazepine, phenobarbital, or phenytoin)
• Rifampin or rifapentine
• St. John's wort
• Dexamethasone (more than a single dose)

Skin and Hypersensitivity Reactions

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. Treatment should be stopped immediately if a severe rash occurs, especially if accompanied by fever, blisters, swelling, or organ dysfunction.

Depressive Disorders

There is a risk of depression, including suicidal thoughts or actions, while taking this medication. Immediate medical evaluation is recommended if new or worsening mood changes, sadness, or anxiety occur.

Hepatotoxicity and Liver Health

Liver injury has been reported in patients taking rilpivirine-containing products. Patients with a history of hepatitis B or C may be at higher risk. Additionally, lactic acidosis and severe liver enlargement with fatty deposits (steatosis) have occurred with the use of nucleoside analogs, which can be fatal.

Kidney and Bone Health

New or worsening kidney impairment, including cases of acute renal failure, can occur. Healthcare providers typically monitor kidney function before and during treatment. Decreases in bone mineral density have also been observed, and monitoring may be considered for those with a history of bone fractures or osteoporosis.

Immune Reconstitution Syndrome

As the immune system strengthens during treatment, it may respond intensely to previously hidden infections, such as tuberculosis, cytomegalovirus, or fungal infections. This may require further medical evaluation and treatment.

Pregnancy

Data regarding the use of Odefsey in pregnant individuals is limited. While animal studies on the individual components of the medication have generally not shown an increased risk of birth defects, there is not enough human data to establish a drug-associated risk. It has been observed that blood levels of rilpivirine, one of the components in Odefsey, may be lower during the second and third trimesters of pregnancy. Consequently, healthcare providers may monitor viral loads more closely to ensure the medication remains effective during this time.

There is an Antiretroviral Pregnancy Registry that monitors outcomes in individuals who take HIV medications while pregnant. Healthcare providers are encouraged to register patients to help collect more information about the safety of Odefsey during pregnancy.

Breastfeeding

The Centers for Disease Control and Prevention (CDC) recommends that individuals with HIV-1 in the United States do not breastfeed their infants. This is primarily to avoid the risk of transmitting the virus to the baby after birth. Additionally, there is a risk that the infant could develop resistance to HIV medications if they are exposed to the drug through breast milk.

One of the active ingredients in Odefsey, emtricitabine, has been shown to pass into human breast milk. It is currently unknown if the other components, rilpivirine or tenofovir alafenamide, are present in human milk. Because of the potential for HIV transmission and the risk of adverse reactions in the nursing infant, breastfeeding is not recommended while using this medication.

Dosage Forms

Odefsey is supplied as a film-coated tablet intended for oral administration. This medication is a fixed-dose combination product, meaning multiple active ingredients are contained within a single tablet. The tablets are typically debossed with specific markings on one side to assist with identification.

FDA Approval

Odefsey was approved by the U.S. Food and Drug Administration (FDA) on March 1, 2016. It is a fixed-dose combination tablet containing emtricitabine, rilpivirine, and tenofovir alafenamide.

Approved Indications

Odefsey is indicated as a complete treatment for HIV-1 infection in adults and pediatric patients weighing at least 35 kg who meet the following criteria:

• They have no history of antiretroviral treatment and have HIV-1 RNA levels less than or equal to 100,000 copies/mL.
• They are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least six months, have no history of treatment failure, and have no known resistance to the components of Odefsey.

Boxed Warning

Odefsey includes a boxed warning regarding the risk of severe acute exacerbations of hepatitis B (HBV). Patients co-infected with HIV-1 and HBV may experience a severe worsening of hepatitis B if they stop taking Odefsey. Healthcare providers typically test patients for HBV infection before starting treatment. If Odefsey is discontinued in co-infected patients, liver function should be monitored closely for several months.

Insurance and Pharmacy Factors

The out-of-pocket cost for Odefsey is primarily determined by your health insurance plan. Most plans include Odefsey on their formulary, but the specific tier level will dictate the copayment or coinsurance amount. For those without insurance, the retail price may vary between different pharmacies and geographic locations.

Financial Assistance Programs

There are several options that may help reduce the cost of Odefsey:

• Copay Cards: The manufacturer may offer savings cards for patients with commercial insurance to lower monthly out-of-pocket expenses.
• Patient Assistance: Programs are often available for individuals who lack insurance or have limited financial resources, providing the medication at a reduced cost or for free to those who qualify.

Generic Availability

Odefsey is a brand-name medication. At this time, there are no generic versions of this specific combination tablet available in the United States. Generic medications are typically less expensive than brand-name versions.