Odefsey

Viral Resistance, Human Immunodeficiency Virus Type 1 (HIV-1), Treatment Naive + 5 more
Treatment
4 FDA approvals
20 Active Studies for Odefsey

What is Odefsey

RilpivirineThe Generic name of this drug
Treatment SummaryTenofovir alafenamide is a medication used to treat chronic hepatitis B, HIV-1 and prevent HIV-1 infections. It is a prodrug form of tenofovir that has been developed to improve renal safety and increase oral bioavailability and intestinal diffusion. Tenofovir alafenamide is characterized by its ability to produce a large antiviral efficacy at doses that are ten times lower than tenofovir disoproxil. It was developed by Gilead Sciences Inc and approved by the FDA in 2015.
Edurantis the brand name
image of different drug pills on a surface
Odefsey Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Edurant
Rilpivirine
2011
12

Approved as Treatment by the FDA

Rilpivirine, also known as Edurant, is approved by the FDA for 4 uses including HIV and weight at least 35 kg .
HIV
Used to treat Human Immunodeficiency Virus Type 1 (HIV-1) Infection in combination with null
weight at least 35 kg
Used to treat weight at least 35 kg in combination with null
Treatment Naive
Used to treat Treatment Naive in combination with null
HIV-1 RNA Less Than or Equal to 100,000 copies/mL
Used to treat HIV-1 RNA Less Than or Equal to 100,000 copies/mL in combination with null

Effectiveness

How Odefsey Affects PatientsTenofovir alafenamide has been found to be very effective at blocking the replication of the hepatitis B virus. It is easier on the kidneys than its counterpart, tenofovir disoproxil, and is believed to be due to the lower amount of tenofovir in the blood. Studies have also found that it is 5 times more effective at fighting HIV-1 than tenofovir disoproxil.
How Odefsey works in the bodyTenofovir alafenamide is a drug that is used to treat viral infections. It works by inhibiting viral replication, which stops the virus from reproducing in the body. Tenofovir alafenamide is more effective than other forms of the drug because it accumulates more in the cells where it is needed and has a longer lasting effect in the body. Tenofovir alafenamide is converted into an active form in the body, which is then able to target the virus and stop it from replicating.

When to interrupt dosage

The recommended dosage of Odefsey hinges upon the recognized disorder, for example Treatment Naive, Chronic Hepatitis B and compensated liver disease. The amount of dosage fluctuates, depending on the delivery technique noted in the table underneath.
Condition
Dosage
Administration
treatment failure
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
Viral Resistance
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
HIV
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
Human Immunodeficiency Virus Type 1 (HIV-1)
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
HIV-1 RNA Less Than or Equal to 100,000 copies/mL
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
virologically-suppressed
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
Treatment Naive
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular
weight at least 35 kg
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Intramuscular, Kit; Suspension, extended release, Kit; Suspension, extended release - Intramuscular, Injection, Injection - Intramuscular

Warnings

Odefsey Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
dexamethasone
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Rilpivirine may interact with Pulse Frequency
There are 20 known major drug interactions with Odefsey.
Common Odefsey Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The metabolism of Abemaciclib can be decreased when combined with Rilpivirine.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be decreased when combined with Rilpivirine.
Alectinib
Major
The metabolism of Alectinib can be decreased when combined with Rilpivirine.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Rilpivirine.
Amoxapine
Major
The metabolism of Amoxapine can be decreased when combined with Rilpivirine.
Odefsey Toxicity & Overdose RiskThe exact toxicity of tenofovir alafenamide is unknown, so it is important to closely monitor vital signs in case of an overdose. Tenofovir alafenamide is also more easily removed from the body than tenofovir disoproxil, with an extraction coefficient of 54%. There is no evidence that tenofovir alafenamide is carcinogenic or mutagenic, but long-term exposure to tenofovir disoproxil in high doses has been linked to liver adenomas in female patients. Additionally, there is no evidence that tenofovir alafenamide

Odefsey Novel Uses: Which Conditions Have a Clinical Trial Featuring Odefsey?

55 active trials are currently examining the potential of Odefsey for treating conditions not requiring CYP3A inhibitors, Chronic Hepatitis B and tenofovir.
Condition
Clinical Trials
Trial Phases
treatment failure
0 Actively Recruiting
HIV
39 Actively Recruiting
Phase 2, Phase 3, Phase 1, Phase 4, Not Applicable, Early Phase 1
Treatment Naive
0 Actively Recruiting
virologically-suppressed
0 Actively Recruiting
Viral Resistance
0 Actively Recruiting
Human Immunodeficiency Virus Type 1 (HIV-1)
5 Actively Recruiting
Phase 3, Phase 2, Phase 1, Early Phase 1
HIV-1 RNA Less Than or Equal to 100,000 copies/mL
0 Actively Recruiting
weight at least 35 kg
0 Actively Recruiting

Odefsey Reviews: What are patients saying about Odefsey?

4Patient Review
3/24/2019
Odefsey for HIV
My CD4 count is now above normal, and I've got the side effects under control. The only issue now is my appetite.
3Patient Review
8/30/2016
Odefsey for HIV
Worked great until I had to get surgery for a hernia. Suddenly, all the side effects showed up: face swelling, neuropathy, itching rash, etc. If you're considering this treatment, just be aware that there may be some unforeseen complications down the road.
2.3Patient Review
10/3/2017
Odefsey for HIV
My CD4 counts have dropped since I started taking this medication a year ago. I'm trying to get in to see my doctor and request a new medication.
2.3Patient Review
9/19/2016
Odefsey for HIV
I've been on the medication for a week now and I will have to get my blood levels checked to see if the virus is still present. If it is, then the bone loss problem should be resolved.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about odefsey

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is Odefsey?

"Odefsey is a medication used to treat HIV. It is a combination of three separate antiretroviral drugs in one pill, taken once a day. It combines 25mg rilpivirine, 200mg emtricitabine, and 25mg tenofovir alafenamide in a grey, capsule-shaped, film-coated tablet."

Answered by AI

What is the drug Odefsey used for?

"ODSEFEY is a medicine used to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children. It is taken by mouth and is only for people who weigh at least 77 pounds (35 kg)."

Answered by AI

How much does Odefsey cost?

"The average monthly cost of Odefsey is $3,086. If you have insurance, your monthly copayments for Odefsey will usually be between $50 and $100, depending on your insurance plan. However, you may qualify for cost-sharing assistance from the manufacturer."

Answered by AI

What are the side effects of Odefsey?

"Depressive disorders can manifest as a depressed mood, general unease, mood changes, negative thoughts, suicide attempts, or suicidal ideation. They can also cause insomnia, headache, nausea, drowsiness, dizziness, abdominal pain, or rash."

Answered by AI

Clinical Trials for Odefsey

Have you considered Odefsey clinical trials? We made a collection of clinical trials featuring Odefsey, we think they might fit your search criteria.
Have you considered Odefsey clinical trials? We made a collection of clinical trials featuring Odefsey, we think they might fit your search criteria.
Have you considered Odefsey clinical trials? We made a collection of clinical trials featuring Odefsey, we think they might fit your search criteria.