What is Odefsey
Tenofovir alafenamideThe 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.
Genvoyais the brand name
Odefsey Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Genvoya
Tenofovir alafenamide
2015
15
Approved as Treatment by the FDA
Tenofovir alafenamide, also known as Genvoya, is approved by the FDA for 9 uses like no resistance to darunavir and compensated liver disease .no resistance to darunavir
Used to treat no resistance to darunavir in combination with Cobicistat
compensated liver disease
Helps manage compensated liver disease
Chronic Hepatitis B Infection
Helps manage Hepatitis B Chronic Infection
tenofovir
Used to treat no resistance to tenofovir in combination with Cobicistat
Virologically supressed for 3 months
Used to treat Virologically supressed for 3 months in combination with Bictegravir
HIV
Used to treat Human Immunodeficiency Virus Type 1 (HIV-1) Infection in combination with Bictegravir
treatment failure
Used to treat no history of treatment failure in combination with Bictegravir
virologically suppressed for 6 months
Used to treat virologically suppressed for 6 months in combination with Cobicistat
Treatment Naive
Used to treat Treatment Naive in combination with Bictegravir
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 Naive
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
Chronic Hepatitis B Infection
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
compensated liver disease
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
Human Immunodeficiency Virus Type 1 (HIV-1)
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
HIV
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
treatment failure
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
weight at least 35 kg
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
no resistance to darunavir
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
tenofovir
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
weight between 25-35 kg
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
not requiring CYP3A inhibitors
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
Virologically supressed for 3 months
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
virologically suppressed for 6 months
, 25.0 mg, 15.0 mg, 10.0 mg
Tablet, film coated - Oral, , Tablet, Oral, Tablet - Oral, Tablet, film coated
Warnings
There are 20 known major drug interactions with Odefsey.Common Odefsey Drug Interactions
Drug Name
Risk Level
Description
Neomycin
Major
The risk or severity of nephrotoxicity can be increased when Tenofovir alafenamide is combined with Neomycin.
Tenofovir
Major
Tenofovir alafenamide may increase the nephrotoxic activities of Tenofovir.
Abacavir
Minor
Tenofovir alafenamide may decrease the excretion rate of Abacavir which could result in a higher serum level.
Aclidinium
Minor
Tenofovir alafenamide may decrease the excretion rate of Aclidinium which could result in a higher serum level.
Acrivastine
Minor
Tenofovir alafenamide may decrease the excretion rate of Acrivastine which could result in a higher serum level.
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
Virologically supressed for 3 months
0 Actively Recruiting
not requiring CYP3A inhibitors
0 Actively Recruiting
Chronic Hepatitis B Infection
4 Actively Recruiting
Phase 3, Phase 2
tenofovir
0 Actively Recruiting
no resistance to darunavir
0 Actively Recruiting
HIV
45 Actively Recruiting
Phase 2, Phase 3, Early Phase 1, Phase 1, Phase 4, Not Applicable
treatment failure
0 Actively Recruiting
Treatment Naive
0 Actively Recruiting
compensated liver disease
0 Actively Recruiting
weight between 25-35 kg
0 Actively Recruiting
weight at least 35 kg
0 Actively Recruiting
virologically suppressed for 6 months
0 Actively Recruiting
Human Immunodeficiency Virus Type 1 (HIV-1)
5 Actively Recruiting
Phase 3, Phase 2, Phase 1
Odefsey Reviews: What are patients saying about Odefsey?
4Patient Review
3/24/2019 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 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 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 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.
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