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 Obesity and HIV-1 RNA Less Than or Equal to 100,000 copies/mL .
Obesity
Used to treat weight at least 35 kg 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
HIV
Used to treat Human Immunodeficiency Virus Type 1 (HIV-1) Infection in combination with null
Treatment Naive
Used to treat Treatment Naive 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
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
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, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection
Obesity
, 25.0 mg, 300.0 mg/mL, 600.0 mg, 900.0 mg
Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Kit; Suspension, extended release - Intramuscular, Kit; Suspension, extended release, Intramuscular, Injection - Intramuscular, Injection

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
Treatment Naive
0 Actively Recruiting
HIV-1 RNA Less Than or Equal to 100,000 copies/mL
0 Actively Recruiting
virologically-suppressed
0 Actively Recruiting
Obesity
0 Actively Recruiting
Viral Resistance
0 Actively Recruiting
Human Immunodeficiency Virus Type 1 (HIV-1)
5 Actively Recruiting
Phase 3, Phase 1, Early Phase 1
HIV
39 Actively Recruiting
Phase 2, Phase 3, Phase 1, Early Phase 1, Not Applicable, Phase 4

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

Image of UCSF Zuckerberg San Francisco General Hospital in San Francisco, United States.

MucoCept-CVN for HIV Prevention

18 - 45
Female
San Francisco, CA
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.
Phase 1
Waitlist Available
UCSF Zuckerberg San Francisco General HospitalCraig Cohen, MD, MPHOsel, Inc.
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Image of Massachusetts General Hospital in Boston, United States.

SGLT2 Inhibitors for Metabolic Diseases

45 - 75
Female
Boston, MA
Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.
Phase 2
Recruiting
Massachusetts General HospitalMarkella V Zanni, MD
Have you considered Odefsey clinical trials? We made a collection of clinical trials featuring Odefsey, we think they might fit your search criteria.Go to Trials
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Acceptance and Commitment Therapy for Alcohol Consumption in People with HIV

18+
All Sexes
Syracuse, NY
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and/or other behaviors to escape or avoid unwanted thoughts, feelings, and/or urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH/NIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.
Recruiting
Has No Placebo
Syracuse University
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GS-1720 + GS-4182 for HIV

18+
All Sexes
West Hollywood, CA
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
Phase 2 & 3
Waitlist Available
Mills Clinical Research (+25 Sites)Gilead Study DirectorGilead Sciences
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DOVATO for HIV

18+
All Sexes
Regina, Canada
The goal of this clinical trial is to determine the efficacy of Dolutegravir/Lamivudine (DTG/3TC), or "Dovato", in virally-suppressed (HIV-1 RNA \< 200 copies/mL) individuals receiving opioid agonist therapy such as methadone, buprenorphine, slow-release morphine, after switching from their current suppressive antiretroviral therapy (ART). The main questions this trial seeks to answer are: 1. whether people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) remain virally suppressed after switching to DTG/3TC from their current suppressive ART 48 weeks post-switch; 2. the number and type of adverse events (AEs) and serious adverse events (SAEs) attributable to DTG/3TC as documented per standard process at each study visit, and any discontinuations of DTG/3TC due to AEs and SAEs as determined by the study investigator; 3. the number of dosing changes in OAT attributable to DTG/3TC as determined by the study investigator and documented as per standard progress at each study visit; 4. the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed (HIV-1 RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC; 5. any change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC of serum creatinine and non-fasting lipid parameters; 6. any change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIV Treatment Satisfaction Questionnaire (Status) (HIVTSQs) scores; 7. the number of persons who remain virally suppressed (HIV RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC in conjunction with differing levels of adherence to DTG/3TC, and; 8. the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events) During the course of the study, participants will complete: * A set of questionnaires * Blood draws * A review of adverse events and concomitant medications * ECG scans at screening and 48 weeks * Urine drug screening * Physical exams * Review of alcohol consumption
Phase 4
Waitlist Available
Saskatchewan Health AuthorityViiV Healthcare
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