Biktarvy

Anti-Retroviral Agents, HIV, treatment failure + 2 more
Treatment
20 Active Studies for Biktarvy

What is Biktarvy

BictegravirThe 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 an improved version of its predecessor, tenofovir disoproxil, as it has a higher oral bioavailability and is better tolerated by the body. Tenofovir alafenamide is able to provide a high antiviral efficacy at much lower doses than tenofovir disoproxil. It was developed by Gilead Sciences Inc and approved by the FDA in 2015.
Biktarvyis the brand name
image of different drug pills on a surface
Biktarvy Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Biktarvy
Bictegravir
2018
4

Effectiveness

How Biktarvy Affects PatientsTenofovir alafenamide is an effective treatment for hepatitis B. It is much better on the kidneys than its counterpart, tenofovir disoproxil, and has been shown to be 5 times more powerful in its anti-HIV activity.
How Biktarvy works in the bodyTenofovir alafenamide is a drug that accumulates more in peripheral blood cells than it does in red blood cells. It then works to inhibit the replication of viruses, stopping them from reproducing and causing harm to cells. This is done by blocking their polymerase and preventing the synthesis of more viruses.

When to interrupt dosage

The prescribed dosage of Biktarvy is contingent upon the diagnosed circumstance, such as Treatment Naive, Chronic Hepatitis B and compensated liver disease. The quantity of dosage depends on the strategy of delivery as detailed in the table hereunder.
Condition
Dosage
Administration
HIV
50.0 mg, , 30.0 mg
, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral
treatment failure
50.0 mg, , 30.0 mg
, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral
Obesity
50.0 mg, , 30.0 mg
, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral
Anti-Retroviral Agents
50.0 mg, , 30.0 mg
, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral
Antiretroviral Treatment-Naïve
50.0 mg, , 30.0 mg
, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Warnings

There are 20 known major drug interactions with Biktarvy.
Common Biktarvy Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The excretion of Abemaciclib can be decreased when combined with Bictegravir.
Procainamide
Major
The excretion of Procainamide can be decreased when combined with Bictegravir.
Topotecan
Major
The excretion of Topotecan can be decreased when combined with Bictegravir.
Acyclovir
Minor
The excretion of Acyclovir can be decreased when combined with Bictegravir.
Cefradine
Minor
The excretion of Cefradine can be decreased when combined with Bictegravir.
Biktarvy Toxicity & Overdose RiskThe exact toxic dose of tenofovir alafenamide is unknown, so close monitoring of vital signs is necessary in cases of overdose. Tenofovir can be removed from the bloodstream by hemodialysis. Research has only been conducted on tenofovir disoproxil, which was reported to cause liver tumors in female mice that had long-term exposure to high doses. Tenofovir alafenamide has not been linked to any mutagenic effects and does not appear to harm fertility.
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Biktarvy Novel Uses: Which Conditions Have a Clinical Trial Featuring Biktarvy?

55 active clinical trials are currently underway to investigate the potential of Biktarvy to treat conditions without necessitating CYP3A inhibitors, Chronic Hepatitis B and tenofovir.
Condition
Clinical Trials
Trial Phases
HIV
39 Actively Recruiting
Phase 2, Phase 3, Phase 1, Early Phase 1, Not Applicable, Phase 4
Anti-Retroviral Agents
0 Actively Recruiting
treatment failure
0 Actively Recruiting
Antiretroviral Treatment-Naïve
0 Actively Recruiting
Obesity
0 Actively Recruiting

Biktarvy Reviews: What are patients saying about Biktarvy?

5Patient Review
11/8/2019
Biktarvy for HIV
I started taking this two weeks ago with zero side effects. My D# was 402 and should be way above that soon. 11/8/19
5Patient Review
10/22/2018
Biktarvy for HIV
I started taking biktarvy 1.5 months ago when I was diagnosed positive my viral load was 78600 copies and my CD4 was 60 I had another test a little over one month after I began taking biktarvy my viral load dropped to 80 copies and my CD4 went up to 346. I along with my doctor was amazed on how fast it reacted in my body I feel 100% better and put about 23 lbs on engery levels are back to normal and I have so far seen any side effects. I couldnâ??t be more happier of the results !
5Patient Review
5/4/2019
Biktarvy for HIV
I was diagnosed with HIV and my viral load was incredibly high. My CD4 levels were also very low. I started taking this medication and it turned things around for me. It's been a life-saving treatment for sure.
5Patient Review
2/1/2019
Biktarvy for HIV
Biktarvy has really helped me be able to eat and sleep better. It's great that I only have to take one pill a day too!
5Patient Review
12/15/2020
Biktarvy for HIV
I've been managing my HIV diagnosis since 1991 and this is by far the best medication I've taken. No side effects whatsoever.
4Patient Review
2/20/2021
Biktarvy for HIV
I was diagnosed with HIV in 2003 and AIDS in 2005, but I fortunately made a full recovery. Since then, my doctor has had me take many different medications for the virus. Some have caused side effects and some haven't, but this one doesn't seem to have any negative effects on me whatsoever. I actually take it at night to avoid feeling fatigued during the day, and so far so good!
3Patient Review
9/17/2022
Biktarvy for HIV
I was diagnosed in 2017 and started Biktarvy 8 months ago. Iâ??ve experienced an incredible fatigue and an intense depression with suicidal ideation. Iâ??ve never experienced such a mood before.
1Patient Review
10/12/2019
Biktarvy for HIV
My cousin was taking this for a few months when he started to experience changes in his mood, thoughts, and dreams. When he told his doctor about these changes, they brushed it off. Four days after that appointment, he killed himself. If you notice any similar changes in yourself or someone you know while taking this drug, please seek help immediately.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about biktarvy

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

What is the monthly cost of Biktarvy?

"BIKTARVY typically costs between $4 and $9 per month, although the list price is $3,584. Some state Medicaid programs offer even lower co-pays."

Answered by AI

Is Biktarvy a high risk medication?

"Biktarvy may have serious consequences, including lactic acidosis, liver problems, new or worsening kidney problems, and drug interactions."

Answered by AI

Does Biktarvy make you undetectable?

"If you are an adult who is replacing your current treatment with BIKTARVY, it can help you to stay undetectable and maintain your CD4 T-cell count. However, before taking BIKTARVY, you must meet certain requirements that your healthcare provider will determine."

Answered by AI

What is Biktarvy used for?

"BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in certain adults that also comes with an important warning on hepatitis b infection. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS."

Answered by AI

Clinical Trials for Biktarvy

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.
Have you considered Biktarvy clinical trials? We made a collection of clinical trials featuring Biktarvy, we think they might fit your search criteria.Go to Trials
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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 Biktarvy clinical trials? We made a collection of clinical trials featuring Biktarvy, we think they might fit your search criteria.Go to Trials
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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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Tesamorelin + Exercise for HIV

50 - 80
All Sexes
Aurora, CO
People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term. The goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated. During a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently. The investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.
Phase 2
Recruiting
University of Colorado - Anschutz Medical Campus (+1 Sites)Lindsay T. Fourman, MD
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