Tenofovir Disoproxil Fumarate

Antiretroviral Therapy, HIV test negative, HIV Infections + 12 more

Treatment

2 FDA approvals

20 Active Studies for Tenofovir Disoproxil Fumarate

What is Tenofovir Disoproxil Fumarate

Emtricitabine

The Generic name of this drug

Treatment Summary

Tenofovir disoproxil fumarate, sold under the brand name Viread, is a medicine used to treat HIV and hepatitis B. It works by interfering with the reproduction of the virus in the body. This drug belongs to a family of antiretroviral medications known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). Tenofovir disoproxil was first approved by the FDA in 2001.

Emtriva

is the brand name

image of different drug pills on a surface

Tenofovir Disoproxil Fumarate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Emtriva

Emtricitabine

2003

131

Approved as Treatment by the FDA

Emtricitabine, also called Emtriva, is approved by the FDA for 2 uses including HIV and adults and pediatric patients weighing at least 17 kg .

HIV

Helps manage Human Immunodeficiency Virus Type 1 (HIV-1) Infection

adults and pediatric patients weighing at least 17 kg

Effectiveness

How Tenofovir Disoproxil Fumarate Affects Patients

Tenofovir is a drug used to treat HIV-1 and Hepatitis B infections. In laboratory tests, the drug has been shown to be effective against HIV-1 with a 50% effective concentration (EC50) of 0.04 - 8.5 μM. Tenofovir works by preventing viral DNA chain elongation, which stops the virus from replicating. Tenofovir has also been found to have a synergistic effect when taken with other drugs such as nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors.

How Tenofovir Disoproxil Fumarate works in the body

Tenofovir is an antiretroviral drug, which works by blocking the enzyme that helps HIV-infected individuals replicate their virus. Tenofovir is first converted to its active form, and then to its active metabolite, tenofovir diphosphate, which stops the virus from replicating by blocking its natural deoxyribonucleotide substrate. In rare cases, HIV-1 isolates can develop a decreased susceptibility to tenofovir, due to a mutation known as K65R.

When to interrupt dosage

The prescribed dosage of Tenofovir Disoproxil Fumarate is contingent upon the diagnosed condition, including Anti-Retroviral Agents, High Risk Patients and Chronic Hepatitis B. The amount of dosage fluctuates as per the method of delivery (e.g. Tablet or Tablet, film coated) listed in the table beneath.

Condition

Dosage

Administration

Antiretroviral Therapy

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV test negative

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV Infections

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV Transmission

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Anti-Retroviral Agents

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

adults and pediatric patients weighing at least 17 kg

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

not requiring CYP3A inhibitors

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

treatment failure

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Sexual Behavior

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet - Oral, Tablet, Solution, Solution - Oral

Warnings

Tenofovir Disoproxil Fumarate Contraindications

Condition

Risk Level

Notes

HIV

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Emtricitabine may interact with Pulse Frequency

There are 20 known major drug interactions with Tenofovir Disoproxil Fumarate.

Common Tenofovir Disoproxil Fumarate Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The excretion of Abemaciclib can be decreased when combined with Emtricitabine.

Procainamide

Major

The excretion of Procainamide can be decreased when combined with Emtricitabine.

Topotecan

Major

The excretion of Topotecan can be decreased when combined with Emtricitabine.

Cefradine

Minor

The excretion of Cefradine can be decreased when combined with Emtricitabine.

Estrone sulfate

Minor

The excretion of Estrone sulfate can be decreased when combined with Emtricitabine.

Tenofovir Disoproxil Fumarate Toxicity & Overdose Risk

Breastfeeding: HIV-1-infected mothers should not breastfeed their infants to prevent postnatal transmission of HIV-1. If a mother is taking tenofovir disoproxil, she should not breastfeed her infant. Carcinogenesis: Long-term studies in mice and rats have found that tenofovir disoproxil fumarate can increase the risk of liver cancer in mice, but no such risk was found in rats. Pregnancy: Tenofovir disoproxil is classified as a pregnancy Category B drug, meaning it

image of a doctor in a lab doing drug, clinical research

Tenofovir Disoproxil Fumarate Novel Uses: Which Conditions Have a Clinical Trial Featuring Tenofovir Disoproxil Fumarate?

Currently, 46 active trials are evaluating the potential of Tenofovir Disoproxil Fumarate to replace current antiretroviral regimens for adult patients with virologically suppressed HIV-1 RNA (<50 copies/mL) at the start of therapy, as well as for the treatment of Chronic Hepatitis B and HIV (Human Immunodeficiency Virus).

Condition

Clinical Trials

Trial Phases

HIV

163 Actively Recruiting

Phase 2, Not Applicable, Phase 1, Phase 3, Phase 4, Early Phase 1

Sexual Behavior

11 Actively Recruiting

Not Applicable, Phase 4

HIV Infections

0 Actively Recruiting

Anti-Retroviral Agents

0 Actively Recruiting

treatment failure

0 Actively Recruiting

adults and pediatric patients weighing at least 17 kg

0 Actively Recruiting

HIV Transmission

0 Actively Recruiting

Obesity

0 Actively Recruiting

Antiretroviral Therapy

0 Actively Recruiting

HIV

0 Actively Recruiting

Obesity

0 Actively Recruiting

not requiring CYP3A inhibitors

0 Actively Recruiting

HIV test negative

0 Actively Recruiting

HIV

39 Actively Recruiting

Phase 2, Phase 3, Phase 1, Early Phase 1, Not Applicable, Phase 4

Obesity

0 Actively Recruiting

Tenofovir Disoproxil Fumarate Reviews: What are patients saying about Tenofovir Disoproxil Fumarate?

5

Patient Review

6/17/2008

Tenofovir Disoproxil Fumarate for HIV

I've been taking this medication in conjunction with other treatments and it's working really well for me. I didn't have any negative side effects, except for some temporary withdrawal symptoms when I first started taking it, but overall it's a great medication that's helped my cells stay undetectable.

4.7

Patient Review

2/1/2012

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I stopped taking this medication for a while and when I started again, I had itchiness all over my body. After taking it for three months though, I feel much better now and the itching has gone away.

4.3

Patient Review

8/30/2013

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've been taking this medication for six months and my viral load is now undetectable. I'm pleased with this outcome, though my doctor wants me to keep taking the drug and getting tested periodically.

4

Patient Review

8/27/2011

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

This treatment has kept my virus load at a chronic level of below 500iu. In fact, it lowered to 50iu after just six months. And as of now, my current viral load is <20ui.

4

Patient Review

4/28/2015

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've gained weight, gotten chronic headaches, and struggled with insomnia since starting this medication, but it has normalized my liver enzymes.

3

Patient Review

6/22/2012

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've been on this medication for five weeks to treat a viral infection. I'm not seeing the results I want yet, but I'm hopeful that with more time it will be effective.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tenofovir disoproxil fumarate

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

When is the best time to take tenofovir disoproxil fumarate?

"You should take tenofovir tablets with a meal or a snack. (However, if you have been prescribed the combination brand Atripla®, these tablets should be taken when your stomach is empty, which means taking them one hour before any food or waiting until two hours afterwards.)"

Answered by AI

Can tenofovir cure hepatitis B?

"Although Tenofovir cannot cure hepatitis b, it might help to prevent further complications such as cirrhosis of the liver or liver cancer. Additionally, it may prevent the spread of the virus to others. However, there are no generic drugs available for this medication."

Answered by AI

What are the side effects of taking tenofovir?

"The side effects of the medication include diarrhea, headache, depression, rash, itching, fever, difficulty falling asleep or staying asleep, and gas."

Answered by AI

What is tenofovir disoproxil fumarate used for?

"Emtricitabine; Tenofovir Disoproxil Fumarate helps manage HIV infection by limiting the spread of the virus in the body. It can also be used for Prep (pre-exposure prophylaxis) to lower the risk of getting HIV through sex."

Answered by AI

Clinical Trials for Tenofovir Disoproxil Fumarate

Image of Albert Einstein College of Medicine in The Bronx, United States.

Vaginal Estradiol vs Moisturizer for Menopause in Women with HIV

40 - 70
Female
The Bronx, NY

This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.

Phase 4
Waitlist Available

Albert Einstein College of Medicine

Kerry J Murphy, MD

Have you considered Tenofovir Disoproxil Fumarate clinical trials?

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Image of CAN Community Health in Clearwater, United States.

Bictegravir + Emtricitabine + Tenofovir Alafenamide for HIV

18+
All Sexes
Clearwater, FL

Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care. The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines. Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.

Phase 4
Waitlist Available

CAN Community Health (+9 Sites)

Jessica Altamirano, MD

Gilead Sciences

Image of Coastal Family Health Center in Biloxi, United States.

PEACHES 2.0 Strategies for HIV/AIDS

18+
All Sexes
Biloxi, MS

This project will test ways to reduce stigma in healthcare settings so that more providers offer, and more patients receive, important anal sex-related HIV services, including anorectal sexually transmitted infection (STI) testing, preventive medications, and cancer screening. By evaluating these stigma-reduction strategies in eight clinics in the Mississippi Delta, a region with high rates of HIV and STIs, the research team will learn whether and how these approaches work to improve access to care. The results will help guide healthcare systems in using the most effective methods to reduce stigma, making it easier for people to get prevention services and improving public health.

Waitlist Available
Has No Placebo

Coastal Family Health Center

Bryan Kutner, PhD, MPH

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Image of Temple University in Philadelphia, United States.

Mobile Health Application for HIV Prevention and Drug Addiction

18+
Female
Philadelphia, PA

Women involved in the carceral system (WICS) are at higher risk for both HIV and substance use than the general public. WICS are also more likely to engage in behaviors both before and after release that put them at risk for HIV and for overdose, due to opioid use. Despite these risk factors, WICS are less likely to be aware of, use, or adhere to pre-exposure prophylaxis (PrEP) and have less access to medications for opioid use disorder (MOUD). The primary goal of the proposed research is to pilot test a systematically developed PrEP and MOUD uptake intervention for WICS using contextually relevant messages developed through novel formative research methods and embedded in a web-based application in a rigorous research design. The investigators will then test this approach (called PA-LINKS) in a pilot randomized trial with women who have recently been incarcerated in Philadelphia in partnership with Philadelphia FIGHT, a federally qualified health center, for promise of efficacy, and to assess feasibility and acceptability.

Waitlist Available
Has No Placebo

Temple University

Image of Howard Brown Health in Chicago, United States.

Social Network Strategies + Screening for Substance Use Disorder

18+
Male
Chicago, IL

This study aims to improve health care for people who may have HIV or substance use disorders by bringing two services to a large community health center in Chicago. First, the clinic will begin offering routine screening for substance use to all patients. Second, the study will offer a social network-based program that helps people identify friends or partners who may need support and link them to care. The goal is to help more people learn their HIV status, reduce HIV levels in the community, and connect people with substance use treatment when needed. The study will also look at how well these services can be added into everyday clinic practice and what is needed to keep them going over time.

Waitlist Available
Has No Placebo

Howard Brown Health

Britt Skaathun

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