MedPath

Tenofovir disoproxil

Generic Name
Tenofovir disoproxil
Brand Names
Atripla, Cimduo, Complera, Delstrigo, Stribild, Symfi, Truvada, Viread, Tenofovir disoproxil Mylan
Drug Type
Small Molecule
Chemical Formula
C19H30N5O10P
CAS Number
201341-05-1
Unique Ingredient Identifier
F4YU4LON7I
Background

Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 .

Indication

Tenofovir disoproxil is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients ≥2 years old and weighing ≥10 kg. It is also indicated for the treatment of chronic hepatitis B in patients ≥2 years old and weighing ≥10 kg.

Tenofovir disoproxil is also an ingredient in several combination products, all of which are indicated either alone or in combination with other antiretrovirals for the treatment of HIV-1 infection.

In addition, tenofovir disoproxil is available in combination with emtricitabine (under the brand name Truvada) for use as pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing ≥ 35kg to reduce the risk of sexually-acquired HIV-1 infection.

Associated Conditions
Chronic Hepatitis B Infection, Human Immunodeficiency Virus Type 1 (HIV-1) Infection

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection

Phase 2
Terminated
Conditions
Hepatitis D
Hepatitis B, Chronic
Interventions
First Posted Date
2021-04-19
Last Posted Date
2022-11-18
Lead Sponsor
Antios Therapeutics, Inc
Target Recruit Count
40
Registration Number
NCT04847440
Locations
🇲🇩

Republican Clinical Hospital "Timofei Mosneaga" Arensia EM Unit, Chisinau, Republic Of Moldova, Moldova, Republic of

🇺🇦

Medical Center of Limited Liability Company "Harmoniya krasy", Kyiv, Ukraine

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

Phase 3
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2021-04-15
Last Posted Date
2024-03-05
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Target Recruit Count
475
Registration Number
NCT04846491
Locations
🇨🇳

The First Affiliated Hospital of Fujian Medical University, Fuzhou, China

🇨🇳

Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region, Urumqi, China

🇨🇳

The First Hospital of Shanxi Medical University, Taiyuan, China

and more 30 locations

Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2021-03-15
Last Posted Date
2022-06-22
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
105711
Registration Number
NCT04798287
Locations
🇺🇸

Brigham And Women's Hospital, Boston, Massachusetts, United States

Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints

Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2021-02-26
Last Posted Date
2022-03-02
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
105711
Registration Number
NCT04772248
Locations
🇺🇸

Brigham And Women's Hospital, Boston, Massachusetts, United States

Reducing Vertical Transmission of Hepatitis B in Africa

Phase 3
Recruiting
Conditions
Hepatitis B Infection
Interventions
First Posted Date
2021-01-11
Last Posted Date
2024-10-18
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
450
Registration Number
NCT04704024
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Phase 2
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2020-12-14
Last Posted Date
2024-07-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
48
Registration Number
NCT04667104
Locations
🇯🇵

Tokyo Medical and Dental University Hospital, Bunkyo Ku, Japan

🇯🇵

Osaka University Hospital, Suita-shi, Japan

🇵🇱

Przychodnia EuroMediCare Wroclaw Lowiecka, Wroclaw, Poland

and more 8 locations

TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months

Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2020-12-03
Last Posted Date
2021-01-12
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
200
Registration Number
NCT04650828
Locations
🇨🇳

Chaoshuang Lin, Guangzhou, China

HBsAg Seroclearance in Adults With HBV Related Liver Fibrosis After Receiving Combined Therapy of Peg-IFN and Tenofovir.

Phase 4
Recruiting
Conditions
Liver Fibrosis
Interventions
Drug: PEG-Interferon Alfa, Tenofovir Disoproxil Fumarate
First Posted Date
2020-11-23
Last Posted Date
2024-01-26
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
336
Registration Number
NCT04640129
Locations
🇨🇳

Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

Phase 2
Completed
Conditions
Hepatitis B
Interventions
First Posted Date
2020-10-14
Last Posted Date
2025-05-21
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
24
Registration Number
NCT04585789
Locations
🇧🇪

UZ Antwerpen, Edegem, Belgium

🇫🇷

Hopital Beaujon, Clichy, France

🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

and more 7 locations

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

First Posted Date
2020-09-02
Last Posted Date
2025-04-25
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
52
Registration Number
NCT04535544
Locations
🇯🇵

National Hospital Organization Shikoku Cancer Center, Iizuka-shi, Japan

🇺🇸

Stanford University School of Medicine, Redwood City, California, United States

🇺🇸

Harvard Medical School Massachusetts General Hospital, Boston, Massachusetts, United States

and more 58 locations
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