Sofosbuvir

Generic Name
Sofosbuvir
Brand Names
Epclusa, Harvoni, Sovaldi, Vosevi
Drug Type
Small Molecule
Chemical Formula
C22H29FN3O9P
CAS Number
1190307-88-0
Unique Ingredient Identifier
WJ6CA3ZU8B
Background

Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, ...

Indication

Sofosbuvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients. Depending on the level of cirrhosis or decompensation, combination therapy can also include either ribavirin alone or ribavirin and peg-interferon alfa.
...

Associated Conditions
Chronic Hepatitis C - Genotype 3, Chronic Hepatitis C Genotype 1, Chronic Hepatitis C Virus (HCV) Infection, Chronic hepatitis C genotype 1a, Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 5, Genotype 4 Chronic Hepatitis C, Genotype 6 chronic hepatitis C infection
Associated Therapies
-
Clinical Trials
Related News

Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

Phase 3
Completed
Conditions
Chronic HCV Infection
Interventions
Drug: Sofosbuvir
Drug: RBV
First Posted Date
2014-02-28
Last Posted Date
2016-10-25
Lead Sponsor
Gilead Sciences
Target Recruit Count
117
Registration Number
NCT02074514

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Phase 3
Completed
Conditions
Hepatitis C
Interventions
Drug: Daclatasvir
Drug: Sofosbuvir
First Posted Date
2014-01-10
Last Posted Date
2015-10-01
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
173
Registration Number
NCT02032901
Locations
🇺🇸

Scripps Clinic, La Jolla, California, United States

🇺🇸

University of Florida Hepatology Research, Gainesville, Florida, United States

🇺🇸

Midland Florida Clinical Research Center, LLC, Deland, Florida, United States

and more 28 locations

A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

Phase 3
Completed
Conditions
Hepatitis C
Interventions
Drug: Daclatasvir
Drug: Sofosbuvir
First Posted Date
2014-01-10
Last Posted Date
2015-10-27
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
238
Registration Number
NCT02032888
Locations
🇺🇸

University Gastroenterology, Providence, Rhode Island, United States

🇺🇸

Lehigh Valley Health Network, Allentown, Pennsylvania, United States

🇺🇸

Tarrant County Inf Dis Assoc, Fort Worth, Texas, United States

and more 34 locations

Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant

First Posted Date
2014-01-10
Last Posted Date
2017-02-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
116
Registration Number
NCT02032875
Locations
🇺🇸

University Of Miami Schiff Center For Liver Diseases, Miami, Florida, United States

🇺🇸

University Of Michigan Health System, Ann Arbor, Michigan, United States

🇺🇸

Baylor St. Luke'S Medical Center, Houston, Texas, United States

and more 2 locations

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

Phase 3
Completed
Conditions
Chronic HCV Infection
Interventions
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
First Posted Date
2013-12-27
Last Posted Date
2018-02-20
Lead Sponsor
Gilead Sciences
Target Recruit Count
687
Registration Number
NCT02021643

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Phase 3
Completed
Conditions
Hepatitis C
Interventions
Drug: Sofosbuvir
Drug: RBV
First Posted Date
2013-07-29
Last Posted Date
2015-03-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
153
Registration Number
NCT01910636

Combination Therapy for Chronic Hepatitis C Infection

First Posted Date
2013-03-06
Last Posted Date
2017-06-08
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
229
Registration Number
NCT01805882
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

🇺🇸

Family Medical and Conseling Services, Washington, D.C., District of Columbia, United States

🇺🇸

Unity Health Care, Inc./DC General, Washington, D.C., District of Columbia, United States

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

First Posted Date
2013-02-05
Last Posted Date
2015-04-30
Lead Sponsor
Gilead Sciences
Target Recruit Count
275
Registration Number
NCT01783678

Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

First Posted Date
2013-01-30
Last Posted Date
2014-01-16
Lead Sponsor
Gilead Sciences
Registration Number
NCT01779518

Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

First Posted Date
2012-09-18
Last Posted Date
2014-12-19
Lead Sponsor
Gilead Sciences
Target Recruit Count
40
Registration Number
NCT01687270
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