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.
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- 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
- -
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
- First Posted Date
- 2012-07-17
- Last Posted Date
- 2014-05-08
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 328
- Registration Number
- NCT01641640
- Locations
- 🇺🇸
Peter J. Ruane, MD, Inc., Los Angeles, California, United States
🇺🇸Borland-Groover Clinic Baptist, Jacksonville, Florida, United States
🇺🇸Infectious Disease Specialist of Atlanta, Decatur, Georgia, United States
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
- Conditions
- Interventions
- First Posted Date
- 2012-03-21
- Last Posted Date
- 2016-07-27
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 61
- Registration Number
- NCT01559844
- Locations
- 🇺🇸
UCLA Medical Center-The Pfleger Liver Institute, Los Angeles, California, United States
🇺🇸St. Louis University Hospital, St. Louis, Missouri, United States
🇺🇸Baylor Health Care System, Dallas, Texas, United States
Phase 3 Study of Sofosbuvir and Ribavirin
- First Posted Date
- 2011-12-22
- Last Posted Date
- 2014-04-02
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 527
- Registration Number
- NCT01497366
- Locations
- 🇺🇸
Peter J. Ruane, M.D. Inc., Los Angeles, California, United States
🇺🇸AIDS Research Consortium of Atlanta, Inc., Atlanta, Georgia, United States
🇺🇸Atlanta Gastroenterology Associates, Atlanta, Georgia, United States
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
- Conditions
- Interventions
- First Posted Date
- 2011-09-15
- Last Posted Date
- 2014-02-06
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 239
- Registration Number
- NCT01435044
- Locations
- 🇺🇸
Advanced Research Institute, Trinity, Florida, United States
🇺🇸UCSD Antiviral Research Center, San Diego, California, United States
🇺🇸eStudy Site, San Diego, California, United States
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
- First Posted Date
- 2011-04-06
- Last Posted Date
- 2014-05-26
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 332
- Registration Number
- NCT01329978
- Locations
- 🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸Asheville Gastroenterology Associates, Asheville, North Carolina, United States
🇺🇸St. Louis University Gastroenterology and Hepatology Clinical Research, St. Louis, Missouri, United States
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
- Conditions
- Interventions
- First Posted Date
- 2010-08-25
- Last Posted Date
- 2014-04-21
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 147
- Registration Number
- NCT01188772
- Locations
- 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸Dr. Bruce Bacon, St. Louis, Missouri, United States
🇺🇸Cedars Sinai Medical Center, Los Angeles, California, United States
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
- First Posted Date
- 2010-01-22
- Last Posted Date
- 2014-04-17
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 64
- Registration Number
- NCT01054729
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸Alamo Medical Research Center, San Antonio, Texas, United States
🇺🇸Virginia Mason Medical Center, Seattle, Washington, United States
Drug Development Updates
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