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
- -
A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
- Conditions
- Interventions
- First Posted Date
- 2015-02-05
- Last Posted Date
- 2017-12-20
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 29
- Registration Number
- NCT02356562
Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- First Posted Date
- 2015-01-07
- Last Posted Date
- 2022-06-29
- Lead Sponsor
- Valme University Hospital
- Target Recruit Count
- 1128
- Registration Number
- NCT02333292
- Locations
- 🇪🇸
Valme University Hospital, Seville, Andalusia, Spain
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
- First Posted Date
- 2014-12-18
- Last Posted Date
- 2017-01-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 53
- Registration Number
- NCT02319031
- Locations
- 🇫🇷
Local Institution, Vandoeuvre Les Nancy, France
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- First Posted Date
- 2014-11-17
- Last Posted Date
- 2023-10-04
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 1609
- Registration Number
- NCT02292706
- Locations
- 🇺🇸
Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States
🇺🇸North Shore Health Inc., Manhasset, New York, United States
🇺🇸Asheville Gastroenterology Associates, PA, Asheville, North Carolina, United States
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
- Conditions
- Interventions
- First Posted Date
- 2014-11-17
- Last Posted Date
- 2021-07-12
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 70
- Registration Number
- NCT02292719
An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection
- First Posted Date
- 2014-10-30
- Last Posted Date
- 2016-10-14
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 63
- Registration Number
- NCT02278419
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
- Conditions
- Interventions
- First Posted Date
- 2014-10-13
- Last Posted Date
- 2019-05-08
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 40
- Registration Number
- NCT02262728
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
- First Posted Date
- 2014-10-01
- Last Posted Date
- 2016-02-24
- Lead Sponsor
- Peter J. Ruane, M.D.
- Target Recruit Count
- 30
- Registration Number
- NCT02253550
- Locations
- 🇺🇸
Peter J. Ruane, MD, Inc., Los Angeles, California, United States
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
- Conditions
- Interventions
- First Posted Date
- 2014-09-26
- Last Posted Date
- 2016-11-17
- Lead Sponsor
- Janssen R&D Ireland
- Target Recruit Count
- 40
- Registration Number
- NCT02250807
SMV + SOF With/Without RBV for IFN-II Patients With CHC
- First Posted Date
- 2014-08-12
- Last Posted Date
- 2018-06-19
- Lead Sponsor
- SC Liver Research Consortium, LLC
- Target Recruit Count
- 24
- Registration Number
- NCT02214420
- Locations
- 🇺🇸
Scripps Clinic, La Jolla, California, United States
🇺🇸Clinical Research Centers of America, LLC, Murray, Utah, United States
🇺🇸Icahn School of Medicine at Mt. Sinai, New York, New York, United States
Drug Development Updates
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