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
-

A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2015-09-22
Last Posted Date
2016-01-20
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT02556086
Locations
🇫🇷

Local Institution, Pessac, France

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

First Posted Date
2015-09-16
Last Posted Date
2016-01-15
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT02551861
Locations
🇫🇷

Local Institution, Vandoeuvre Les Nancy, France

Directly Observed Therapy for HCV in Chennai, India

First Posted Date
2015-09-04
Last Posted Date
2021-04-15
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Target Recruit Count
50
Registration Number
NCT02541409
Locations
🇮🇳

YR Gaitonde Centre for AIDS Research and Education, Chennai, Tamil Nadu, India

Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C

First Posted Date
2015-08-19
Last Posted Date
2020-04-07
Lead Sponsor
University of Aarhus
Target Recruit Count
71
Registration Number
NCT02528461
Locations
🇩🇰

Aarhus University Hospital, Aarhus C, Denmark

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2015-06-30
Last Posted Date
2016-10-13
Lead Sponsor
Stanford University
Registration Number
NCT02485080
Locations
🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

🇺🇸

Yale University Medical Center, New Haven, Connecticut, United States

SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

First Posted Date
2015-06-16
Last Posted Date
2018-03-19
Lead Sponsor
Humanity and Health Research Centre
Target Recruit Count
106
Registration Number
NCT02473211
Locations
🇨🇳

Humanity and Health GI and Liver Centre, Hong Kong, Hong Kong, China

🇨🇳

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital, Beijing, Beijing, China

Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-06-11
Last Posted Date
2020-03-19
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
72
Registration Number
NCT02468648
Locations
🇺🇸

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

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

First Posted Date
2015-04-01
Last Posted Date
2017-12-13
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
120
Registration Number
NCT02405013
Locations
🇨🇮

CHU de Youpougon - Service de Gastro-entéro-hépatologie, Abidjan, Côte D'Ivoire

🇨🇲

Clinique de la Cathédrale, Yaoundé, Cameroon

🇸🇳

CHU Fann, Service des Maladies Infectieuses, Dakar, Senegal

and more 1 locations

A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4

First Posted Date
2015-02-25
Last Posted Date
2016-04-07
Lead Sponsor
Pharco Pharmaceuticals
Target Recruit Count
300
Registration Number
NCT02371408
Locations
🇪🇬

National Liver Institute, Menoufiya, Egypt

🇪🇬

Al-Qahira Al-Fatimeya MoH Hospital, Cairo, Egypt

🇪🇬

Kasr El Aini Viral Hepatitis Center, Cairo, Egypt

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