Sovaldi

(sofosbuvir)

ApprovedSmall molecule

Sofosbuvir is used to treat hepatitis C, a viral infection that damages the liver. It works by stopping the hepatitis C virus from reproducing in the body.[2] Sovaldi is currently approved and in use across 18 indications[4].[1]

Sovaldi is one of 521 small molecule programs targeting Hepatitis C. It is currently in Approved.

Indications

187

Total Trials

Active Trials

520

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatitis CRecruiting

CirrhosisCompleted

Chronic HepatitisWithdrawn

TreatmentRecruiting

Liver DiseaseActive, not recruiting

Viral DiseaseActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

ThrombocytopeniaActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

DrugCompleted

Hepatitis CApproved

Recruiting

CirrhosisApproved

Completed

Chronic HepatitisApproved

Withdrawn

TreatmentApproved

Recruiting

Liver DiseaseApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Hepatocellular CarcinomaPreclinical

Active, not recruiting

ThrombocytopeniaPreclinical

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

DrugPreclinical

Completed

Showing 10 of 17 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Sovaldi

Gilead

Approved

14 2

Biltricide

Bayer

Preclinical

4 3

Dexilant

Takeda

Preclinical

2 4

Minipress

Pfizer

Preclinical

1 5

Niclocide

Bayer

Preclinical

1 6

Alfenta

Jazz Pharmaceuticals

Preclinical

1 7

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 8

Valium

Akero Therapeutics

Preclinical

2 9

Intuniv

PPromius Pharma, LLC

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Hepatitis C

NCT06159504

Phase 3Active, not recruiting

Efficacy and Safety

NCT06868264

Q1 2027

Recruiting

Efficacy

NCT06180590

Phase 3Active, not recruiting

HEPATITIS C VIRUS CHRONIC INFECTION

NCT07037277

Q3 2027

Post-ApprovalRecruiting

Treatment

NCT06953479

Q3 2029

ApprovedRecruiting

Hepatitis C

NCT03855917

Clinical

Trials by Indication[1]

Hepatitis C48 trials

Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT02133131·143 enrolled

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 1·NCT02128217·44 enrolled

Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)

Unknown status·MMacfarlane Burnet Institute for Medical Research and Public Health Ltd·Phase 4·NCT05016609·1,800 enrolled

Show 45 more trials

A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT02206932

DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)

Completed·AANRS, Emerging Infectious Diseases·Phase 4·NCT03537196·979 enrolled

Hepatitis C Treatment in Idaho County Jails

Not yet recruiting·EEastern Idaho Public Health·N/A·NCT06533319·100 enrolled

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

Completed·PPartners in Health·Phase 4·NCT02964091·300 enrolled

Surveillance and Treatment of Prisoners With Hepatitis C

Completed·KKirby Institute·Phase 4·NCT02064049·3,692 enrolled

Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

Unknown status·KKirby Institute··NCT03776760·600 enrolled

Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Completed·OOhio State University·Phase 2/3·NCT03801707·54 enrolled

Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Completed·TTehran University of Medical Sciences·Phase 4·NCT03063879·95 enrolled

Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania

Recruiting·MMédecins du Monde·Phase 1·NCT06159504·3,040 enrolled

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)

Completed·KKirby Institute·Phase 4·NCT02156570·20 enrolled

Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

Completed·JJohns Hopkins University·Phase 4·NCT02781649·10 enrolled

Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience

Unknown status·—··NCT02485262·340 enrolled

Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir

Completed·HHannover Medical School·Phase 2·NCT03818308·20 enrolled

Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

Completed·RRight to Care··NCT04038320·868 enrolled

Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

Unknown status·KKirby Institute·N/A·NCT03981211·60 enrolled

Elimination of Hepatitis C Virus Among Users of Substances

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran··NCT05503979·1,000 enrolled

the Pulmonary Safety of Antihepatitis C Treatment

Unknown status·—··NCT04122066·50 enrolled

Transplanting Hepatitis C Positive Organs

Unknown status·—·Phase 4·NCT03086044·148 enrolled

Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02125500·68 enrolled

Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Completed·—·Phase 2/3·NCT05616598·200 enrolled

Hepatitis C Virus(HCV) Heart and Lung Study

Completed·—·Phase 4·NCT02858180·15 enrolled

Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial

Completed·AAla'a Sharara·Phase 4·NCT03032666·7 enrolled

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032888·238 enrolled

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Completed·TTanta University·Phase 4·NCT02992457·10,000 enrolled

Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

Completed·TTehran University of Medical Sciences·Phase 3·NCT02596880·100 enrolled

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

Approved for marketing· Gilead logo

Gilead··NCT01779518

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

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02405013·120 enrolled

Hepatitis C Treatment Study in Myanmar

Withdrawn·MMyanmar Oxford Clinical Research Unit··NCT03158857

Hepatitis c and Vitamin D and Iron Status

Unknown status·EEman Sayed Hassan Abd Allah··NCT03166280·87 enrolled

Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Unknown status·ZZagazig University··NCT02772744·250 enrolled

Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis

Terminated·UUniversity of Colorado, Denver·Phase 3·NCT02455167·9 enrolled

Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)

Completed·IInstituto de Investigación Marqués de Valdecilla·Phase 4·NCT02768961·64 enrolled

Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

Completed· Gilead logo

Gilead·Phase 2·NCT01559844·61 enrolled

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

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT02468648·72 enrolled

Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02717949·1 enrolled

Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1

Completed·TTehran University of Medical Sciences·Phase 3·NCT02705534·50 enrolled

Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2/3·NCT03480932·150 enrolled

Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients

Completed· Gilead logo

Gilead·Phase 2·NCT01188772·147 enrolled

Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

Completed· Gilead logo

Gilead·Phase 2·NCT01329978·332 enrolled

The SIM-SOF Trial for Hepatitis C

Completed·CCenter For Hepatitis C, Atlanta, GA·Phase 4·NCT02168361·93 enrolled

Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

Completed· AbbVie logo

AbbVie·Phase 3·NCT02939989·33 enrolled

Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02358044·257 enrolled

Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients

Completed·TTehran University of Medical Sciences·Phase 4·NCT03200184·1,448 enrolled

A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease

Recruiting·KKirby Institute·Approved·NCT03855917·30 enrolled

Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients

Completed·MMary E. Keebler, MD·Phase 2·NCT03222531·20 enrolled

Chronic Hepatitis34 trials

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02262728·40 enrolled

A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A

Withdrawn·FFundacion SEIMC-GESIDA·Phase 4·NCT03105349

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02161939

Show 31 more trials

Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients

Unknown status·—·Phase 3·NCT03163849·50 enrolled

Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

Completed·UUnknown Sponsor·Phase 4·NCT02220868·10 enrolled

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Completed·CCatherine Anne Chappell·Phase 1·NCT04382404·11 enrolled

Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders

Completed·HHelwan University·Phase 4·NCT04695769·281 enrolled

Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Recruiting·CCatherine Anne Chappell·Phase 4·NCT05140941·100 enrolled

Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03402165·1,200 enrolled

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Completed·—·Phase 2/3·NCT03490097·100 enrolled

Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium

Completed·—··NCT02799355·1,203 enrolled

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

Withdrawn·SStanford University·Phase 4·NCT02485080

Combination Therapy for Chronic Hepatitis C Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01805882·229 enrolled

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

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02551861

EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02097966

A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Terminated· Gilead logo

Gilead··NCT02510300·461 enrolled

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02349048·68 enrolled

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02421211·41 enrolled

8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C

Completed·MMuhammad Radzi Abu Hassan·Phase 2/3·NCT04885855·322 enrolled

Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C

Completed·KKawin Technology Share-holding Co., Ltd.·Phase 2·NCT03416491·110 enrolled

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)

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02556086

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

Completed·UUniversity of Aarhus··NCT02528461·71 enrolled

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

Terminated· Gilead logo

Gilead··NCT02292706·1,609 enrolled

Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea

Completed· Gilead logo

Gilead··NCT02907996·2,033 enrolled

Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

Completed· Gilead logo

Gilead·Phase 2·NCT01435044·239 enrolled

KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

Completed·KKawin Technology Share-holding Co., Ltd.·Phase 3·NCT03995485·371 enrolled

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02175966·35 enrolled

Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT02601573·101 enrolled

HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)

Completed·HHannover Medical School·Phase 2·NCT03282474·10 enrolled

Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03487848·5 enrolled

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

Completed·RR-Pharm·Phase 2·NCT04246723·85 enrolled

Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C

Completed·KKawin Technology Share-holding Co., Ltd.·N/A·NCT03453346·136 enrolled

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

Unknown status·PPharco Pharmaceuticals·Phase 2/3·NCT02371408·300 enrolled

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

Completed· Gilead logo

Gilead·Phase 2·NCT01687270·40 enrolled

Treatment14 trials

Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

Completed· Gilead logo

Gilead·Phase 2·NCT01054729·64 enrolled

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

Completed·HHumanity and Health Research Centre·Phase 2/3·NCT02555943·23 enrolled

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Completed·—·Phase 4·NCT03069001·90 enrolled

Show 11 more trials

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Completed·HHumanity and Health Research Centre·Phase 3·NCT02576314·48 enrolled

Implementing Low-Barrier HCV Treatment in a Jail Setting

Recruiting·LLifespan·Phase 4·NCT06953479·40 enrolled

Strategic Transformation of the Market of HCV Treatments

Unknown status·DDrugs for Neglected Diseases·Phase 2/3·NCT02961426·603 enrolled

Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT03512210·400 enrolled

Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

Unknown status·FFixHepC··NCT02657694·10,000 enrolled

Sofosbuvir in Treatment of COVID 19

Unknown status·TTanta University·Phase 2/3·NCT04460443·60 enrolled

SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Completed·HHumanity and Health Research Centre·Phase 2/3·NCT02473211·106 enrolled

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

Completed· AbbVie logo

AbbVie·Phase 3·NCT02399345·10 enrolled

A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study

Completed·UUniversity of Dundee·Phase 2·NCT03236506·129 enrolled

Effect Of DAAs For Treatment Of HCV On Normal Kidney

Unknown status·—·Phase 4·NCT03296930·100 enrolled

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Unknown status·TTanta University·Phase 2/3·NCT04497649·100 enrolled

Chronic Hepatitis C Virus Infection7 trials

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT05717400·2 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT02292719·70 enrolled

A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use

Completed·KKirby Institute·Phase 2·NCT02336139·103 enrolled

Show 4 more trials

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02114151·103 enrolled

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection

Completed· AbbVie logo

AbbVie·Phase 3·NCT02723084·136 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT02356562·29 enrolled

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02114177·310 enrolled

Efficacy and Safety7 trials

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

Completed· Gilead logo

Gilead·Phase 3·NCT01910636·153 enrolled

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

Active, not recruiting·AAtea Pharmaceuticals, Inc.·Phase 3·NCT06868264·880 enrolled

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Completed·VValme University Hospital··NCT02333292·1,128 enrolled

Show 4 more trials

A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

Completed· AbbVie logo

AbbVie·Phase 3·NCT02640157·506 enrolled

Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02647632·26 enrolled

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

Completed· Gilead logo

Gilead·Phase 3·NCT02021643·687 enrolled

Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon

Completed·PPharmEvo Pvt Ltd·Phase 4·NCT02804386·573 enrolled

44 more indications

Liver Transplant6 trials

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02165189·46 enrolled

Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)

Terminated·UUniversity Health Network, Toronto·Phase 3·NCT02478229·1 enrolled

LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Completed·MMedical University of South Carolina·Phase 4·NCT02631772·32 enrolled

Show 3 more trials

The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

Completed·FFernanda P Silveira, MD, MS·Phase 2·NCT03819322·73 enrolled

Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C

Terminated·MMassBiologics·Phase 2·NCT01532908·11 enrolled

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032875·116 enrolled

Hepatitis C Virus Infection6 trials

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients

Unknown status·IIran Hepatitis Network·Phase 3·NCT03061032·200 enrolled

Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

Unknown status·GGinkgopharma CO., LTD·Phase 3·NCT04001608·206 enrolled

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02250807·40 enrolled

Show 3 more trials

Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

Completed·—·Phase 2·NCT02253550·30 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02278419·63 enrolled

Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients

Unknown status·GGinkgopharma CO., LTD·Phase 2·NCT04111367·36 enrolled

Cirrhosis5 trials

Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

Completed· Gilead logo

Gilead·Phase 4·NCT02128542·66 enrolled

The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China

Unknown status·PPeking University First Hospital·Phase 4·NCT04997564·120 enrolled

To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis

Terminated·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02464631·62 enrolled

Show 2 more trials

Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis

Unknown status·PPeking University People's Hospital·Phase 4·NCT05467826·100 enrolled

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02319031·53 enrolled

COVID-195 trials

Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment

Completed·—·Phase 3·NCT04530422·250 enrolled

Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19

Completed·SShin Poong Pharmaceutical Co. Ltd.·Phase 2·NCT04532931·192 enrolled

Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)

Unknown status·MMansoura University·Phase 3·NCT04535869·50 enrolled

Show 2 more trials

Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19

Completed·—·Phase 4·NCT04498936·240 enrolled

COVID-19 Prophylaxis South Africa (COVER HCW)

Completed·UUniversity of Witwatersrand, South Africa·Phase 2·NCT04561063·1,950 enrolled

Safety and Efficacy5 trials

Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

Completed·TTarek I. Hassanein, M.D., FACP, FAG, AGAF·Phase 4·NCT02304159·39 enrolled

A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection

Completed·—·Phase 3·NCT03186313·72 enrolled

Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection

Completed·—·Phase 2/3·NCT02483156·80 enrolled

Show 2 more trials

Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients

Unknown status·NNational Liver Institute, Egypt·Phase 2/3·NCT02985281·41 enrolled

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

Completed· Gilead logo

Gilead·Phase 3·NCT02074514·117 enrolled

Chronic4 trials

Metabolic Changes in Chronic HCV Patients Receiving DAAS

Unknown status·—··NCT04211844·100 enrolled

The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

Unknown status·MMTI University·Phase 4·NCT04169464·200 enrolled

Direct Acting Anti-Viral's In Chronic HCV Patients

Completed·GGetz Pharma··NCT04664894·511 enrolled

Show 1 more trial

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Unknown status·NNational Hepatology & Tropical Medicine Research Institute·Phase 3·NCT02771405·150 enrolled

HCV Infection3 trials

Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy

Unknown status·WWilhelminenspital Vienna·Phase 4·NCT02638233·40 enrolled

Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Completed· Gilead logo

Gilead·Phase 3·NCT01641640·328 enrolled

Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia

Active, not recruiting·AANRS, Emerging Infectious Diseases·N/A·NCT05992077·21,000 enrolled

Drug2 trials

A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams

Completed·KKirby Institute·N/A·NCT03492112·101 enrolled

The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach

Unknown status·MMacfarlane Burnet Institute for Medical Research and Public Health Ltd·Phase 3·NCT02363517·420 enrolled

Kidney Transplant2 trials

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

Active, not recruiting·—·Phase 2·NCT03809533·30 enrolled

Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

Completed·UUniversity of California, San Francisco·Phase 4·NCT03619837·122 enrolled

Efficacy2 trials

The Efficacy of Vosevi in Treating DAA-experienced Patients

Recruiting·TThe Third Affiliated Hospital of Guangzhou Medical University··NCT06180590·200 enrolled

Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT02745535·77 enrolled

Immunodeficiency2 trials

Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

Completed·TTehran University of Medical Sciences·Phase 3·NCT03369327·232 enrolled

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

Completed· Gilead logo

Gilead·Phase 3·NCT01783678·275 enrolled

Age2 trials

Management of Decompensated HCV Cirrhotic Patients

Completed·ZZagazig University·N/A·NCT03547895·80 enrolled

Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Completed·—·N/A·NCT03549832·40 enrolled

Antiviral Drug1 trial

Effect of Direct-acting Antiviral Drugs on Erectile Function

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT03444272·105 enrolled

Hepatocellular Carcinoma1 trial

Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

Unknown status·MMTI University··NCT03247296·200 enrolled

Opioid Use Disorder1 trial

Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection

Completed·—·Phase 4·NCT03057847·32 enrolled

Insulin resistance1 trial

Effect of Hepatitis C Clearance on Insulin Resistance

Completed·—·Phase 4·NCT04457050·160 enrolled

Elderly1 trial

Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients

Completed·AAzienda Ospedaliera San Camillo Forlanini·Phase 4·NCT02702739·270 enrolled

ACL1 trial

Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt

Completed·—·Phase 4·NCT04773756·54 enrolled

HIV1 trial

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

Completed·NNational Taiwan University Hospital·Phase 4·NCT03250910·228 enrolled

Chronic Kidney Disease1 trial

Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)

Terminated·MMassachusetts General Hospital·N/A·NCT02503735·14 enrolled

Acceptability1 trial

Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children

Unknown status·—·Phase 3·NCT05854511·30 enrolled

Concentration1 trial

Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

Completed·HHospices Civils de Lyon··NCT03318887·130 enrolled

Liver1 trial

deLIVER: Direct Acting Antiviral Effects on the Liver

Completed·JJohns Hopkins University·Phase 4·NCT02938013·15 enrolled

Prophylaxis1 trial

HCV Post-Exposure Prophylaxis for Health Care Workers

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT03313414

Lymphoma1 trial

Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection

Completed·FFondazione Italiana Linfomi - ETS·Phase 2·NCT02836925·40 enrolled

Angiogenesis1 trial

Effect of Sofosbuvir-daclatasuvir on Angiogenesis

Unknown status·SSherief Abd-Elsalam·N/A·NCT03646396·40 enrolled

Complication1 trial

Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir in Patients With Hepatitis C

Unknown status·MMohamed Saad··NCT04159246·30 enrolled

Growth1 trial

Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera

Unknown status·—·Phase 1·NCT03882307·40 enrolled

LPA1 trial

Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet

Withdrawn·RRadboud University Medical Center·Phase 4·NCT03389061

Thrombocytopenia1 trial

The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia

Unknown status·—·N/A·NCT03169348·50 enrolled

Adolescent1 trial

PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders

Unknown status·—·Phase 3·NCT04353986·24 enrolled

Lung Transplant1 trial

Lung Transplant HCV, Pilot Study

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT03112044·26 enrolled

TIA1 trial

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Completed·—·Phase 2·NCT04385407·203 enrolled

Pilot Study1 trial

A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic

Completed·CCommunity Research Initiative of New England·Phase 4·NCT03235154·11 enrolled

Kidney Failure1 trial

Safety of Sofosbuvir in People With Advanced Kidney Failure

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 3·NCT03883698·30 enrolled

Hepatic Impairment1 trial

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

Completed·VViriom·Phase 1·NCT03706898·36 enrolled

EGFR1 trial

eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs

Completed·NNational Taiwan University Hospital··NCT04047680·441 enrolled

Tics1 trial

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

Completed· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1/2·NCT04202952·24 enrolled

Hepatitis B Virus Infection1 trial

Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT03312023·21 enrolled

HCV1 trial

Directly Observed Therapy for HCV in Chennai, India

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2·NCT02541409·50 enrolled

Phase II1 trial

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032901·173 enrolled

Hepatitis1 trial

The Kentucky Viral Hepatitis Treatment Study

Completed·JJennifer Havens·Phase 4·NCT03949764·374 enrolled

HEPATITIS C VIRUS CHRONIC INFECTION1 trial

An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study

Active, not recruiting·AAtea Pharmaceuticals, Inc.·Phase 3·NCT07037277·880 enrolled

Unspecified2 trials

Phase 3 Study of Sofosbuvir and Ribavirin

Completed· Gilead logo

Gilead·Phase 3·NCT01497366·527 enrolled

SMV + SOF With/Without RBV for IFN-II Patients With CHC

Completed·SSC Liver Research Consortium, LLC·Phase 4·NCT02214420·24 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 28, 2019

SOVALDI

NDA NDA212480

Aug 28, 2019

SOVALDI

NDA NDA204671

Sources

References

[1]
ClinicalTrials.gov — 187 trial records for sofosbuvir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sovaldi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — sofosbuvir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for sofosbuvir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212480). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sovaldi. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RNA-Directed RNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Patent Landscape[6]

Patent Cliff

Mar 21, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8580765Mar 21, 2028

7964580Mar 26, 2029

8633309Mar 26, 2029

9549941Mar 26, 2029

9549941*PEDSep 26, 2029

Sovaldi

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q3 2029

Trials by Indication[1]

Hepatitis C48 trials

Chronic Hepatitis34 trials

Treatment14 trials

Chronic Hepatitis C Virus Infection7 trials

Efficacy and Safety7 trials

Liver Transplant6 trials

Hepatitis C Virus Infection6 trials

Cirrhosis5 trials

COVID-195 trials

Safety and Efficacy5 trials

Chronic4 trials

HCV Infection3 trials

Drug2 trials

Kidney Transplant2 trials

Efficacy2 trials

Immunodeficiency2 trials

Age2 trials

Antiviral Drug1 trial

Hepatocellular Carcinoma1 trial

Opioid Use Disorder1 trial

Insulin resistance1 trial

Elderly1 trial

ACL1 trial

HIV1 trial

Chronic Kidney Disease1 trial

Acceptability1 trial

Concentration1 trial

Liver1 trial

Prophylaxis1 trial

Lymphoma1 trial

Angiogenesis1 trial

Complication1 trial

Growth1 trial

LPA1 trial

Thrombocytopenia1 trial

Adolescent1 trial

Lung Transplant1 trial

TIA1 trial

Pilot Study1 trial

Kidney Failure1 trial

Hepatic Impairment1 trial

EGFR1 trial

Tics1 trial

Hepatitis B Virus Infection1 trial

HCV1 trial

Phase II1 trial

Hepatitis1 trial

HEPATITIS C VIRUS CHRONIC INFECTION1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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