Hepatitis C

Infectious Diseases
124
Pipeline Programs
23
Companies
50
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
38
4
36
3
24
19
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
44100%
+ 140 programs with unclassified modality

On Market (4)

Approved therapies currently available

VP
INCIVEKApproved
telaprevir
Vertex Pharmaceuticals
oral2011
GS
SOVALDIApproved
sofosbuvir
Gilead Sciences
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]oral2013
M&
VICTRELISApproved
boceprevir
Merck & Co.
oral2011
GS
VOSEVIApproved
sofosbuvir, velpatasvir, and voxilaprevir
Gilead Sciences
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]oral2017

Competitive Landscape

23 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
54 programs
6
9
1
2
3
Sofosbuvir/Velpatasvir Treatment for 14 daysPhase 4
Sofosbuvir/Velpatasvir Treatment for 14 daysPhase 41 trial
Sofosbuvir/velpatasvirPhase 4Small Molecule1 trial
SOVALDI(SOF)Phase 35 trials
SOF/VEL/VOXPhase 31 trial
+49 more programs
Active Trials
NCT03000023Completed100Est. Jul 2018
NCT02573376Completed73Est. Jun 2021
NCT04061551Unknown25Est. Dec 2021
+36 more trials
M&
Merck & Co.RAHWAY, NJ
41 programs
11
4
1
4
7
EBR/GZRPhase 41 trial
Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]Phase 41 trial
Elbasvir/grazoprevirPhase 4Small Molecule1 trial
Grazoprevir/ElbasvirPhase 4Small Molecule1 trial
MK-5172APhase 41 trial
+36 more programs
Active Trials
NCT03127358Completed11Est. Feb 2019
NCT03441542Terminated6Est. Feb 2019
NCT03426787Completed70Est. Jul 2019
+36 more trials
VP
25 programs
7
2
8
1
5
1
TelaprevirPhase 4Small Molecule1 trial
MP-424Phase 31 trial
MP-424Phase 31 trial
Pegylated Interferon Alfa 2aPhase 31 trial
TelaprevirPhase 3Small Molecule1 trial
+20 more programs
Active Trials
NCT00916474Completed408Est. Dec 2013
NCT00630058Completed20Est. Mar 2009
NCT00973388Completed44Est. Jan 2010
+21 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
4 programs
1
1
ABT450r-ABT267-ABT333 +/- RibavirinPhase 41 trial
ABT-450Phase 2
Functional Hepatic Nitrogen ClearanceN/A1 trial
Telehealth in Parole/Probation OfficeN/A1 trial
Active Trials
NCT02526641Completed16Est. Nov 2020
NCT05413785Completed77Est. May 2024
NCT02734173Completed24Est. May 2017
Astellas
AstellasChina - Shenyang
4 programs
2
1
1
Pegylated InterferonPhase 41 trial
Interferon alfacon-1Phase 31 trial
FK788Phase 21 trial
TacrolimusPhase 21 trial
Active Trials
NCT00047814Completed48Est. Mar 2006
NCT00295607Completed138Est. Jun 2008
NCT00239252Completed
+1 more trials
Tempus
TempusIL - Chicago
2 programs
2
Pegylated IFN- alpha 2bPhase 41 trial
Pegylated interferon alpha 2Phase 41 trial
Active Trials
NCT00277862CompletedEst. Apr 2007
NCT00241618CompletedEst. Jan 2006
Bristol Myers Squibb
15 programs
5
2
4
DaclatasvirPhase 3Small Molecule1 trial
DaclatasvirPhase 3Small Molecule5 trials
DaclatasvirPhase 3Small Molecule1 trial
Peginterferon Lambda-1aPhase 34 trials
DCV/ASV/BMS-791325Phase 21 trial
+10 more programs
Active Trials
NCT02865369Unknown103Est. Dec 2022
NCT02580474Completed21Est. Apr 2018
NCT02727933Completed1,941Est. Jul 2020
+28 more trials
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
10 programs
4
2
4
BI 201335Phase 31 trial
BI 201335 high dosePhase 31 trial
BI201335Phase 31 trial
PegIFN/RBVPhase 31 trial
BI 201335Phase 21 trial
+5 more programs
Active Trials
NCT01580306Completed32Est. Jun 2012
NCT01637922Completed34Est. Nov 2012
NCT01909778Completed2Est. Oct 2008
+7 more trials
Debiopharm
DebiopharmSwitzerland - Lausanne
8 programs
3
4
AlisporivirPhase 3Small Molecule1 trial
AlisporivirPhase 3Small Molecule1 trial
AlisporivirPhase 3Small Molecule1 trial
AlisporivirPhase 3Small Molecule1 trial
AlisporivirPhase 2Small Molecule1 trial
+3 more programs
Active Trials
NCT01970904CompletedEst. Mar 2015
NCT01215643CompletedEst. May 2012
NCT02094443CompletedEst. Apr 2015
+5 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
2 programs
1
1
calcineurin inhibitor-based immunosuppressionPhase 21 trial
ITX 5061Phase 11 trial
Active Trials
NCT01165359CompletedEst. Mar 2012
NCT00135694CompletedEst. Sep 2015
Cellectar Biosciences
Cellectar BiosciencesFLORHAM PARK, NJ
2 programs
1
1
NOV-205Phase 21 trial
NOV-205Phase 11 trial
Active Trials
NCT00372983CompletedEst. Dec 2007
NCT01058512CompletedEst. Dec 2010
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
PF-00868554Phase 23 trials
filibuvir + Oral ContraceptivesPhase 11 trial
Active Trials
NCT00918476Completed14Est. Feb 2011
NCT00861458Completed14Est. Jun 2009
NCT00823745Completed7Est. Feb 2009
+1 more trials
Atea Pharmaceuticals
2 programs
1
1
AT-527Phase 21 trial
AT-777Phase 1/21 trial
Active Trials
NCT04309734WithdrawnEst. Sep 2022
NCT04019717CompletedEst. Mar 2020
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
1
UT-231BPhase 21 trial
Active Trials
NCT00069511Unknown72Est. Dec 2004
BioLineRx
BioLineRxIsrael - Modi’in
1 program
1
RibavirinPhase 1/21 trial
Active Trials
NCT01833845TerminatedEst. Apr 2014
Abbott
AbbottABBOTT PARK, IL
3 programs
1
ABT-072Phase 12 trials
Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II TestN/A1 trial
Panbio™ HCV Self TestN/A1 trial
Active Trials
NCT00979979Completed255Est. Oct 2013
NCT06492018Not Yet Recruiting150Est. Mar 2025
NCT01221298Completed11Est. Apr 2012
+1 more trials
Cocrystal Pharma
Cocrystal PharmaBOTHELL, WA
1 program
1
CDI-31244Phase 11 trial
Active Trials
NCT02760758CompletedEst. Apr 2017
City Therapeutics
City TherapeuticsMA - Cambridge
2 programs
Accessible CareN/A1 trial
Bundled HCV/HIV ScreeningN/A1 trial
Active Trials
NCT03214679CompletedEst. Jun 2021
NCT03252483CompletedEst. May 2013
Cook Medical
Cook MedicalIN - Bloomington
1 program
Control GroupN/A1 trial
Active Trials
NCT02641158CompletedEst. May 2018
Roche
RocheSTAVANGER NORWAY, Norway
1 program
Peginterferon Alpha-2aN/A1 trial
Active Trials
NCT00252642Completed60Est. Sep 2007
Design Therapeutics
1 program
Register of Telaprevir and Boceprevir in Routine Clinical PracticeN/A1 trial
Active Trials
NCT02004379CompletedEst. Jun 2015
Arrowhead Pharmaceuticals
1 program
Sofosbuvir and simeprevirN/ASmall Molecule1 trial
Active Trials
NCT02485262Unknown340Est. Nov 2016
Alliance Pharmaceuticals
1 program
Tele-HCVN/A1 trial
Active Trials
NCT04798521Completed203Est. Jan 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Gilead SciencesSOF
Gilead SciencesSofosbuvir/velpatasvir
Merck & Co.Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Gilead SciencesSofosbuvir/Velpatasvir Treatment for 14 days
Merck & Co.Zepatier
Merck & Co.Elbasvir/grazoprevir
Merck & Co.EBR/GZR
Merck & Co.Zepatier
Merck & Co.MK-5172A
Merck & Co.Grazoprevir/Elbasvir
Gilead SciencesSOF
Gilead SciencesSOF
Bristol Myers SquibbAsunaprevir
Gilead SciencesSOF
AbbVieABT450r-ABT267-ABT333 +/- Ribavirin

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 7,780 patients across 50 trials

NCT03987503Gilead SciencesSOF

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Start: Jul 2020Est. completion: Dec 202287 patients
Phase 4Completed
NCT03949764Gilead SciencesSofosbuvir/velpatasvir

The Kentucky Viral Hepatitis Treatment Study

Start: Sep 2019Est. completion: Jun 2025374 patients
Phase 4Completed
NCT03365635Merck & Co.Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]

Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C

Start: Sep 2019Est. completion: Sep 20206 patients
Phase 4Completed
NCT03313414Gilead SciencesSofosbuvir/Velpatasvir Treatment for 14 days

HCV Post-Exposure Prophylaxis for Health Care Workers

Start: Aug 2019Est. completion: Jan 20200
Phase 4Withdrawn
NCT03791814Merck & Co.Zepatier

A Prospective Cohort Study to Improve HCV Care in Dialysis Patients

Start: Jan 2019Est. completion: Jun 20190
Phase 4Withdrawn
NCT03585101Merck & Co.Elbasvir/grazoprevir

A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk

Start: Aug 2018Est. completion: Apr 20200
Phase 4Withdrawn
NCT03420300Merck & Co.EBR/GZR

EBR/GZR for HCV-1b Patients Receiving Hemodialysis

Start: Jun 2018Est. completion: Feb 202040 patients
Phase 4Completed
NCT02895958Merck & Co.Zepatier

The Dublin Zepatier Study

Start: Mar 2018Est. completion: Dec 20193 patients
Phase 4Terminated
NCT03143998Merck & Co.MK-5172A

Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)

Start: Feb 2018Est. completion: Jan 20190
Phase 4Withdrawn
NCT03359746Merck & Co.Grazoprevir/Elbasvir

Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant

Start: Dec 2017Est. completion: Dec 201840 patients
Phase 4Unknown
NCT02858180Gilead SciencesSOF

Hepatitis C Virus(HCV) Heart and Lung Study

Start: Dec 2016Est. completion: Jul 201915 patients
Phase 4Completed
NCT02691728Gilead SciencesSOF

Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

Start: Feb 2016Est. completion: May 201740 patients
Phase 4Unknown
NCT02580474Bristol Myers SquibbAsunaprevir

The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Start: Feb 2016Est. completion: Apr 201821 patients
Phase 4Completed
NCT02638233Gilead SciencesSOF

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

Start: Sep 2015Est. completion: Sep 201640 patients
Phase 4Unknown
NCT02734173AbbVieABT450r-ABT267-ABT333 +/- Ribavirin

Pilot HCV Direct Acting Antiviral Therapy and Metabolism

Start: Jul 2015Est. completion: May 201724 patients
Phase 4Completed
NCT01467492Vertex PharmaceuticalsTelaprevir

Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

Start: Jan 2012Est. completion: May 2014121 patients
Phase 4Terminated
NCT00167557AstellasPegylated Interferon

Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment

Start: Jan 2005Est. completion: Mar 20080
Phase 4Withdrawn
NCT00277862TempusPegylated IFN- alpha 2b

Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

Start: Apr 2002Est. completion: Apr 2007
Phase 4Completed
NCT00241618TempusPegylated interferon alpha 2

Timing and Duration of Acute Hepatitis C Treatment

Start: Jan 2002Est. completion: Jan 2006
Phase 4Completed
NCT00239252AstellasInterferon alfacon-1

Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

Phase 3Completed
NCT04112303Gilead SciencesSOF

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

Start: Oct 2019Est. completion: Jun 202137 patients
Phase 3Completed
NCT03118843Gilead SciencesSOF

Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Start: Apr 2017Est. completion: Mar 201831 patients
Phase 3Completed
NCT02996682Gilead SciencesSOF

Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

Start: Dec 2016Est. completion: May 2018102 patients
Phase 3Completed
NCT02671500Gilead SciencesSOF

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

Start: Apr 2016Est. completion: Mar 2018375 patients
Phase 3Completed
NCT02738333Gilead SciencesSOF

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

Start: Apr 2016Est. completion: May 2017239 patients
Phase 3Completed
NCT02722837Gilead SciencesSOF

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Start: Apr 2016Est. completion: Sep 2017119 patients
Phase 3Completed
NCT02673489Bristol Myers SquibbDaclatasvir

A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Start: Mar 2016Est. completion: May 2017106 patients
Phase 3Completed
NCT02597166Gilead SciencesSOF

Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection

Start: Jan 2016Est. completion: Jun 201814 patients
Phase 3Completed
NCT02639247Gilead SciencesSOF

Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Start: Dec 2015Est. completion: Jan 2017333 patients
Phase 3Completed
NCT02639338Gilead SciencesSOF

Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis

Start: Dec 2015Est. completion: Jan 2017220 patients
Phase 3Completed
NCT02613871Gilead SciencesSOF

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

Start: Dec 2015Est. completion: Nov 2018111 patients
Phase 3Completed
NCT02607800Gilead SciencesSOF/VEL/VOX

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy

Start: Nov 2015Est. completion: Jan 2017943 patients
Phase 3Completed
NCT02607735Gilead SciencesSOF

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy

Start: Nov 2015Est. completion: Jun 2017416 patients
Phase 3Completed
NCT02487030Gilead SciencesSOF

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Start: Sep 2015Est. completion: Feb 2017255 patients
Phase 3Completed
NCT02496078Bristol Myers SquibbAsunaprevir

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Start: Aug 2015Est. completion: Feb 2017207 patients
Phase 3Completed
NCT02472886Gilead SciencesSOF

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Start: Jun 2015Est. completion: Jun 2016153 patients
Phase 3Completed
NCT02358044Merck & Co.Sofosbuvir

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)

Start: Feb 2015Est. completion: Feb 2016257 patients
Phase 3Completed
NCT02346721Gilead SciencesSOF

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

Start: Feb 2015Est. completion: Jun 2016111 patients
Phase 3Completed
NCT02319031Bristol Myers SquibbDaclatasvir

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

Start: Feb 2015Est. completion: Dec 201553 patients
Phase 3Completed
NCT02204475Merck & Co.Grazoprevir/Elbasvir

Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)

Start: Nov 2014Est. completion: Sep 20160
Phase 3Withdrawn
NCT02170727Bristol Myers SquibbAsunaprevir

A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

Start: Jun 2014Est. completion: Sep 2015199 patients
Phase 3Completed
NCT02123654Bristol Myers SquibbAsunaprevir

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Start: Apr 2014Est. completion: Aug 2015297 patients
Phase 3Completed
NCT02032875Bristol Myers SquibbDaclatasvir

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

Start: Mar 2014Est. completion: Jan 2016116 patients
Phase 3Completed
NCT01995266Bristol Myers SquibbAsunaprevir

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Start: Feb 2014Est. completion: Jul 2015218 patients
Phase 3Completed
NCT02032888Bristol Myers SquibbDaclatasvir

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

Start: Feb 2014Est. completion: Jan 2015238 patients
Phase 3Completed
NCT02032901Bristol Myers SquibbDaclatasvir

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Start: Jan 2014Est. completion: Dec 2014173 patients
Phase 3Completed
NCT02021643Gilead SciencesSOF

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

Start: Dec 2013Est. completion: Nov 2016687 patients
Phase 3Completed
NCT01973049Bristol Myers SquibbAsunaprevir

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

Start: Dec 2013Est. completion: Nov 2014202 patients
Phase 3Completed
NCT01979939Bristol Myers SquibbAsunaprevir

UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

Start: Dec 2013Est. completion: Nov 2014416 patients
Phase 3Completed
NCT01975675Gilead SciencesSOF

Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

Start: Oct 2013Est. completion: Aug 2014341 patients
Phase 3Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

24 late-stage (Phase 3) programs — potential near-term approvals
23 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)HIV Infection(75)