Hepatitis C Virus Infection

Infectious Diseases
40
Pipeline Programs
6
Companies
47
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
19
1
14
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
6100%
+ 37 programs with unclassified modality

On Market (2)

Approved therapies currently available

GS
EPCLUSAApproved
velpatasvir and sofosbuvir
Gilead Sciences
Hepatitis C Virus NS5A Inhibitor [EPC]oral2016
GS
SOVALDIApproved
sofosbuvir
Gilead Sciences
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]oral2013

Competitive Landscape

6 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
34 programs
17
12
2
SofosbuvirPhase 4Small Molecule1 trial
SofosbuvirPhase 4Small Molecule
LDV/SOFPhase 31 trial
SOF/VELPhase 3
SOF/VELPhase 31 trial
+29 more programs
Active Trials
NCT02537379Completed552Est. Jun 2017
NCT02292706Terminated1,609Est. Dec 2021
NCT02510300Terminated461Est. Jan 2023
+23 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
5 programs
1
1
2
ABT-493/ABT-530Phase 31 trial
SofosbuvirPhase 3Small Molecule1 trial
ABT-450/r/ABT-267Phase 2/35 trials
ABT-072Phase 2
glecaprevirN/ASmall Molecule5 trials
Active Trials
NCT03123965Approved For Marketing
NCT05582681Terminated8Est. Nov 2024
NCT03868163Completed161Est. Sep 2020
+9 more trials
Abbott
AbbottABBOTT PARK, IL
1 program
1
ABT-072Phase 21 trial
Active Trials
NCT00872196Completed5Est. Apr 2010
M&
Merck & Co.RAHWAY, NJ
1 program
1
200 mg MK-1075Phase 11 trial
Active Trials
NCT02461563Completed12Est. Dec 2015
Bristol Myers Squibb
1 program
1
BMS-791325Phase 11 trial
Active Trials
NCT02112110Completed8Est. May 2014
CP
Chugai PharmaJapan - Tokyo
1 program
SOFN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AbbVieglecaprevir
AbbVieglecaprevir
Gilead SciencesSofosbuvir
Gilead SciencesSOF/VEL
Gilead SciencesSOF/VEL
AbbVieSofosbuvir
Gilead SciencesSOF/VEL
AbbVieABT-493/ABT-530
Gilead SciencesLDV/SOF
AbbVieABT-450/r/ABT-267
Gilead SciencesSOF/VEL
AbbVieABT-450/r/ABT-267
AbbVieABT-450/r/ABT-267
AbbVieABT-450/r/ABT-267
Gilead SciencesSOF/VEL

Showing 15 of 46 trials with date data

Clinical Trials (47)

Total enrollment: 12,748 patients across 47 trials

HCV Test and Treat Utilizing Simplified HCV Patient Education

Start: Nov 2022Est. completion: Nov 20248 patients
Phase 4Terminated

Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

Start: Jan 2018Est. completion: Mar 201930 patients
Phase 4Unknown

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

Start: Jun 2014Est. completion: Jun 201566 patients
Phase 4Completed

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Start: Jan 2020Est. completion: Nov 202087 patients
Phase 3Completed

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Start: Mar 2017Est. completion: Feb 2018130 patients
Phase 3Completed

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

Start: Nov 2016Est. completion: Jul 202133 patients
Phase 3Completed

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Start: Jul 2016Est. completion: Aug 2017117 patients
Phase 3Completed
NCT02642432AbbVieABT-493/ABT-530

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

Start: Dec 2015Est. completion: Feb 2017146 patients
Phase 3Completed

Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

Start: Nov 2015Est. completion: May 201787 patients
Phase 3Terminated
NCT02517528AbbVieABT-450/r/ABT-267

ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

Start: Jul 2015Est. completion: Mar 2017104 patients
Phase 3Completed

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Start: Jul 2015Est. completion: Jun 2016107 patients
Phase 3Completed
NCT02517515AbbVieABT-450/r/ABT-267

ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Start: Jul 2015Est. completion: Jun 2017650 patients
Phase 3Completed
NCT02247401AbbVieABT-450/r/ABT-267

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

Start: Nov 2014Est. completion: Aug 2016160 patients
Phase 3Completed
NCT02219490AbbVieABT-450/r/ABT-267

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Start: Oct 2014Est. completion: May 20211,596 patients
Phase 3Completed

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection

Start: Sep 2014Est. completion: Sep 2015269 patients
Phase 3Completed

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Start: Jul 2014Est. completion: Nov 2015268 patients
Phase 3Completed

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

Start: Jul 2014Est. completion: Sep 2015741 patients
Phase 3Completed

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

Start: Jul 2014Est. completion: Dec 2015558 patients
Phase 3Completed
NCT02167945AbbVieABT-450/r/ABT-267

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Start: Jun 2014Est. completion: May 2021615 patients
Phase 3Completed
NCT02023112AbbVieABT-450/r/ABT-267

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

Start: Jan 2014Est. completion: Sep 2015171 patients
Phase 3Completed
NCT02023099AbbVieABT-450/r/ABT-267

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Start: Dec 2013Est. completion: Oct 2015363 patients
Phase 3Completed
NCT01939197AbbVieABT-450/r/ABT-267

A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

Start: Aug 2013Est. completion: Oct 2016318 patients
Phase 2/3Completed

Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection

Start: Jan 2019Est. completion: Feb 202021 patients
Phase 2Terminated

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

Start: Jun 2017Est. completion: Feb 201995 patients
Phase 2Completed

Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Start: Jan 2017Est. completion: Feb 2020216 patients
Phase 2Completed

Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

Start: Jan 2017Est. completion: Dec 201832 patients
Phase 2Completed

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Start: Jul 2016Est. completion: Jul 201779 patients
Phase 2Completed

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Start: Jul 2015Est. completion: Jun 201649 patients
Phase 2Completed

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

Start: May 2015Est. completion: Apr 201617 patients
Phase 2Completed

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

Start: Apr 2015Est. completion: Jan 2016111 patients
Phase 2Completed

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

Start: Feb 2015Est. completion: Jan 2016128 patients
Phase 2Completed

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Start: Oct 2014Est. completion: Jun 2016114 patients
Phase 2Completed

Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

Start: Aug 2014Est. completion: Apr 201640 patients
Phase 2Completed

Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Start: Jul 2014Est. completion: Sep 2018106 patients
Phase 2Completed

Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

Start: Jul 2014Est. completion: Feb 201547 patients
Phase 2Completed
NCT01995071AbbVieABT-450/r/ABT-267

A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

Start: Nov 2013Est. completion: Jun 201589 patients
Phase 2Completed
NCT01911845AbbVieABT-450/r/ABT-267

An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

Start: Apr 2013Est. completion: Sep 201438 patients
Phase 2Completed

A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies

Start: Apr 2009Est. completion: Apr 20105 patients
Phase 2Completed

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

Start: Jun 2015Est. completion: Dec 201512 patients
Phase 1Completed

Absolute Bioavailability of BMS-791325

Start: Apr 2014Est. completion: May 20148 patients
Phase 1Completed
NCT02052362AbbVieABT-450/r/ABT-267

Bioavailability of ABT-450 and ABT-267 With Ritonavir

Start: Jan 2014Est. completion: Feb 201416 patients
Phase 1Completed

Expanded Access to Glecaprevir/ Pibrentasvir

N/AApproved For Marketing

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation

Start: Feb 2019Est. completion: Sep 2020161 patients
N/ACompleted

Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Start: Nov 2017Est. completion: Jan 20202,118 patients
N/ACompleted

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

Start: Oct 2015Est. completion: Jan 2023461 patients
N/ATerminated

Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Start: Sep 2015Est. completion: Jun 2017552 patients
N/ACompleted

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

Start: Dec 2014Est. completion: Dec 20211,609 patients
N/ATerminated

Related Jobs in Infectious Diseases

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

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