Asunaprevir

Generic Name: Asunaprevir

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₄₆ClN_₅O_₉S

CAS Number: 630420-16-5

Unique Ingredient Identifier: S9X0KRJ00S

Background: Asunaprevir, also named BMS-650032, is a potent hepatitis C virus (HCV) NS3 protease inhibitor. It has been shown to have a very high efficacy in dual-combination regimens with daclatasvir in patients chronically infected with HCV genotype 1b. It was developed by Bristol-Myers Squibb Canada and approved by Health Canada on April 22, 2016. The commercialization of asunaprevir was cancelled one year later on October 16, 2017.

Indication: Asunaprevir is indicated in combination with other agents for the treatment of chronic hepatitis C in adult patients with hepatitis C virus genotypes 1 or 4 and compensated liver cirrhosis.

Hepatitis C is a liver disease caused by the hepatitis C virus. The chronic state of this condition accounts for 60-80% of the cases from which the risk of cirrhosis of the liver within 20 years is of around 15-30%. The genotype 1 is the most common type of hepatitis C in the United States and the most difficult to treat.

Associated Conditions: Chronic Hepatitis C Genotype 1, Genotype 4 Chronic Hepatitis C

Clinical Trials

Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

Phase 3

Completed

Conditions: Hepatitis C

Interventions: Drug: daclatasvir
Drug: asunaprevir
Drug: Ribavirin

First Posted Date: 2016-12-29

Last Posted Date: 2019-01-09

Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Target Recruit Count: 70

Registration Number: NCT03004625

Locations: 🇨🇳
Kaohsiung Medical Universsity, Kaohsiung, Taiwan

Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas

Withdrawn

Conditions: Hepatitis c

Interventions: Drug: Daclatasvir+ Asunaprevir

First Posted Date: 2016-05-05

Last Posted Date: 2018-04-19

Lead Sponsor: Tainan Municipal Hospital

Registration Number: NCT02762448

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

Phase 3

Completed

Conditions: Hepatitis C

Interventions: Drug: Daclatasvir
Drug: Asunaprevir

First Posted Date: 2015-07-14

Last Posted Date: 2017-04-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 207

Registration Number: NCT02496078

Locations: 🇷🇺
Local Institution, St.petersburg, Russian Federation

A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Phase 1

Completed

Conditions: Hepatitis C Infection

Interventions: Drug: Daclatasvir
Drug: Asunaprevir

First Posted Date: 2014-12-23

Last Posted Date: 2015-02-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 88

Registration Number: NCT02323594

Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism

Phase 4

Withdrawn

Conditions: Hepatitis C, Chronic

Interventions: Drug: DCV/ASV/BCV

First Posted Date: 2014-11-18

Last Posted Date: 2016-06-03

Lead Sponsor: Kirby Institute

Registration Number: NCT02292966

Locations: 🇦🇺
Westmead Hospital, Westmead, New South Wales, Australia
🇦🇺
St Vincent's Hospital, Sydney, New South Wales, Australia

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

Phase 3

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: Daclatasvir
Drug: asunaprevir

First Posted Date: 2014-11-04

Last Posted Date: 2015-10-19

Lead Sponsor: Foundation for Liver Research

Target Recruit Count: 12

Registration Number: NCT02282709

Locations: 🇳🇱
Erasmus Medical Center, Rotterdam, Netherlands

Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV

Phase 2

Completed

Conditions: HIV-HCV

Interventions: Drug: Asunaprevir and Daclatasvir
Drug: Asunaprevir and Daclatasvir with BMS-791325

First Posted Date: 2014-04-28

Last Posted Date: 2017-05-16

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 30

Registration Number: NCT02124044

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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

Phase 3

Completed

Conditions: Hepatitis C Virus Infection

Interventions: Drug: DCV 3DAA
Drug: Daclatasvir
Drug: Asunaprevir
Other: Placebo for Daclatasvir
Other: Placebo for Asunaprevir
Other: Placebo for DCV 3DAA