Asunaprevir
Trials 37
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2017-04-28 | Bristol-Myers Squibb | Regulatory China FDA Approves Country’s First All-Oral Regimen for Chronic Hepatitis C, Daklinza® (daclatasvir) in Combination with Sunvepra® (asunaprevir) bms.com ↗
Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate |
| 2016-02-22 | Bristol-Myers Squibb | Results Data Presented at APASL from First Completed Phase 3 Trial of All-oral Chronic Hepatitis C Regimen in Chinese Patient Population Shows Daclatasvir and Asunaprevir DUAL Therapy Demonstrated High Cure Rates Among HCV Genotype 1b Patients bms.com ↗
In the study, 91% of patients from China achieved SVR24, which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. |
| 2014-11-08 | Bristol-Myers Squibb | Results Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis bms.com ↗
Daclatasvir TRIO achieves 98% cure rate in treatment-naïve and 93% cure rate in treatment-experienced genotype 1 patients with cirrhosis when used with ribavirin, as shown in UNITY 2 |
| 2014-10-07 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Statement about Asunaprevir in the U.S. bms.com ↗
has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. |
| 2014-07-07 | Bristol-Myers Squibb | Regulatory Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen bms.com ↗
The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients. |
| 2014-04-10 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Presents Phase III Data Demonstrating that Investigational All-oral Daclatasvir and Asunaprevir Therapy Achieved SVR12 Rates of up to 90% Among Broad Range of Genotype 1b Hepatitis C Patients bms.com ↗
In the study the DCV+ASV regimen was generally well tolerated. |
| 2014-04-07 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. |
| 2014-02-24 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C bms.com ↗
FDA grants Designation request for investigational daclatasvir (DCV) and asunaprevir (ASV) combination therapy for treatment of genotype 1b chronic hepatitis C (HCV) infection |
| 2013-11-02 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced the submission of a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency seeking the world’s first interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C. |
| 2013-04-23 | Bristol-Myers Squibb | Results High Rates of SVR Demonstrated in Phase II Study with Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection bms.com ↗ |
| 2012-11-12 | Bristol-Myers Squibb | Results Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial bms.com ↗
The remaining one patient had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR 24 . |
| 2012-11-11 | Bristol-Myers Squibb | Results Investigational Hepatitis C Quad Therapy Regimen of Daclatasvir and Asunaprevir Plus Interferon Alfa and Ribavirin Achieved SVR24 in 93% of Difficult-to-Treat Genotype 1a/b Prior Null Responders in Expanded Phase II Study bms.com ↗ |
| 2012-11-11 | Bristol-Myers Squibb | Results Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study bms.com ↗
In this study, the DCV/ASV Dual regimen achieved SVR 12 in 78% (14/18) and 65% (13/20) of GT1b patients when asunaprevir was dosed twice daily (Group A1) or once daily (Group A2), respectively. |
| 2012-10-16 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗ |
| 2012-04-19 | Bristol-Myers Squibb | Results All-Oral Hepatitis C Virus Treatment with Bristol-Myers Squibb’s Investigational Compounds Daclatasvir and Asunaprevir Achieved Sustained Virologic Response in 77% of Difficult-to-Treat Patients bms.com ↗ |
| 2012-01-18 | Bristol-Myers Squibb | Results First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published bms.com ↗
The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible with a direct-acting antiviral (DAA)-only combination containing daclatasvir and asunaprevir (4/11 patients, including two of two patients infected with HCV genotype 1b). |
| 2011-11-07 | Bristol-Myers Squibb | Results All-Oral Treatment Regimen of Bristol-Myers Squibb’s Investigational NS5A and NS3 Inhibitors Achieved 90% Sustained Virologic Response (SVR12) in Phase II Study Sentinel Cohort of Genotype 1b Null Responders bms.com ↗
Results add to data suggesting that SVR can be achieved with the combination of daclatasvir (BMS-790052) and asunaprevir (BMS-650032) in HCV genotype 1b patients |
| 2011-03-07 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 bms.com ↗
Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV for 24 weeks results in 100% SVR12 in HCV Genotype 1 null responders (Late-Breakers Oral Session) |
| 2010-10-01 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Compounds to be Presented at AASLD 2010 bms.com ↗
Combination therapy with BMS-790052 and BMS-650032 alone or with pegIFN/RBV results in undetectable HCV RNA through 12 weeks of therapy in HCV genotype 1 null responders |
All press releases naming this drug 20 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asunaprevir | “Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 201632“All participants will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.” NCT02292966 ↗ “To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639 ↗ “Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily” NCT02175602 ↗ “DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily” NCT02045693 ↗ “Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C.” PMID 25038486 ↗ Jul 2014 “Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks” NCT01979939 ↗ “DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks” NCT02170727 ↗ “Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966 ↗ “Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day” NCT02098616 ↗ “Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860 ↗ |
| Known as | ASV | “To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639 ↗16“We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis.” PMID 30400729 ↗ Mar 2019 “The efficacy of daclatasvir (DCV), asunaprevir (ASV), pegylated interferon and ribavirin (Peg-IFN/RBV) association was investigated in these patients.” PMID 29271782 ↗ Mar 2018 “Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients” NCT02124044 ↗ “UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination” NCT01979939 ↗ “whether a rapid reduction in viremia by daclatasvir (DCV) and asunaprevir (ASV) improves the response to pegylated interferon” PMID 26733671 ↗ Jan 2016 “DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks” NCT02170727 ↗ “Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966 ↗ “The combination of daclatasvir (DCV, pan-genotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease inhibitor)” PMID 27287851 ↗ Jun 2016 “Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860 ↗ “Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy” NCT01718145 ↗ |
| Known as | BMS-650032 | “BMS-650032 (Asunaprevir)” NCT01497834 ↗ |
| Known as | Sunvepra | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02639585 ↗ |
| Action | Inhibit | “Asunaprevir is a selective HCV NS3 protease inhibitor” PMID 25038486 ↗ Jul 2014 |
| Modality | Small molecule | — CHEMBL2105735 ↗ |
| Route | Oral | “single oral doses of BMS-650032” NCT00559247 ↗ |