Drugs / dasabuvir
dasabuvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Exviera | — | 2024-09-25 | europa.eu ↗ |
| Approved | EU (EMA) | Exviera | — | 2015-01-14 | europa.eu ↗ |
| Approved | US (FDA) | VIEKIRA PAK (COPACKAGED) | — | 2014-12-19 | fda.gov ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02534870 | Sep 2015 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02052349 | Nov → Dec 2013 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00919490 | Jun → Aug 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00768690 | Oct 2008 → Feb 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00696904 | Jun 2008 → Feb 2009 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT02194998 | Sep 2015 → May 2018 | HIV infectious disease, chronic hepatitis C virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02356562 | Feb 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01911845 | Apr → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01782495 | Feb 2013 → Nov 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01464827 | Oct 2011 → Mar 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 2 | NCT01074008 | Mar 2010 → Jun 2011 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 2 | NCT00851890 | Mar → Jul 2009 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 2/33 trials · 1 met primary | ||||||
| Phase 2/3 | NCT02486406 | Oct 2015 → Nov 2020 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02555943 | Feb 2015 → May 2021 | chronic hepatitis C virus infection, hepatitis B virus infection | Humanity and Health Research Centre | Completed | No outcome recorded |
| Phase 2/3 | NCT01939197 | Aug 2013 → Jul 2016 | HIV infectious disease, chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 326 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT02634008 | Jun 2016 → Apr 2021 | acute hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 3 | NCT02646111 | Jan 2016 → Jan 2018 | chronic hepatitis C virus infection | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02582632 | Nov 2015 → Aug 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02609659 | Oct 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 3 | NCT02487199 | Sep 2015 → Dec 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02517528 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02504099 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02517515 | Jul 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02476617 | Jun 2015 → Aug 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442284 | May 2015 → Aug 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442271 | Apr 2015 → Jul 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02399345 | Mar → Nov 2015 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219477 | Nov 2014 → Jun 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219490 | Oct 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 3 | NCT02207088 | Sep 2014 → Dec 2016 | chronic hepatitis C virus infection, cirrhosis of liver, end stage renal failure | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219503 | Sep 2014 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02216422 | Sep 2014 → Dec 2015 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02167945 | Jun 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 3 | NCT01854528 | Jun 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01854697 | Mar 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01833533 | Mar → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01767116 | Dec 2012 → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01715415 | Nov 2012 → Nov 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01716585 | Nov 2012 → Oct 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01704755 | Oct 2012 → Jan 2014 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01674725 | Aug 2012 → Jan 2014 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT03003338 | Oct 2017 → Oct 2018 | chronic hepatitis C virus infection | Hannover Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03050905 | Jun → Nov 2017 | hepatitis C virus infection | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| Phase 4 | NCT02874066 | Mar 2017 → Oct 2018 | viral hepatitis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02950870 | Dec 2016 → Dec 2017 | chronic hepatitis C virus infection | University of Modena and Reggio Emilia | Unknown | No outcome recorded |
| Phase 4 | NCT02498015 | Aug 2016 → Aug 2017 | chronic hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT03710252 | Mar 2016 → Sep 2017 | chronic hepatitis C virus infection | American Research Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02460133 | Jul 2015 → Oct 2025 overdue | hepatitis C virus infection | Nova Scotia Health Authority | Active not recruiting | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT00909636 Comparator | May → Jul 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00895102 Comparator | Apr → Jun 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT02493855 Background | Jun 2015 → Apr 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 2 | NCT01995071 Background | Nov 2013 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01563536 Background | Feb → Apr 2012 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 2 | NCT01306617 Background | Feb → Nov 2011 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00726882 Background | Aug 2008 → May 2010 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01773070 Background | Jun 2013 → Oct 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT02786537 Comparator | Jun 2016 → Jun 2019 | chronic hepatitis C virus infection | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02734173 Comparator | Jul 2015 → Feb 2017 | hepatitis C virus infection | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02461745 Comparator | Jun 2015 → May 2017 | chronic hepatitis C virus infection | Kaiser Permanente | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 58
| Date | Issuer | Release |
|---|---|---|
| 2017-02-27 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗
With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b. |
| 2017-02-27 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces CHMP Grants Positive Opinion for an Eight-Week Treatment Option with AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for an eight-week treatment regimen of AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV infection and minimal to moderate fibrosis.* |
| 2016-09-23 | AbbVie | Results AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗
In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR 12 ). |
| 2016-09-23 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Data on Eight-Week Treatment of AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C enanta.com ↗
In AbbVie’s Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12). |
| 2016-07-25 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. |
| 2016-07-25 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces the U.S. Food and Drug Administration has approved AbbVie’s New, Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C Virus enanta.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved AbbVie’s New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended release tablets. |
| 2016-04-25 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗ |
| 2016-04-25 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces U.S. FDA has Approved AbbVie’s Supplemental New Drug Application for Use of VIEKIRA PAK® without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis enanta.com ↗
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved AbbVie’s supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). |
| 2016-04-15 | AbbVie | Results AbbVie Announces Real-World Data with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) from Large German Hepatitis C-Registry abbvie.com ↗
These data support results seen in Phase 3 clinical trials for chronic GT1 or GT4 hepatitis C virus (HCV) infected patients treated with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV). |
| 2016-04-14 | AbbVie | Results AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients abbvie.com ↗ |
| 2016-04-14 | Enanta Pharmaceuticals, Inc | Results Enanta Announces High SVR Rates with AbbVie’s VIEKIRAX® + EXVIERA® Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients enanta.com ↗
The study found that no matter whether certain NS5A RAVs were present, 100 percent (n=148/148) of patients with GT1b chronic HCV infection who received VIEKIRAX + EXVIERA without RBV for 12 weeks, achieved SVR12. |
| 2016-02-26 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis (Child-Pugh A) in abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A) . |
| 2016-02-26 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces CHMP Positive Opinion for AbbVie’s VIEKIRAX® + EXVIERA® Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis enanta.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion |
| 2016-01-07 | AbbVie | Regulatory FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK ® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A). |
| 2016-01-07 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces the U.S. FDA Grants Priority Review to AbbVie’s Supplemental New Drug Application for VIEKIRA PAK® Without Ribavirin in Genotype 1B Chronic Hepatitis C Virus Patients with Compensated Cirrhosis enanta.com ↗ |
| 2015-12-02 | AbbVie | Regulatory AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection abbvie.com ↗ |
| 2015-12-02 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces FDA Acceptance of AbbVie’s New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® for the Treatment of Genotype 1 Chronic Hepatitis C Virus Infection enanta.com ↗
today announced AbbVie’s New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). |
| 2015-11-14 | AbbVie | Results AbbVie Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis abbvie.com ↗
Results show that 95 percent (n=586/615) of patients in the TOPAZ-II trial achieved a sustained virologic response at 12 weeks post-treatment (SVR 12 ) after 12 or 24 weeks of treatment, a secondary endpoint for the study. |
| 2015-11-14 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis enanta.com ↗
Interim data show that 95 percent (n=586/615) of patients in the TOPAZ-II trial achieved a sustained virological response at 12 weeks post-treatment after 12 or 24 weeks of treatment, a secondary endpoint for the study. |
| 2015-10-22 | AbbVie | Regulatory AbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE™ abbvie.com ↗
The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients. |
| 2015-09-11 | AbbVie | Results Ongoing Real World Study Reports High Sustained Viral Response Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Genotype 1 Hepatitis C Patients abbvie.com ↗
This study of Polish patients who reached post-treatment at week 12 (n=40 of 186 enrolled to date), demonstrated 98 percent (n=39/40) SVR 12 . |
| 2015-06-24 | AbbVie | Results AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR 12 ) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. |
| 2015-04-25 | AbbVie | Results AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015 abbvie.com ↗
Patients who reached post-treatment week four to date (n=10 of 20 enrolled) achieved 100 percent SVR 4 (n=10/10). |
| 2015-04-25 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Preliminary Data from AbbVie’s Phase 3b RUBY-I Study in Chronic Hepatitis C Patients with Renal Impairment Presented at The International Liver Congress™ 2015 enanta.com ↗
The first ten patients, or 100 percent, who have reached post-treatment week four to date (n=10 of 20 enrolled) achieved SVR4 (n=10/10). |
| 2015-04-08 | AbbVie | Results AbbVie to Present New Data from Hepatitis C Clinical Development Program at The International Liver Congress™ 2015 abbvie.com ↗
No Significant Interaction Among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir |
| 2015-02-23 | AbbVie | Results Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) Published Online in JAMA; Sub-analyses to be Presented at the Annual Confere abbvie.com ↗
The SVR 12 rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection. |
| 2015-02-23 | Enanta Pharmaceuticals, Inc | Results Enanta Announces JAMA Publication of Results from AbbVie’s Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) enanta.com ↗
The SVR12 rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection. |
| 2015-01-16 | AbbVie | Regulatory European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX ® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA ® (dasabuvir tablets). |
| 2015-01-16 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces European Commission Grants Marketing Authorizations for AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)... enanta.com ↗
Enanta Announces European Commission Grants Marketing Authorizations for AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Genotypes 1 and 4 Chronic Hepatitis C Virus |
| 2014-12-19 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C abbvie.com ↗
The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE:ABBV) VIEKIRA PAK ™ , an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. |
| 2014-12-19 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces U.S. Food and Drug Administration Approves AbbVie’s VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C Virus enanta.com ↗
The U.S. approval of VIEKIRA PAK triggers a $75 million regulatory approval milestone payment to Enanta from AbbVie. |
| 2014-11-21 | AbbVie | Regulatory CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe abbvie.com ↗ |
| 2014-11-21 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Announces CHMP Grants Positive Opinions of AbbVie’s VIEKIRAX™ (ombitasvir/paritaprevir(ABT-450)/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe enanta.com ↗ |
| 2014-11-11 | AbbVie | Results AbbVie to Present Results from Studies in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) and Liver Transplant Recipients (CORAL-I) at The Liver Meeting® 2014 abbvie.com ↗
AbbVie (NYSE: ABBV) today announced results from studies in chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection (TURQUOISE-I) and liver transplant recipients (CORAL-I) at The Liver Meeting®2014. |
| 2014-06-17 | AbbVie | Regulatory European Medicines Agency Validates Marketing Authorization Applications for AbbVie's Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. |
| 2014-06-17 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Applications for AbbVie’s Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C enanta.com ↗
Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. |
| 2014-06-13 | AbbVie | Regulatory U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. |
| 2014-06-13 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C enanta.com ↗
has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. |
| 2014-05-08 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces Submission of EU Marketing Authorization Applications to the European Medicines Agency for All-Oral, Interferon-Free Hepatitis C Regimen Containing ABT-450 enanta.com ↗
AbbVie, Enanta’s collaboration partner for ABT-450, has submitted Marketing Authorization Applications (MAA) to the European Medicines Agency (EMA) seeking approval for its investigational, all-oral, interferon-free regimen for the treatment of adult patients infected with chronic genotype 1 (GT1) hepatitis C virus (HCV). |
| 2014-04-22 | AbbVie | Regulatory AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. |
| 2014-04-22 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces New Drug Application Submission to the U.S. FDA for All-Oral, Interferon-Free Hepatitis C Regimen enanta.com ↗
The U.S. NDA filing triggers a $20 million milestone payment to Enanta from AbbVie. |
| 2014-04-12 | AbbVie | Results AbbVie to Present Late-Breaking Results from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis at the 2014 International Liver Congress™ abbvie.com ↗
Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR 12 ) of 91.8 percent and 95.9 percent in the 12-week and 24-week treatment arms, respectively. |
| 2014-04-12 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis being Presented at the European Association for the Study of the Liver (EASL) Meeting enanta.com ↗
In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic hepatitis C virus, TURQUOISE-II demonstrated SVR12 rates of 91.8% and 95.9% after 12 and 24 weeks of treatment, respectively |
| 2014-04-11 | AbbVie | Results AbbVie to Present Detailed Phase III Results from SAPPHIRE-I and SAPPHIRE-II Studies in Chronic Hepatitis C Patients at the 2014 International Liver Congress™ abbvie.com ↗
These data show very promising results in people who are infected with either subtype of the GT1 hepatitis C virus and who are either new to therapy or treatment-experienced. |
| 2014-04-11 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Detailed Data from SAPPHIRE-I and SAPPHIRE-II Phase 3 Studies in Patients with Chronic Hepatitis C Virus Being Presented at the European Association for the Study of the Liver (EASL) Meeting enanta.com ↗
SVR12 rates of 96% were demonstrated in both treatment-naïve and treatment-experienced genotype 1 (GT1) patients with chronic hepatitis C virus |
| 2014-03-03 | Enanta Pharmaceuticals, Inc | Results PEARL-III Study Results in Patients with Chronic Hepatitis C Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) enanta.com ↗
In the 419-patient study, sustained virologic response rates 12 weeks post-treatment (SVR12) of 99.5 and 99.0 percent were achieved with the three-direct-acting antiviral regimen with and without RBV, respectively. |
| 2014-01-31 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Results from Four All-Oral, Interferon-Free, Phase 3 Studies for the Treatment of Genotype 1 Hepatitis C Virus Infection enanta.com ↗
Results from these studies demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients and low rates of discontinuation due to adverse events. |
| 2013-12-10 | AbbVie | Results AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of Treatment-Experienced Patients with Genotype 1 Hepatitis C abbvie.com ↗
In the 394-patient SAPPHIRE-II study, 96 percent of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49 percent of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR 12 ) with the regimen. |
| 2013-12-10 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II Study enanta.com ↗
Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. |
| 2013-11-18 | AbbVie | Results AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1 Hepatitis C Patients New to Therapy abbvie.com ↗
In the 631-patient SAPPHIRE-I study, patients new to therapy receiving 12 weeks of AbbVie's 3D regimen achieved a sustained virologic response at 12 weeks post-treatment (SVR 12 ) of 96 percent. |
| 2013-11-18 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces 96 Percent SVR12 in SAPPHIRE-I Study enanta.com ↗
Results from the 631 patient SAPPHIRE-I trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in treatment-naïve adult patients chronically infected with GT1 HCV. |
| 2013-10-01 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver Meeting (AASLD) enanta.com ↗
Low Relapse Rate Leads to High Concordance of SVR4 and SVR12 with SVR24 After Treatment with ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients with Chronic HCV Genotype 1 Infection in the AVIATOR Study |
| 2013-05-06 | AbbVie | Regulatory AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration abbvie.com ↗
AbbVie is pleased that the FDA has granted Breakthrough Therapy designation to our 3-DAA combination with and without ribavirin. |
| 2013-05-06 | Enanta Pharmaceuticals, Inc | Regulatory Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450 enanta.com ↗ |
| 2013-04-23 | AbbVie | Results New Data from AbbVie's Phase IIb Aviator Trial Demonstrate High Sustained Viral Response Rates Across Multiple Patient Types with HCV Genotype 1 abbvie.com ↗
Data show greater than 90 percent SVR were achieved in patients new to treatment and in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). |
| 2013-04-23 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data From Phase 2b Interferon-Free Combination Studies with Protease Inhibitor ABT-450 for Hepatitis C Treatment to be Presented at EASL enanta.com ↗
SVR rates of 96% to 99% after 12 weeks of treatment were achieved in patients new to treatment (naïve) and 93% in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). |
| 2012-04-19 | Enanta Pharmaceuticals, Inc | Results Abbott Presents Positive Results from Interferon-Free Phase 2 "Co-Pilot" Study for the Treatment of Hepatitis C enanta.com ↗
In addition, SVR12 was achieved in 47 percent of patients who were previous nonresponders to past HCV treatment. |
| 2012-04-04 | Enanta Pharmaceuticals, Inc | Results Enanta Announces Positive Phase 2 Results From Interferon-Free Combination Studies with ABT-450 for Hepatitis C Treatment to be Presented at EASL enanta.com ↗
In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 93 percent and 95 percent of treatment-naïve genotype 1 (GT1) patients. |
All press releases naming this drug 60 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dasabuvir | “A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With...” NCT03003338 ↗34“Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.” PMID 29909549 ↗ Feb 2019 “12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.” NCT02646111 ↗ “A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection” NCT02498015 ↗ “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗ “All subjects will receive Dasabuvir (Exviera).” NCT03050905 ↗ “a polymerase inhibitor (ABT-333; Dasabuvir)” NCT02734173 ↗ “ABT-333 (also known as dasabuvir)” NCT01704755 ↗ “ABT-333 also known as dasabuvir” NCT02167945 ↗ “ABT-333 also known as dasabuvir” NCT01833533 ↗ |
| Known as | ABT-333 | “a polymerase inhibitor (ABT-333; Dasabuvir)” NCT02734173 ↗ |
| Known as | ABT-333 also known as dasabuvir | “ABT-333 also known as dasabuvir” NCT01854528 ↗7“ABT-333 also known as dasabuvir” NCT01715415 ↗ “ABT-333 also known as dasabuvir” NCT01716585 ↗ “ABT-333 also known as dasabuvir” NCT01767116 ↗ “ABT-333 also known as dasabuvir” NCT01995071 ↗ “ABT-333 also known as dasabuvir” NCT01854697 ↗ “ABT-333 also known as dasabuvir” NCT02219490 ↗ “ABT-333 also known as dasabuvir” NCT01674725 ↗ |
| Known as | ABT-333 also known as Exviera | “ABT-333 also known as Exviera” NCT02219490 ↗ |
| Known as | ABT-333 SODIUM MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | dasabuvir also known as ABT-333 | “dasabuvir also known as ABT-333” NCT02442271 ↗5“dasabuvir also known as ABT-333” NCT02442284 ↗ “dasabuvir also known as ABT-333” NCT02609659 ↗ “dasabuvir also known as ABT-333” NCT02399345 ↗ “dasabuvir also known as ABT-333” NCT02504099 ↗ “dasabuvir also known as ABT-333” NCT01782495 ↗ |
| Known as | Dasabuvir sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | DASABUVIR SODIUM MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137312 ↗ |
| Known as | DSV | “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗1“Dasabuvir (DSV)” NCT02194998 ↗ |
| Known as | Exviera | “Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day” NCT02874066 ↗2“All subjects will receive Dasabuvir (Exviera).” NCT03050905 ↗ “ABT-333 also known as Exviera” NCT02167945 ↗ |
| Action | Inhibit | “an experimental Hepatitis C virus (HCV) polymerase inhibitor” NCT00895102 ↗ |
| Modality | Small molecule | — CHEMBL3137312 ↗ |
| Route | Oral | “oral doses of ABT-333” NCT00919490 ↗ |