Drugs / Ombitasvir/Paritaprevir/Ritonavir
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02219503 | Sep 2014 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| 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. |
| 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 ). |
| 2016-07-25 | AbbVie | Regulatory CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A) abbvie.com ↗ |
| 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 ↗ |
| 2016-03-30 | AbbVie | Results AbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) and Investigational, Pan-Genotypic Regimen at The International Liver Congress™ 2016 abbvie.com ↗
Ombitasvir/Paritaprevir/Ritonavir With Ribavirin Achieves High Sustained Virologic Response (SVR) Rates in Egyptian Adults With Chronic HCV Genotype 4 Infection (AGATE-II) |
| 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) . |
| 2015-09-28 | AbbVie | Regulatory AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗ |
| 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. |
| 2015-05-26 | AbbVie | Results AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis abbvie.com ↗
The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR 12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. |
| 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). |
| 2015-04-15 | AbbVie | Regulatory AbbVie's Investigational Chronic Hepatitis C Treatment Granted Priority Review in Japan abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. |
| 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 |
| 2015-02-11 | AbbVie | Regulatory AbbVie Submits New Drug Application in Japan for its Investigational, All-Oral, Treatment for Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. |
| 2015-01-30 | AbbVie | Results AbbVie Announces Top-line Results from Phase 3 Study of All-Oral Treatment for Hepatitis C in Japan abbvie.com ↗ |
| 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). |
| 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. |
| 2014-11-21 | 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 ↗ |
All press releases naming this drug 19 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ombitasvir/Paritaprevir/Ritonavir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02219503 ↗ |