 |
|
|
| |
Abbvie at AASLD / Hep Dart 2015
|
| |
| |
AASLD: Summary from AASLD 2015 for Hepatitis C Beyond 95% SVR cure rates: still room for improvement? - Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany -
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 - (12/11/15).....The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.
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 - (01/08/16)
AbbVie's TECHNIVIE_ Receives Health Canada Approval for Genotype 4 Chronic Hepatitis C Infection - (12/11/15)
------------------------------
AASLD: High Rates of SVR in Patients With HCV Genotype 2 or 3 Infection Treated With Ombitasvir/Paritaprevir/r and Sofosbuvir With or Without Ribavirin - (11/23/15)
AASLD: QUARTZ-I: Retreatment of HCV Genotype 1 DAA-failures With Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir - (11/17/15)
AASLD: ABBVIE ANNOUNCES HIGH SUSTAINED VIROLOGIC RESPONSE RATES IN PHASE 2 STUDIES WITH PAN-GENOTYPIC, INVESTIGATIONAL REGIMEN IN PATIENTS WITH CHRONIC HEPATITIS C - (11/19/15)
AASLD: Ombitasvir/Paritaprevir/r and Dasabuvir With Ribavirin for HCV Genotype 1 Patients With Decompensated Cirrhosis - (11/18/15)
EACS: TURQUOISE-I STUDY: USE OF OMBITASVIR/PARITAPREVIR/RITONAVIR + DASABUVIR + RIBAVIRIN IN PATIENTS WITH HCV/HIV-1 CO-INFECTION ON STABLE DARUNAVIR-CONTAINING ANTIRETROVIRAL THERAPY (10/27/15)
AASLD: 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 - (11/16/15)
AASLD: 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the Combination of ABT-493 and ABT-530 for 8 Weeks (SURVEYOR-I)....[8 weeks] - (11/17/15)
AASLD: SURVEYOR-I: 98% - 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null-Responders with the Combination of the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 - (11/16/15)
hepDART: (HepDart) SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection - (12/22/15)
AASLD: SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection - (12/01/15)
AASLD: SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection - (12/01/15)
AASLD: Analysis of HCV Genotype 1 Variants Detected During Monotherapy and Combination Therapy With Next Generation HCV Direct-Acting Anti viral Agents ABT-493 and ABT-530 "........COMBINATION THERAPY (SURVEYOR-I PART 1, PHASE 2 DOSE-RANGING STUDY) .....All patients with baseline NS3 or NS5A variants achieved SVR12 (Study SVR12: 99%)" - (11/18/15)
AASLD: Absence of Significant Drug-Drug Interactions Between Next Generation Direct Acting Antivirals ABT-493 and ABT-530 and Methadone or Buprenorphine/Naloxone in Subjects on Opioid Maintenance Therapy ..... "no dose adjustments required" - (11/18/15)
AASLD: Drug-Drug Interactions Between Next Generation Direct Acting Antivirals ABT-493 and ABT-530 with Cyclosporine or Tacrolimus in Healthy Subjects - (11/18/15)
AASLD: Effect of Renal Function on the Pharmacokinetics of Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir and Ribavirin in Over 2000 Subjects with HCV GT1 Infection - (12/16/15)
AASLD: Efficacy and Safety of Ombitasvir/Paritaprevir/r and Dasabuvir ± Ribavirin in HCV Genotype 1-Infected Patients With a History of Bleeding Disorders: Results From Phase 3 Trials - (12/16/15)
AASLD: RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir ± Ribavirin in Non-Cirrhotic HCV Genotype 1-Infected Patients With Severe Renal Impairment or End-Stage Renal Disease - (12/16/15)
AASLD: Efficacy and Safety of Co-Formulated Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Chronic HCV Genotype 4 Infection Without Cirrhosis and With Compensated Cirrhosis in Egypt (AGATE-II) - (11/18/15)
AASLD: Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir Co-Administered With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Infection and Cirrhosis (AGATE-I) - (11/18/15)
Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis - (10/20/15)
----------------------------
hepDART: (HepDart) Treatment With Ombitasvir/Paritaprevir/r Plus Dasabuvir With Ribavirin Was Not Associated With Changes in Renal Function: An Analysis of 1211 Patients Enrolled in Four Phase 2 and 3 Trials (12/14/15)
hepDART: (HepDart) Efficacy and Safety of Ombitasvir/Paritaprevir/r + Dasabuvir ± Ribavirin According to Baseline Renal Function: Analysis of 2005 Patients Enrolled in Six Phase 3 Trials (12/14/15)
AASLD: TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients With HCV Genotype 1b and Cirrhosis - (12/22/15)
AASLD: Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in the Phase 3 TURQUOISE-II Trial - (12/07/15)
AASLD: Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin for Patients With Post-Transplant HCV Recurrence - (12/18/15)
AASLD: Better Work Productivity and Activity in Patients On Ombitasvir/Paritaprevir/Ritonavirand Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 (GT1) Chronic Hepatitis C - 2 - (12/18/15)
AASLD: Preliminary Safety and Efficacy Results From TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-Infected Patients Receiving Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin - (12/18/15)
AASLD: Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Patients With or Without Cirrhosis - (12/18/15)
More Hep C Articles...
|
| |
|
|
|
|
|
