Wednesday, August 20, 2014

Paritaprevir (ABT-450)/ombitasvir/dasabuvir- List Of Upcoming and Recruiting Clinical Trials

Paritaprevir (ABT-450)/ombitasvir/dasabuvir- List Of Upcoming and Recruiting Clinical Trials

Provided below is a list of verified clinical trials using AbbVie's three direct-acting antiviral oral free regimen or "3-DAA combination" consisting of boosted protease inhibitor paritaprevir (also known as ABT-450/r ), NS5A inhibitor ombitasvir (ABT-267), non-nucleoside polymerase inhibitor dasabuvir (ABT-333) with and without ribavirin for the treatment of hepatitis C, and Type 1 (HIV-1) co-infection. Trial participants will represent different stages of disease and genotype. A bit of background information on AbbVie's 3-DAA combination is included as well.

Clinical trials on this page are not a complete list; to learn more about HCV trials or to find out if a study is enrolling patients in your area, please click here. View additional hepatitis trials updated in the last 30 days @ ClinicalTrials.gov

 Updates
In June 2014, the U.S. FDA Granted Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C.

NORTH CHICAGO, Ill., June 13, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. 
The NDA was submitted on April 21, 2014 and is supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

In addition, accelerated assessment was granted a few days later by the European Medicines Agency (EMA) 
Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie's investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie's regimen could be available for marketing in the European Union (EU) in the first quarter of 2015.
August
Paritaprevir (ABT-450/ritonavir)/ombitasvir/dasabuvir with and without ribavirin

Interferon-free regimens yield 96%-100% SVRs
By: MARY ANN MOON
The primary efficacy endpoint – a sustained virologic response (SVR) rate noninferior to the historical rate for interferon-containing regimens in comparable patients – was met and surpassed: 96.6% for ABT-450/ritonavir/ombitasvir/dasabuvir plus ribavirin and 100% for ABT-450/ritonavir/ombitasvir/dasabuvir without ribavirin.


Dr. Pietro Andreone discusses his manuscript "ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection."
 

April - May 2014
VIDEO – ‘Three D’ for hepatitis C called ‘revolutionary’
Dr. Bruce R. Bacon called this oral regimen "revolutionary" Hear his thoughts on treatment with ABT-450 with ritonavir, ombitasvir, and dasabuvir (known as the "three D" regimen) with or without ribavirin. 

New England Journal of Medicine
Retreatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin
In this phase 3 trial we evaluated the efficacy and safety of the interferon-free combination of ABT-450 with ritonavir (ABT-450/r), ombitasvir (also known as ABT-267), dasabuvir (also known as ABT-333), and ribavirin for the retreatment of HCV in patients who were previously treated with peginterferon–ribavirin.

New England Journal of Medicine: With Cirrhosis
ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis
Interferon-containing regimens for the treatment of hepatitis C virus (HCV) infection are associated with increased toxic effects in patients who also have cirrhosis. We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r), the NS5A inhibitor ombitasvir (ABT-267), the nonnucleoside polymerase inhibitor dasabuvir (ABT-333), and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis.

New England Journal of Medicine: No Cirrhosis
Treatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin
The interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r) and the NS5A inhibitor ombitasvir (also known as ABT-267) plus the nonnucleoside polymerase inhibitor dasabuvir (also known as ABT-333) and ribavirin has shown efficacy against the hepatitis C virus (HCV) in patients with HCV genotype 1 infection. In this phase 3 trial, we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis.


Recruiting 

Recruiting
Locations  United States 28 Study Locations 3 in Puerto Rico
ClinicalTrials.gov Identifier: NCT01939197
Conditions: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Contact: Melanie Gloria, BS 847-936-0714 melanie.gloria@abbvie.com
Contact: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com

Recruiting - Some locations Active and not recruiting
Locations  United States, Australia, France, Germany, Spain, United Kingdom
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Contact: Sundeep K Grewal, BS 847-937-3249 sundeep.grewal@abbvie.com
Contact: George S LIOSSIS 847-937-6450 george.liossis@abbvie.com

Recruiting - Most Study Locations Recruiting 
135 Study Locations United States, Australia, Belgium, Canada, Denmark, Germany, Ireland, Netherlands, New Zealand, Puerto Rico, Spain, United Kingdom
ClinicalTrials.gov Identifier: NCT01773070
Condition: Hepatitis C
Interventions: Drug: ABT-450/ritonavir; Drug: ABT-333; Drug: ABT-267
Contact: Rebecca Craft, BS1-901-854-2643 rebecca.craft@abbvie.com
Contact: Lia Hunter, PhD+44 (0)208 761 7684 lia.hunter@abbvie.com

Recruiting - Some locations Active and not recruiting
Locations  United States, Australia, France, Germany, Spain, United Kingdom
ClinicalTrials.gov Identifier: NCT01782495
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: ribavirin (RBV)
Contact: Elizabeth Colon, BA 847-938-4572 elizabeth.colon@abbvie.com
Contact: Melissa Cook, MS 847-937-1399 melissa.cook@abbvie.com

 Recruiting
Locations United States
ClinicalTrials.gov Identifier: NCT02068222
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r Drug: ABT-530 Drug: Ribavirin (RBV)
Contact: Charles E Meyer, BS (847) 938-6564 charles.e.meyer@abbvie.com
Contact: Traci Baker, MS (847) 936-6555 traci.baker@abbvie.com

Not yet recruiting 

‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02219477
Conditions: Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
Interventions: Drug: ABT-450/ritonavir/ABT-267; Drug: ABT-333; Drug: Ribavirin
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
ClinicalTrials.gov Identifier: NCT02219503
Conditions: Chronic Hepatitis C Infection; Compensated Cirrhosis; Hepatitis C Virus
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
ClinicalTrials.gov Identifier: NCT02219490
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate Chronic Hepatitis C Infection in Cirrhotic Adults With Genotype 1b Infection
‎Tuesday, ‎August ‎12, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02216422
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Not yet recruiting - verified August 2014

Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in Treatment-Naïve HCV Genotype 1-Infected Adults With Chronic Kidney Disease
‎Thursday, ‎July ‎31, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02207088
Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Not yet recruiting - verified July 2014

For additional information visit HCV Advocate News and Pipeline for trial updates;
AbbVie
Bristol-Myers Squibb (BMS)
Gilead
Merck
Tibotec / Janssen
Vertex
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