Showing posts with label ABT-450/R/ ABT-267/ABT-333 no ribavirin. Show all posts
Showing posts with label ABT-450/R/ ABT-267/ABT-333 no ribavirin. Show all posts
Monday, March 24, 2014
EASL-AbbVie to Present Results from SAPPHIRE-I, SAPPHIRE-II, PEARL-III, and TURQUOISE-II
AbbVie to Present Detailed Results from Phase III Studies in Patients with Chronic Hepatitis C at the 2014 International Liver Congress™
Mar 24, 2014
NORTH CHICAGO, Ill., March 24, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present new data from its phase III hepatitis C development program at the 2014 International Liver Congress™ (ILC) in London, April 9-13. Detailed results from the SAPPHIRE-I, SAPPHIRE-II, PEARL-III, and TURQUOISE-II studies will be presented at the ILC on April 10-12.
In presentations at the ILC, investigators will share detailed data results of four studies from AbbVie's phase III clinical trial program, the largest phase III program of an investigational, all-oral, interferon-free regimen for the treatment of chronic hepatitis C virus (HCV) infection in genotype 1 (GT1) adult patients.
Following is a list of AbbVie's phase III clinical trial program data being presented at the ILC:
SAPPHIRE-II: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 394 Treatment-Experienced Adults with HCV GT1
Oral Presentation: General Session 1 and Opening
April 10, 14:00-14:15 BST; ICC Auditorium
SAPPHIRE-I: Phase III Placebo-Controlled Study of an Investigational Interferon-Free, 12-Week Regimen in 631 Treatment-Naive Adults with HCV GT1
Oral Presentation: General Session 2 and Awards 1
April 11, 10:15-10:30 BST; ICC Auditorium
PEARL-III: Sustained Virologic Response 12 Weeks Post-treatment (SVR12) with an Investigational 12-Week Regimen in 419 Treatment-Naive HCV GT1b-Infected Adults
Late Breaker Poster: Poster P1299
April 12, 9:00-18:00 BST; Poster Exhibition
TURQUOISE-II: SVR12 Rates in 380 HCV GT1-Infected Adults with Compensated Cirrhosis Treated with an Investigational Regimen
Oral Presentation: Late Breakers
April 12, 15:30-15:45 BST; ICC Auditorium
AbbVie will present additional data in presentations throughout the Congress. The full ILC 2014 scientific program can be found at www.ilc-congress.eu/.
About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (RBV) (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing sustained virologic response (SVR) rates across different patient populations.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without RBV with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ³6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.
AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
SOURCE AbbVie
For further information: Media: Elizabeth Hoff, +1 (847) 935-4236, elizabeth.hoff@abbvie.com; Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com; Investor Relations: Elizabeth Shea, +1 (847) 935-2211, elizabeth.shea@abbvie.com
Tuesday, March 4, 2014
Hepatitis C - New Interferon-Free Drugs for Hep C Show High Cure Rates
Related -
Hepatitis C- AbbVie to Present Late-breaker PEARL-III Study at the 21st Conference on Retroviruses and Opportunistic Infections
Medscape Medical News > Conference News
New Interferon-Free Drugs for Hep C Show High Cure Rates
BOSTON — A revolution is happening in the treatment of hepatitis C virus, with new interferon-free drugs bringing cure rates of more than 90%.
Results from several trials were presented on opening day here at the 2014 Conference on Retroviruses and Opportunistic Infections.
PEARL-III
In the PEARL-III trial, treatment-naïve noncirrhotic adults with chronic genotype 1b (GT1b) hepatitis C were treated with an investigational all-oral interferon-free treatment from AbbVie plus ribavirin. After 12 weeks of treatment, sustained virologic response rates reached 99.5%. Even in difficult-to-treat cirrhotic patients, response rates reached 92% to 96%.
"Therapies currently being developed for the treatment of hepatitis C offer patients new options with shorter durations of treatment," said Javier Boix, a spokesperson for AbbVie.
This investigational regimen is appropriate for broad use in all genotype 1 patient populations, and in subgroups with GT1a or GT1b disease, in both treatment-naïve and treatment-experienced patients, Boix told Medscape Medical News. It's also appropriate for "those who typically do not respond well to treatment, such as previous nonresponders to interferon-based therapy and patients with advanced liver fibrosis or cirrhosis," he added.
SYNERGY
This National Institutes of Health (NIH) SYNERGY study looked at 3 different regimens of interferon-free therapy in a difficult-to-treat hepatitis C patient population, 88% of whom were black. After 6 and 12 weeks of treatment, sustained virologic response rates reached 95% to 100%.
"One of the things we learned from this trial is that we can treat people with short durations of therapy," said Anita Kohli, MD, from the NIH in Bethesda, Maryland. "Also, these regimens are very simple. They are 1, 2, or 3 pills once a day," she explained.
PHOTON-1
The phase 3 PHOTON-1 study is the first study of an interferon-free agent in the treatment of patients coinfected with HIV and hepatitis C. After 24 weeks of the once-a-day nucleotide analog polymerase inhibitor sofosbuvir ( Sovaldi), from Gilead, overall sustained virologic response was 76% in patients with genotype 1 hepatitis C, 88% in those with genotype 2 disease, and 90% in those with genotype 3 disease.
In December 2013, the US Food and Drug Administration approved sofosbuvir for the treatment of chronic hepatitis C infection.
Reaching Those in Need
The development of hepatitis C drugs "in the past few years is unprecedented," said Lynn Taylor, MD, from the division of infectious diseases at Miriam Hospital, Brown Medical School, in Providence, Rhode Island.
In the United States, the next step is to build the infrastructure to get the new drugs to the people who need them, she told Medscape Medical News. This will include building up a workforce of people who treat hepatitis C and providing financial incentives and reimbursement reforms.
"Medicare and Medicaid are going to have to pick up the tab for these drugs," because hepatitis C most often occurs in low-income populations. "It's going to be a crisis," she said. "But it will also force people into a rational, deliberate, thoughtful discussion about what we are going to do about hepatitis C."
2014 Conference on Retroviruses and Opportunistic Infections (CROI). Presented March 3, 2014.
Hepatitis C- AbbVie to Present Late-breaker PEARL-III Study at the 21st Conference on Retroviruses and Opportunistic Infections
Medscape Medical News > Conference News
New Interferon-Free Drugs for Hep C Show High Cure Rates
BOSTON — A revolution is happening in the treatment of hepatitis C virus, with new interferon-free drugs bringing cure rates of more than 90%.
Results from several trials were presented on opening day here at the 2014 Conference on Retroviruses and Opportunistic Infections.
PEARL-III
In the PEARL-III trial, treatment-naïve noncirrhotic adults with chronic genotype 1b (GT1b) hepatitis C were treated with an investigational all-oral interferon-free treatment from AbbVie plus ribavirin. After 12 weeks of treatment, sustained virologic response rates reached 99.5%. Even in difficult-to-treat cirrhotic patients, response rates reached 92% to 96%.
"Therapies currently being developed for the treatment of hepatitis C offer patients new options with shorter durations of treatment," said Javier Boix, a spokesperson for AbbVie.
This investigational regimen is appropriate for broad use in all genotype 1 patient populations, and in subgroups with GT1a or GT1b disease, in both treatment-naïve and treatment-experienced patients, Boix told Medscape Medical News. It's also appropriate for "those who typically do not respond well to treatment, such as previous nonresponders to interferon-based therapy and patients with advanced liver fibrosis or cirrhosis," he added.
SYNERGY
This National Institutes of Health (NIH) SYNERGY study looked at 3 different regimens of interferon-free therapy in a difficult-to-treat hepatitis C patient population, 88% of whom were black. After 6 and 12 weeks of treatment, sustained virologic response rates reached 95% to 100%.
"One of the things we learned from this trial is that we can treat people with short durations of therapy," said Anita Kohli, MD, from the NIH in Bethesda, Maryland. "Also, these regimens are very simple. They are 1, 2, or 3 pills once a day," she explained.
PHOTON-1
The phase 3 PHOTON-1 study is the first study of an interferon-free agent in the treatment of patients coinfected with HIV and hepatitis C. After 24 weeks of the once-a-day nucleotide analog polymerase inhibitor sofosbuvir ( Sovaldi), from Gilead, overall sustained virologic response was 76% in patients with genotype 1 hepatitis C, 88% in those with genotype 2 disease, and 90% in those with genotype 3 disease.
In December 2013, the US Food and Drug Administration approved sofosbuvir for the treatment of chronic hepatitis C infection.
Reaching Those in Need
The development of hepatitis C drugs "in the past few years is unprecedented," said Lynn Taylor, MD, from the division of infectious diseases at Miriam Hospital, Brown Medical School, in Providence, Rhode Island.
In the United States, the next step is to build the infrastructure to get the new drugs to the people who need them, she told Medscape Medical News. This will include building up a workforce of people who treat hepatitis C and providing financial incentives and reimbursement reforms.
"Medicare and Medicaid are going to have to pick up the tab for these drugs," because hepatitis C most often occurs in low-income populations. "It's going to be a crisis," she said. "But it will also force people into a rational, deliberate, thoughtful discussion about what we are going to do about hepatitis C."
2014 Conference on Retroviruses and Opportunistic Infections (CROI). Presented March 3, 2014.
Monday, March 3, 2014
Hepatitis C- AbbVie to Present Late-breaker PEARL-III Study at the 21st Conference on Retroviruses and Opportunistic Infections
AbbVie to Present Late-breaker PEARL-III Study in Patients with Chronic Hepatitis C at the 21st Conference on Retroviruses and Opportunistic Infections
-- SVR(12) rates of 99 percent with and without ribavirin were achieved in genotype 1b patients new to treatment
-- Response rates in PEARL-III were also high in specific patient characteristics, such as gender, race and genetics
The PEARL-III study met its primary and secondary endpoints. 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 AbbVie regimen with and without
RBV, respectively. There were no study drug discontinuations due to
adverse events.
"Results from PEARL-III are encouraging, as they demonstrate AbbVie's regimen can achieve high rates of SVR, with and without ribavirin across several patient characteristics in those with genotype 1b chronic hepatitis C infection," said Peter Ferenci, M.D., professor of Gastroenterology and Hepatology, Medical University of Vienna.
PEARL-III enrolled patients across different demographics and characteristics. Response rates in patients with certain characteristics (male gender, Black race and IL28B non-CC genotypes) were examined, as these patient populations have historically been associated with having a decreased response to treatment. High response rates were observed across all patients in the study, including those with these characteristics.
"We are excited about the strong PEARL-III results which demonstrate the AbbVie regimen achieved high SVR rates with no discontinuations due to adverse events in patients new to treatment with genotype 1b infection," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "Additionally, with these data, we continue to be on track to begin major regulatory submissions in the second quarter of 2014. AbbVie will continue to disclose additional detailed phase III study results at future scientific congresses and in publications."
About Study M13-961 (PEARL-III)
PEARL-III is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's regimen with and without RBV in non-cirrhotic, GT1b HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without RBV for 12 weeks, and 210 patients randomized to the regimen with RBV for 12 weeks. Following 12 weeks of treatment, 99.0 percent receiving the regimen without RBV (n=207/209) and 99.5 percent receiving the regimen with RBV (n=209/210) achieved SVR12. Patients in the treatment arm without RBV received placebo in substitution for RBV.
Patients with different demographics and characteristics were enrolled in the study, including gender, race (Black vs. non-Black), Hispanic/Latino ethnicity, age, geographic region, body mass index (BMI), liver fibrosis stage, IL28B genotype and viral load.
Across treatment arms in PEARL-III, there were no documented relapses within 12 weeks post-treatment. No on-treatment virologic failures occurred in the treatment arm without RBV and a single virologic failure occurred in the treatment arm with RBV. While all patients in the study completed therapy, two patients in the arm without RBV were lost to follow-up and therefore were considered treatment failures.
The most commonly reported adverse events (>10 percent for either arm) were headache, fatigue, pruritus, nausea and asthenia, with pruritus and nausea occurring at a statistically higher rate in the treatment arm with RBV compared to the arm without RBV. Anemia occurred more commonly among patients in the RBV-containing arm with clinically significant anemia requiring RBV dose reductions occurring in 9 percent of these patients.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without RBV with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score greater than or equal to 6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
-- SVR(12) rates of 99 percent with and without ribavirin were achieved in genotype 1b patients new to treatment
-- Response rates in PEARL-III were also high in specific patient characteristics, such as gender, race and genetics
Mar 3, 2014
BOSTON, March 3, 2014 /PRNewswire/
-- The first detailed results from AbbVie's (NYSE: ABBV) pivotal phase
III study, PEARL-III, were presented today as part of the 21st
Conference on Retroviruses and Opportunistic Infections (CROI) press
conference and will also be presented as a late-breaker at the
conference on March 4.
PEARL-III evaluated the efficacy and safety of 12 weeks of treatment
with AbbVie's investigational therapy with or without ribavirin (RBV) in
non-cirrhotic, adult patients with chronic genotype 1b (GT1b) hepatitis
C virus (HCV) infection who were new to treatment.
"Results from PEARL-III are encouraging, as they demonstrate AbbVie's regimen can achieve high rates of SVR, with and without ribavirin across several patient characteristics in those with genotype 1b chronic hepatitis C infection," said Peter Ferenci, M.D., professor of Gastroenterology and Hepatology, Medical University of Vienna.
PEARL-III enrolled patients across different demographics and characteristics. Response rates in patients with certain characteristics (male gender, Black race and IL28B non-CC genotypes) were examined, as these patient populations have historically been associated with having a decreased response to treatment. High response rates were observed across all patients in the study, including those with these characteristics.
"We are excited about the strong PEARL-III results which demonstrate the AbbVie regimen achieved high SVR rates with no discontinuations due to adverse events in patients new to treatment with genotype 1b infection," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "Additionally, with these data, we continue to be on track to begin major regulatory submissions in the second quarter of 2014. AbbVie will continue to disclose additional detailed phase III study results at future scientific congresses and in publications."
About Study M13-961 (PEARL-III)
PEARL-III is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's regimen with and without RBV in non-cirrhotic, GT1b HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without RBV for 12 weeks, and 210 patients randomized to the regimen with RBV for 12 weeks. Following 12 weeks of treatment, 99.0 percent receiving the regimen without RBV (n=207/209) and 99.5 percent receiving the regimen with RBV (n=209/210) achieved SVR12. Patients in the treatment arm without RBV received placebo in substitution for RBV.
Patients with different demographics and characteristics were enrolled in the study, including gender, race (Black vs. non-Black), Hispanic/Latino ethnicity, age, geographic region, body mass index (BMI), liver fibrosis stage, IL28B genotype and viral load.
Across treatment arms in PEARL-III, there were no documented relapses within 12 weeks post-treatment. No on-treatment virologic failures occurred in the treatment arm without RBV and a single virologic failure occurred in the treatment arm with RBV. While all patients in the study completed therapy, two patients in the arm without RBV were lost to follow-up and therefore were considered treatment failures.
The most commonly reported adverse events (>10 percent for either arm) were headache, fatigue, pruritus, nausea and asthenia, with pruritus and nausea occurring at a statistically higher rate in the treatment arm with RBV compared to the arm without RBV. Anemia occurred more commonly among patients in the RBV-containing arm with clinically significant anemia requiring RBV dose reductions occurring in 9 percent of these patients.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without RBV with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score greater than or equal to 6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
SOURCE AbbVie
For
further information: Media: Elizabeth Hoff, +1 (847) 935-4236,
elizabeth.hoff@abbvie.com, or Javier Boix, +1 (847) 937-6113,
javier.boix@abbvie.com; Investor Relations: Elizabeth Shea, +1 (847)
935-2211, elizabeth.shea@abbvie.com
Saturday, March 1, 2014
An Update: Treat Hepatitis C Now Or Wait?
Only twenty more days until spring folks! The family is so over winter, we're all hoping March comes in like a lamb and stays! How about you?
To usher in March, we have a collection of slides which offer SVR rates on both FDA approved and investigational HCV agents, including interferon-free regimens in late stage clinical trials. A few other topics touch on off-label use by combining two newly approved drugs, terminology used to determine treatment response and links to relevant information.
The slide-set is best viewed in full screen mode, please click here to begin.
Wednesday, February 19, 2014
HCV Antivirals Race to Market - Gilead, AbbVie, Janssen, Boehringer Ingelheim and Bristol-Myers Squibb
Just In
March 2014
Hepatitis C: Treat Now Or Wait?
To usher in March, we have a collection of slides which offer SVR rates on both FDA approved and investigational HCV agents, including interferon-free regimens in late stage clinical trials. A few other topics touch on off-label use by combining two newly approved drugs, terminology used to determine treatment response and links to relevant information.
The slide-set is best viewed in full screen mode, please click here to begin.
Related-
Bristol-Myers Daclatasvir Hepatitis C Treatment to Get Faster Review by the European Medicines Agency
Daclatasvir and Sofosbuvir: New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies
AbbVie Amazing All-oral Regimen: 100--96 percent cure rates mostly in 12weeks even in patients w-cirrhosis
Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C
ISSUE: FEBRUARY 2014 | VOLUME: 65:2
Source - Gastroenterology & Endoscopy News
by Kate O'Rourke
Boston—Over the next five years, a whirlwind of new direct-acting antiviral agents (DAAs) for hepatitis C are expected to get the green light from the FDA. The recent approval of simeprevir (Olysio, Janssen) and sofosbuvir (Sovaldi, Gilead)–containing regimens is only the tip of the iceberg.“There are multiple, oral, interferon [IFN]-free DAA regimens in late-stage clinical trials with high SVR [sustained virologic response] rates,” said Mark Sulkowski, MD, medical director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology & Hepatology and professor of medicine at the Johns Hopkins School of Medicine, in Baltimore.
These include the Gilead-based regimen of sofosbuvir plus ledipasvir, with or without GS-9669; AbbVie’s ABT450/r plus ABT267 and ABT333; Boehringer Ingelheim’s faldaprevir plus deleobuvir, with or without PPI-668; Janssen’s simeprevir and samatasvir plus TMC647055/r; and Merck’s MK-8742 plus MK-5172. At press time, Bristol-Myers Squibb was in the process of submitting a regulatory filing for either daclatasvir plus asunaprevir, or this combination plus BMS 791325..............
Continue reading.........
Monday, February 10, 2014
The Hep C Race Is Heating Up: AbbVie Vs. Gilead
Jan 10 -Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C
Investment Commentary
The Hep C Race Is Heating Up: AbbVie Vs. Gilead
Investment Commentary
The Hep C Race Is Heating Up: AbbVie Vs. Gilead
Friday, January 31, 2014
AbbVie Amazing All-oral Regimen: 100--96 percent cure rates mostly in 12weeks even in patients w-cirrhosis
In AbbVie's Interferon-free late-stage studies of 6 phase 3 trials most HCV genotype 1 participants achieved an impressive 99% cure rates in 12 weeks. AbbVie said it will file for regulatory approval early in the second quarter, expecting to launch in late 2014.
AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of HCV Genotype 1
- Ninety-nine percent SVR(12) rates with and without ribavirin in certain patient types
- Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates
- AbbVie expects U.S. launch in 2014
NORTH CHICAGO, Ill., Jan. 31, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie's investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients.
AbbVie Phase III Clinical Program Results
Study
|
Patients
|
Treatment Regimen
|
SVR12
|
PEARL-II
(12 weeks)
|
GT1b treatment-experienced
(N=179)
|
AbbVie regimen + RBV (n=88)
|
97%
(85/88)
|
AbbVie regimen only (n=91)
|
100%
(91/91)
| ||
PEARL-III
(12 weeks)
|
GT1b treatment-naive
(N=419)
|
AbbVie regimen + RBV (n=210)
|
99%
(209/210)
|
AbbVie regimen only (n=209)
|
99%
(207/209)
| ||
PEARL-IV
(12 weeks)
|
GT1a treatment-naive
(N=305)
|
AbbVie regimen + RBV (n=100)
|
97%
(97/100)
|
AbbVie regimen only (n=205)
|
90%
(185/205)
| ||
TURQUOISE-II
(12 & 24 weeks)
|
GT1 treatment-naive
and treatment-experienced with compensated cirrhosis
(N=380)
|
AbbVie regimen + RBV, 12 weeks (n=208)
|
92%
(191/208)
|
AbbVie regimen + RBV, 24 weeks (n=172)
|
96%
(165/172)
| ||
SAPPHIRE-I
(12 weeks)
|
GT1 treatment-naive
(N=631)
|
AbbVie regimen + RBV (n=473)
|
96%
(455/473)
|
SAPPHIRE-II
(12 weeks)
|
GT1 treatment-experienced
(N=394)
|
AbbVie regimen + RBV (n=297)
|
96%
(286/297)
|
"The
outcomes of AbbVie's comprehensive phase III studies in 2,300 patients
across 25 countries demonstrate how our investigational regimen performs
across a broad spectrum of genotype 1 patients, including those with
compensated liver cirrhosis," said Scott Brun,
M.D., vice president, pharmaceutical development, AbbVie. "The high
rates of response and tolerability of our regimen, coupled with the low
rates of discontinuation are promising."
The
AbbVie investigational regimen consists of the fixed-dose combination
of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg),
dosed once daily, and ABT-333 (250mg) with or without ribavirin
(weight-based), dosed twice daily. The combination of three different
mechanisms of action interrupts the HCV replication process with the
goal of optimizing SVR rates across different patient populations. In
May of 2013, AbbVie's regimen with and without ribavirin for HCV GT1 was
designated as a Breakthrough Therapy by the U.S. Food and Drug
Administration (FDA). AbbVie is on track to begin major regulatory
submissions early in the second quarter of 2014. AbbVie will disclose
detailed study results at future scientific congresses and in
publications.
About Study M13-389 (PEARL-II)
PEARL-II
is a global, multi-center, randomized, open-label, controlled study to
evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's
regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected,
treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients randomized to the regimen without ribavirin for 12 weeks, and 88 patients randomized to the regimen with ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients randomized to the regimen without ribavirin for 12 weeks, and 88 patients randomized to the regimen with ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The
most commonly reported adverse events were fatigue and headache.
Discontinuations due to adverse events were reported in none of the
patients in the ribavirin-free arm and two (2 percent) patients in the
ribavirin-containing arm. There were no patients in either arm of the
study that experienced virologic relapse or breakthrough.
About Study M13-961 (PEARL-III)
PEARL-III
is a global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment with
AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1b
HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without ribavirin for 12 weeks, and 210 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen with ribavirin (n=209/210) achieved SVR12.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without ribavirin for 12 weeks, and 210 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen with ribavirin (n=209/210) achieved SVR12.
The
most commonly reported adverse events were headache and fatigue. No
patient discontinued study drug due to adverse events. Virologic relapse
or breakthrough was noted in none of the patients receiving the regimen
without ribavirin and 0.5 percent of patients receiving the regimen
with ribavirin.
About Study M14-002 (PEARL-IV)
PEARL-IV
is a global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment with
AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1a
HCV-infected, treatment-naive adult patients.
The study population consisted of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis: 205 patients randomized to the regimen without ribavirin for 12 weeks, and 100 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of patients receiving the regimen without ribavirin (n=185/205) and 97 percent receiving the regimen with ribavirin (n=97/100) achieved SVR12.
The study population consisted of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis: 205 patients randomized to the regimen without ribavirin for 12 weeks, and 100 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of patients receiving the regimen without ribavirin (n=185/205) and 97 percent receiving the regimen with ribavirin (n=97/100) achieved SVR12.
The
most commonly reported adverse events were fatigue, headache and
nausea. Discontinuations due to adverse events were reported in two (1
percent) patients receiving the regimen without ribavirin and no
patients in the ribavirin-containing arm. Virologic relapse or
breakthrough was noted in 8 percent of patients receiving the regimen
without ribavirin and 2 percent of patients receiving the regimen with
ribavirin.
About Study M13-099 (TURQUOISE-II)
TURQUOISE-II
is the first phase III study completed exclusively in GT1 cirrhotic
patients investigating an all-oral, interferon-free regimen. It is a
global, multi-center, randomized, open-label study evaluating the
efficacy and safety of 12 or 24 weeks of treatment with AbbVie's regimen
with ribavirin in cirrhotic, GT1a and GT1b HCV-infected,
treatment-naive and treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomized to the regimen with ribavirin for 12 weeks, and 172 patients randomized to the regimen with ribavirin for 24 weeks. Following 12 weeks of treatment, 92 percent of patients (n=191/208) achieved SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
The study population consisted of 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomized to the regimen with ribavirin for 12 weeks, and 172 patients randomized to the regimen with ribavirin for 24 weeks. Following 12 weeks of treatment, 92 percent of patients (n=191/208) achieved SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
The
most commonly reported adverse events were fatigue, headache and
nausea. Discontinuations due to adverse events were reported in four (2
percent) patients receiving the regimen with ribavirin for 12 weeks and
four (2 percent) patients in the 24-week arm. Virologic relapse or
breakthrough was noted in 6 percent of patients in the 12-week arm and 2
percent in the 24-week arm.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
Globally,
approximately 160 million people are chronically infected with
hepatitis C[1]. AbbVie's multinational HCV program is the largest
all-oral, interferon-free clinical program in GT1 patients being
conducted to date[2]. GT1 (with subtypes 1a and 1b) is the most
prevalent genotype worldwide.
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450
was discovered during the ongoing collaboration between AbbVie and
Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and
regimens that include protease inhibitors. ABT-450 is being developed by
AbbVie for use in combination with AbbVie's other investigational
medicines for the treatment of HCV.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir
must not be used with certain medications due to significant drug-drug
interactions and in patients with known hypersensitivity to ritonavir or
any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some
statements in this news release may be forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995. The
words "believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.
AbbVie
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments, except as required by law.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
[2] Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
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