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Dec 01, 2012 - 0 comments
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Saw hepatologist last week. News is good. Liver is compensated, no sign of cancer, labs good.
CT results good. Portal/hepatic veins are fine, no ascites.
Labs are good: WBC 7.41 THOU/uL (normal), RBC 4.8 mil/uL (normal), Hgb 15.6 g/dL (normal), Hematocrit 44% (normal), platelet count 158 THOU/uL (low normal), Albumin 3.5 g/dL (low normal), total bilirubin 0.6 mg/dL (normal), direct bilirubin 0.1 mg/dL (normal), and prothrombin time 12.6s (normal), and prothrombin INR 1 (normal).
He will have endoscopy (routine screening). He will do labs, ultrasound, and see hepatologist in May.
His hepatologist referred him for possible trials (Hep C, G1s, with Cirrhosis and compensated liver, treatment experienced, prior partial responders) but nothing has come up. She went to the liver meeting in Boston. It’s her impression that Gilead will apply for approval for sofosbuvir about April, 2013, sofosbuivr treatment for G2's and G3's will likely be interferon free, but sofosbuvir treatment for G1a's will likely include sofosbuvir, interferon, and ribavirin.
No one knows can know what the final phase trial results with sofosbuvir will show for difficult to treat Cirrhotic, G1a, prior null/partial responders or how long from submission meds available, but things are promising. She feels sofosbuvir will be approved about the end of 2013.
We are so thankful his liver is still compensated, no cancer, and new treatment is around the corner. We are so blessed to have a hepatologist who is dedicated to getting rid of his Hep C!
Advocate1955
CT results good. Portal/hepatic veins are fine, no ascites.
Labs are good: WBC 7.41 THOU/uL (normal), RBC 4.8 mil/uL (normal), Hgb 15.6 g/dL (normal), Hematocrit 44% (normal), platelet count 158 THOU/uL (low normal), Albumin 3.5 g/dL (low normal), total bilirubin 0.6 mg/dL (normal), direct bilirubin 0.1 mg/dL (normal), and prothrombin time 12.6s (normal), and prothrombin INR 1 (normal).
He will have endoscopy (routine screening). He will do labs, ultrasound, and see hepatologist in May.
His hepatologist referred him for possible trials (Hep C, G1s, with Cirrhosis and compensated liver, treatment experienced, prior partial responders) but nothing has come up. She went to the liver meeting in Boston. It’s her impression that Gilead will apply for approval for sofosbuvir about April, 2013, sofosbuivr treatment for G2's and G3's will likely be interferon free, but sofosbuvir treatment for G1a's will likely include sofosbuvir, interferon, and ribavirin.
No one knows can know what the final phase trial results with sofosbuvir will show for difficult to treat Cirrhotic, G1a, prior null/partial responders or how long from submission meds available, but things are promising. She feels sofosbuvir will be approved about the end of 2013.
We are so thankful his liver is still compensated, no cancer, and new treatment is around the corner. We are so blessed to have a hepatologist who is dedicated to getting rid of his Hep C!
Advocate1955
Nov 12, 2012 - 1 comments
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Bristol-Myers Squibb Company (BMS) announced yesterday at the Liver Meeting in Boston, Nov. 2012, that the dual regimen of the NS3 protease inhibitor asunaprevir (ASB) with the NS5A inhibitor daclatasvir (DCV) without Interferon or Ribavirin showed up to 78% SVR12 rates in G1b's who were previously null responders.
Advocate1955
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AASLD-Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders
Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study
• Interferon- and ribavirin-free dual DAA regimen is one of multiple daclatasvir-based regimens in development to help meet the needs of diverse HCV patient population
• Findings support both the global and Japanese daclatasvir registrational programs
Sunday, November 11, 2012 4:45 pm EST
BOSTON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced new Phase II data demonstrating that the dual regimen of the investigational NS5A replication complex inhibitor daclatasvir (DCV) and the investigational NS3 protease inhibitor asunaprevir (ASV), without interferon or ribavirin, achieved high rates of sustained virologic response 12 weeks post-treatment (SVR12) in patients with genotype 1b (GT1b) hepatitis C virus (HCV) who were prior null responders to alfa interferon and ribavirin (alfa/RBV). In this study, the DCV/ASV Dual regimen achieved SVR12 in 78% (14/18) and 65% (13/20) of GT1b patients when asunaprevir was dosed twice daily (Group A1) or once daily (Group A2), respectively.
These results were presented today at the American Association for the Study of Liver Diseases congress in Boston, along with data from this same study on the safety and efficacy of quadruple therapy with DCV/ASV/alfa/RBV in predominantly GT1a prior null responders.
In the patients treated with the DCV/ASV Dual regimen therapy, there were no serious adverse events related to study drug or discontinuations due to adverse events. Overall, headache was the most common adverse event in the DCV/ASV Dual regimen groups (Group A1: 44%, Group A2: 40%).
“We continue to see a significant unmet need for treatment approaches that improve response rates in patients with hepatitis C genotype1b who have not responded to prior therapy, with currently available treatment regimens achieving low cure rates of 30 to 40%,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The high response rates seen in this study with daclatasvir and asunaprevir are encouraging as we seek interferon- and ribavirin-free hepatitis C regimens for this difficult-to-treat patient population.”
Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an oral, NS3 protease inhibitor in Phase III development with daclatasvir. The DCV/ASV Dual regimen is part of a global registrational program and a registrational program specific to Japan, where the majority of HCV patients have GT1b.
Study Design and Results
The expansion of this randomized, open-label, phase IIa study evaluated the antiviral activity and safety of the combination of DCV and ASV with and without alfa/RBV in 101 HCV genotype 1 prior null responders to alfa/RBV. The primary endpoint of the study was the proportion of patients achieving undetectable viral load (HCV RNA < LLOQTND) 12 weeks post-treatment (SVR12).
Patients received one of five treatment regimens for 24 weeks. Genotype 1b infected patients were randomized to receive one of four treatment regimens for 24 weeks (two DCV/ASV Dual treatment groups, two DCV/ASV/Alfa/RBV Quad treatment groups). Genotype 1a infected patients were randomized to receive one of two treatment regimens for 24 weeks (two DCV/ASV/Alfa/RBV Quad treatment groups). A fifth group (DCV/ASV/RBV Triple therapy) included both GT1a and GT1b infected patients and enrolled separately. The DCV/ASV Dual treatment groups received DCV 60 mg once daily and ASV 200 mg either twice daily (Group A1) or once daily (Group A2).
Virologic Response
• In Group A1 (DCV + ASV 200 mg BID), 78% (14/18) of patients achieved SVR12. Of the four patients who did not achieve SVR12, one patient was missing a viral load measurement at 12 weeks post-treatment and one had transient viremia (detectable viral load). Both of these patients had undetectable viral load on subsequent visits.
• In Group A2 (DCV + ASV 200 mg QD), 65% (13/20) of patients achieved SVR12
• With DCV/ASV Dual therapy, eight total patients experienced virologic breakthrough1 – two Group A1 patients and six Group A2 patients. All received rescue therapy with the addition of alfa/RBV to their regimen. One Group A2 patient relapsed post-treatment at week 4.
• An analysis of HCV sequences confirmed that five of the six Group A2 patients with virologic breakthrough had baseline polymorphisms that confer DCV resistance (NS5A domain). Additionally, at breakthrough, seven patients had confirmed resistance to both DCV and ASV.
Safety
In the patients treated with DCV/ASV Dual therapy, there were no serious adverse events due to study drug, no deaths, and no treatment discontinuations due to adverse events (AEs). Most AEs were mild to moderate in severity. The most common AEs (≥40% in any group) were:
Adverse Event Group A1*
DCV + ASV 200 mg BID Group A2*
DCV + ASV 200 mg QD
Headache 44% (8/18) 40% (8/20)
Diarrhea 28% (5/18) 40% (8/20)
Weakness (asthenia) 28% (5/18) 30% (6/20)
Fatigue 28% (5/18) 10% (2/20)
Insomnia 22% (4/18) 15% (3/20)
* Adverse events in groups A1 and A2 includes patients who had alfa/RBV added to their regimen
Grade 3-4 AEs in Group A2 included neutropenia in one patient receiving alfa/RBV as rescue therapy. SAEs in Groups A1 and A2 included panic attack, forearm fracture, viral gastroenteritis, and prostate cancer; all were determined by study investigators to be unrelated to study therapy. Grade 3-4 ALT/AST elevations were infrequent and none were accompanied by elevated total or direct bilirubin. All AST/ALT elevations improved without intervention. All patients in groups A1/A2 with cytopenias were receiving alfa/RBV as rescue therapy.
About Bristol-Myers Squibb’s Commitment to Liver Disease
Bristol-Myers Squibb is studying a portfolio of compounds that aims to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes compounds with different mechanisms of action, pursuing both biologics as well as small molecule DAAs. These compounds are being studied as part of multiple treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies.
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential DAA-based hepatitis C treatment regimens. Studied in more than 3,000 patients to date, daclatasvir is in Phase III development. Asunaprevir is an NS3 protease inhibitor in Phase III development for hepatitis C as a component of daclatasvir-based treatment regimens, and has been studied in more than 1,200 patients to date.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compounds described in this release will support regulatory filings, or that the compounds will receive regulatory approvals or, if approved, they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2011, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
1 Virologic breakthrough defined as ≥ 1 log increase from nadir in HCV RNA, HCV RNA ≥ LLOQ on or after Week 8, and confirmed HCV RNA < LLOQ-TD on or after Week 8 (DUAL and TRIPLE arms only)
Contact:
Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.***@****
Advocate1955
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
AASLD-Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders
Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study
• Interferon- and ribavirin-free dual DAA regimen is one of multiple daclatasvir-based regimens in development to help meet the needs of diverse HCV patient population
• Findings support both the global and Japanese daclatasvir registrational programs
Sunday, November 11, 2012 4:45 pm EST
BOSTON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced new Phase II data demonstrating that the dual regimen of the investigational NS5A replication complex inhibitor daclatasvir (DCV) and the investigational NS3 protease inhibitor asunaprevir (ASV), without interferon or ribavirin, achieved high rates of sustained virologic response 12 weeks post-treatment (SVR12) in patients with genotype 1b (GT1b) hepatitis C virus (HCV) who were prior null responders to alfa interferon and ribavirin (alfa/RBV). In this study, the DCV/ASV Dual regimen achieved SVR12 in 78% (14/18) and 65% (13/20) of GT1b patients when asunaprevir was dosed twice daily (Group A1) or once daily (Group A2), respectively.
These results were presented today at the American Association for the Study of Liver Diseases congress in Boston, along with data from this same study on the safety and efficacy of quadruple therapy with DCV/ASV/alfa/RBV in predominantly GT1a prior null responders.
In the patients treated with the DCV/ASV Dual regimen therapy, there were no serious adverse events related to study drug or discontinuations due to adverse events. Overall, headache was the most common adverse event in the DCV/ASV Dual regimen groups (Group A1: 44%, Group A2: 40%).
“We continue to see a significant unmet need for treatment approaches that improve response rates in patients with hepatitis C genotype1b who have not responded to prior therapy, with currently available treatment regimens achieving low cure rates of 30 to 40%,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The high response rates seen in this study with daclatasvir and asunaprevir are encouraging as we seek interferon- and ribavirin-free hepatitis C regimens for this difficult-to-treat patient population.”
Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an oral, NS3 protease inhibitor in Phase III development with daclatasvir. The DCV/ASV Dual regimen is part of a global registrational program and a registrational program specific to Japan, where the majority of HCV patients have GT1b.
Study Design and Results
The expansion of this randomized, open-label, phase IIa study evaluated the antiviral activity and safety of the combination of DCV and ASV with and without alfa/RBV in 101 HCV genotype 1 prior null responders to alfa/RBV. The primary endpoint of the study was the proportion of patients achieving undetectable viral load (HCV RNA < LLOQTND) 12 weeks post-treatment (SVR12).
Patients received one of five treatment regimens for 24 weeks. Genotype 1b infected patients were randomized to receive one of four treatment regimens for 24 weeks (two DCV/ASV Dual treatment groups, two DCV/ASV/Alfa/RBV Quad treatment groups). Genotype 1a infected patients were randomized to receive one of two treatment regimens for 24 weeks (two DCV/ASV/Alfa/RBV Quad treatment groups). A fifth group (DCV/ASV/RBV Triple therapy) included both GT1a and GT1b infected patients and enrolled separately. The DCV/ASV Dual treatment groups received DCV 60 mg once daily and ASV 200 mg either twice daily (Group A1) or once daily (Group A2).
Virologic Response
• In Group A1 (DCV + ASV 200 mg BID), 78% (14/18) of patients achieved SVR12. Of the four patients who did not achieve SVR12, one patient was missing a viral load measurement at 12 weeks post-treatment and one had transient viremia (detectable viral load). Both of these patients had undetectable viral load on subsequent visits.
• In Group A2 (DCV + ASV 200 mg QD), 65% (13/20) of patients achieved SVR12
• With DCV/ASV Dual therapy, eight total patients experienced virologic breakthrough1 – two Group A1 patients and six Group A2 patients. All received rescue therapy with the addition of alfa/RBV to their regimen. One Group A2 patient relapsed post-treatment at week 4.
• An analysis of HCV sequences confirmed that five of the six Group A2 patients with virologic breakthrough had baseline polymorphisms that confer DCV resistance (NS5A domain). Additionally, at breakthrough, seven patients had confirmed resistance to both DCV and ASV.
Safety
In the patients treated with DCV/ASV Dual therapy, there were no serious adverse events due to study drug, no deaths, and no treatment discontinuations due to adverse events (AEs). Most AEs were mild to moderate in severity. The most common AEs (≥40% in any group) were:
Adverse Event Group A1*
DCV + ASV 200 mg BID Group A2*
DCV + ASV 200 mg QD
Headache 44% (8/18) 40% (8/20)
Diarrhea 28% (5/18) 40% (8/20)
Weakness (asthenia) 28% (5/18) 30% (6/20)
Fatigue 28% (5/18) 10% (2/20)
Insomnia 22% (4/18) 15% (3/20)
* Adverse events in groups A1 and A2 includes patients who had alfa/RBV added to their regimen
Grade 3-4 AEs in Group A2 included neutropenia in one patient receiving alfa/RBV as rescue therapy. SAEs in Groups A1 and A2 included panic attack, forearm fracture, viral gastroenteritis, and prostate cancer; all were determined by study investigators to be unrelated to study therapy. Grade 3-4 ALT/AST elevations were infrequent and none were accompanied by elevated total or direct bilirubin. All AST/ALT elevations improved without intervention. All patients in groups A1/A2 with cytopenias were receiving alfa/RBV as rescue therapy.
About Bristol-Myers Squibb’s Commitment to Liver Disease
Bristol-Myers Squibb is studying a portfolio of compounds that aims to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes compounds with different mechanisms of action, pursuing both biologics as well as small molecule DAAs. These compounds are being studied as part of multiple treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies.
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential DAA-based hepatitis C treatment regimens. Studied in more than 3,000 patients to date, daclatasvir is in Phase III development. Asunaprevir is an NS3 protease inhibitor in Phase III development for hepatitis C as a component of daclatasvir-based treatment regimens, and has been studied in more than 1,200 patients to date.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compounds described in this release will support regulatory filings, or that the compounds will receive regulatory approvals or, if approved, they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2011, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
1 Virologic breakthrough defined as ≥ 1 log increase from nadir in HCV RNA, HCV RNA ≥ LLOQ on or after Week 8, and confirmed HCV RNA < LLOQ-TD on or after Week 8 (DUAL and TRIPLE arms only)
Contact:
Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.***@****
Nov 11, 2012 - 1 comments
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This information has already been posted on the Hep C forum, but I wanted to post it in my journals for future reference. Abbott (ABT) will be presenting information at the AASLD meeting in Boston, Nov, 2012, regarding it's triple DAA regimen which produced high rates of SVR both in treatment naive and null responders both with and without Ribavirin, although results with Ribavirin are higher. According to ABT's press release, the SVR rates after 12 weeks of treatment were:
GT1, treatment naive 97.5% SVR, null responders 93.3% SVR
GT1a, treatment naive 96% SVR, null responders 89% SVR
GT1b, treatment naive 100% SVR, null responders 100% SVR
ABT-450r is a protease inhibitor, ABT-333 is a polymerase inhibitor, and ABT-267 is a NS5A inhibitor. Phase 3 will be enrolling.
Advocate1955
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Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012 Liver Meeting®
• Investigational Triple-DAA Regimen plus Ribavirin Treatment for 12 Weeks Demonstrated High SVR12 Rates in Intent-to-Treat Analysis
• Phase 3 Registrational Program Currently Enrolling
November 10, 2012
Abbott Park, Illinois (NYSE: ABT) — Results from Abbott’s phase 2b clinical trial, "Aviator," demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR12) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). Results will be presented at the President's Press Conference and the latebreaking clinical trials session at the Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.
Based on promising results from Aviator, Abbott has selected triple-DAA regimens, with and without ribavirin, to move forward into phase 3 clinical trials. Topline intent-to-treat results for the 12-week, triple-DAA regimen with ribavirin are as follows:
• SVR12 in treatment-naïve genotype 1 (GT1) patients was 97.5 percent (77 of 79), and 93.3 percent (42 of 45) in GT1 null responder patients
• In GT1a patients, SVR12 was achieved in 96 percent (52 of 54) of treatment naïve patients and 89 percent (25 of 28) of null responder patients
• In GT1b patients, SVR12 was achieved in 100 percent of treatment naïve (25 of 25) and null responder patients (17 of 17)
In addition, results from the 12-week triple-DAA regimen without RBV in treatment naïve patients showed:
• SVR12 was achieved in 87.3 percent (69 of 79) of GT1 patients
• SVR12 in GT1a patients was 83 percent (43 of 52)
• SVR12 in GT1b patients was 96 percent (24 of 25)
"Based on the high SVR12 results with Abbott’s triple-direct acting antiviral regimen in GT1 patients, it appears we are moving closer to potential oral treatment regimens that do not require interferon to treat HCV," said Kris Kowdley, M.D., director of the Liver Center of Excellence in the Digestive Disease Institute at Virginia Mason Medical Center, and Clinical Professor of Medicine at the University of Washington in Seattle. "This is encouraging news for the many patients who are unable or unwilling to take interferon."
About Study M11-652 (Aviator)
This phase 2b study assesses the safety, and efficacy of ABT-450/r (dosed 100/100mg to 200/100mg QD), ABT-267 (25mg QD), ABT-333 (400mg BID) and ribavirin in non-cirrhotic treatment-naïve patients and prior peg-interferon/ribavirin null responders for 8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based. Results from the treatment groups are summarized in the chart below.
Treatment-Naïve Null Responders
Duration 8 weeks 12 weeks 12 weeks
Regimen ABT-450/r
ABT-267
ABT-333
RBV ABT-450/r
ABT-333
RBV ABT-450/r
ABT-267
RBV ABT-450/r
ABT-267
ABT-333 ABT-450/r
ABT-267
ABT-333
RBV ABT-450/r
ABT-267
RBV ABT-450/r
ABT-267
ABT-333
RBV
Number dosed 80 41 79 79 79 45 45
Relapses 9 4 5 5 1 5 0
Breakthroughs 0 1 1 1 0 0 3
Lost to Follow up (LTFU) or withdrew consent 1 1 2 4 1 0 0
SVR12 (ITT)1 87.5%
(70/80) 85.4% (35/41) 89.9% (71/79) 87.3% (69/79) 97.5% (77/79) 88.9% (40/45) 93.3% (42/45)
SVR12 (OD)2 88.6% (70/79) 87.5% (35/40) 92.2% (71/77) 92% (69/75) 98.7% (77/78) 88.9% (40/45) 93.3% (42/45)
SVR12 (ITT) GT1a 84%
(47/56) 79%
(23/29) 85%
(44/52) 83%
(43/52) 96%
(52/54) 81%
(21/26) 89%
(25/28)
SVR12 (ITT) GT1b 96%
(23/24) 100%
(12/12) 100%
(27/27) 96%
(24/25) 100%
(25/25) 100%
(18/18) 100%
(17/17)
1. ITT (Intent-to-treat) population: includes all patients who received at least one dose of study drug
2. OD (Observed data): Excludes patients with values missing for reasons other than virologic failure or discontinuation due to AEs
"The 93.3 percent SVR12 seen with triple-DAA therapy with ribavirin in previous null responder patients in Aviator is noteworthy given the limited treatment options with interferon-based therapies for this patient population," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "As the data from the Aviator study have matured, we are encouraged that we have continued to see high SVR12 rates. Results from Aviator have allowed Abbott to confidently move into larger, confirmatory Phase 3 trials with the goal of being the first company to bring an interferon-free treatment regimen to genotype 1 patients."
Aviator Safety Results
Four of 448 patients (one percent) in the 8- and 12-week arms discontinued due to adverse events. Of five serious AEs (1 percent), one (arthralgia or joint pain) was possibly study drug-related. In the trial, the most common adverse events were fatigue (28 and 27 percent) and headache (28 and 31 percent) for treatment naïve and null responders respectively.
About the Hepatitis C Virus
Hepatitis C is a liver disease affecting as many as 170 million people worldwide. The virus is primarily spread through direct contact with the blood of an infected person. HCV increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death; and liver disease associated with HCV infection is growing rapidly.
Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most widespread. Genotype 1 is the most common genotype in the U.S. and the most difficult to treat with interferon based therapies. Patients with genotypes 2 and 3 are more likely than individuals with genotype 1 to respond to therapy with peg-interferon or the combination of peg-interferon and ribavirin.
About Abbott's HCV Development Programs
Abbott's HCV portfolio includes investigational medicines with three different mechanisms of action, including protease (ABT-450/r), polymerase (ABT-333) and NS5A (ABT-267) inhibitors, currently being studied in clinical trials. ABT-450 is being developed with low dose ritonavir which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100mg with ABT-450 for the treatment of HCV is investigational.
ABT-450 was discovered during the course of a collaboration between Abbott and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by Abbott for use in combination with Abbott's other investigational medicines for the treatment of HCV. Abbott is well-positioned to explore combinations and co-formulations of these medicines.
On Monday, November 12 at 5:30 p.m. EST, Abbott will host an investor webcast to discuss the phase 2b Aviator data, as well as our recently initiated phase 3 registrational program. The webcast can be accessed on Abbott’s investor relations website at abbottinvestor.com.
Ritonavir Use in Treatment of HIV
Ritonavir is in a class of medicines called the HIV protease inhibitors. Ritonavir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and for children greater than 1 month in age and older.
Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
Ritonavir Safety in Treatment of HIV
Patients should not take ritonavir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Patients should not take ritonavir if they have had a serious allergic reaction to any of its ingredients. Some patients taking ritonavir may develop liver and pancreas problems, which can cause death.
Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines.
For more information, please see Important Safety Information and Full Prescribing Information.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
http://abbott.com/news-media/press-releases/abbott-presents-promising-phase-2b-interferonfree-hepatitis-c-results-at-2012-liver-meeting.htm
GT1, treatment naive 97.5% SVR, null responders 93.3% SVR
GT1a, treatment naive 96% SVR, null responders 89% SVR
GT1b, treatment naive 100% SVR, null responders 100% SVR
ABT-450r is a protease inhibitor, ABT-333 is a polymerase inhibitor, and ABT-267 is a NS5A inhibitor. Phase 3 will be enrolling.
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Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012 Liver Meeting®
• Investigational Triple-DAA Regimen plus Ribavirin Treatment for 12 Weeks Demonstrated High SVR12 Rates in Intent-to-Treat Analysis
• Phase 3 Registrational Program Currently Enrolling
November 10, 2012
Abbott Park, Illinois (NYSE: ABT) — Results from Abbott’s phase 2b clinical trial, "Aviator," demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR12) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). Results will be presented at the President's Press Conference and the latebreaking clinical trials session at the Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.
Based on promising results from Aviator, Abbott has selected triple-DAA regimens, with and without ribavirin, to move forward into phase 3 clinical trials. Topline intent-to-treat results for the 12-week, triple-DAA regimen with ribavirin are as follows:
• SVR12 in treatment-naïve genotype 1 (GT1) patients was 97.5 percent (77 of 79), and 93.3 percent (42 of 45) in GT1 null responder patients
• In GT1a patients, SVR12 was achieved in 96 percent (52 of 54) of treatment naïve patients and 89 percent (25 of 28) of null responder patients
• In GT1b patients, SVR12 was achieved in 100 percent of treatment naïve (25 of 25) and null responder patients (17 of 17)
In addition, results from the 12-week triple-DAA regimen without RBV in treatment naïve patients showed:
• SVR12 was achieved in 87.3 percent (69 of 79) of GT1 patients
• SVR12 in GT1a patients was 83 percent (43 of 52)
• SVR12 in GT1b patients was 96 percent (24 of 25)
"Based on the high SVR12 results with Abbott’s triple-direct acting antiviral regimen in GT1 patients, it appears we are moving closer to potential oral treatment regimens that do not require interferon to treat HCV," said Kris Kowdley, M.D., director of the Liver Center of Excellence in the Digestive Disease Institute at Virginia Mason Medical Center, and Clinical Professor of Medicine at the University of Washington in Seattle. "This is encouraging news for the many patients who are unable or unwilling to take interferon."
About Study M11-652 (Aviator)
This phase 2b study assesses the safety, and efficacy of ABT-450/r (dosed 100/100mg to 200/100mg QD), ABT-267 (25mg QD), ABT-333 (400mg BID) and ribavirin in non-cirrhotic treatment-naïve patients and prior peg-interferon/ribavirin null responders for 8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based. Results from the treatment groups are summarized in the chart below.
Treatment-Naïve Null Responders
Duration 8 weeks 12 weeks 12 weeks
Regimen ABT-450/r
ABT-267
ABT-333
RBV ABT-450/r
ABT-333
RBV ABT-450/r
ABT-267
RBV ABT-450/r
ABT-267
ABT-333 ABT-450/r
ABT-267
ABT-333
RBV ABT-450/r
ABT-267
RBV ABT-450/r
ABT-267
ABT-333
RBV
Number dosed 80 41 79 79 79 45 45
Relapses 9 4 5 5 1 5 0
Breakthroughs 0 1 1 1 0 0 3
Lost to Follow up (LTFU) or withdrew consent 1 1 2 4 1 0 0
SVR12 (ITT)1 87.5%
(70/80) 85.4% (35/41) 89.9% (71/79) 87.3% (69/79) 97.5% (77/79) 88.9% (40/45) 93.3% (42/45)
SVR12 (OD)2 88.6% (70/79) 87.5% (35/40) 92.2% (71/77) 92% (69/75) 98.7% (77/78) 88.9% (40/45) 93.3% (42/45)
SVR12 (ITT) GT1a 84%
(47/56) 79%
(23/29) 85%
(44/52) 83%
(43/52) 96%
(52/54) 81%
(21/26) 89%
(25/28)
SVR12 (ITT) GT1b 96%
(23/24) 100%
(12/12) 100%
(27/27) 96%
(24/25) 100%
(25/25) 100%
(18/18) 100%
(17/17)
1. ITT (Intent-to-treat) population: includes all patients who received at least one dose of study drug
2. OD (Observed data): Excludes patients with values missing for reasons other than virologic failure or discontinuation due to AEs
"The 93.3 percent SVR12 seen with triple-DAA therapy with ribavirin in previous null responder patients in Aviator is noteworthy given the limited treatment options with interferon-based therapies for this patient population," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "As the data from the Aviator study have matured, we are encouraged that we have continued to see high SVR12 rates. Results from Aviator have allowed Abbott to confidently move into larger, confirmatory Phase 3 trials with the goal of being the first company to bring an interferon-free treatment regimen to genotype 1 patients."
Aviator Safety Results
Four of 448 patients (one percent) in the 8- and 12-week arms discontinued due to adverse events. Of five serious AEs (1 percent), one (arthralgia or joint pain) was possibly study drug-related. In the trial, the most common adverse events were fatigue (28 and 27 percent) and headache (28 and 31 percent) for treatment naïve and null responders respectively.
About the Hepatitis C Virus
Hepatitis C is a liver disease affecting as many as 170 million people worldwide. The virus is primarily spread through direct contact with the blood of an infected person. HCV increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death; and liver disease associated with HCV infection is growing rapidly.
Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most widespread. Genotype 1 is the most common genotype in the U.S. and the most difficult to treat with interferon based therapies. Patients with genotypes 2 and 3 are more likely than individuals with genotype 1 to respond to therapy with peg-interferon or the combination of peg-interferon and ribavirin.
About Abbott's HCV Development Programs
Abbott's HCV portfolio includes investigational medicines with three different mechanisms of action, including protease (ABT-450/r), polymerase (ABT-333) and NS5A (ABT-267) inhibitors, currently being studied in clinical trials. ABT-450 is being developed with low dose ritonavir which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100mg with ABT-450 for the treatment of HCV is investigational.
ABT-450 was discovered during the course of a collaboration between Abbott and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by Abbott for use in combination with Abbott's other investigational medicines for the treatment of HCV. Abbott is well-positioned to explore combinations and co-formulations of these medicines.
On Monday, November 12 at 5:30 p.m. EST, Abbott will host an investor webcast to discuss the phase 2b Aviator data, as well as our recently initiated phase 3 registrational program. The webcast can be accessed on Abbott’s investor relations website at abbottinvestor.com.
Ritonavir Use in Treatment of HIV
Ritonavir is in a class of medicines called the HIV protease inhibitors. Ritonavir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and for children greater than 1 month in age and older.
Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
Ritonavir Safety in Treatment of HIV
Patients should not take ritonavir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Patients should not take ritonavir if they have had a serious allergic reaction to any of its ingredients. Some patients taking ritonavir may develop liver and pancreas problems, which can cause death.
Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines.
For more information, please see Important Safety Information and Full Prescribing Information.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
http://abbott.com/news-media/press-releases/abbott-presents-promising-phase-2b-interferonfree-hepatitis-c-results-at-2012-liver-meeting.htm
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