From Medscape Medical News
New Antivirals Show Poor Safety in HCV With Cirrhosis
Daniel M. Keller, PhD
May 2, 2012 (Barcelona, Spain) — Two relatively new direct-acting antiviral drugs have poor safety profiles in patients with hepatitis C virus (HCV) and cirrhosis, including a high rate of serious adverse events leading to study discontinuation. However, the efficacy of the drugs is good, as evidenced by high rates of on-treatment virologic responses, Christophe Hézode, MD, from Hôpital Henri Mondor in Créteil, France, reported here at the International Liver Congress 2012.
In phase 3 trials of the 2 drugs — telaprevir and boceprevir — rash, pruritus, and anemia were reported with telaprevir, and anemia and dysgeusia were reported with boceprevir. However, those trials included a relatively small number of patients with cirrhosis. A French compassionate-use program allowed the early use of these 2 protease inhibitors before they were approved for patients with cirrhosis, who were entered into a national multicenter registry to prospectively collect clinical data and biological specimens.
An interim analysis evaluated the safety and efficacy of the drugs in these patients who received at least 16 weeks of antiviral treatment (n = 455). The patients had compensated cirrhosis and had relapsed after previous treatment or were partial responders (defined as having had a decrease in HCV RNA of at least 2 log10 IU/mL at week 12 of therapy).
Telaprevir patients (n = 296) received 12 weeks of telaprevir with pegylated interferon (pegIFN) plus ribavirin and then continued only the pegIFN/ribavirin out to week 48. Boceprevir patients (n = 159) received pgIFN/ribavirin for 48 weeks, during which they also received boceprevir for weeks 4 to 48. Both groups were followed for virologic response after week 48.
The telaprevir and boceprevir groups were similar at baseline; mean age was 57 years, HCV RNA level was 6.5 log10 IU/mL, mean hemoglobin was 14.4 to 14.8 g/dL, mean neutrophil count was 3.2 to 3.3 × 109/mm3, and mean platelet count was 150,000/mm3.
High Serious Adverse Event Rate
"The rate of serious adverse events was high, around 50%, with early discontinuation due to severe adverse events observed in 14% of the patients," Dr. Hézode said.
"The second message is that 6 patients died — 2% of the cohort. The main reasons for these deaths were sepsis and hepatic decompensation" that was probably related to interferon, not telaprevir.
A third safety signal was the "difficult management of anemia," requiring the use of recombinant erythropoietin or transfusions, he explained.
Dr. Hézode said that in the boceprevir group, "the serious adverse event rate was high, around 40%, and early discontinuation due to serious adverse events was observed in 7% of patients." Two patients died from sepsis. Hepatic decompensation occurred in 4.4% of patients. Significant anemia occurred in one third of patients, two thirds required recombinant erythropoietin, and 10.7% received transfusions.
Dr. Hézode presented efficacy data on boceprevir, which was fairly good; 37% achieved undetectable HCV RNA levels at week 8 in an intention-to-treat analysis, rising to 58% at week 12 and 61% at week 16.
He concluded that the safety profile of these 2 direct-acting antiviral drugs in compensated cirrhotic patients is poor, but virologic responses are good. The high rate of serious adverse events (38.4% to 48.6%) was much higher than in phase 3 trials (9% to 14%).
Dr. Hézode recommended that patients with cirrhosis be treated cautiously with telaprevir or boceprevir and that they be monitored carefully, especially in light of the high incidence of anemia and its poor response to erythropoietin administration.
Session moderator George Papatheodoridis, MD, associate professor of medicine and gastroenterology at the Medical School of Athens University, staff member at Hippokration General Hospital in Athens, Greece, and member of the European Association for the Study of the Liver Governing Board Scientific Committee, told Medscape Medical News that "we were surprised by that high rate of so many serious adverse events, and even deaths, but I believe...they had included many patients with, in fact, contraindications to treatment."
He cited, for example, a low platelet count as a contraindication to interferon. "They went beyond the official indications, beyond the inclusion and exclusion criteria that were present in the phase 3 trials. I believe this is why they had such high rates of serious adverse events," Dr. Papatheodoridis said.
He noted that the number of platelets or neutrophils is a laboratory marker that reflects the severity of liver disease. "These were patients with very advanced liver disease who...should not have been treated with interferons," he said. "If you add the [protease inhibitor], which has more side effects, of course the safety profile will be worse."
Dr. Papatheodoridis said the investigators should do "the easy subanalysis" of patients with and without contraindications or who met or failed to meet prespecified criteria for entry into the trial, which Dr. Hézode said he plans to do.
Although there were no deaths in the telaprevir or boceprevir phase 3 trials, it is now obvious that it is very dangerous to use these drugs in such advanced patients.
"The usual indications are the indications for interferon — the inclusion criteria," Dr. Papatheodoridis said.
"For the new drugs, the only new contraindication might be other drugs that the patients take for other diseases because they might have drug–drug interactions."
Dr. Hézode and Dr. Papatheodoridis have disclosed no relevant financial relationships.
The International Liver Congress 2012: Abstract 8. Presented April 19, 2012.
Wednesday, May 2, 2012
Hepatitis C a latent legacy of baby boomers' youth
In an article published today by the Los Angeles Times journalist Anna Gorman discusses the increase of hepatitis c infections and the push for nationwide testing by federal officials. The author writes according to the Centers for Disease Control and Prevention three in four of the estimated 3.2 million people who have chronic hepatitis C are baby boomers.
Hepatitis C a latent legacy of baby boomers' youth
Continue Reading.......
Hepatitis C a latent legacy of baby boomers' youth
May 2, 2012
"We have sort of a perfect storm of an age wave of people who are moving through time who are progressively becoming sicker from an infection that was acquired several decades ago," said John Ward, director of the Division of Viral Hepatitis at the CDC. "We think we are at a very critical juncture."
Many boomers unknowingly contracted the virus in younger years from using drugs or having blood transfusions before screening was improved during the AIDS crisis. Unaware of the risk and without symptoms, most have never been tested for hepatitis C and don't know they have it. The disease — primarily contracted through blood — often remains hidden for decades while it slowly destroys liver cells. There is no vaccine.
The CDC recommendation is coming in an era when safer, faster and more effective drug treatments are becoming available, and more are being tested. The new medications still have side effects but increase the odds of suppressing the virus and its complications, according to research.
Health officials say the new medications, although they aren't cheap, are far less costly than liver transplants and liver cancer treatment, which can climb into the hundreds of thousands of dollars.
Continue Reading.......
Tuesday, May 1, 2012
Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety
Date: May 1, 2012
FOR IMMEDIATE RELEASE
Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety
WASHINGTON — Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine.
According to recent estimates, nearly half of all Americans take at least one prescription drug daily and many older people use five or more, noted the committee that wrote the report. The report's recommendations build on the new authorities and tools provided to the U.S. Food and Drug Administration through the Food and Drug Administration Amendments Act of 2007, which increased the agency's capacity to monitor drugs after approval and act if signs of safety problems appear.
One of the committee's key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug. This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market. The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product's use, as well as benefit and risk assessments specific to these questions. It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions. Much of this information is already being gathered by FDA, but it is currently scattered across multiple records. Putting the information into an accessible format in a single document would make FDA's commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.
There are too many individual factors involved in each case and too great a variety of drugs to provide a single universal set of criteria for determining what should trigger a postmarket study, the committee concluded. However, it identified some circumstances in which a product's benefits or risks are particularly uncertain, including "first in class" drugs that have been approved based on surrogate endpoints used previously for other drug classes, and drugs for which several endpoints provide conflicting evidence about risk, such as an anti-hypertensive drug that lowers blood pressure but increases weight. In such cases, the committee recommended that FDA require safety research after approval or provide a public rationale for why it is not necessary. Early initiation of such studies could limit the harm done by drugs with risks that are later found to be unacceptable and avoid crises in which the agency is faced with few good options, the committee said.
When deciding whether to require manufacturers to conduct postmarket studies, FDA must balance its ethical obligations to protect the public's health and to protect research participants. The agency should require postmarket research only if a regulatory decision cannot be made based on existing safety evidence; the research can sufficiently reduce uncertainties about the benefit-risk balance to help inform a regulatory decision; the results will be used to make a decision in a timely fashion; and the rights and interests of the research participants can be adequately protected.
FDA should ensure that the postmarket studies it requires are conducted in ways that are ethically and scientifically sound. Continuing advances in electronic health record systems and analytic techniques likely will mean that observational approaches using large data sets will become more important over time, and these approaches could create new ethical challenges, the committee noted. The agency should seek additional guidance to assure the public that postmarket research and surveillance are being properly overseen, the committee said.
"It is not possible to know what the full range of a drug's benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continue to monitor and learn about the effects of drugs after they are marketed," said committee co-chair Ruth Faden, Philip Franklin Wagley Professor of Biomedical Ethics and executive director, Berman Institute of Bioethics, Johns Hopkins University, Baltimore. "Our report focuses on how the agency can be proactive so that situations in which a drug's benefit-risk profile becomes problematic can be detected earlier, and it details how FDA can get the additional information on a drug's safety in the most ethical and scientifically sound ways when questions arise."
"We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency's ability to protect public health," said co-chair Steven N. Goodman, professor of medicine, health research, and policy, and associate dean for clinical and translational research, Stanford University School of Medicine, Stanford, Calif. "This will become increasingly important as FDA looks for ways to safely expedite the drug approval process."
The report was sponsored by the U.S. Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.
Additional Resources:
Report in Brief
Full Report
Project Website
Contacts:
Christine Stencel, Senior Media Relations Officer
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13219
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety
WASHINGTON — Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine.
According to recent estimates, nearly half of all Americans take at least one prescription drug daily and many older people use five or more, noted the committee that wrote the report. The report's recommendations build on the new authorities and tools provided to the U.S. Food and Drug Administration through the Food and Drug Administration Amendments Act of 2007, which increased the agency's capacity to monitor drugs after approval and act if signs of safety problems appear.
One of the committee's key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug. This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market. The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product's use, as well as benefit and risk assessments specific to these questions. It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions. Much of this information is already being gathered by FDA, but it is currently scattered across multiple records. Putting the information into an accessible format in a single document would make FDA's commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.
There are too many individual factors involved in each case and too great a variety of drugs to provide a single universal set of criteria for determining what should trigger a postmarket study, the committee concluded. However, it identified some circumstances in which a product's benefits or risks are particularly uncertain, including "first in class" drugs that have been approved based on surrogate endpoints used previously for other drug classes, and drugs for which several endpoints provide conflicting evidence about risk, such as an anti-hypertensive drug that lowers blood pressure but increases weight. In such cases, the committee recommended that FDA require safety research after approval or provide a public rationale for why it is not necessary. Early initiation of such studies could limit the harm done by drugs with risks that are later found to be unacceptable and avoid crises in which the agency is faced with few good options, the committee said.
When deciding whether to require manufacturers to conduct postmarket studies, FDA must balance its ethical obligations to protect the public's health and to protect research participants. The agency should require postmarket research only if a regulatory decision cannot be made based on existing safety evidence; the research can sufficiently reduce uncertainties about the benefit-risk balance to help inform a regulatory decision; the results will be used to make a decision in a timely fashion; and the rights and interests of the research participants can be adequately protected.
FDA should ensure that the postmarket studies it requires are conducted in ways that are ethically and scientifically sound. Continuing advances in electronic health record systems and analytic techniques likely will mean that observational approaches using large data sets will become more important over time, and these approaches could create new ethical challenges, the committee noted. The agency should seek additional guidance to assure the public that postmarket research and surveillance are being properly overseen, the committee said.
"It is not possible to know what the full range of a drug's benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continue to monitor and learn about the effects of drugs after they are marketed," said committee co-chair Ruth Faden, Philip Franklin Wagley Professor of Biomedical Ethics and executive director, Berman Institute of Bioethics, Johns Hopkins University, Baltimore. "Our report focuses on how the agency can be proactive so that situations in which a drug's benefit-risk profile becomes problematic can be detected earlier, and it details how FDA can get the additional information on a drug's safety in the most ethical and scientifically sound ways when questions arise."
"We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency's ability to protect public health," said co-chair Steven N. Goodman, professor of medicine, health research, and policy, and associate dean for clinical and translational research, Stanford University School of Medicine, Stanford, Calif. "This will become increasingly important as FDA looks for ways to safely expedite the drug approval process."
The report was sponsored by the U.S. Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.
Additional Resources:
Report in Brief
Full Report
Project Website
Contacts:
Christine Stencel, Senior Media Relations Officer
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13219
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
Galectin Therapeutics Announces Long-term Engagement of Dr. Scott Friedman to Advise on Liver Fibrosis Programs
May 1, 2012, 9:00 a.m. EDT
Galectin Therapeutics Announces Long-term Engagement of Dr. Scott Friedman to Advise on Liver Fibrosis Programs
Renowned Physician and Researcher in Liver Diseases-
NEWTON, Mass., May 01, 2012 (BUSINESS WIRE) -- Galectin Therapeutics Inc. /quotes/zigman/9334018/quotes/nls/galt GALT 0.00% ("the Company"), the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins for therapy of liver fibrosis and cancer, today announced entering into a five-year consulting agreement with world-renowned expert in liver fibrosis, Dr. Scott Friedman of the Mount Sinai School of Medicine. He will advise the Company on its scientific programs, clinical trials and the landscape of therapies for liver fibrosis.
"Dr. Friedman is one of the world's foremost authorities on liver fibrosis and its therapy, whose work and perspectives have shaped the world's current view of the disease," said Dr. Peter Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics, Inc. "We look forward to his guidance and contributions as we develop a new class of therapeutics for the treatment of liver fibrosis."
"Galectins appear to play a significant role in the pathogenesis of liver fibrosis, a potentially fatal disease with no efficacious therapies," commented Scott Friedman, M.D., Mount Sinai School of Medicine. "However, preclinical data on the Company's galectin inhibitors show very promising activity in the prevention and even reversal of liver fibrosis. Based on the potential of galectin inhibition to treat fibrotic liver disease, I am enthusiastic to join with Galectin Therapeutics as we work to develop potential new therapies for this highly prevalent and serious disease."
Dr. Friedman is Professor of Medicine, Chief of the Division of Liver Disease and Dean for Therapeutic Discovery at the Mount Sinai School of Medicine. In his recently appointed position as Dean, he oversees an innovative program of drug discovery and development within an academic setting in partnership with biotech and pharmaceutical partners, a novel program within an academic institution. Dr. Friedman has performed pioneering research into the underlying causes of scarring, or fibrosis, associated with chronic liver disease, which affects millions worldwide. He was the first to isolate and characterize the hepatic stellate cell, which is the key cell type responsible for scar production in liver. He has written definitive reviews, delivered authoritative lectures and consulted extensively to industry, the NIH and FDA on the pathogenesis of liver fibrosis, including therapeutic approaches. He will be awarded the International Recognition Prize from the European Association for the Study of Liver Diseases in Barcelona on April 20, 2012, and is the past recipient, in 2003, of the International Hans Popper Prize awarded to the outstanding liver researcher in the world under the age of 50.
About Galectin Therapeutics
Galectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT 0.00% is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com .
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
SOURCE: Galectin Therapeutics
Galectin Therapeutics Announces Long-term Engagement of Dr. Scott Friedman to Advise on Liver Fibrosis Programs
Renowned Physician and Researcher in Liver Diseases-
NEWTON, Mass., May 01, 2012 (BUSINESS WIRE) -- Galectin Therapeutics Inc. /quotes/zigman/9334018/quotes/nls/galt GALT 0.00% ("the Company"), the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins for therapy of liver fibrosis and cancer, today announced entering into a five-year consulting agreement with world-renowned expert in liver fibrosis, Dr. Scott Friedman of the Mount Sinai School of Medicine. He will advise the Company on its scientific programs, clinical trials and the landscape of therapies for liver fibrosis.
"Dr. Friedman is one of the world's foremost authorities on liver fibrosis and its therapy, whose work and perspectives have shaped the world's current view of the disease," said Dr. Peter Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics, Inc. "We look forward to his guidance and contributions as we develop a new class of therapeutics for the treatment of liver fibrosis."
"Galectins appear to play a significant role in the pathogenesis of liver fibrosis, a potentially fatal disease with no efficacious therapies," commented Scott Friedman, M.D., Mount Sinai School of Medicine. "However, preclinical data on the Company's galectin inhibitors show very promising activity in the prevention and even reversal of liver fibrosis. Based on the potential of galectin inhibition to treat fibrotic liver disease, I am enthusiastic to join with Galectin Therapeutics as we work to develop potential new therapies for this highly prevalent and serious disease."
Dr. Friedman is Professor of Medicine, Chief of the Division of Liver Disease and Dean for Therapeutic Discovery at the Mount Sinai School of Medicine. In his recently appointed position as Dean, he oversees an innovative program of drug discovery and development within an academic setting in partnership with biotech and pharmaceutical partners, a novel program within an academic institution. Dr. Friedman has performed pioneering research into the underlying causes of scarring, or fibrosis, associated with chronic liver disease, which affects millions worldwide. He was the first to isolate and characterize the hepatic stellate cell, which is the key cell type responsible for scar production in liver. He has written definitive reviews, delivered authoritative lectures and consulted extensively to industry, the NIH and FDA on the pathogenesis of liver fibrosis, including therapeutic approaches. He will be awarded the International Recognition Prize from the European Association for the Study of Liver Diseases in Barcelona on April 20, 2012, and is the past recipient, in 2003, of the International Hans Popper Prize awarded to the outstanding liver researcher in the world under the age of 50.
About Galectin Therapeutics
Galectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT 0.00% is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com .
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
SOURCE: Galectin Therapeutics
May Is Hepatitis Awareness Month
May Is Hepatitis Awareness Month
April 30, 2012
Every May, the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and our public health partners across the nation observe Hepatitis Awareness Month. This year, we are very pleased to be marking this observance during a time of increased awareness about and collaboration around viral hepatitis –due in large part to the work of our federal partners over the past year on the implementation of the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis.
Developed by an inter-agency working group and announced last May by Dr. Howard Koh, Assistant Secretary for Health, the Action Plan details steps to increase viral hepatitis awareness and knowledge among healthcare providers and communities and strategies to improve access to quality prevention, care, and treatment services for persons living with viral hepatitis. For the past year, we have been collaborating with our colleagues across HHS, as well as from the Department of Veterans Affairs and Department of Justice’s Federal Bureau of Prisons, to pursue the strategies detailed in the Action Plan. Together, we are working to ensure that new cases of viral hepatitis are prevented and that persons who are already infected are tested, informed about their infection, and provided with counseling, care, and treatment.
Learn More About Viral Hepatitis Risks, Tests and Treatment
An estimated 3.5–5.3 million Americans are living with chronic (lifelong) hepatitis B or hepatitis C virus infection. Most of them do not know that they are infected, placing them at greater risk for severe, even fatal, complications from the disease and increasing the likelihood that they will spread the virus to others. We encourage you to use Hepatitis Awareness Month to learn more about this “silent epidemic.” One place to start learning more is CDC’s Hepatitis Awareness Month webpage. Check back over the course of the month as exciting new resources and tools are added to this page. The CDCNPIN webpage is another important resource, where federal partners working to implement the Action Plan have posted downloadable materials designed to educate the public, patients, and providers about viral hepatitis. Select “hepatitis” as your topic and add relevant keywords below, such as “testing,” “treatment,” or “Asian American,” and you will get a list of materials to read and share with others.
Inaugural Hepatitis Testing Day Coming on May 19
As called for in the Action Plan, May 19th has been designated as Hepatitis Testing Day in the United States. Coinciding with Hepatitis Awareness Month, this inaugural Hepatitis Testing Day offers an important opportunity to remind healthcare providers and educate the public about who should be tested for viral hepatitis. We’ll be sharing more about this observance in a blog post later this month. In the meantime, to learn more and start thinking about how you and your organization can participate in promoting viral hepatitis awareness and testing, visit CDC’s Hepatitis Testing Day webpage.
We hope you will join with us in promoting both important observances as a way to enhance public awareness of viral hepatitis prevention, testing, care and treatment across the United States. Won’t you please commit to learning more yourself and/or sharing information about viral hepatitis with at least two other people? They can be family, friends, co-workers or neighbors. Working together, we can end the silence around this epidemic and in so doing, make great strides in improving the health of persons who are at risk for or living with viral hepatitis.
Source
April 30, 2012Every May, the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and our public health partners across the nation observe Hepatitis Awareness Month. This year, we are very pleased to be marking this observance during a time of increased awareness about and collaboration around viral hepatitis –due in large part to the work of our federal partners over the past year on the implementation of the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis.
Developed by an inter-agency working group and announced last May by Dr. Howard Koh, Assistant Secretary for Health, the Action Plan details steps to increase viral hepatitis awareness and knowledge among healthcare providers and communities and strategies to improve access to quality prevention, care, and treatment services for persons living with viral hepatitis. For the past year, we have been collaborating with our colleagues across HHS, as well as from the Department of Veterans Affairs and Department of Justice’s Federal Bureau of Prisons, to pursue the strategies detailed in the Action Plan. Together, we are working to ensure that new cases of viral hepatitis are prevented and that persons who are already infected are tested, informed about their infection, and provided with counseling, care, and treatment.
Learn More About Viral Hepatitis Risks, Tests and Treatment
An estimated 3.5–5.3 million Americans are living with chronic (lifelong) hepatitis B or hepatitis C virus infection. Most of them do not know that they are infected, placing them at greater risk for severe, even fatal, complications from the disease and increasing the likelihood that they will spread the virus to others. We encourage you to use Hepatitis Awareness Month to learn more about this “silent epidemic.” One place to start learning more is CDC’s Hepatitis Awareness Month webpage. Check back over the course of the month as exciting new resources and tools are added to this page. The CDCNPIN webpage is another important resource, where federal partners working to implement the Action Plan have posted downloadable materials designed to educate the public, patients, and providers about viral hepatitis. Select “hepatitis” as your topic and add relevant keywords below, such as “testing,” “treatment,” or “Asian American,” and you will get a list of materials to read and share with others.
Inaugural Hepatitis Testing Day Coming on May 19
As called for in the Action Plan, May 19th has been designated as Hepatitis Testing Day in the United States. Coinciding with Hepatitis Awareness Month, this inaugural Hepatitis Testing Day offers an important opportunity to remind healthcare providers and educate the public about who should be tested for viral hepatitis. We’ll be sharing more about this observance in a blog post later this month. In the meantime, to learn more and start thinking about how you and your organization can participate in promoting viral hepatitis awareness and testing, visit CDC’s Hepatitis Testing Day webpage.
We hope you will join with us in promoting both important observances as a way to enhance public awareness of viral hepatitis prevention, testing, care and treatment across the United States. Won’t you please commit to learning more yourself and/or sharing information about viral hepatitis with at least two other people? They can be family, friends, co-workers or neighbors. Working together, we can end the silence around this epidemic and in so doing, make great strides in improving the health of persons who are at risk for or living with viral hepatitis.
Source
Interferon - Hepatitis C Drug Can Cause Depression
Hepatitis C Drug can Cause Depression
Released:5/1/2012 2:20 PM EDT
Source:Loyola University Health System
Released:5/1/2012 2:20 PM EDT
Source:Loyola University Health System
Newswise — MAYWOOD, Ill. -- There's a high rate of depression among patients with hepatitis C, but a standard treatment for the disease includes a drug, interferon, that can cause depression.
In a review article, researchers tackle the complexities of diagnosing and managing depression before and after initiating treatment with interferon.
Dr. Murali S. Rao of Loyola University Medical Center is a co-author of the study, published in the International Journal of Interferon, Cytokine and Mediator Research.
"Depression is a relatively frequent and potentially serious complication of interferon therapy for hepatitis C virus infection," the researchers write. "However, other etiologies [causes] of depression may coexist and have to be carefully excluded."
Hepatitis C is the most common chronic blood-borne infection in the United States. At least 4 million people have been exposed and 3.2 million are chronic carriers.
The drugs ribavirin and pegylated interferon are mainstay treatments. Pegylated interferon can help relieve muscle and joint pain and reduce the disabling fatigue. But a well-established side effect of interferon is depression of variable severity -- including suicidal thoughts. The prevalence of depression among hepatitis C patients receiving interferon has been reported to be between 10 percent and 40 percent, depending on the screening method used.
One of the main concerns in treating hepatitis C patients is the risk of suicide, especially since many patients already are depressed before beginning therapy. Patients who have a personal or family history of a serious mood disorder, depression, suicidal thoughts or suicide attempts "should be carefully interviewed and referred to a specialist for assessment of suicide risk and treatment of the underlying disorder before treatment with interferon can be considered," the authors write.
The SSRI class of antidepressants, such as citalopram (brand name, Celexa), have been shown to be effective in treating depression in hepatitis patients treated with interferon. The related SNRI class of antidepressants, such as milnacipran (Savella), also can reduce depressive symptoms in patients taking interferon. But there have been conflicting results in studies on whether giving antidepressants before starting interferon can prevent depression, the authors write.
Interferon can affect the level of serotonin, a compound that is responsible in part for regulating mood and other brain functions. This may be the reason why antidepressants don't always work in patients who take interferon, the authors write.
Rao, an expert on depression, is chair of the Department of Psychiatry and Behavioral Neurosciences of Loyola University Chicago Stritch School of Medicine. Other authors are Dr. Haris Papafragkakis (first author) and Dr. Paul Martin of the University of Miami, Dr. Martin Moehlen of Tulane University and Dr. Sonu Dhillon of St. Francis Medical Center in Peoria, Ill.
Rao, an expert on depression, is chair of the Department of Psychiatry and Behavioral Neurosciences of Loyola University Chicago Stritch School of Medicine. Other authors are Dr. Haris Papafragkakis (first author) and Dr. Paul Martin of the University of Miami, Dr. Martin Moehlen of Tulane University and Dr. Sonu Dhillon of St. Francis Medical Center in Peoria, Ill.
2012 EASL On Demand Internet Symposium
The much anticipated - 2012 EASL Internet Symposium at Viral Ed is up and ready to view.
Program Overview
This Internet symposium will review and discuss the key studies on chronic hepatitis C management and treatment presented at EASL. The symposium will feature four well-known and recognized thought leaders in the HCV field, with three serving as presenting faculty/discussants and one as program moderator.
Advances in Chronic Hepatitis C Management and Treatment
Ready To View
*Free registration required
,
,
Slide-Deck Ready To View
Online Expert Poster Review and Discussion
Still In Progress
The 47th Annual EASL:
Advances in Chronic Hepatitis C Management and Treatment begins here.
GS-7977 Induces Rapid, Durable Drops in Viral Load
Medscape Medical News from:
The International Liver Congress 2012
This coverage is not sanctioned by, nor a part of, the European Association for the Study
of the Liver.
From Medscape Medical News
New HCV Drug Induces Rapid, Durable Drops in Viral Load
Daniel M. Keller, PhD
April 30, 2012 (Barcelona, Spain) — In 3 phase 2 trials of GS-7977, there was a concordance between the sustained virologic response (SVR) 4 weeks after the end of therapy (SVR4) and SVRs at 12 and 24 weeks after therapy (SVR12 and SVR24) in treatment-naive patients infected with hepatitis C virus (HCV) genotypes 1, 2, or 3.
No patient relapsed after posttreatment week 12, and 99% of patients with SVR4 for whom posttreatment week 12 data were available achieved SVR12, Eric Lawitz, MD, from Alamo Medical Research in San Antonio, Texas, reported here at the International Liver Congress 2012.
GS-7977 (formerly PSI-7977) is a specific nucleotide analogue inhibitor of HCV NS5B RNA polymerase and is taken orally once daily. Previous reports have shown that it has broad antiviral activity against HCV genotypes 1, 2, and 3, with or without interferon, in treatment-naive patients, and has a high barrier to the development of viral resistance.
The aim of the study was to evaluate concordance between SVR4 and SVR12 or SVR24 among treatment-naive patients taking GS-7977 400 mg daily in the PROTON (n = 144), ELECTRON (n = 120), and ATOMIC (n = 332) phase 2 clinical trials. The trial protocols differed somewhat, but in general were various combinations and durations of GS-7977, pegylated interferon (Peg-IFN), and ribavirin.
In the PROTON and ATOMIC trials, depending on viral genotype, patients received GS-7977 plus Peg-IFN/ribavirin for 12 weeks followed by Peg-IFN for 12 weeks, Peg-IFN/ribavirin alone for 48 weeks, GS-7977 plus Peg-IFN/ribavirin for 12 or 24 weeks, GS-7977 plus PegIFN/ribavirin for 12 weeks followed by 12 weeks of GS-7977 alone or by GS-7977 plus ribavirin.
In the ELECTRON trial, some patients with genotypes 2 or 3 virus received similar combinations but only out to 12 weeks. Other patients with genotypes 1, 2, or 3 received GS-7977 plus ribavirin for 12 weeks.
The analysis involved only patients treated with GS-7977 400 mg in combination with interferon, ribavirin, or both for at least 4 weeks who had SVR4 plus SVR12 or SVR4 plus SVR24 data available. Of the 596 patients in the 3 studies, 259 (43%) were eligible for analysis.
At baseline in all treatment groups, mean age ranged from 43 to 52 years, and most patients were white, male, had similar body mass indices (mean, 26 to 28 kg/m²), and had interleukin-28B genotype non-CC. Mean baseline HCV RNA levels were mainly in the range of 6.3 to 6.7 log10 IU/mL.
Dr. Lawitz presented results for virologic response at the end of therapy and for SVR4, SVR12, and SVR24.
"If we look at all regimens and look at the concordance between SVR4 and SVR12, we can see that 249 of the 251 [patients] were concordant between SVR4 and SVR12 — a concordance rate of 99%," he said. "If we look at concordance between SVR4 and SVR24, we can see that although the numbers are smaller, there is complete concordance — all 107 patients who had an SVR4 achieved an SVR24.... The concordance held, irrespective of the presence or absence of interferon. However, the dataset is fairly small in the noninterferon arm, limiting conclusions."
Dr. Lawitz concluded that "much of the concordance is due to the high response rates observed across all treatment groups. To date, relapse after week 4 is infrequent and was only observed in patients who received a peg-interferon-containing regimen."
Session moderator George Papatheodoridis, MD, associate professor of medicine and gastroenterology at the Medical School of Athens University, staff member at Hippokration General Hospital, in Athens, Greece, and a member of the European Association for the Study of the Liver Governing Board Scientific Committee, told Medscape Medical News that GS-7977 "is a very interesting, very promising molecule. It seems to be rather safe and very effective, even in combination with ribavirin." Dr. Papatheodoridis was not involved in any of the studies.
In terms of new drugs to treat HCV, he said, "some of the new molecules are very genotype-specific.... Most of the protease inhibitors are developed to work only for genotype 1; some of them work for genotype 2, but not 3 and 4. The nucleoside polymerase inhibitors seem to work better across almost all genotypes, so this is the only class [of drug] that is not that genotype-specific."
Dr. Papatheodoridis wondered about the use of SVR4 as a standard efficacy measure. "I don't think that SVR4 will and should be the standard for SVR," he told Medscape Medical News. "Of course, we know that the FDA and most of the physicians have now accepted SVR12. So probably...SVR12 is going to be the standard for reporting trials in the near future. Still, with all these combinations, patients should have at least 1 examination, maybe 6 months or 12 months after SVR12, so we can be sure that this SVR remains over time. I think that SVR12 is going to be the standard from now on, but the patients treated with the new regimens should be followed for a bit longer."
He admitted that SVR4 looks predictive of later sustained responses. "You expect most of the patients to relapse soon after stopping treatment [if they are going relapse]. Of course, SVR4 is reasonable; we know and we expect that it is going to be associated with SVR12 and SVR24. There is no rush to decide the SVR just 4 weeks after treatment.... We should be sure that we eradicated the virus," he cautioned.
Dr. Lawitz reports financial relationships with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Medarex, Medtronic, Merck, Novartis, Pharmasset, Roche, sanofi-aventis, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Tibotec, Vertex Pharmaceuticals, ViroChem Pharma, and ZymoGenetics. Dr. Papatheodoridis has disclosed no relevant financial relationships.
The International Liver Congress 2012: Abstract 7. Presented April 19, 2012.
Conference News
The International Liver Congress 2012
This coverage is not sanctioned by, nor a part of, the European Association for the Study
of the Liver.
From Medscape Medical News
New HCV Drug Induces Rapid, Durable Drops in Viral Load
Daniel M. Keller, PhD
April 30, 2012 (Barcelona, Spain) — In 3 phase 2 trials of GS-7977, there was a concordance between the sustained virologic response (SVR) 4 weeks after the end of therapy (SVR4) and SVRs at 12 and 24 weeks after therapy (SVR12 and SVR24) in treatment-naive patients infected with hepatitis C virus (HCV) genotypes 1, 2, or 3.
No patient relapsed after posttreatment week 12, and 99% of patients with SVR4 for whom posttreatment week 12 data were available achieved SVR12, Eric Lawitz, MD, from Alamo Medical Research in San Antonio, Texas, reported here at the International Liver Congress 2012.
GS-7977 (formerly PSI-7977) is a specific nucleotide analogue inhibitor of HCV NS5B RNA polymerase and is taken orally once daily. Previous reports have shown that it has broad antiviral activity against HCV genotypes 1, 2, and 3, with or without interferon, in treatment-naive patients, and has a high barrier to the development of viral resistance.
The aim of the study was to evaluate concordance between SVR4 and SVR12 or SVR24 among treatment-naive patients taking GS-7977 400 mg daily in the PROTON (n = 144), ELECTRON (n = 120), and ATOMIC (n = 332) phase 2 clinical trials. The trial protocols differed somewhat, but in general were various combinations and durations of GS-7977, pegylated interferon (Peg-IFN), and ribavirin.
In the PROTON and ATOMIC trials, depending on viral genotype, patients received GS-7977 plus Peg-IFN/ribavirin for 12 weeks followed by Peg-IFN for 12 weeks, Peg-IFN/ribavirin alone for 48 weeks, GS-7977 plus Peg-IFN/ribavirin for 12 or 24 weeks, GS-7977 plus PegIFN/ribavirin for 12 weeks followed by 12 weeks of GS-7977 alone or by GS-7977 plus ribavirin.
In the ELECTRON trial, some patients with genotypes 2 or 3 virus received similar combinations but only out to 12 weeks. Other patients with genotypes 1, 2, or 3 received GS-7977 plus ribavirin for 12 weeks.
The analysis involved only patients treated with GS-7977 400 mg in combination with interferon, ribavirin, or both for at least 4 weeks who had SVR4 plus SVR12 or SVR4 plus SVR24 data available. Of the 596 patients in the 3 studies, 259 (43%) were eligible for analysis.
At baseline in all treatment groups, mean age ranged from 43 to 52 years, and most patients were white, male, had similar body mass indices (mean, 26 to 28 kg/m²), and had interleukin-28B genotype non-CC. Mean baseline HCV RNA levels were mainly in the range of 6.3 to 6.7 log10 IU/mL.
Dr. Lawitz presented results for virologic response at the end of therapy and for SVR4, SVR12, and SVR24.
"If we look at all regimens and look at the concordance between SVR4 and SVR12, we can see that 249 of the 251 [patients] were concordant between SVR4 and SVR12 — a concordance rate of 99%," he said. "If we look at concordance between SVR4 and SVR24, we can see that although the numbers are smaller, there is complete concordance — all 107 patients who had an SVR4 achieved an SVR24.... The concordance held, irrespective of the presence or absence of interferon. However, the dataset is fairly small in the noninterferon arm, limiting conclusions."
Dr. Lawitz concluded that "much of the concordance is due to the high response rates observed across all treatment groups. To date, relapse after week 4 is infrequent and was only observed in patients who received a peg-interferon-containing regimen."
Session moderator George Papatheodoridis, MD, associate professor of medicine and gastroenterology at the Medical School of Athens University, staff member at Hippokration General Hospital, in Athens, Greece, and a member of the European Association for the Study of the Liver Governing Board Scientific Committee, told Medscape Medical News that GS-7977 "is a very interesting, very promising molecule. It seems to be rather safe and very effective, even in combination with ribavirin." Dr. Papatheodoridis was not involved in any of the studies.
In terms of new drugs to treat HCV, he said, "some of the new molecules are very genotype-specific.... Most of the protease inhibitors are developed to work only for genotype 1; some of them work for genotype 2, but not 3 and 4. The nucleoside polymerase inhibitors seem to work better across almost all genotypes, so this is the only class [of drug] that is not that genotype-specific."
Dr. Papatheodoridis wondered about the use of SVR4 as a standard efficacy measure. "I don't think that SVR4 will and should be the standard for SVR," he told Medscape Medical News. "Of course, we know that the FDA and most of the physicians have now accepted SVR12. So probably...SVR12 is going to be the standard for reporting trials in the near future. Still, with all these combinations, patients should have at least 1 examination, maybe 6 months or 12 months after SVR12, so we can be sure that this SVR remains over time. I think that SVR12 is going to be the standard from now on, but the patients treated with the new regimens should be followed for a bit longer."
He admitted that SVR4 looks predictive of later sustained responses. "You expect most of the patients to relapse soon after stopping treatment [if they are going relapse]. Of course, SVR4 is reasonable; we know and we expect that it is going to be associated with SVR12 and SVR24. There is no rush to decide the SVR just 4 weeks after treatment.... We should be sure that we eradicated the virus," he cautioned.
Dr. Lawitz reports financial relationships with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Medarex, Medtronic, Merck, Novartis, Pharmasset, Roche, sanofi-aventis, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Tibotec, Vertex Pharmaceuticals, ViroChem Pharma, and ZymoGenetics. Dr. Papatheodoridis has disclosed no relevant financial relationships.
The International Liver Congress 2012: Abstract 7. Presented April 19, 2012.
Conference News
- EASLNew HCV Drug Induces Rapid, Durable Drops in Viral Load
- EASLInterferon Lambda Beats Alfa in Clearing HCV Genotype 2 or 3
- EASLNonalcoholic Fatty Liver Disease Raises Liver Cancer Risk
- EASLNew Protease Inhibitor TMC435 Cures Most HCV Patients
- EASLPancreatitis Events Halt Development of Alisporivir for HCV
Medscape Gastroenterology © 2012 WebMD, LLC
Subscribe to:
Posts (Atom)