In August 2012, the big news in the hepatitis community was a new set of CDC guidelines recommending that all Baby Boomers (those born between 1945 and 1965) receive a hepatitis C test. According to the CDC, at that time, more than two million U.S. baby boomers were infected with hepatitis C (HCV), representing approximately 75% of all HCV-infected individuals and the vast majority of the 15,000 people who would die of HCV-related causes that year.
The goal of universal testing for this age cohort was to help identify more than 800,000 additional HCV-infected individuals, who had not yet been diagnosed.
A lot has changed in the last two and a half years. "With the new treatments, people are excited about being treated and cured," Alan Franciscus, founder and executive director of the Hepatitis C Support Project and editor-in-chief of the HCV Advocate, told BioPharma Dive in an interview. "Prior to the approval of interferon-free therapies, there was usually a reluctance from patients—maybe a better word is fear—of treatment."
Read more...
Thursday, August 6, 2015
AASLD/IDSA release updated HCV treatment guidelines
The AASLD and IDSA HCV Guidance Panel has released updated guidelines for the treatment of hepatitis C virus infection, according to newly published data in Hepatology.
AASLD/IDSA HCV Guidance Panel. Hepatology. 2015;doi:10.1002/hep.27950.
“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”
The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.
Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.
Download the Practice Guidance here (PDF)
Source: http://www.healio.com/hepatology/hepatitis-c/news/online/%7Bb26d77d8-268d-49de-b524-e5e01d669a71%7D/aasldidsa-release-updated-hcv-treatment-guidelines
AASLD/IDSA HCV Guidance Panel. Hepatology. 2015;doi:10.1002/hep.27950.
“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”
The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.
Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.
Download the Practice Guidance here (PDF)
Source: http://www.healio.com/hepatology/hepatitis-c/news/online/%7Bb26d77d8-268d-49de-b524-e5e01d669a71%7D/aasldidsa-release-updated-hcv-treatment-guidelines
Patients First: HCV and Depression, by Alan Franciscus, Editor-in-Chief
In January 2015, I wrote about HCV and Depression. Since that time, I have thought a lot about the link between depression and hepatitis C. There does seem to be a pretty strong link between the two. Add on to that just having a chronic disease, such as hepatitis C, it is not surprising that many people with hepatitis C are depressed.
If you think about it there are many additional issues that increase the level of anxiety and depression that people with hepatitis C are now facing even more than before:
- Will I be approved for the new medications by my insurance company?
- Will I be approved for treatment through a patient assistance program?
- Will I be able to afford the co-pays?
- Will the treatment work?
- What if I am not cured?
- What does my future hold?
- Will I be able to work?
There are also people, unfortunately, who have just given up and believe they have no choice at all—no insurance, no physician, no future.
The list of uncertainties could go on and on and on.
I’m bringing this up because I just recently ran across an article that startled me because it discussed Baby Boomers (without HCV) and the increased risk of suicide—Baby Boomers are at the highest risk for suicide and the risk increases as a Baby Boomer ages. Additionally, the suicide rates were much higher in men than in women—In 2013, 78% of the 41,149 suicides in the U.S. were among men.
Note: Among Baby Boomer’s with HCV more than 2/3 are men.
Remember, depression is an illness that is treatable. There are resources at the end of this article and a link to the original article published in January 2015.
I hope that people with HCV and their caregivers will be on the look-out for the signs of anxiety, depression and suicidal behavior to offer support. Be sure to get professional help as needed.
Resources
Source:
Baby boomers are killing themselves at an alarming rate, raising question: Why?
http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#5
Wednesday, August 5, 2015
FDA Safety Alert: NSAIDS
The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. This includes prescribed and over-the-counter non-aspirin NSAID labels.
http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm
Many people with hepatitis C suffer from extrahepatic conditions of hepatitis C and may take NSAIDs or medications that contain NSAIDs.
In a related story it was found there was an increased risk of intracranial bleeding when taking non-steroidal anti-inflammatory drugs (NSAIDs)—ibuprofen and aspirin—during the first 30 days of taking a new prescription of an anti-depressant. This was more common in men than in women. (BMJ. Published online July 14, 2015.)
Read this FDA communication carefully. Talk with your medical provider about what you should take, how often and what are the alternatives that are safe to take.
Canada: Diane Parsons, who fought for hepatitis C victims, dead at 64
Diane Forsyth, better known under maiden name, Diane Parsons, famed for leading legal fight for those infected with hepatitis C from tainted blood transfusions.
HALIFAX — A Halifax woman who led a $1.18 billion class-action settlement for those infected with hepatitis C died Saturday at the age of 64.
Diane Forsyth became known nationally under her maiden name, Diane Parsons, for leading the legal fight for those infected with hepatitis C from blood transfusions.
Her family doctor, Patricia Beresford, said Forsyth, who had a bleeding disorder, became ill after getting a blood transfusion before dental surgery in 1989.
Snapshots, by Alan Franciscus, Editor-in-Chief
Article: Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials—ZM Younossi—et. al
Source: Hepatology 2015 Jun;61(6):1798-808. doi: 10.1002/hep.27724. Epub 2015 Mar 18.
Results and Conclusions: In the phase 3 clinical trials of ledipasvir and sofosbuvir with and without ribavirin patient report outcomes were measured. There was a total of 1,952 patients in the study. Patients were treated for 8, 12 or 24 weeks. In the groups that received ledipasvir and sofosbuvir (without ribavirin) who had early viral load suppression there was improved quality of life that was maximized by the end of treatment. In the group that received ledipasvir/sofosbuvir and ribavirin their quality of life decreased regardless of treatment duration until the end of treatment.
Source: Hepatology 2015 Jun;61(6):1798-808. doi: 10.1002/hep.27724. Epub 2015 Mar 18.
Results and Conclusions: In the phase 3 clinical trials of ledipasvir and sofosbuvir with and without ribavirin patient report outcomes were measured. There was a total of 1,952 patients in the study. Patients were treated for 8, 12 or 24 weeks. In the groups that received ledipasvir and sofosbuvir (without ribavirin) who had early viral load suppression there was improved quality of life that was maximized by the end of treatment. In the group that received ledipasvir/sofosbuvir and ribavirin their quality of life decreased regardless of treatment duration until the end of treatment.
The Bottom Line: Ribavirin during treatment reduced quality of life, but achieving a cure improved quality of life for all of the groups including the groups who received ribavirin.
Editorial Comments: This is a no-brainer, but we need more of these studies to show that being cured improved quality of life and improved overall survival. I hope that insurance companies are hearing this and loosen up the restrictions.
Article: Antigenic cooperation among intrahost HCV variants organized into a complex network of cross-immunoreactivity—P Skums
Source: Proc Natl Acad Sci USA. 2015 May 26;112(21):6653-8.doi:10.1073/pnas.1422942112. Epub 2015 May 4.
Source: Proc Natl Acad Sci USA. 2015 May 26;112(21):6653-8.doi:10.1073/pnas.1422942112. Epub 2015 May 4.
Results and Conclusions:
Most people who become acutely infected with hepatitis C become chronically infected – up to 85%. The reason there is such a high rate of chronic infection is not completely understood, but there are many theories. The current paper presented a mathematical model to show how the virus contributes to hepatitis C chronicity.
Most people who become acutely infected with hepatitis C become chronically infected – up to 85%. The reason there is such a high rate of chronic infection is not completely understood, but there are many theories. The current paper presented a mathematical model to show how the virus contributes to hepatitis C chronicity.
What is interesting is that various proteins of the hepatitis C virus seem to act together to escape the human host—that is certain proteins of the virus work together to draw off parts of the immune system cells so that other parts of the hepatitis C virus can survive and persist in the body and infect liver cells. This enables the hepatitis C virus to act as a network of parts to establish a chronic infection.
The Bottom Line: As with any discovery in science these findings need to be replicated. If the exact mechanism can be understood an effective protective vaccine could be developed.
Editorial Comment: Isn’t science interesting? The hepatitis C virus is a wily little bugger and endlessly fascinating. The key would be to understand why this strategy works for some and not others. This could lead to the development of an effective vaccine.
Article: Differentiation of acute from chronic hepatitis C virus infection by nonstructural 5B deep sequencing: A population-level tool for incidence estimation—V. Montoya et. al
Source: Hepatology Volume 61, Issue 6, pages 1842–1850, June 2015
Source: Hepatology Volume 61, Issue 6, pages 1842–1850, June 2015
Results and Conclusions: In the current study the authors examined the viral proteins from 13 acute and 54 chronic individuals by sequencing the NS5B region of the virus. They were able to differentiate the viral diversity between the acute and chronic infection. The viral diversity was significantly different between acute vs. chronic infection.
Editorial Comment: This and the last issue of the HCV Advocate have discussed the difficult task of trying to diagnose an acute infection of HCV. If this study is replicated and IF the tool is made available at a reasonable cost it could be a game changer in the way we understand how many people are acutely infected with hepatitis C.
Source: http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#3
House Passes Two Historic VA Reform Bills
WASHINGTON, DC – Today, the House passed two pieces of VA reform legislation. The VA Accountability Act of 2015 passed with a vote of 256 – 170. The Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 passed with a vote of 385 – 34. Chairman Miller released the following statement:
“I applaud my colleagues for stepping up today to address the troubling lack of accountability eroding VA’s ability to care for our veterans. The VA Accountability Act will provide the Secretary of the Department of Veterans Affairs the ability to make real reforms and bring much needed accountability to the department. Today, we stand with our veterans because the status quo has failed them and the American people for far too long.
“Just over two weeks ago, the Department of Veterans Affairs announced that because of its inability to budget, VA hospitals around the country would be shutting down in August. Today, the House passed the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 to ensure that does not happen. The bill is designed to rescue a mismanaged VA, providing the resources to keep the doors open, expanding access and choice to veterans and setting the stage to consolidate VA’s uncoordinated and wasteful non-VA care programs into the Veterans Choice Program.
“I urge the Senate to take up both these measures immediately. We cannot allow VA’s incompetence to continue to harm America’s veterans. And I sincerely ask President Obama to sign both in to law – to take the money without the accountability will only lead to continued failure.” – Rep. Jeff Miller, Chairman, House Committee on Veterans’ Affairs
Related:
Chairman Miller’s Floor Statement on The VA Accountability Act of 2015
Chairman Miller’s Floor Statement on The Surface Transportation and Veterans Health Care Choice Improvement Act of 2015
“I applaud my colleagues for stepping up today to address the troubling lack of accountability eroding VA’s ability to care for our veterans. The VA Accountability Act will provide the Secretary of the Department of Veterans Affairs the ability to make real reforms and bring much needed accountability to the department. Today, we stand with our veterans because the status quo has failed them and the American people for far too long.
“Just over two weeks ago, the Department of Veterans Affairs announced that because of its inability to budget, VA hospitals around the country would be shutting down in August. Today, the House passed the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 to ensure that does not happen. The bill is designed to rescue a mismanaged VA, providing the resources to keep the doors open, expanding access and choice to veterans and setting the stage to consolidate VA’s uncoordinated and wasteful non-VA care programs into the Veterans Choice Program.
“I urge the Senate to take up both these measures immediately. We cannot allow VA’s incompetence to continue to harm America’s veterans. And I sincerely ask President Obama to sign both in to law – to take the money without the accountability will only lead to continued failure.” – Rep. Jeff Miller, Chairman, House Committee on Veterans’ Affairs
Related:
Chairman Miller’s Floor Statement on The VA Accountability Act of 2015
Chairman Miller’s Floor Statement on The Surface Transportation and Veterans Health Care Choice Improvement Act of 2015
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