Note: There are some interesting studies of AbbVie drugs being presented that will feature new combination of drugs that will offer shorter treatment durations and more treatment options for people with genotypes 1, 2 and 3.
- New data to be presented on VIEKIRA PAK in genotype 1 hepatitis C patients with chronic kidney disease and on AbbVie's investigational HCV pipeline medicines, ABT-493 and ABT-530
NORTH CHICAGO, Ill., Oct. 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection.
Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.
"We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection."
Select AbbVie clinical presentations include:
RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir +/- Ribavirin in Non-Cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease; Pockros, P, et al.; Poster #1039; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)RUBY-I is an ongoing open-label study evaluating 3D+/-RBV in patients with stage four or five chronic kidney disease and GT1 infection.
TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients with HCV Genotype 1b and Cirrhosis; Poordad, F, et al.; Poster #1051; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Hepatitis C virus infected patients have historically been more difficult to treat when they have cirrhosis. This poster reports on the safety and efficacy of the 3D regimen without RBV in patients with HCV GT1b infection and compensated cirrhosis. VIEKIRA PAK is not recommended for patients with decompensated liver disease.
Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in Phase 3 TURQUOISE-II Trial; Jacobson, I, et al.; Poster #1106; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Model for end-stage liver disease (MELD) scores assess liver disease severity. In this analysis, the efficacy and safety of 3D+RBV and changes in MELD score by baseline MELD score is evaluated.
Preliminary Safety and Efficacy Results in TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin; Reau, N, et al.; Poster #1065; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)TOPAZ-I (ex-U.S.) and TOPAZ-II (U.S.) are evaluating the impact of SVR12 on the progression of liver disease through five years post-treatment in a broad population of HCV GT1-infected patients receiving 3D+/-RBV. This interim analysis reports on-treatment safety and efficacy of 3D+/-RBV among patients in the TOPAZ-II study.
Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV GT1-Infected Patients With or Without Cirrhosis; Zeuzem, S, et al.; Poster #1086; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)In this analysis, the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis is examined.
SVR4 Results in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null Responders with the Combination of the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 (SURVEYOR-1); Poordad, F, et al.; Oral presentation #41; Sunday, November 15, 2015, 4:00 p.m. – 4:15 p.m. PT; Parallel Session 5, Hep C Clinical TrialsIn this Phase 2 study, treatment with ABT-493 and ABT-530 for 12 weeks is evaluated in HCV GT1-infected subjects without cirrhosis. Efficacy and safety results are reported.
SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection (SURVEYOR-2); Wyles, D, et al.; Oral presentation #250; Tuesday, November 17, 2015; 12:00 p.m. – 12:15 p.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without RBV in non-cirrhotic GT2-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.
SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (SURVEYOR-2); Kwo, P, et al.; Oral presentation #248; Tuesday, November 17, 2015, 11:30 a.m.– 11:45 a.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in non-cirrhotic GT3-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.
Select Health Economics and Outcomes Research (HEOR) abstracts include:
Lifetime Risks of Liver Morbidity and Mortality in Patients with Chronic Genotype 1 Hepatitis C Virus and HIV Coinfection Treated with 3D±R (Ombitasvir/ Paritaprevir/ Ritonavir, Dasabuvir ± Ribavirin) vs other Standards of Care in the U.S.; Saab, S, et al.; Poster #1087; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m.
Hepatitis C: Therapeutics (Approved Agents). This study evaluates the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the U.S.PT
The Healthcare Cost Burden of HCV-infected Baby Boomers in the U.S.; Brookmeyer R, et al.; Poster #1068; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)This study quantifies healthcare costs for 50-64 year-old "baby boomers" with HCV by diagnosis and insurance status.
The full AASLD 2015 scientific program can be found at www.aasld.org.
Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.
For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials click here
Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.
Alan Franciscus
Editor-in-Chief
HCV Advocate
Thursday, October 1, 2015
HCV Advocate Eblast: October 1, 2015
Check out what we have in store for you in the October 2015 Newsletter -
HCV Drugs by Alan Franciscus, Editor-in-Chief
Read about Achillion’s latest clinical trial results from their PROXY study, information about insurance denials, how far we have come in treating the most difficult to treat patients, but how far we still have to go to cure everyone with hepatitis C, drug-drug interactions and re-treatment issues.
____
HealthWise by Lucinda K. Porter, RN
In this month’s column, Lucinda answers some important post-treatment questions from people living with hepatitis C.
____
What The Heck Are RAVs? by Alan Franciscus, Editor-in-Chief
If you have been treated before with a direct-acting antiviral medication, but not cured, this brief overview is an important topic to understand.
____
SnapShots by Alan Franciscus, Editor-in-Chief
Three studies that look at treating people with advanced liver disease and re-treatment of people who had been previously treated with direct-acting antiviral medications but did not achieve a cure.
____
What's New? by Alan Franciscus, Editor-in-Chief
We have merged our HBV Website to our HCV Website – find out more…. Don’t forget to check out our newly re-designed Facebook and Twitter accounts! Just go to Facebook and Twitter and type in 'HCV Advocate'. Follow us and learn all the latest information about hepatitis C and about what we are doing.
To read the newsletter click here
The Five: Coffee —Alan Franciscus, Editor-in-Chief
In celebration of National Coffee Day.....but remember adding a bunch of sugar and cream most likely eliminates the benefits! Alan
For some people that morning cup of Joe is the perfect way to start the day. Surprisingly, there are many published studies that show that caffeinated coffee can improve the health of the liver and provide other health benefits. There are some caveats to these health claims that I will discuss at the end of this article. First let’s talk about the good news—the possible health benefits:
1. Liver Fibrosis / HCV Disease Progression:
In a review of 177 patients—121 patients with HCV who drank about 2 ¼ cups of coffee a day were found to have reduced levels of liver fibrosis. The results were only found in those who drank caffeinated coffee.
In another review, 766 participants in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial found more good news. Those who had hepatitis C-related bridging fibrosis or cirrhosis on a liver biopsy and who failed to achieve a cure after being treated with pegylated interferon and ribavirin therapy also yielded some surprising results. Those with advanced liver disease who regularly consumed coffee were found to have lower rates of HCV disease progression.
2. Liver Cancer:
A small study found that people who drank one to three cups of coffee a day had a 29% lower risk of developing liver cancer compared to those who drank 6 cups or less a week.
Another study which reviewed 16 different studies involving over 3,200 patients found that drinking more than 3 cups of coffee a day might cut the risk of liver cancer by up to 50%.
3. Other Conditions:
There are many studies that show a link between the reduction or prevention of certain types of cancers and drinking caffeinated coffee (skin, breast, colon, prostate, uterine, oral). There are also studies that show that caffeinated coffee can lower the risk of diabetes and death.
4. The Downside:
Now, I am going to burst the bubble! Coffee, specifically caffeine, is a drug (a stimulant). Moreover, with any drug you can have withdrawal: It can take more than eight weeks to withdraw entirely from caffeine—although, caffeine withdrawal is usually just an annoying headache and some light fatigue.
Drinking or consuming caffeine can raise blood pressure, lead to heart arrhythmia (irregular heartbeats), can cause cramps, diarrhea and other gastrointestinal health issues. If you drink it too close to bedtime, it can cause insomnia. Too much caffeine can cause depression, anxiety and other types of nervous behaviors. Although rare there have been serious health consequences from people drinking energy drinks and shots.
Examples of the typical amount of caffeine:*
*http://www.nlm.nih.gov/medlineplus/ ency/article/002445.htm
There are many other side effects of caffeine, but I will stop here. However, for most people caffeine in moderation is safe and well-tolerated!
5. Final Thoughts:
What does all of this mean? It is hard to draw concrete conclusions from these studies because you cannot measure what people drink, how it is made and what chemicals are in the coffee. However, there must be something in caffeinated coffee that is contributing to all of these positive outcomes. There are over 1,000 natural chemicals in coffee, and some of these chemicals may be contributing to the caffeine and providing these benefits. Scientists are studying the various chemicals, and we may soon have more concrete information that may lead the way to more potent medications to treat many conditions. In the meantime, it could not hurt to have a cup of Joe—that is if your health allows it.
For some people that morning cup of Joe is the perfect way to start the day. Surprisingly, there are many published studies that show that caffeinated coffee can improve the health of the liver and provide other health benefits. There are some caveats to these health claims that I will discuss at the end of this article. First let’s talk about the good news—the possible health benefits:
1. Liver Fibrosis / HCV Disease Progression:
In a review of 177 patients—121 patients with HCV who drank about 2 ¼ cups of coffee a day were found to have reduced levels of liver fibrosis. The results were only found in those who drank caffeinated coffee.
In another review, 766 participants in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial found more good news. Those who had hepatitis C-related bridging fibrosis or cirrhosis on a liver biopsy and who failed to achieve a cure after being treated with pegylated interferon and ribavirin therapy also yielded some surprising results. Those with advanced liver disease who regularly consumed coffee were found to have lower rates of HCV disease progression.
2. Liver Cancer:
A small study found that people who drank one to three cups of coffee a day had a 29% lower risk of developing liver cancer compared to those who drank 6 cups or less a week.
Another study which reviewed 16 different studies involving over 3,200 patients found that drinking more than 3 cups of coffee a day might cut the risk of liver cancer by up to 50%.
3. Other Conditions:
There are many studies that show a link between the reduction or prevention of certain types of cancers and drinking caffeinated coffee (skin, breast, colon, prostate, uterine, oral). There are also studies that show that caffeinated coffee can lower the risk of diabetes and death.
4. The Downside:
Now, I am going to burst the bubble! Coffee, specifically caffeine, is a drug (a stimulant). Moreover, with any drug you can have withdrawal: It can take more than eight weeks to withdraw entirely from caffeine—although, caffeine withdrawal is usually just an annoying headache and some light fatigue.
Drinking or consuming caffeine can raise blood pressure, lead to heart arrhythmia (irregular heartbeats), can cause cramps, diarrhea and other gastrointestinal health issues. If you drink it too close to bedtime, it can cause insomnia. Too much caffeine can cause depression, anxiety and other types of nervous behaviors. Although rare there have been serious health consequences from people drinking energy drinks and shots.
Examples of the typical amount of caffeine:*
- Coffee – 100 mg per cup
- Tea – 14 mg to 60 mg per cup
- Chocolate – 45 mg in 1.5 oz bar
- Most colas (unless they are labeled “caffeine-free”) – 45 mg in 12 oz. drink
- Candies, energy drinks, snacks, gum – 40-100 mg per serving
*http://www.nlm.nih.gov/medlineplus/ ency/article/002445.htm
There are many other side effects of caffeine, but I will stop here. However, for most people caffeine in moderation is safe and well-tolerated!
5. Final Thoughts:
What does all of this mean? It is hard to draw concrete conclusions from these studies because you cannot measure what people drink, how it is made and what chemicals are in the coffee. However, there must be something in caffeinated coffee that is contributing to all of these positive outcomes. There are over 1,000 natural chemicals in coffee, and some of these chemicals may be contributing to the caffeine and providing these benefits. Scientists are studying the various chemicals, and we may soon have more concrete information that may lead the way to more potent medications to treat many conditions. In the meantime, it could not hurt to have a cup of Joe—that is if your health allows it.
Labels:
coffee,
Fibrosis,
liver cancer
Wednesday, September 30, 2015
Why needle exchange programs work
By Kara Blake
As a vocal advocate for harm reduction and needle exchange services, I have often been asked, “why needle exchange?” To public health professionals, needle exchange programs (NEPs) are an obvious and urgently needed intervention. Research study after research study continues to show conclusively that NEPs reduce the transmission of HIV and viral hepatitis, are tremendously cost-effective, and provide a range of other services that benefit the participants and greater community. Even though the evidence is clear, public and political pushback against NEPs persists across the country. Cape Cod is no exception.Without proper information, it might make sense that a citizen or politician may be resistant to the idea of a needle exchange. How could this intervention possibly support drug users? Won’t this only perpetuate their addiction and its consequences? Won’t this facility increase crime and drug use in my community? The answer, plainly, across the board, is no.Someone who accesses a needle exchange is making what can be the first contact with a professional about their addiction. Recognizing that not all people using drugs are ready, willing or able to stop using at that moment, staff compassionately discuss and educate participants on the potential harms associated with their drug use, and how to reduce those harms. Rather than shame drug users and require abstinence, staff meet and talk with people where they are in their addiction without judgment. This approach is called “harm reduction.” Through such relationships, participants are also able to access services such as screening for HIV, hepatitis C and sexually transmitted infections, access to Narcan and overdose prevention, enrollment in health insurance, and referrals to substance use treatment and medical care.Read more....
Emotional Issues When Leaving Work on Disability —By Jacques Chambers, CLU, September 2015
QUOTE: There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future.
For persons dealing with HCV, the recent introduction of the new medications that appear to provide the complete annihilation of the virus truly is miraculous. Access to the medications is another story, however. Insurance companies want to protect their profits; Medicaid programs are scrambling to find a way to budget the enormous cost of providing these medications to those who need them.
Also, as marvelous as the medications are at killing the virus, they are unable to repair the damage to the body that the virus has already caused, up to and including cirrhosis. While dealing with the physical and medical issues is vital, there are emotional issues as well that need to be at least acknowledged and dealt with should you find yourself in the position that you are no longer able to work and stay healthy.
The emotional impact of such an event may seem like one of those issues that is too basic to spend much time thinking about. Of course, there’s an emotional impact on leaving work for disability. Who wouldn’t be depressed? However, there is usually more to it than that, and not being prepared for it can put you into a tailspin that can affect your mental well being as well as your physical health.
In my years of working with clients, I have found that making the transition from work to disability is a major life event, right up there with getting married or moving, and it can have broad repercussions on actions as well as feelings and emotions. It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.
What, emotionally, will happen to me?
Don’t worry, you won’t “totally lose it.” As with medical symptoms the emotional impact will vary from person to person. The emotional repercussions of leaving work on disability often take the form of depression, lack of concentration, inability to focus on a goal and achieve it, as well as general feelings of malaise, helplessness, and fear of the future. It can also interfere with your ability to think objectively and react rationally. There may be other symptoms both emotional and physical. The important thing to remember is that, uncomfortable as these symptoms are, they are a natural part of this change you are making, and they will pass. Everyone in a similar situation goes through a similar process.
Why does this happen?
Part of it is obvious. You are moving from active work to inactive disability; that’s a major life event and would upset anyone. There are other factors as well, primarily the sense of loss of control and having to battle old messages drilled into you by society since childhood. In many cases, a person self-identifies with the work they do.
There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future. You may feel like you no longer have the power to decide what direction to take or what to do next. Such a feeling of helplessness can be devastating emotionally and can create all sorts of symptoms.
Finally, there are all those good work ethic messages you learned growing up and which you are probably still replaying from the early stages of your condition till now. Many people feel that stopping work is “giving up” or “surrendering” to the medical condition; that the disease is now in control of his or her body and all he or she can do is watch helplessly. Who wouldn’t have emotional issues if, in the back of their mind, they keep thinking things like:
Of course, none of these are true or even rational, but our emotions aren’t based on reason.
Those messages even may get communicated from friends and family. People who haven’t been disabled do not understand the price you must pay for stopping work. I have heard some refer to their disabled friend as “retired” or “taking it easy.” There may even be “jokes” about “envy you.”
Also, do not forget that disability benefits are not always easy to obtain, whether from a private insurance company or Social Security. A denial, which should always be appealed, can cause those messages to replay even louder.
Family dynamics as well as your social relationships will be changing. Your family and friends have known you as one person. Now, even though it is not true, they may perceive you as someone different. This can cause a strain in these relationships that you need to be ready to recognize and work through.
What can I do about it?
Fortunately, there’s a lot you can do about it, and all of the suggestions below would come under the overall title of “Take back control of your life.”
But what will I do once I go on disability?
Many people worry that after they leave work, they will have nothing to do. Some people have an image of themselves lying in bed, face to the wall, doing nothing but waiting. That’s not the way it is. More than one of my clients has worried that they will have too much time on their hands only to return after leaving work to tell me they are so busy, they have no idea how they were able to work full-time.
Initially at least, there’s a lot to do, applications and claims to file, health insurance to adjust, government benefits to apply for. I have heard complaints that, initially, they are busier with those than when they were working; an exaggeration perhaps, but it may seem so.
If you are the type of personality that was always busy before, trust me, you will be as busy as you want and are able to be once you leave work on disability. Depending on how you feel and your interests, there are classes to be taken, family to be enjoyed, other people or agencies that you could volunteer to assist.
Be aware that you can expect some emotional upheaval when leaving work. Recognize it as a natural part of the process and don’t let it scare you into believing that it is more than just a passing reaction to what’s going on with your life at the moment. It will pass; you will move on. Life will continue; you will be healthier and happier for it.
QUOTE: It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.
For persons dealing with HCV, the recent introduction of the new medications that appear to provide the complete annihilation of the virus truly is miraculous. Access to the medications is another story, however. Insurance companies want to protect their profits; Medicaid programs are scrambling to find a way to budget the enormous cost of providing these medications to those who need them.
Also, as marvelous as the medications are at killing the virus, they are unable to repair the damage to the body that the virus has already caused, up to and including cirrhosis. While dealing with the physical and medical issues is vital, there are emotional issues as well that need to be at least acknowledged and dealt with should you find yourself in the position that you are no longer able to work and stay healthy.
The emotional impact of such an event may seem like one of those issues that is too basic to spend much time thinking about. Of course, there’s an emotional impact on leaving work for disability. Who wouldn’t be depressed? However, there is usually more to it than that, and not being prepared for it can put you into a tailspin that can affect your mental well being as well as your physical health.
In my years of working with clients, I have found that making the transition from work to disability is a major life event, right up there with getting married or moving, and it can have broad repercussions on actions as well as feelings and emotions. It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.
What, emotionally, will happen to me?
Don’t worry, you won’t “totally lose it.” As with medical symptoms the emotional impact will vary from person to person. The emotional repercussions of leaving work on disability often take the form of depression, lack of concentration, inability to focus on a goal and achieve it, as well as general feelings of malaise, helplessness, and fear of the future. It can also interfere with your ability to think objectively and react rationally. There may be other symptoms both emotional and physical. The important thing to remember is that, uncomfortable as these symptoms are, they are a natural part of this change you are making, and they will pass. Everyone in a similar situation goes through a similar process.
Why does this happen?
Part of it is obvious. You are moving from active work to inactive disability; that’s a major life event and would upset anyone. There are other factors as well, primarily the sense of loss of control and having to battle old messages drilled into you by society since childhood. In many cases, a person self-identifies with the work they do.
There is frequently a feeling of loss of control over not only the direction of your life, but also a sense of losing control over your very own body. Likewise, the medical condition is now dictating your future. You may feel like you no longer have the power to decide what direction to take or what to do next. Such a feeling of helplessness can be devastating emotionally and can create all sorts of symptoms.
Finally, there are all those good work ethic messages you learned growing up and which you are probably still replaying from the early stages of your condition till now. Many people feel that stopping work is “giving up” or “surrendering” to the medical condition; that the disease is now in control of his or her body and all he or she can do is watch helplessly. Who wouldn’t have emotional issues if, in the back of their mind, they keep thinking things like:
- You’re giving up by stopping work. You’re a quitter.
- You’re surrendering to the disease.
- You’re no longer a contributing member of society.
- You’re taking a giant step closer to “The End.”
- You’re going to “milk the system.”
- You’re weak, needy, plus many other not-so-nice adjectives.
Of course, none of these are true or even rational, but our emotions aren’t based on reason.
Those messages even may get communicated from friends and family. People who haven’t been disabled do not understand the price you must pay for stopping work. I have heard some refer to their disabled friend as “retired” or “taking it easy.” There may even be “jokes” about “envy you.”
Also, do not forget that disability benefits are not always easy to obtain, whether from a private insurance company or Social Security. A denial, which should always be appealed, can cause those messages to replay even louder.
Family dynamics as well as your social relationships will be changing. Your family and friends have known you as one person. Now, even though it is not true, they may perceive you as someone different. This can cause a strain in these relationships that you need to be ready to recognize and work through.
What can I do about it?
Fortunately, there’s a lot you can do about it, and all of the suggestions below would come under the overall title of “Take back control of your life.”
- Control how and when you leave work – Know what you are doing. Make your plans; do your research; create your own timetable for stopping work.
- Take one step at a time to avoid being overwhelmed – You can do this by breaking down your tasks into smaller steps. First, work with your doctor on the process of leaving work, and then apply for the employer’s sick leave and short-term disability. Then decide whether to continue the employer’s health insurance to COBRA or switch to a health plan under the Affordable Care Act (Obamacare). Next you should apply for your employer’s Long Term Disability coverage, if available, then for Social Security Disability (SSD). A list or timeline will help you focus your attention on the next small step without being overwhelmed by the entire process.
- Build, activate and use your support network – Your family, friends, and caregivers can give you emotional support as well as practical assistance, but you may need to ask for it.
- Consider short-term therapy – Perhaps your support network is strong enough that they will give you all the help you need to get through this time. Many clients have also found that a few months with a therapist trained in the emotional issues of the disabled can be of great help as well.
- Speak up, politely but firmly – Do not hesitate to tell those who don’t understand what you are going through that this is not a vacation and you wish you could return to work and understand any snide or “comic” remarks are coming from ignorance.
- Be a little selfish – Finally, it is time, for at least a while, to take care of yourself first. You have been accommodating to others and have been putting their needs and wants ahead of yours. It is time to take a break from that. Let them know as much as you love them that you need to focus on yourself right now, and deeply appreciate their support through this period.
But what will I do once I go on disability?
Many people worry that after they leave work, they will have nothing to do. Some people have an image of themselves lying in bed, face to the wall, doing nothing but waiting. That’s not the way it is. More than one of my clients has worried that they will have too much time on their hands only to return after leaving work to tell me they are so busy, they have no idea how they were able to work full-time.
Initially at least, there’s a lot to do, applications and claims to file, health insurance to adjust, government benefits to apply for. I have heard complaints that, initially, they are busier with those than when they were working; an exaggeration perhaps, but it may seem so.
If you are the type of personality that was always busy before, trust me, you will be as busy as you want and are able to be once you leave work on disability. Depending on how you feel and your interests, there are classes to be taken, family to be enjoyed, other people or agencies that you could volunteer to assist.
Be aware that you can expect some emotional upheaval when leaving work. Recognize it as a natural part of the process and don’t let it scare you into believing that it is more than just a passing reaction to what’s going on with your life at the moment. It will pass; you will move on. Life will continue; you will be healthier and happier for it.
QUOTE: It can also have a dramatic effect on your ability to make decisions objectively and rationally. Clients who recognize this impact and know to expect such feelings are better prepared to deal with them and minimize them when they occur.
Labels:
Disability,
emotional,
medicaid,
Obamacare
Tuesday, September 29, 2015
Hepatitis C Doctor Investigation Report Released -- Health Department Releases Report in Dr. Thomashefsky Investigation
This is unbelievable in this day and age......Alan
Santa Barbara, CA. The Santa Barbara County Public Health Department has released a report into the investigation of Allen Thomashefsky, the Santa Barbara doctor accused of malpractice that lead to several patients contracting Hepatitis C
The report found that during an unannounced visit to Thomashefsky's medical practice by health officials, the physician did not wash his hands prior to a procedure. "When questioned, the physician stated that the sink was in the kitchen, he didn't want to walk back and forth, and believed his hands were clean," the report says.
According to the report, the physician did not wear gloves during the procedure either and when asked to wear gloves, he replied, "He has been practicing the same way for over 30 years and has never had a patient report any problems...The physician declined to wear gloves and used bare hands during the procedure."
Read more....
Santa Barbara, CA. The Santa Barbara County Public Health Department has released a report into the investigation of Allen Thomashefsky, the Santa Barbara doctor accused of malpractice that lead to several patients contracting Hepatitis C
The report found that during an unannounced visit to Thomashefsky's medical practice by health officials, the physician did not wash his hands prior to a procedure. "When questioned, the physician stated that the sink was in the kitchen, he didn't want to walk back and forth, and believed his hands were clean," the report says.
According to the report, the physician did not wear gloves during the procedure either and when asked to wear gloves, he replied, "He has been practicing the same way for over 30 years and has never had a patient report any problems...The physician declined to wear gloves and used bare hands during the procedure."
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THE FIVE: Cirrhosis —Alan Franciscus, Editor-in-Chief
This month’s column is about cirrhosis—the causes, how it develops, the symptoms and
consequences and issues about HCV treatment related to cirrhosis.
1. What are the Causes of Cirrhosis?
Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus. Cirrhosis caused by hepatitis C is responsible for more than 19,000 deaths every year. Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.
2. How Does Cirrhosis Develop?
In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus. Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it. As a result, scar tissue develops. Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds. As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver. This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.
3. What are the Tests to Identify Cirrhosis?
There are many types of tests to find out if someone has cirrhosis. In the past, the most common test was a liver biopsy. The procedure requires a medical person to insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope. The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.
There are many models used to grade and stage the degree of liver damage. The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:
Note: This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.
4. What are the Symptoms and Consequences of Cirrhosis?
In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms. As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening. In addition to the symptoms described above I have listed some of the more common serious conditions below:
Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis. At this point, a person should be evaluated for a liver transplant. The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.
5. HCV Treatment
Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever. However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States. Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2). Many insurance companies are only covering F3 and F4 unless there are other severe complications. Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications. Does this scenario make any sense to you? It does not make any sense to me either!
consequences and issues about HCV treatment related to cirrhosis.
1. What are the Causes of Cirrhosis?
Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus. Cirrhosis caused by hepatitis C is responsible for more than 19,000 deaths every year. Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.
2. How Does Cirrhosis Develop?
In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus. Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it. As a result, scar tissue develops. Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds. As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver. This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.
3. What are the Tests to Identify Cirrhosis?
There are many types of tests to find out if someone has cirrhosis. In the past, the most common test was a liver biopsy. The procedure requires a medical person to insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope. The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.
There are many models used to grade and stage the degree of liver damage. The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:
- Stage F0 = no fibrosis
- Stage F1 = mild fibrosis
- Stage 2 = moderate fibrosis
- Stage 3 = bridging fibrosis
- Stage 4 = cirrhosis
Note: This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.
4. What are the Symptoms and Consequences of Cirrhosis?
In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms. As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening. In addition to the symptoms described above I have listed some of the more common serious conditions below:
- Portal Hypertension: blood cannot flow through the liver because of the extensive scarring.
- Encephalopathy: the liver is not able to remove toxins such as ammonia, and the result is that these toxins invade the brain. Symptoms include personality changes, and changes in sleep patterns (sleep reversal—awake all night, sleep all day).
- Ascites: accumulation of fluids in the abdominal cavity.
- Edema: accumulation of fluid in the extremities—usually in the feet and legs.
- Coagulopathy: the liver is not able to produce clotting factors that stop the blood from bleeding.
- Male and Female Hormone Regulation: the liver may not be able to regulate female and male hormones.
- Severe Itching: the impairment of bile flow that can cause severe and at times debilitating itching.
- Wasting Syndrome: the liver is not able to process nutrients so people can have severe muscle wasting and weight loss.
Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis. At this point, a person should be evaluated for a liver transplant. The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.
5. HCV Treatment
Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever. However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States. Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2). Many insurance companies are only covering F3 and F4 unless there are other severe complications. Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications. Does this scenario make any sense to you? It does not make any sense to me either!
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