I want to take a moment to give props to my friend, Debbie Green. She is the driving force behind The Greenview Foundation and is on the frontline of fighting Hepatitis C. Her foundation has already funded one clinical trial and she is currently raising money for a second. One of the most important goals of the Foundation is to fund research aimed at non-interferon based treatment for HCV, which I believe is VERY important. For anyone who has undergone interferon-based treatment, it is no picnic and a large number of people quit treatment due to its debilitating side effects. I went through two rounds of the stuff and you'd have to hog-tie me to get me to do it again. It was absolutely awful, particularly the 48 week option. I honestly wasn't sure I could do it, so finding a viable alternative is essential.
She raises funds in a variety of ways, but her cookbook is a big hit. Please check out her foundation's website at:
http://www.hepcfund.org/index.html
And....consider donating to the foundation or purchasing a cookbook; her foundation is highly respected and well organized. I'm also very fortunate to call Debbie my friend, and we met through my blog.
Hats off to Ms. Debbie Green of the Greenview Foundation for Hepatitis C Research! Who says one woman can't change the world?
Saturday, April 16, 2011
Thursday, April 14, 2011
Novartis first-in-class antiviral DEB025 achieved sustained viral response in 76% of patients with chronic hepatitis C, new phase II study show
This information came from my friend Debbie via IEWY News:
DEB025 plus standard of care (pegylated-interferon alfa 2a/ribavirin) showed superior viral cure vs standard of care alone (p=0.008)[1]
*
A cyclophilin inhibitor, DEB025 belongs to a new class of medicines that limit hepatitis C virus replication and have the potential to reshape hepatitis C therapy
*
Phase III study with DEB025 commenced recently with previously untreated patients infected by the most common form of hepatitis C virus
Basel, – Novartis announced today that a Phase II study with the first-in-class antiviral DEB025 (alisporivir) met its primary endpoint for achieving viral cure (24 weeks after stopping treatment) in 76% of patients with chronic hepatitis C[1]. The study involved nearly 300 previously untreated patients infected with the most common form of hepatitis C virus (HCV), the genotype 1 (G1)[1].
The data were presented today at the European Association for the Study of the Liver (EASL) congress in Berlin, Germany. The findings show that 76% of G1 chronic hepatitis C patients treated with DEB025 plus standard of care (pegylated-interferon alfa 2a/ribavirin) achieved superior viral cure (known as sustained viral response, or SVR) compared to 55% of patients on standard of care alone (p=0.008)[1]. Treatment with DEB025 demonstrated a low incidence of adverse events, with discontinuation rates comparable between treatment groups[1].
“Hepatitis C is difficult to treat and current therapies are only effective in about half of patients infected with the most prevalent genotype of HCV[2],” said Stefan Zeuzem, Professor of Medicine at the Goethe University Hospital in Frankfurt, Germany, and the study’s principal investigator. “These results are exciting because a large majority of patients achieved sustained viral response with DEB025, with some who also benefited from a shorter duration of treatment compared to standard therapy[1].”
DEB025 is the first in a new class of drugs called cyclophilin inhibitors. Unlike other compounds in development that target the virus directly, DEB025 is a host targeting antiviral (HTA) that targets so-called host proteins which are essential for the replication of HCV. As these proteins play a key role in the replication of all types of HCV, DEB025 may offer an effective treatment option for a broad range of HCV forms. In other clinical trials, DEB025 has also shown effective antiviral activity against other common HCV genotypes (G2, G3 and G4)[3].
“There is a critical need for more effective drugs to treat chronic hepatitis C, and Novartis is dedicated to developing medicines that will reduce the burden of this disease for patients and physicians,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “DEB025 has a new mode of action that may stop the virus from replicating and could reshape the future approach to treatment of hepatitis C.”
More than 170 million people worldwide are infected with HCV, which can cause serious liver disease leading to cirrhosis, liver cancer, and in some cases death. HCV is a blood borne virus that predominantly affects the liver[4],[5]. As an RNA (ribonucleic acid) virus, it mutates much more than DNA (deoxyribonucleic acid) viruses. This ability to change makes it harder for the immune system to clear (or eliminate) the virus. There are six major variations of HCV, known as genotypes and labelled from G1 to G6[5].
The study presented at EASL was a 48-week, global, double-blind, randomized, placebo-controlled trial in G1 treatment-naïve chronic hepatitis C patients. It evaluated the efficacy and safety of DEB025 combined with pegylated-interferon alfa 2a/ribavirin (PegIFN/RBV) vs. PegIFN/RBV alone. The primary endpoint was sustained viral response after 24 weeks (SVR24)[1].
Transient and reversible increase in bilirubin was observed in association with the initial DEB025 loading dose[1]. A small proportion of patients (4.2%) had a transient increase in bilirubin more than five times the upper limit of normal (ULN), but this was not associated with liver damage[1].
A pivotal Phase III study with DEB025 commenced recently to evaluate the efficacy and safety of DEB025 combined with standard of care and enrolling previously untreated HCV G1 patients. Other Phase II studies are ongoing in other patient populations i.e., G1 treatment-experienced patients and G2 and G3 treatment-naive patients.
Novartis in-licensed DEB025 from Debiopharm Group(TM), an independent biopharmaceuticals company based in Switzerland, under an agreement which gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan).
DEB025 plus standard of care (pegylated-interferon alfa 2a/ribavirin) showed superior viral cure vs standard of care alone (p=0.008)[1]
*
A cyclophilin inhibitor, DEB025 belongs to a new class of medicines that limit hepatitis C virus replication and have the potential to reshape hepatitis C therapy
*
Phase III study with DEB025 commenced recently with previously untreated patients infected by the most common form of hepatitis C virus
Basel, – Novartis announced today that a Phase II study with the first-in-class antiviral DEB025 (alisporivir) met its primary endpoint for achieving viral cure (24 weeks after stopping treatment) in 76% of patients with chronic hepatitis C[1]. The study involved nearly 300 previously untreated patients infected with the most common form of hepatitis C virus (HCV), the genotype 1 (G1)[1].
The data were presented today at the European Association for the Study of the Liver (EASL) congress in Berlin, Germany. The findings show that 76% of G1 chronic hepatitis C patients treated with DEB025 plus standard of care (pegylated-interferon alfa 2a/ribavirin) achieved superior viral cure (known as sustained viral response, or SVR) compared to 55% of patients on standard of care alone (p=0.008)[1]. Treatment with DEB025 demonstrated a low incidence of adverse events, with discontinuation rates comparable between treatment groups[1].
“Hepatitis C is difficult to treat and current therapies are only effective in about half of patients infected with the most prevalent genotype of HCV[2],” said Stefan Zeuzem, Professor of Medicine at the Goethe University Hospital in Frankfurt, Germany, and the study’s principal investigator. “These results are exciting because a large majority of patients achieved sustained viral response with DEB025, with some who also benefited from a shorter duration of treatment compared to standard therapy[1].”
DEB025 is the first in a new class of drugs called cyclophilin inhibitors. Unlike other compounds in development that target the virus directly, DEB025 is a host targeting antiviral (HTA) that targets so-called host proteins which are essential for the replication of HCV. As these proteins play a key role in the replication of all types of HCV, DEB025 may offer an effective treatment option for a broad range of HCV forms. In other clinical trials, DEB025 has also shown effective antiviral activity against other common HCV genotypes (G2, G3 and G4)[3].
“There is a critical need for more effective drugs to treat chronic hepatitis C, and Novartis is dedicated to developing medicines that will reduce the burden of this disease for patients and physicians,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “DEB025 has a new mode of action that may stop the virus from replicating and could reshape the future approach to treatment of hepatitis C.”
More than 170 million people worldwide are infected with HCV, which can cause serious liver disease leading to cirrhosis, liver cancer, and in some cases death. HCV is a blood borne virus that predominantly affects the liver[4],[5]. As an RNA (ribonucleic acid) virus, it mutates much more than DNA (deoxyribonucleic acid) viruses. This ability to change makes it harder for the immune system to clear (or eliminate) the virus. There are six major variations of HCV, known as genotypes and labelled from G1 to G6[5].
The study presented at EASL was a 48-week, global, double-blind, randomized, placebo-controlled trial in G1 treatment-naïve chronic hepatitis C patients. It evaluated the efficacy and safety of DEB025 combined with pegylated-interferon alfa 2a/ribavirin (PegIFN/RBV) vs. PegIFN/RBV alone. The primary endpoint was sustained viral response after 24 weeks (SVR24)[1].
Transient and reversible increase in bilirubin was observed in association with the initial DEB025 loading dose[1]. A small proportion of patients (4.2%) had a transient increase in bilirubin more than five times the upper limit of normal (ULN), but this was not associated with liver damage[1].
A pivotal Phase III study with DEB025 commenced recently to evaluate the efficacy and safety of DEB025 combined with standard of care and enrolling previously untreated HCV G1 patients. Other Phase II studies are ongoing in other patient populations i.e., G1 treatment-experienced patients and G2 and G3 treatment-naive patients.
Novartis in-licensed DEB025 from Debiopharm Group(TM), an independent biopharmaceuticals company based in Switzerland, under an agreement which gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan).
Wednesday, April 6, 2011
A shocking storyline...
"Over the past decade in the United States, 35 outbreaks of Hepatitis C have been linked to unsafe injection practices in healthcare facilities" I just read this on a Hepatitis C website. I read about the hospital in Colorado where a surgical tech was abusing injectable drugs and replacing the liquid with water so the multi-dose vial appeared to have enough medication. Investigators believed that this had been going on for 10 years and had the potential to effect hundreds, if not thousands of patients who had surgery there. I do know that some patients tested positive.
I also read a 6-part series written by Meg Heckman, who acquired the disease at birth by getting a tainted blood transfusion. The blood supply was unsafe in the U.S. until 1993, so anyone who received a transfusion prior to that date should be tested.
Here's a link to Meg's story, which is very well written and compelling:
http://www.concordmonitor.com/article/228639/infected-at-birth
I also read a 6-part series written by Meg Heckman, who acquired the disease at birth by getting a tainted blood transfusion. The blood supply was unsafe in the U.S. until 1993, so anyone who received a transfusion prior to that date should be tested.
Here's a link to Meg's story, which is very well written and compelling:
http://www.concordmonitor.com/article/228639/infected-at-birth
Tuesday, April 5, 2011
Treatment failure and Hep C + Music
I'm really feeling a tug on my heart to do something for people who've been through HCV treatment that failed. It's a small percentage, especially with the new drugs that are working so well on genotype 1 (the most common in the US). The last I read is that less than 30% of people with HCV end up like me (treatment failure, no more options until liver fails and you get either 1. transplant or 2. die). But we're out here and we need support. I'm pulling together a few resources to see what I come up with.
One of my friends tweeted this the other day: *The function of music is to release us from the tyranny of conscious thought.* I'm a music lover, that's for sure and I need music in my life. Being raised in the 60's & 70's had an effect on what I like today but there are a few great new bands and one that I've come to appreciate is The Flaming Lips. One of my son's friends is a gifted musician with a good ear for music - he knows what I typically like and suggested that I try them out. So, here I will share the lyrics from my favorite song by the Flaming Lips. It's a sweet song with simple, almost childlike lyrics but it captures a piece of my heart and how I feel about those I love:
The Spiderbite Song:
When you got that spider bite on your hand
I thought we would have to break up the band
To lose your arm would surely upset your brain
The poison then could reach your heart from a vein
I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
When you had that accident in your car
That whole thing just really seemed too bizarre
Dodging holes and telephone poles through the dash
A million to one that you would survive such a crash
I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
When you fell in love, it was so sweet
So devoted, completely swept off your feet
Love is the greatest thing a heart can know
But the hole that it leaves in its absence can make you feel so low
And I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
One of my friends tweeted this the other day: *The function of music is to release us from the tyranny of conscious thought.* I'm a music lover, that's for sure and I need music in my life. Being raised in the 60's & 70's had an effect on what I like today but there are a few great new bands and one that I've come to appreciate is The Flaming Lips. One of my son's friends is a gifted musician with a good ear for music - he knows what I typically like and suggested that I try them out. So, here I will share the lyrics from my favorite song by the Flaming Lips. It's a sweet song with simple, almost childlike lyrics but it captures a piece of my heart and how I feel about those I love:
The Spiderbite Song:
When you got that spider bite on your hand
I thought we would have to break up the band
To lose your arm would surely upset your brain
The poison then could reach your heart from a vein
I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
When you had that accident in your car
That whole thing just really seemed too bizarre
Dodging holes and telephone poles through the dash
A million to one that you would survive such a crash
I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
When you fell in love, it was so sweet
So devoted, completely swept off your feet
Love is the greatest thing a heart can know
But the hole that it leaves in its absence can make you feel so low
And I was glad that it didn’t destroy you
How sad that would be
Cause if it destroyed you
It would destroy me
Monday, April 4, 2011
Social Support
Social support is very important when you have a chronic illness. While support networks for illnesses such as diabetes, heart disease and alcoholism are well developed - there just isn't much out there for those of us with Hep C. There is one support group in my area that's about 35 miles away and meets once a month on Thursday nights. Not the best location/time for me. Another place people turn to is the internet. I have a friend with an unusual mental illness who finds great support through internet forums online with other people who share her illness.
I know of 4 online Hep C forums. There are many other Hep C resources containing information, etc. but most are geared toward the newly diagnosed or people who are just beginning treatment. One forum is geared toward anyone with Hep C and does have long-term members, but once you've been diagnosed and have gone through unsuccessful treatment your needs change. I feel like I need ongoing support from others in my situation with practical, helpful information on what can help me feel better. Another need is to talk to others like me who understand what it's like to live the daily challenges of Hep C after treatment failure.
If any reader is aware of something that might be helpful, I would be very interested - particularly if it's online. HCV is now considered a national epidemic with an estimated 3.2 million people who have the disease in the U.S. (Centers for Disease Control).
I'm going to continue to look into this and maybe something needs to be done. With a bit of help, I may be up to the task so please leave your feedback. I need as much information as possible.
I know of 4 online Hep C forums. There are many other Hep C resources containing information, etc. but most are geared toward the newly diagnosed or people who are just beginning treatment. One forum is geared toward anyone with Hep C and does have long-term members, but once you've been diagnosed and have gone through unsuccessful treatment your needs change. I feel like I need ongoing support from others in my situation with practical, helpful information on what can help me feel better. Another need is to talk to others like me who understand what it's like to live the daily challenges of Hep C after treatment failure.
If any reader is aware of something that might be helpful, I would be very interested - particularly if it's online. HCV is now considered a national epidemic with an estimated 3.2 million people who have the disease in the U.S. (Centers for Disease Control).
I'm going to continue to look into this and maybe something needs to be done. With a bit of help, I may be up to the task so please leave your feedback. I need as much information as possible.
Thursday, March 31, 2011
Hospice and Chronic Illness
I met with Hospice for the first time today. Now don't get too worked up; Hospice is NOT what it used to be. When the Hospice movement first began, a patient needed to have a diagnosis with 6 months or less to live. Since that time the field of palliative care has expanded dramatically and Hospice care is offered much earlier. Hospice employees are working hard to get people in sooner, so it seemed to be a good time for me. I met with an intake person who sent me on to a grief counselor. And before I get too far into this, I saw my doctor yesterday - he is very pleased that Fentanyl is working so well for me but unhappy with my weight loss (10 more lbs, bringing the total to 68 lbs.) So I'm going to work on EATING more. Otherwise everything was pretty good for me. I now weigh the same as both of my daughters (give or take 5) - too bad they don't live closer so we could share clothes. JUST KIDDING.
The counselor gave me a few excellent handouts and I want to include excerpts that really spoke to me. First this from The Chronic Illness Experience by Cheri Register:
There is a spectrum between the two choices of perfectly healthy and hopelessly ill. For example,
"You can tough it out, ignoring symptoms at the risk of getting worse, or you can trust one doctor's judgment at the risk of selecting unwisely."
"You can keep your ailment secret at the risk of deception, or you can talk openly about it at the risk of self-pity."
"You can ask friends for help at the risk of becoming a burden, or you can hold fast to your independence at the risk of isolation."
"You can strain your body to its limit at the risk of harming yourself, or you can play it safe at the risk of becoming an invalid."
"You can be angry about your fate at the risk of bitterness or you can focus only on your blessings, at the risk of self-delusion."
Wow wow wow!
Then, and interview with Elvira Aletta, a clinical psychologist who also suffers from a chronic illness, who has 5 rules for living:
1. Be confident you have the right doctor.(I am 100% good on this one)
2. Define your circle of support carefully. People may surprise you! Peripheral friends may step up and be terrific support while others you thought you could count on cave. (I have truly had this experience and it is absolutely shocking when I think back to who my "friends" were before my illness and take stock of my current friendships).
3. Protect your health as you would a small child. When you see those yellow lights blinking, its time to stop, assess and make changes.
4. Create a new measuring stick. Our self-esteem lies in the standards in which we measure ourselves as we go through life. To thrive with chronic illness, throw out the old and re-think your standards.
5. Have dreams and strive for them! Keep having goals for living, both big and small. (I have found it imperative to have things to look forward to. I can't survive without it!)
I can tell this is going to be helpful for me. These handouts seemed to be speaking directly to me, so it's obvious that Hospice counselors know what they are doing.
Oh, and another thing: the services are free. 100% free. Finally, a dose of justice!
Ooh, this is going to be good. I'll keep you posted!
The counselor gave me a few excellent handouts and I want to include excerpts that really spoke to me. First this from The Chronic Illness Experience by Cheri Register:
There is a spectrum between the two choices of perfectly healthy and hopelessly ill. For example,
"You can tough it out, ignoring symptoms at the risk of getting worse, or you can trust one doctor's judgment at the risk of selecting unwisely."
"You can keep your ailment secret at the risk of deception, or you can talk openly about it at the risk of self-pity."
"You can ask friends for help at the risk of becoming a burden, or you can hold fast to your independence at the risk of isolation."
"You can strain your body to its limit at the risk of harming yourself, or you can play it safe at the risk of becoming an invalid."
"You can be angry about your fate at the risk of bitterness or you can focus only on your blessings, at the risk of self-delusion."
Wow wow wow!
Then, and interview with Elvira Aletta, a clinical psychologist who also suffers from a chronic illness, who has 5 rules for living:
1. Be confident you have the right doctor.(I am 100% good on this one)
2. Define your circle of support carefully. People may surprise you! Peripheral friends may step up and be terrific support while others you thought you could count on cave. (I have truly had this experience and it is absolutely shocking when I think back to who my "friends" were before my illness and take stock of my current friendships).
3. Protect your health as you would a small child. When you see those yellow lights blinking, its time to stop, assess and make changes.
4. Create a new measuring stick. Our self-esteem lies in the standards in which we measure ourselves as we go through life. To thrive with chronic illness, throw out the old and re-think your standards.
5. Have dreams and strive for them! Keep having goals for living, both big and small. (I have found it imperative to have things to look forward to. I can't survive without it!)
I can tell this is going to be helpful for me. These handouts seemed to be speaking directly to me, so it's obvious that Hospice counselors know what they are doing.
Oh, and another thing: the services are free. 100% free. Finally, a dose of justice!
Ooh, this is going to be good. I'll keep you posted!
Wednesday, March 30, 2011
A Tribute to my friend
I lost my closest friend on October 20, 2010, very suddenly. The two of us had spent an idyllic week together at her family's cabin in northern Michigan in August - a time I will cherish forever. Tonight, a memorial service is being held for her in Washington, DC, where she headed a large branch of the U.S. Agency for International Development. Since I am unable to attend, this is for you, dear friend - in my heart always:
From “The Prophet” by Khalil Gibran
On Friendship
And a youth said, "Speak to us of Friendship."
Your friend is your needs answered.
He is your field which you sow with love and reap with thanksgiving.
And he is your board and your fireside.
For you come to him with your hunger, and you seek him for peace.
When your friend speaks his mind you fear not the "nay" in your own mind, nor do you withhold the "ay."
And when he is silent, your heart ceases not to listen to his heart;
For without words, in friendship, all thoughts, all desires, all expectations are born and shared, with joy that is unacclaimed.
When you part from your friend, you grieve not;
For that which you love most in him may be clearer in his absence, as the mountain to the climber is clearer from the plain.
And let there be no purpose in friendship save the deepening of the spirit.
For love that seeks aught but the disclosure of its own mystery is not love but a net cast forth: and only the unprofitable is caught.
And let your best be for your friend.
If he must know the ebb of your tide, let him know its flood also.
For what is your friend that you should seek him with hours to kill?
Seek him always with hours to live.
For it is his to fill your need, but not your emptiness.
And in the sweetness of friendship let there be laughter, and sharing of pleasures.
For in the dew of little things the heart finds its morning and is refreshed.
From “The Prophet” by Khalil Gibran
On Friendship
And a youth said, "Speak to us of Friendship."
Your friend is your needs answered.
He is your field which you sow with love and reap with thanksgiving.
And he is your board and your fireside.
For you come to him with your hunger, and you seek him for peace.
When your friend speaks his mind you fear not the "nay" in your own mind, nor do you withhold the "ay."
And when he is silent, your heart ceases not to listen to his heart;
For without words, in friendship, all thoughts, all desires, all expectations are born and shared, with joy that is unacclaimed.
When you part from your friend, you grieve not;
For that which you love most in him may be clearer in his absence, as the mountain to the climber is clearer from the plain.
And let there be no purpose in friendship save the deepening of the spirit.
For love that seeks aught but the disclosure of its own mystery is not love but a net cast forth: and only the unprofitable is caught.
And let your best be for your friend.
If he must know the ebb of your tide, let him know its flood also.
For what is your friend that you should seek him with hours to kill?
Seek him always with hours to live.
For it is his to fill your need, but not your emptiness.
And in the sweetness of friendship let there be laughter, and sharing of pleasures.
For in the dew of little things the heart finds its morning and is refreshed.
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