Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Sorry for the long post but no specific url to this discussion is available.
I copied this from the HCV Advocate Newsletter Sept. 2012 which you can find at:
http://www.hcvadvocate.org/news/newsLetter/2012/advocate0912.html#5
The Waiting Game
Alan Franciscus, Editor-in-Chief
Back in July 2010, I wrote an editorial about whether it was safe to wait for the new HCV protease inhibitor combination therapy. At that time, I was of the opinion that the sooner that people were treated the better. Examining the same issue 2 years later I realize that this time it is not such a black and white issue. The medications (PEG/RBV and HCV protease inhibitor) we were waiting for in 2010 have been approved. However, studies of newer therapies to treat hepatitis C have escalated at a phenomenal rate and there is a very real possibility that the newer therapies could be available within 2 to 3 years. But is it safe to wait? In this article I will explore some of the issues that patients and medical providers should consider before making the decision.
Now
The current standard of care is pegylated interferon/ribavirin (PEG/RBV) for genotypes 2 and 3 and the triple combo of PEG/RBV and an HCV protease inhibitor (telaprevir or boceprevir) for genotype 1. These therapies can cure up to about 80% of people who take them. But treatment is not easycurrent therapies include a large pill burden and serious side effects. PEG is injected once a week, RBV is taken twice a daythe number of pills depends on the genotype and brand of ribavirinand the HCV protease inhibitors are taken every 7 to 9 hours (boceprevir daily pill total is 12, and telaprevir requires 6 pills/day). I think that everyone is familiar with the side effects of PEG/RBV that can range from difficult to very difficult. When you add in the HCV protease inhibitors (PIs) some of the side effects of PEG/RBV are even more pronounced and boecpreivr and telaprevir have additional side effects of their own. But the big pay-off could be a cure!
Near Future
The next generation of HCV therapy will be a triple combination of PEG/RBV with the addition a direct acting antivirals (DAAs) TMC 435, BI 201335 or BMS-790052 for the treatment of genotype 1.
GS-7977 plus RBV entered into phase III studies this year for genotypes 2 and 3. The benefit of these therapies is that the addition of a new DAA to PEG/RBV means a lower pill burden (the DDA will be once-a-day) and a shorter treatment duration for some. The combination of GS7977/RBV promise an interferon-free therapy for genotypes 2 and 3 and, even further down the road, for genotype 1. In phase II studies the new DAA combination therapies also had higher cure rates and a lower side effect profile. The reality, however, is that we wont have a better picture of the cure rates or side effect profile until the phase III studies are completed and the data is tabulated and released. It looks like at least one of the new DAA therapies will be approved by the end of 2013 or early 2014 if there are no glitches in the clinical trials and Food and Drug Administration (FDA) approval process.
Not So Near Future
What everyone is waiting for is the approval of a combination HCV interferon-free therapy for HCV genotype 1. That timing of an all oral therapy is a bit trickier because of the unknownspotential toxicities or side effects, development of drug resistance, time to drug approval, durability of cure and cost of the new medications. However, it is more of a question of WHEN rather than IF. Currently, there are 10 DAA interferon-free studies in phase II clinical development.
Weighing Risk and Benefit
The question of whether to treat now or wait is a very serious issue that a patient and medical provider should carefully consider. It is clear that treatment now is appropriate for some patients and that some patients can wait, but for many people the decision is less clear.
Treatment Now .
Those patients who are more likely to have higher risk for disease progression are clearly the people who should be considered for treatment now. This includes people who have factors that could increase HCV disease progression or lower chances of achieving a cure in the future:
Fibrosisstage 2, 3 or compensated cirrhosis (stage 4): The more the liver is damaged the more likely that newer treatment may not work. Additionally, if the damage to the liver progresses to decompensated cirrhosis (stage 4), future treatment options may be limited especially if interferon is part of the treatment.
Age: treatment does not work as well in someone who is older so waiting might mean that the treatments wont work as well as they may now.
Fatty liver disease: If a form of fatty liver disease that can lead to inflammation and scaring develops or becomes worse treatment will not work as well.
Age (40 yo or older) at time of infection: a person infected after age 40 should be treated sooner rather than later because of the increased risk of disease progression.
Viral load: generally HCV RNA increases over time so waiting could mean a higher viral load which is a negative predictor of treatment outcome.
There are many other issues to take into consideration when making the decision including:
Would treatment help with the symptoms of hepatitis C: fatigue, muscle or joint pain, brain fog, etc.?
Is there an extrahepatic disorder ((EH) cryoglobulemia, non-Hodgkins lymphoma, etc.)) that may respond to HCV treatment?
Is your work-life situation at a point where treatment would be doable?
But its also not that easy to take into consideration the above factors because some of them predict a lower treatment response now. Thats why you have a medical provider who can offer the professional guidance needed to make a decision.
Waiting..
On the other end of the spectrum are people who have a lower degree of liver damage (stage 0 1 and maybe early stage 2). Most would agree that those who have little or no damage, are relatively symptom free and who do not have an EH can wait until some of the newer therapies are approved. The only caveat with this view is that those who have less damage and who are at a younger age are more likely to respond to current therapy.
While Waiting
If you and your medical provider decide to postpone treatment, now would be a good time to start some careful planning for the day when the newer treatments are available. Start to investigate your medical insurance coverage, support and work-related issues. It would also be a good time to make some of those not so easy lifestyle changes (eating well, exercising, etc.) that would increase the chances of being cured of hepatitis C. I think that most people would agree that the best therapy outcomes are the result of good planning.
Are you totally confused? There are a lot of issues to weigh and questions to ask, but thats why we have medical providers: Talk to your provider, ask the hard questions and come to a consensus together about whether it is safe for you to wait or if you should be treated now.
I copied this from the HCV Advocate Newsletter Sept. 2012 which you can find at:
http://www.hcvadvocate.org/news/newsLetter/2012/advocate0912.html#5
The Waiting Game
Alan Franciscus, Editor-in-Chief
Back in July 2010, I wrote an editorial about whether it was safe to wait for the new HCV protease inhibitor combination therapy. At that time, I was of the opinion that the sooner that people were treated the better. Examining the same issue 2 years later I realize that this time it is not such a black and white issue. The medications (PEG/RBV and HCV protease inhibitor) we were waiting for in 2010 have been approved. However, studies of newer therapies to treat hepatitis C have escalated at a phenomenal rate and there is a very real possibility that the newer therapies could be available within 2 to 3 years. But is it safe to wait? In this article I will explore some of the issues that patients and medical providers should consider before making the decision.
Now
The current standard of care is pegylated interferon/ribavirin (PEG/RBV) for genotypes 2 and 3 and the triple combo of PEG/RBV and an HCV protease inhibitor (telaprevir or boceprevir) for genotype 1. These therapies can cure up to about 80% of people who take them. But treatment is not easycurrent therapies include a large pill burden and serious side effects. PEG is injected once a week, RBV is taken twice a daythe number of pills depends on the genotype and brand of ribavirinand the HCV protease inhibitors are taken every 7 to 9 hours (boceprevir daily pill total is 12, and telaprevir requires 6 pills/day). I think that everyone is familiar with the side effects of PEG/RBV that can range from difficult to very difficult. When you add in the HCV protease inhibitors (PIs) some of the side effects of PEG/RBV are even more pronounced and boecpreivr and telaprevir have additional side effects of their own. But the big pay-off could be a cure!
Near Future
The next generation of HCV therapy will be a triple combination of PEG/RBV with the addition a direct acting antivirals (DAAs) TMC 435, BI 201335 or BMS-790052 for the treatment of genotype 1.
GS-7977 plus RBV entered into phase III studies this year for genotypes 2 and 3. The benefit of these therapies is that the addition of a new DAA to PEG/RBV means a lower pill burden (the DDA will be once-a-day) and a shorter treatment duration for some. The combination of GS7977/RBV promise an interferon-free therapy for genotypes 2 and 3 and, even further down the road, for genotype 1. In phase II studies the new DAA combination therapies also had higher cure rates and a lower side effect profile. The reality, however, is that we wont have a better picture of the cure rates or side effect profile until the phase III studies are completed and the data is tabulated and released. It looks like at least one of the new DAA therapies will be approved by the end of 2013 or early 2014 if there are no glitches in the clinical trials and Food and Drug Administration (FDA) approval process.
Not So Near Future
What everyone is waiting for is the approval of a combination HCV interferon-free therapy for HCV genotype 1. That timing of an all oral therapy is a bit trickier because of the unknownspotential toxicities or side effects, development of drug resistance, time to drug approval, durability of cure and cost of the new medications. However, it is more of a question of WHEN rather than IF. Currently, there are 10 DAA interferon-free studies in phase II clinical development.
Weighing Risk and Benefit
The question of whether to treat now or wait is a very serious issue that a patient and medical provider should carefully consider. It is clear that treatment now is appropriate for some patients and that some patients can wait, but for many people the decision is less clear.
Treatment Now .
Those patients who are more likely to have higher risk for disease progression are clearly the people who should be considered for treatment now. This includes people who have factors that could increase HCV disease progression or lower chances of achieving a cure in the future:
Fibrosisstage 2, 3 or compensated cirrhosis (stage 4): The more the liver is damaged the more likely that newer treatment may not work. Additionally, if the damage to the liver progresses to decompensated cirrhosis (stage 4), future treatment options may be limited especially if interferon is part of the treatment.
Age: treatment does not work as well in someone who is older so waiting might mean that the treatments wont work as well as they may now.
Fatty liver disease: If a form of fatty liver disease that can lead to inflammation and scaring develops or becomes worse treatment will not work as well.
Age (40 yo or older) at time of infection: a person infected after age 40 should be treated sooner rather than later because of the increased risk of disease progression.
Viral load: generally HCV RNA increases over time so waiting could mean a higher viral load which is a negative predictor of treatment outcome.
There are many other issues to take into consideration when making the decision including:
Would treatment help with the symptoms of hepatitis C: fatigue, muscle or joint pain, brain fog, etc.?
Is there an extrahepatic disorder ((EH) cryoglobulemia, non-Hodgkins lymphoma, etc.)) that may respond to HCV treatment?
Is your work-life situation at a point where treatment would be doable?
But its also not that easy to take into consideration the above factors because some of them predict a lower treatment response now. Thats why you have a medical provider who can offer the professional guidance needed to make a decision.
Waiting..
On the other end of the spectrum are people who have a lower degree of liver damage (stage 0 1 and maybe early stage 2). Most would agree that those who have little or no damage, are relatively symptom free and who do not have an EH can wait until some of the newer therapies are approved. The only caveat with this view is that those who have less damage and who are at a younger age are more likely to respond to current therapy.
While Waiting
If you and your medical provider decide to postpone treatment, now would be a good time to start some careful planning for the day when the newer treatments are available. Start to investigate your medical insurance coverage, support and work-related issues. It would also be a good time to make some of those not so easy lifestyle changes (eating well, exercising, etc.) that would increase the chances of being cured of hepatitis C. I think that most people would agree that the best therapy outcomes are the result of good planning.
Are you totally confused? There are a lot of issues to weigh and questions to ask, but thats why we have medical providers: Talk to your provider, ask the hard questions and come to a consensus together about whether it is safe for you to wait or if you should be treated now.
lots of info there.
Sure hope something comes along for geno 2's
It's good stuff altogether. Thanks for posting
Did you see "GS-7977 plus RBV entered into phase III studies this year for genotypes 2 and 3."?
No interferon! :)
It's all we can do. Gen 1a TT non responder fatty liver and 60 years old HCV over 40 years so the cards (at present) are stacked against us ..
BUT... I'm hoping the new drug regimes with no Interferon will gives us a good whack at the bug!
Hang in with us and embrace every day!
((((HUGS)))))
I am clinging to the idea that I'm undie but I won't know the results for quite some time after the trial ends. This is all blinded. But everything I read says stay positive. So I don't know how I will react if I get bad news. DON'T EVEN GO THERE!!
Again best of luck and every success!