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.
- New Medications -
...'First lets take a practical look at the new medications in development. There has been a lot of news about investigational HCV drugs in clinical development within the last year.
We are entering an exciting period of HCV drug discovery that not only offers hope for medications with improved treatment outcomes, but also newer drugs that will have a potential for less side effects than the current HCV medications.
However, new antiviral drugs that are farthest along in clinical development are only in phase II studies.
Phase II clinical trials are conducted to obtain preliminary data on the effectiveness of the drug and collect information about the side effects and the risks associated with taking the drug. The number of participants in a phase II study is relatively small (a few hundred to over 500 hundred).
At the completion of a phase II study the data is collected and analyzed and a much larger (up to several thousand patients) phase III study is initiated.
A larger population of HCV patients treated with a new drug will give us a better picture of the effectiveness of the drug, side effect profile and other important information.
Once the phase III study is completed and the data is collected, the pharmaceutical company applies to the Food and Drug Administration (FDA) for marketing approval to treat the general HCV population. The FDA will review the application and data from the clinical trials and will either approve the drug for marketing, request additional studies or more information, or deny approval.
It is really difficult to gauge how long it will be before new drugs are available to the general population, but it is estimated that approval of the first new antiviral drug to treat hepatitis C is 3 to 5 years from now.
One certainty is that the new drug(s) approved to treat HCV will be used in combination with pegylated interferon or pegylated interferon plus ribavirin at least for many years to come.
- The Media Hype -
..'The media has done a great job of making us believe that new and better drugs are going to be available soon.
Almost every day we hear of a new drug that is sure to cure hepatitis C and we are led to believe that the cure is right around the corner.
Another reason why we all want new medications is the hope that we will discover new medications that will effectively treat everyone with hepatitis C.
If you have already been treated and did not respond, the new drugs offer much needed hope for the future.
Due in part to the media hype and our own hopes for more effective treatment, many people believe that the newer drugs will be available in the very near future.
Unfortunately, treating a disease such as HCV is a complex issue and while it is a certainty that new and improved drugs will be developed, the development process will be slower than many of us want or have been led to believe.
- Unresolved Questions -
..'There are many issues that need to be resolved that will be answered during and after the development process.
The potential of drug resistance will be at the forefront of research since we are entering an era of medications to treat hepatitis C that directly attack the virus and interfere with the HCV viral replication process.
Adherence to the current indirect HCV medications (pegylated interferon plus ribavirin) is important because 100% adherence increases the chances for a successful sustained virological response by increasing the drug concentrations in the blood.
Adherence to the new direct antivirals will also be critical for making sure there is the highest possible drug concentration in the blood; but adherence will become even more critical for preventing drug resistance that could render the drug ineffective. The new drugs will also have to be taken three or four times a day (at the same time every day).
Most people think this is a simple matter, but it has been shown that adherence is one of the most difficult issues facing successful management and treatment of any disease.
There are many additional questions that need to be resolved including:
What is the most effective dose and how often will it have to be taken (once every 6 hours, 8 hours, etc.) ?
What is the optimal duration of treatment ?
Will a sustained virological response translate into a durable or long-lasting response ?
If someone develops drug resistance to a new medication, will it mean that they will not be able to be treated with the same drug or class of drugs ?
Will treatment for some people consist of the long-term use of a certain drug if viral eradication can not be achieved ?
What are the drug interactions between the new medications and any medications people are currently taking for other conditions ?
Will the drugs create any short- or long-term health consequences ?
Hopefully, these questions and more will be answered as the new drugs advance through clinical trials.
- Should I be Treated ? -
..'Most experts would agree that a person with moderate to severe liver fibrosis should be treated now rather than waiting until the newer medications are approved for treatment. Of course there are other considerations for seeking treatment, including quality of life issues (such as severe fatigue), personal issues (starting a family, career goals), insurance issues (comprehensive insurance coverage, part time disability insurance), and other personal issues.
- Should I Wait ? -
..'Since hepatitis C is a slowly progressive disease (for most people), most experts would recommend that someone with mild liver damage could safely wait until the newer medications are approved. Unfortunately, there is no one size fits all for hepatitis C. For instance, minimal liver damage is a predictor of successful treatment outcome.
This means that a person with minimal liver damage who has that opportunity to wait for new medications should weigh the predictive factor against the possibility of waiting for the new drugs to be approved. Another issue for consideration is genotype since the chances of achieving an SVR in people with genotype 2 and 3 are so high, many experts recommend that these individuals should be treated now.
Living with hepatitis C forces us to make many health-related decisions every day. In order to make the best possible decision it is important to educate ourselves with the facts as much as possible and carefully weigh the pros and cons before we decide on a certain course of action.
This course of action should always include a discussion with a medical provider, but it is important to remember that the final decision is yours.
Predictors of Treatment Response:
Genotype 2 or 3
HCV RNA or Viral Load under 800,000 IU/mL
Age: Under 40 years old
Gender: Females respond better than males
Minimal liver disease
Little or no steatosis
Healthy weight or non-obese
Asian or Caucasian race
You can find more from this litterature at:
http://www.hcvadvocate.org/news/newsLetter/2007/advocate0207/html
...'First lets take a practical look at the new medications in development. There has been a lot of news about investigational HCV drugs in clinical development within the last year.
We are entering an exciting period of HCV drug discovery that not only offers hope for medications with improved treatment outcomes, but also newer drugs that will have a potential for less side effects than the current HCV medications.
However, new antiviral drugs that are farthest along in clinical development are only in phase II studies.
Phase II clinical trials are conducted to obtain preliminary data on the effectiveness of the drug and collect information about the side effects and the risks associated with taking the drug. The number of participants in a phase II study is relatively small (a few hundred to over 500 hundred).
At the completion of a phase II study the data is collected and analyzed and a much larger (up to several thousand patients) phase III study is initiated.
A larger population of HCV patients treated with a new drug will give us a better picture of the effectiveness of the drug, side effect profile and other important information.
Once the phase III study is completed and the data is collected, the pharmaceutical company applies to the Food and Drug Administration (FDA) for marketing approval to treat the general HCV population. The FDA will review the application and data from the clinical trials and will either approve the drug for marketing, request additional studies or more information, or deny approval.
It is really difficult to gauge how long it will be before new drugs are available to the general population, but it is estimated that approval of the first new antiviral drug to treat hepatitis C is 3 to 5 years from now.
One certainty is that the new drug(s) approved to treat HCV will be used in combination with pegylated interferon or pegylated interferon plus ribavirin at least for many years to come.
- The Media Hype -
..'The media has done a great job of making us believe that new and better drugs are going to be available soon.
Almost every day we hear of a new drug that is sure to cure hepatitis C and we are led to believe that the cure is right around the corner.
Another reason why we all want new medications is the hope that we will discover new medications that will effectively treat everyone with hepatitis C.
If you have already been treated and did not respond, the new drugs offer much needed hope for the future.
Due in part to the media hype and our own hopes for more effective treatment, many people believe that the newer drugs will be available in the very near future.
Unfortunately, treating a disease such as HCV is a complex issue and while it is a certainty that new and improved drugs will be developed, the development process will be slower than many of us want or have been led to believe.
- Unresolved Questions -
..'There are many issues that need to be resolved that will be answered during and after the development process.
The potential of drug resistance will be at the forefront of research since we are entering an era of medications to treat hepatitis C that directly attack the virus and interfere with the HCV viral replication process.
Adherence to the current indirect HCV medications (pegylated interferon plus ribavirin) is important because 100% adherence increases the chances for a successful sustained virological response by increasing the drug concentrations in the blood.
Adherence to the new direct antivirals will also be critical for making sure there is the highest possible drug concentration in the blood; but adherence will become even more critical for preventing drug resistance that could render the drug ineffective. The new drugs will also have to be taken three or four times a day (at the same time every day).
Most people think this is a simple matter, but it has been shown that adherence is one of the most difficult issues facing successful management and treatment of any disease.
There are many additional questions that need to be resolved including:
What is the most effective dose and how often will it have to be taken (once every 6 hours, 8 hours, etc.) ?
What is the optimal duration of treatment ?
Will a sustained virological response translate into a durable or long-lasting response ?
If someone develops drug resistance to a new medication, will it mean that they will not be able to be treated with the same drug or class of drugs ?
Will treatment for some people consist of the long-term use of a certain drug if viral eradication can not be achieved ?
What are the drug interactions between the new medications and any medications people are currently taking for other conditions ?
Will the drugs create any short- or long-term health consequences ?
Hopefully, these questions and more will be answered as the new drugs advance through clinical trials.
- Should I be Treated ? -
..'Most experts would agree that a person with moderate to severe liver fibrosis should be treated now rather than waiting until the newer medications are approved for treatment. Of course there are other considerations for seeking treatment, including quality of life issues (such as severe fatigue), personal issues (starting a family, career goals), insurance issues (comprehensive insurance coverage, part time disability insurance), and other personal issues.
- Should I Wait ? -
..'Since hepatitis C is a slowly progressive disease (for most people), most experts would recommend that someone with mild liver damage could safely wait until the newer medications are approved. Unfortunately, there is no one size fits all for hepatitis C. For instance, minimal liver damage is a predictor of successful treatment outcome.
This means that a person with minimal liver damage who has that opportunity to wait for new medications should weigh the predictive factor against the possibility of waiting for the new drugs to be approved. Another issue for consideration is genotype since the chances of achieving an SVR in people with genotype 2 and 3 are so high, many experts recommend that these individuals should be treated now.
Living with hepatitis C forces us to make many health-related decisions every day. In order to make the best possible decision it is important to educate ourselves with the facts as much as possible and carefully weigh the pros and cons before we decide on a certain course of action.
This course of action should always include a discussion with a medical provider, but it is important to remember that the final decision is yours.
Predictors of Treatment Response:
Genotype 2 or 3
HCV RNA or Viral Load under 800,000 IU/mL
Age: Under 40 years old
Gender: Females respond better than males
Minimal liver disease
Little or no steatosis
Healthy weight or non-obese
Asian or Caucasian race
You can find more from this litterature at:
http://www.hcvadvocate.org/news/newsLetter/2007/advocate0207/html
deleted_user
Im not sure if this is the post that you were referring to sister,But what ya told me this morning about maybe that I could have built up a resistance to all PEG/INTRONS injections/Ribavirons>WOW,Ain't that a Bitch??????? It makes since sister,But WHY didnt my PA tell me this sister!!!!! Im sure glad your here sister!!!
Mckenzie
bumped
deleted_user
To Mckenzie - don't mean to sound stupid but I see you say 'bumped' alot - what does this mean - sounds like you are adding more info? If so how do I get to it? Appreciative of all you wonderful info!
deleted_user
Hey Mckenzie thanks for the info. Yea we are always hearing about these new drugs coming down the pike. I have cleared the virus with a year of the Peg but we all know that is no guarantee that the dragon will not come back. If he does he'll be meaner than before and I will just have to kick his BUTT again. I do pray for all that they will come up with a CURE for this monster and that no one will die waiting for an organ and that we can put this monster out to pasture. That's what I want. Thanks for all your info it really helps these new people who are looking for answers. God Bless ya. Love Paula
deleted_user
Id go for it. I dont know why the doctors say, "well, you can wait. Your not "that bad". Yea, your not "that bad" YET!! But, you eventually WiLL be. I dont want anybody to die from Hepatitis C ever again anymore. With these drugs available to us who've been infected (unless your liver is pretty much doomed) should ABS0LUTELY go on the treatments. If your healthy enough of course and if everythings ok for you to start the treatments. If your not sick now from the Hep C.. Good, that's wonderful, however like I said, eventually, you will be ill from Hep C so my best advice is to G0 F0R iT!! =-)
deleted_user
Honey.....this post is 4 years old...................there are even newer treatments around now.................
deleted_user
Yes, very old post. I've already done a Tx w. no Interferon. Yes, It was a clinical Trial and not on the Market yet but the time is coming quickly when Interferon based Tx will be considered archaic!
deleted_user
So, I am turning the thoughts of treat or not to treat in my head b/c of the interferon and sides of the drugs etc. And then started to calculate in my head 3 to 5 years on a post dated 2007 and feeling more assured of the choice I am leaning towards.
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