Aa
Fluvastatin plus IFN every 5d
Humbly asking yr considered opinions:
Genotype 1. Fibrosis 3/4. Age 50. 5'10", 225lb.
Wk 5 PegIFN2b 150micrograms + 1400mg/d - 1600mg/day ribavirin.
Wk 4 RNA pending.
Literature review shows some options if a nonresponder(2Log decrease):
1. Maybe take IFN q5d? or double dose?
2 Fluvastatin? I know there's a trial going on currently (VA in Oklahoma)
1.There seems to be evidence that viral loads increase on PegIFN toward the end of the week, as the concentration of IFN decreases...therefore the idea is to keep IFN levels high with more frequent dosing - take it every 5d or increase the dose.
2. Fluvastatin shows in vitro and in vivo reduction of viral loads. Whether this results in higher SVR is not clear. But being a scientific type, I'ld be just as happy taking a rather benign drug which has been used in millions of people and has demonstrated antiviral activity - rather than a cocktail of vitamins/supplements(some perhaps made in China?) And eat blueberries daily, drink one cup green tea/day, Indian takeout twice weekly, grapes, multivit no iron, etc
Appreciate all comments.
FG
Genotype 1. Fibrosis 3/4. Age 50. 5'10", 225lb.
Wk 5 PegIFN2b 150micrograms + 1400mg/d - 1600mg/day ribavirin.
Wk 4 RNA pending.
Literature review shows some options if a nonresponder(2Log decrease):
1. Maybe take IFN q5d? or double dose?
2 Fluvastatin? I know there's a trial going on currently (VA in Oklahoma)
1.There seems to be evidence that viral loads increase on PegIFN toward the end of the week, as the concentration of IFN decreases...therefore the idea is to keep IFN levels high with more frequent dosing - take it every 5d or increase the dose.
2. Fluvastatin shows in vitro and in vivo reduction of viral loads. Whether this results in higher SVR is not clear. But being a scientific type, I'ld be just as happy taking a rather benign drug which has been used in millions of people and has demonstrated antiviral activity - rather than a cocktail of vitamins/supplements(some perhaps made in China?) And eat blueberries daily, drink one cup green tea/day, Indian takeout twice weekly, grapes, multivit no iron, etc
Appreciate all comments.
FG
i think what you are saying makes perfect sense. you are correct about the importance of the 4 week pcr test. sounds like you are well informed about latest protocols. if you do not get the 2 log drop at 4 weeks then changing or adding to your present regimen makes perfect sense. only 40-50% of genotype 1's clear this virus but i believe that number would be better if more doctors & patients would "think outside the box" and make changes to SOC. if they see on the 4 week test a poor response to peg & riba alone why not make changes! another option you may want to consider is adding aliana instead of fluvastatin. this has real human trial results that look very promising. best of luck
I think you are being way too pessimistic about treatment. I think you have a number of misunderstandings about this disease. The standard treatment of PEGinterferon and Ribiviron works for most people!!! Check out all the people on this forum who have cleared this virus!!! Why you would want to try a treatment different from a proven successful treatment frankly doesn't make sense to me.??? If you had failed the standard treatment before then it is understandable that you would need to try a new approach. This disease if serious business. If not managed properly it can KILL you. I have cirrhosis and my options are getting less and less. You don't want his to happen to you trust me.
The side effects can be bad but we all handle them. You can too. The reward of being clear of the virus and not living your life having extensive liver disease and all it complications is well worth it. Fine a good Hepatologist that you trust. They treat people like you and me with HCV everyday. It's their job. They will give you the best chance you have of clearing the virus. They "cure" people every day using the standard treatment.
...First things first. This is what's important. These factors are the best indicators of successful treatment.
What is your genotype?
What is your viral load?
What is the status of your liver? Biopsy results?
This info will help you and your doctor to decide IF and HOW to treat.
DO YOU EVEN NEED TO TREAT NOW?
This is the algorithm your doctor would follow.
You need to take it one step at a time otherwise you reduce your chances of successfully treating this disease!!!
Predictors of Sustained Virologic Response: Fixed Factors
PegIFN alfa-2a + RBV or PegIFN alfa-2b + RBV treatment
HCV RNA, %[1,2]
• 2 x 106 copies/mL 42-53
Genotype, %[1,2]
• 2 or 3 76-82
• 1 42-46
Genotype 1 and high viral load, % 30-41
Liver histology, %[1,2]
• Stage 0-2 55-57
• Stage 3-4 41-44
Age[1,2] Older age, lower SVR*
Weight[1,2] Higher weight, lower SVR*
Most of us are in the same boat as you. If you are genotype 1. A good Hepatologist knows when to start and when to stop treatment. They will take VL at appropreaite intervals. This is all standard procedure. Why do you think a doc wouldn't take VL at appropreiate intervals. That how they evaluate if the treatment if working! Most genotype 1s have their VL drop to undetecable by week 12. And have a good chance of clearing the virus. Some people even go to undetectabe between week 12 and 24. If treatment is extend to 72 they have a good chance of clearing the virus (SVR).
All this is explained in the article I referred you to!
There is a lot much to this disease then you may realize. In my opinion to try to play doctor is like the defendant trying to be his own lawyer. You can do it but you'll probably end up on the losing side! Continue to educate yourself about this disease and find a good doctor that you can work with.
This is just my opinion based on my own experience. Let others post there input and see what they have to say also.
Best of luck.
Hector
The side effects can be bad but we all handle them. You can too. The reward of being clear of the virus and not living your life having extensive liver disease and all it complications is well worth it. Fine a good Hepatologist that you trust. They treat people like you and me with HCV everyday. It's their job. They will give you the best chance you have of clearing the virus. They "cure" people every day using the standard treatment.
...First things first. This is what's important. These factors are the best indicators of successful treatment.
What is your genotype?
What is your viral load?
What is the status of your liver? Biopsy results?
This info will help you and your doctor to decide IF and HOW to treat.
DO YOU EVEN NEED TO TREAT NOW?
This is the algorithm your doctor would follow.
You need to take it one step at a time otherwise you reduce your chances of successfully treating this disease!!!
Predictors of Sustained Virologic Response: Fixed Factors
PegIFN alfa-2a + RBV or PegIFN alfa-2b + RBV treatment
HCV RNA, %[1,2]
• 2 x 106 copies/mL 42-53
Genotype, %[1,2]
• 2 or 3 76-82
• 1 42-46
Genotype 1 and high viral load, % 30-41
Liver histology, %[1,2]
• Stage 0-2 55-57
• Stage 3-4 41-44
Age[1,2] Older age, lower SVR*
Weight[1,2] Higher weight, lower SVR*
Most of us are in the same boat as you. If you are genotype 1. A good Hepatologist knows when to start and when to stop treatment. They will take VL at appropreaite intervals. This is all standard procedure. Why do you think a doc wouldn't take VL at appropreiate intervals. That how they evaluate if the treatment if working! Most genotype 1s have their VL drop to undetecable by week 12. And have a good chance of clearing the virus. Some people even go to undetectabe between week 12 and 24. If treatment is extend to 72 they have a good chance of clearing the virus (SVR).
All this is explained in the article I referred you to!
There is a lot much to this disease then you may realize. In my opinion to try to play doctor is like the defendant trying to be his own lawyer. You can do it but you'll probably end up on the losing side! Continue to educate yourself about this disease and find a good doctor that you can work with.
This is just my opinion based on my own experience. Let others post there input and see what they have to say also.
Best of luck.
Hector
Thank you Hector for your response.
I have never previously had treatment. I am awaiting results of my 4-wk RNA.
As I understand it, if I have a less than 100-fold (or so-called 2Log) decrease in viral load on the 4 week test, the chances of acheiving SVR are very small. With a greater than 100-fold decrease in viral load, there is a fightin' chance I can get SVR at 12 or 24 wks.
My thinking is that if I do not see a 100fold decrease in viral load, then to extend the treatment seems pointless - unless I do something different. Why put myself thru 48 weeks of treatment when the data is so bleak? Better I back off and wait for telapravir or the new schering product.
Ok let's say I push total treatment time of 12 or 24 weeks - well I might as well do something different.
So i'm thinking of trying to get my doctor to try the approaches in the studies I mentioned: at least two studies are looking at higher dose interferon and/or shorter dosing interval; and lescol has in vitro and in vivo data supporting it, and is the focus of a large study at the VA. The potential downside is interferon toxicity and less so, lescol toxicity. That's what I'm thinking, and I appreciate your comments
More questions: any good labs who will do HCV quantitative assays? It seems to me that treatment should be followed a bit more closely than with measurements at 1, 3, 6 mos and 1 year, and I would be eager to know if there's somewhere I can send a vial of blood to get my own results....
I have never previously had treatment. I am awaiting results of my 4-wk RNA.
As I understand it, if I have a less than 100-fold (or so-called 2Log) decrease in viral load on the 4 week test, the chances of acheiving SVR are very small. With a greater than 100-fold decrease in viral load, there is a fightin' chance I can get SVR at 12 or 24 wks.
My thinking is that if I do not see a 100fold decrease in viral load, then to extend the treatment seems pointless - unless I do something different. Why put myself thru 48 weeks of treatment when the data is so bleak? Better I back off and wait for telapravir or the new schering product.
Ok let's say I push total treatment time of 12 or 24 weeks - well I might as well do something different.
So i'm thinking of trying to get my doctor to try the approaches in the studies I mentioned: at least two studies are looking at higher dose interferon and/or shorter dosing interval; and lescol has in vitro and in vivo data supporting it, and is the focus of a large study at the VA. The potential downside is interferon toxicity and less so, lescol toxicity. That's what I'm thinking, and I appreciate your comments
More questions: any good labs who will do HCV quantitative assays? It seems to me that treatment should be followed a bit more closely than with measurements at 1, 3, 6 mos and 1 year, and I would be eager to know if there's somewhere I can send a vial of blood to get my own results....
Maybe I am misunderstanding what you are asking?
Are you saying you were a "non responder" while on tx before?
Are you asking what options they are currently to retreat "non responders"?
You say...."Literature review shows some options if a nonresponder(2Log decrease):"
Definition: Null Response is a < 100 fold drop by week 12 of the pretreatment VL. A "nonresponder" does NOT drop virus by 2Log so never becomes UND, and therefore never can achieve SVR.
1. From my knowledge it is the Ribiviron (Not the PEG-INFN) the keeps the virus from coming back at any time otherwise you will have "breakthrough. Once you have breakthrough it is not possible to acheive SVR.
2. Antiviral activity or lowering you VL will actually do no good. AS the only way to acheive SVR is to have the virus be UND for a sustained period of months. This is why Genotype 1 is usually treated for 48 weeks. Genotype 2,3 for 24 weeks and slow responders for 72 weeks. (For more details about this read Mitchell L. Shiffman, MD entire presentation.
Understanding HCV Nonresponse and Identifying Candidates for Retreatment
Source: New Management Strategies for HCV Nonresponders and Relapsers
By: Mitchell L. Shiffman, MD (I believe this article is contains recent data as it was published in 2007)
Null ResponsePatients with a well-defined null response during previous treatment are poor candidates for retreatment. Such patients have no significant decline in HCV RNA during treatment and are essentially refractory to the effects of interferon. Studies have shown that retreatment of peginterferon and ribavirin null responders with another course of peginterferon and ribavirin is not beneficial and results in only a 3% to 10% SVR rate. No studies to date have shown that patients with a null response can benefit from higher doses of peginterferon alfa and/or ribavirin. An alternative approach to intensification for null responders is to utilize high-dose daily consensus interferon (interferon alfacon). The large, registration DIRECT trial is currently evaluating the use of 9 µg/day or 15 µg/day interferon alfacon both with ribavirin as a treatment option in patients that had a null response during their treatment with peginterferon and ribavirin regimens. An interim analysis of 500 patients in this study who had a null response to peginterferon alfa was shown to achieve SVR in up to 15% of treated patients (Capsule Summary). Of note, 77% of the patients in this study had advanced fibrosis, a particularly difficult-to-treat population. It remains to be seen if such patients will benefit from retreatment with peginterferon alfa and ribavirin in combination with 1 or more of the HCV protease or polymerase inhibitors that are currently in development.At the present time, patients with null response who are not retreated should be monitored at regular intervals. If these patients also have cirrhosis, screening for hepatocellular carcinoma should be performed at regular intervals. It is currently unknown whether continuing peginterferon alfa long term as maintenance therapy could prevent fibrosis progression, hepatic decompensation, hepatocellular carcinoma, and the need for liver transplantation in patients with a null response. The only previous study of maintenance interferon therapy suggested that this treatment could be effective in patients with a partial response and at least a 2 log10 IU/mL decline in HCV RNA. For the past 5 years, the HALT-C trial has investigated whether maintenance peginterferon alfa therapy could be of benefit in HCV nonresponders with advanced fibrosis or cirrhosis. The results from this trial will be available in November 2007.
Update: HALT-C RESULTS 2008 = Maintenance therapy shows no benefit!!!
For the entire article, audio and graphics follow this link. (You will have sign up to access).
http://clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Nonresponders/Module/Shiffman.aspx
Regards,
Hector
Are you saying you were a "non responder" while on tx before?
Are you asking what options they are currently to retreat "non responders"?
You say...."Literature review shows some options if a nonresponder(2Log decrease):"
Definition: Null Response is a < 100 fold drop by week 12 of the pretreatment VL. A "nonresponder" does NOT drop virus by 2Log so never becomes UND, and therefore never can achieve SVR.
1. From my knowledge it is the Ribiviron (Not the PEG-INFN) the keeps the virus from coming back at any time otherwise you will have "breakthrough. Once you have breakthrough it is not possible to acheive SVR.
2. Antiviral activity or lowering you VL will actually do no good. AS the only way to acheive SVR is to have the virus be UND for a sustained period of months. This is why Genotype 1 is usually treated for 48 weeks. Genotype 2,3 for 24 weeks and slow responders for 72 weeks. (For more details about this read Mitchell L. Shiffman, MD entire presentation.
Understanding HCV Nonresponse and Identifying Candidates for Retreatment
Source: New Management Strategies for HCV Nonresponders and Relapsers
By: Mitchell L. Shiffman, MD (I believe this article is contains recent data as it was published in 2007)
Null ResponsePatients with a well-defined null response during previous treatment are poor candidates for retreatment. Such patients have no significant decline in HCV RNA during treatment and are essentially refractory to the effects of interferon. Studies have shown that retreatment of peginterferon and ribavirin null responders with another course of peginterferon and ribavirin is not beneficial and results in only a 3% to 10% SVR rate. No studies to date have shown that patients with a null response can benefit from higher doses of peginterferon alfa and/or ribavirin. An alternative approach to intensification for null responders is to utilize high-dose daily consensus interferon (interferon alfacon). The large, registration DIRECT trial is currently evaluating the use of 9 µg/day or 15 µg/day interferon alfacon both with ribavirin as a treatment option in patients that had a null response during their treatment with peginterferon and ribavirin regimens. An interim analysis of 500 patients in this study who had a null response to peginterferon alfa was shown to achieve SVR in up to 15% of treated patients (Capsule Summary). Of note, 77% of the patients in this study had advanced fibrosis, a particularly difficult-to-treat population. It remains to be seen if such patients will benefit from retreatment with peginterferon alfa and ribavirin in combination with 1 or more of the HCV protease or polymerase inhibitors that are currently in development.At the present time, patients with null response who are not retreated should be monitored at regular intervals. If these patients also have cirrhosis, screening for hepatocellular carcinoma should be performed at regular intervals. It is currently unknown whether continuing peginterferon alfa long term as maintenance therapy could prevent fibrosis progression, hepatic decompensation, hepatocellular carcinoma, and the need for liver transplantation in patients with a null response. The only previous study of maintenance interferon therapy suggested that this treatment could be effective in patients with a partial response and at least a 2 log10 IU/mL decline in HCV RNA. For the past 5 years, the HALT-C trial has investigated whether maintenance peginterferon alfa therapy could be of benefit in HCV nonresponders with advanced fibrosis or cirrhosis. The results from this trial will be available in November 2007.
Update: HALT-C RESULTS 2008 = Maintenance therapy shows no benefit!!!
For the entire article, audio and graphics follow this link. (You will have sign up to access).
http://clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Nonresponders/Module/Shiffman.aspx
Regards,
Hector
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