Aa
tapering off slowly or remaining on reduced INF dose to prevent relapse
Something I was curious about... has there been any experimentation on tapering off INF slowly at the end of treatment or remaining on a reduced dose to prevent relapse?
Most people whose liver isn't in bad shape it doesn't matter as much as they have time to wait for better things and not deal with INF. But those with more degraded liver conditions or livers that degrade quicker over time, I was wondering why don't they try to reduce the dosage slowly or remain on a low dosage?
My personal experience is a lower dose of INF is not nearly as debilitating as the full dose and, something like a 1/4 dose (45 mcg) would be a relative breeze. Personally I rather take this route all day long than have the virus return. Meanwhile the new drugs keep getting closer and closer so once those are available, the INF could be terminated completely and there'd be a safety net.
Just curious about these things. I'm still in the middle of treatment with first post-Incivek VL test next week. If I were to remain UND for until the EOT next year, I dunno, it's certainly something I would consider to buy more time. I'm a three-time partial responder, never went UND until this 4th time with the PI, so statistically my chances might be less of an SVR. I had HCV for 30 years and I'm pretty happy to be UND (understatement) and think ya know some INF would be better than having a VL again.
Most people whose liver isn't in bad shape it doesn't matter as much as they have time to wait for better things and not deal with INF. But those with more degraded liver conditions or livers that degrade quicker over time, I was wondering why don't they try to reduce the dosage slowly or remain on a low dosage?
My personal experience is a lower dose of INF is not nearly as debilitating as the full dose and, something like a 1/4 dose (45 mcg) would be a relative breeze. Personally I rather take this route all day long than have the virus return. Meanwhile the new drugs keep getting closer and closer so once those are available, the INF could be terminated completely and there'd be a safety net.
Just curious about these things. I'm still in the middle of treatment with first post-Incivek VL test next week. If I were to remain UND for until the EOT next year, I dunno, it's certainly something I would consider to buy more time. I'm a three-time partial responder, never went UND until this 4th time with the PI, so statistically my chances might be less of an SVR. I had HCV for 30 years and I'm pretty happy to be UND (understatement) and think ya know some INF would be better than having a VL again.
I tapered off at the end of my treatment. Not sure if it was HR's recommendation or jim's (old timers know who I'm talking about). Either way I liked the concept and felt it gave me a better chance. I figured it couldn't hurt.
As explained to me by a well known Hepatologist, the immune system has been helped for duration of TX, mostly by the interferon, tapering at end will allow the immune system time to learn how to fight on its own.
As explained to me by a well known Hepatologist, the immune system has been helped for duration of TX, mostly by the interferon, tapering at end will allow the immune system time to learn how to fight on its own.
I am also cirrhotic, if not for being able to get in the last boceprevir trial I asked about retreating even though the outcome would more then likely been the same. At the time I asked about going on maintenance therapy once I became und hoping that would save me until the new drugs was approved, was told it did not stop the progression. And from the above study it says the same thing..........
Interferon is not a friend of ours, I can understand your willing to try anything and don't fault you for that. But it is what it is, wishing the best going forward.
Interferon is not a friend of ours, I can understand your willing to try anything and don't fault you for that. But it is what it is, wishing the best going forward.
Could you point out in the study where they describe the outcome for subjects who achieved either very low or UND VLs on maintenance therapy? Were they checking VLs?
For me is doesn't matter as I am now SVR do to victrelis, my point is your reading the studies wrong as anybody that relapses is a nonresponder.
I wouldn't offer advice for what you ought to do but if I had the choice of being UND and on INF or with high VL and high enzymes on nothing, I'd take the former with not a second thought.
I tried the latter and it didn't work out so good.
I tried the latter and it didn't work out so good.
From my letter from my doctor.
We are going to make some nonresponder studies availabe for him. We will try to make a nonresponder study available to him, though I cautioned him that his chance of relapse nonetheless is higher.
We are going to make some nonresponder studies availabe for him. We will try to make a nonresponder study available to him, though I cautioned him that his chance of relapse nonetheless is higher.
""We had hoped that maintenance therapy would prevent the progression of liver disease due to hepatitis C among patients who had not responded to conventional therapy."
So your saying that the above means none of these people had any response during treatment? I relapsed and was considered a non responder. Why? Because I didn't SVR.
So your saying that the above means none of these people had any response during treatment? I relapsed and was considered a non responder. Why? Because I didn't SVR.
Yes, it's the HALT-C study to which you refer. It basically says people who don't respond to INF and RIBA don't get a benefit. Makes sense.
On the other hand, if you are a responder and can go to an UND or even very low level and stay there while on the drugs, ask yourself, what's the logical outcome of that.
On the other hand, if you are a responder and can go to an UND or even very low level and stay there while on the drugs, ask yourself, what's the logical outcome of that.
I am interested in what would be the difference with TP paitents, as one can see at least from this study it didn't help...
Maintenance Therapy for Hepatitis C Not Helpful, Says Study
"Before this study, many physicians had assumed that maintenance therapy was beneficial and had used this approach for their patients," said Adrian M. Di Bisceglie, MD, one of the study's researchers. "We had hoped that maintenance therapy would prevent the progression of liver disease due to hepatitis C among patients who had not responded to conventional therapy. Of course, [according to the study's results] things did not turn out that way."
The study, recently published in the New England Journal of Medicine, followed over one thousand hepatitis C patients who didn't respond to a first round of treatment for 3.5 years. The results did not support what many doctors believed. In fact, it showed that maintenance therapy with peginterferon did nothing to stop the progression of fibrosis, which is liver scarring that leads to cirrhosis and other complications.
What does this mean for the many who are using maintenance therapy? It might lead your physician to stop using it and focus on another therapy. "Right now," says Dr. Di Bisceglie,
http://hepatitis.about.com/b/2008/12/09/maintenance-therapy-for-hepatitis-c-not-helpful-says-study.htm
Maintenance Therapy for Hepatitis C Not Helpful, Says Study
"Before this study, many physicians had assumed that maintenance therapy was beneficial and had used this approach for their patients," said Adrian M. Di Bisceglie, MD, one of the study's researchers. "We had hoped that maintenance therapy would prevent the progression of liver disease due to hepatitis C among patients who had not responded to conventional therapy. Of course, [according to the study's results] things did not turn out that way."
The study, recently published in the New England Journal of Medicine, followed over one thousand hepatitis C patients who didn't respond to a first round of treatment for 3.5 years. The results did not support what many doctors believed. In fact, it showed that maintenance therapy with peginterferon did nothing to stop the progression of fibrosis, which is liver scarring that leads to cirrhosis and other complications.
What does this mean for the many who are using maintenance therapy? It might lead your physician to stop using it and focus on another therapy. "Right now," says Dr. Di Bisceglie,
http://hepatitis.about.com/b/2008/12/09/maintenance-therapy-for-hepatitis-c-not-helpful-says-study.htm
Saw my doctor today. He cited three relatively recent studies (only one I recall was in California) that showed slower progression of fibrosis in HCV post-liver transplant patients on maintenance interferon. And I know they have experience at this transplant center doing that. Grant you I didn't say patients with post-LT. Maybe that's the difference.
One important item you left out was patients in the HALT-C studies were non-responders who didn't experience VL suppression. So you can kind of infer that wouldn't lead to improved outcomes.
"Dr. Shiffman also notes that many of those being studied, because of their response to earlier treatment protocols, might not be the ideal candidates for maintenance therapy. “The bottom line is, most people in the HALT-C and all people in the COPILOT trials are not having viral suppression. They are nonresponders,” he says. “It is unclear, therefore, if interferon will be a benefit in those studied.”
In his own practice, Dr. Shiffman is selective with those he puts on maintenance interferon. “I don’t advocate using interferon maintenance therapy unless you can maintain significant viral suppression,” he says. “In our own practice, the only patients we have on maintenance therapy -– and we have many, about 30 – are those that have cirrhosis that have relapsed, and the goal is to keep them virus negative.”
Also it was pretty easy to find on google Doctors who keep patients on INF if they can remain VL negative to prevent further disease progression.
Hope that helps.
One important item you left out was patients in the HALT-C studies were non-responders who didn't experience VL suppression. So you can kind of infer that wouldn't lead to improved outcomes.
"Dr. Shiffman also notes that many of those being studied, because of their response to earlier treatment protocols, might not be the ideal candidates for maintenance therapy. “The bottom line is, most people in the HALT-C and all people in the COPILOT trials are not having viral suppression. They are nonresponders,” he says. “It is unclear, therefore, if interferon will be a benefit in those studied.”
In his own practice, Dr. Shiffman is selective with those he puts on maintenance interferon. “I don’t advocate using interferon maintenance therapy unless you can maintain significant viral suppression,” he says. “In our own practice, the only patients we have on maintenance therapy -– and we have many, about 30 – are those that have cirrhosis that have relapsed, and the goal is to keep them virus negative.”
Also it was pretty easy to find on google Doctors who keep patients on INF if they can remain VL negative to prevent further disease progression.
Hope that helps.
I would think a study with the lead investigor being Dr. Jacobson with scientific proof would trump just about any guesses.
Hey CandyBabe! :)
Hey CandyBabe! :)
HR made that comment 5 years ago, as we know alot happens in the world of Hep-C. His answer might very well be different now.
Hi Deb...:)
Hi Deb...:)
Again,
That was before the HALT-C study was done five years ago and showed it didn't work. It is never used now. Ask any hepatologist. "
People ask questions but they dont really want to hear the answers quite often Candyman this is true. Damned if we do and damned if we dont. We could just start saying 'sure whatever you want' it might be easier sometimes. :(
That was before the HALT-C study was done five years ago and showed it didn't work. It is never used now. Ask any hepatologist. "
People ask questions but they dont really want to hear the answers quite often Candyman this is true. Damned if we do and damned if we dont. We could just start saying 'sure whatever you want' it might be easier sometimes. :(
HR recommends tapering after end of treatment by cutting the dose by half every week so it would be 1/2, 1/4, 1/8, etc
Any more here it seems the truth or facts does not matter, you get slammed if you tell it the way it is. Thats exactly why other forums are ghost towns and one day this one will be no different........
" This community is for providing others concerned about hepatitis C with correct information about the virus and its treatment so people can educate themselves and make better choices."
Good luck with that! All I can say is thank goodness for copy and paste.
Good luck with that! All I can say is thank goodness for copy and paste.
I am afraid the information you have is incorrect. I don't know where you got the information but the statement you make have no foundation in of HCV treatment or the association between viral load and liver disease progression.
If you have evidence to the contrary, please post links to the medical papers to back up your statements. This community is for providing others concerned about hepatitis C with correct information about the virus and its treatment so people can educate themselves and make better choices. The Social side is for people's opinions on many different topics. I think you might agree that there are too many rumors and misinformation about hep C in the general public and we want this community to add some light to the subject.
"If the liver is going fast, then maintenance INF therapy is not all the uncommon. Not in the tapering context of this thread but as a general course of action. "
That was before the HALT-C study was done five years ago and showed it didn't work. It is never used now. Ask any hepatologist. It was a major study which proved that long term interferon Does do improve fibrosis.
HALT-C study Results
* Death: 6.6% in the treatment group vs 4.6% in the control group;
* Hepatic decompensation: 14.3% vs 13.2%, respectively;
* HCC: 2.8% vs 3.2%;
* Increased fibrosis: 28.2% vs 31.9%.
* The rate of serious adverse events was similar in both groups: 284 events among 175 treated patients and 283 events among 155 control subjects.
Conclusion
“Long-term therapy with peginterferon did not reduce the rate of disease progression,” the investigator concluded. “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
"Long-term maintenance therapy with peginterferon failed to halt liver disease progression, and it's not indicated in patients with [HCV] who have advanced hepatic fibrosis and who have not responded to a standard course of interferon and ribavirin therapy," said lead author Adrian Di Bisceglie, MD, from the St. Louis University School of Medicine."
" If the VL can be reduced then the degradation may be slowed."
VL load has no impact on progression of liver disease.
Cheers!
Hector
If you have evidence to the contrary, please post links to the medical papers to back up your statements. This community is for providing others concerned about hepatitis C with correct information about the virus and its treatment so people can educate themselves and make better choices. The Social side is for people's opinions on many different topics. I think you might agree that there are too many rumors and misinformation about hep C in the general public and we want this community to add some light to the subject.
"If the liver is going fast, then maintenance INF therapy is not all the uncommon. Not in the tapering context of this thread but as a general course of action. "
That was before the HALT-C study was done five years ago and showed it didn't work. It is never used now. Ask any hepatologist. It was a major study which proved that long term interferon Does do improve fibrosis.
HALT-C study Results
* Death: 6.6% in the treatment group vs 4.6% in the control group;
* Hepatic decompensation: 14.3% vs 13.2%, respectively;
* HCC: 2.8% vs 3.2%;
* Increased fibrosis: 28.2% vs 31.9%.
* The rate of serious adverse events was similar in both groups: 284 events among 175 treated patients and 283 events among 155 control subjects.
Conclusion
“Long-term therapy with peginterferon did not reduce the rate of disease progression,” the investigator concluded. “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
"Long-term maintenance therapy with peginterferon failed to halt liver disease progression, and it's not indicated in patients with [HCV] who have advanced hepatic fibrosis and who have not responded to a standard course of interferon and ribavirin therapy," said lead author Adrian Di Bisceglie, MD, from the St. Louis University School of Medicine."
" If the VL can be reduced then the degradation may be slowed."
VL load has no impact on progression of liver disease.
Cheers!
Hector
I agree with the above poster in that tapering will do nothing to enhance success .It is what happens in the beginning that is important.
Will
Will
The one thing that sticks out in tapering is it does not mean it gives an edge when coming off treatment. If the immune system has not effectively suppressed the virus with inf & riba including triple no amount of tapering is going to jump start it back. The virus can and does start to replicate immediately after cessation of treatment regardless of how much interferon has been pumped into the body on a decreased level. If the interferon does does not work effectively to suppress the virus once and for all then relapse will occur. With the PI's you've got an direct hit to the virus and then SOC has to take over in order to ensure the virus is supposed effectively and permanently. If the immune system is unable to do it's job with inf & riba then game over.
It's all about response on the front end, not the techniques used on the back end.
It's all about response on the front end, not the techniques used on the back end.
If the liver is going fast, then maintenance INF therapy is not all the uncommon. Not in the tapering context of this thread but as a general course of action. If the VL can be reduced then the degradation may be slowed. I wouldn't want it to come to that but it's done when there's no other good course to take.
I think they proved years ago that any type of maintence therapy was a waste of time. As per Hectors valuable information above. As soon as you finish your last shot - you are tapering.
Bill,
“Has there been any experimentation on tapering off INF slowly at the end of treatment or remaining on a reduced dose to prevent relapse? “
As someone said on the link hrsepwrguy posted all treatment drugs taper off over time when they are stopped. That is why it takes time for blood levels to return to previous pretreatment levels and for people to free better after treatment. But tapering INF would not prevent relapse anyway as you will see.
As far as remaining on a reduced dose of IFN…
How treatment produces SVR
http://www.hindawi.com/journals/av/2012/267483/
“Several events need to work in concert in order to achieve SVR, including (1) successfully achieve a rapid phase 1 effect by turning off viral replication
(2) * effectively suppress the viral load throughout treatment
(3) induce a solid and persistent Phase 2 effect.
Both IFN and direct antiviral agents (DAAs) have very potent antiviral abilities and induce a very strong phase (1) response.
* During phase (2) Ribavirin is needed to prevent viral breakthrough during treatment and relapses after treatment, in patients who respond to the antiviral effect of IFN.
Without a sufficient duration of treatment to promote the Phase 2 effect until all infected cells have been cleared, HCV replication will resume shortly after treatment completion and patients will experience a relapse.”
You would have to continue BOTH INF + Ribavirin as was done in previous years with 2 drug therapy beyond 48 weeks if you are undetectable to prevent relapse. A reduced dosage of INF alone will not prevent relapse. In fact, it is the RIBAVIRIN, NOT Interferon that accelerates the clearance of infected cells to prevent viral breakthrough during treatment, and relapses following treatment.
Long-term dosage using peg-INF -(Note this is people that FAILED 2 drug treatment)
HALT-C Study
“Researchers from multiple U.S. centers conducted a randomized controlled trial in which 1050 patients with chronic hepatitis C and advanced fibrosis who were non-responders to prior therapy with pegylated interferon plus ribavirin were randomly assigned to received either 90 mcg once-weekly pegylated interferon alfa-2a (Pegasys) for 3.5 years or no further treatment. For comparison, the usual Pegasys dose in combination therapy is 180 mcg once-weekly for 24 (genotypes 2/3) or 48 (genotype 1) weeks.
Participants eligible for enrollment had an Ishak fibrosis score of > 3 on liver biopsy, a Child-Turcotte-Pugh score of >6, no history of ascites, encephalopathy, or bleeding varices, and no other identifiable cause of liver disease. Participants were stratified according to their stage of fibrosis: Ishak stage 3 or 4 (622 with fibrosis) vs 5 or 6 (428 with cirrhosis).
Participants were seen at 3-month intervals, underwent liver biopsies at 1.5 and 3.5 years after randomization, and were monitored for the occurrence of death, HCC, hepatic decompensation (variceal hemorrhage, ascites, spontaneous bacterial peritonitis, encephalopathy, or a Child-Turcotte-Pugh score of = 7), and -- for those with pre-cirrhotic fibrosis at baseline -- an increase in fibrosis score of = 2 points.”
The conclusion of the HALT-C study was - “Long-term therapy with peginterferon did not reduce the rate of disease progression (fibrosis),” the investigator concluded. “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
There has been a new study analyzing the data from the HALT-C study use of INF after SVR has failed it shows that INF REDUCES INFLAMMATION and could slow liver disease progression—notably the development of liver cancer, liver failure or death—in people living with hepatitis C virus (HCV) who weren't able to achieve an SVR using peg-IFN plus ribavirin.
Cheers!
Hector
“Has there been any experimentation on tapering off INF slowly at the end of treatment or remaining on a reduced dose to prevent relapse? “
As someone said on the link hrsepwrguy posted all treatment drugs taper off over time when they are stopped. That is why it takes time for blood levels to return to previous pretreatment levels and for people to free better after treatment. But tapering INF would not prevent relapse anyway as you will see.
As far as remaining on a reduced dose of IFN…
How treatment produces SVR
http://www.hindawi.com/journals/av/2012/267483/
“Several events need to work in concert in order to achieve SVR, including (1) successfully achieve a rapid phase 1 effect by turning off viral replication
(2) * effectively suppress the viral load throughout treatment
(3) induce a solid and persistent Phase 2 effect.
Both IFN and direct antiviral agents (DAAs) have very potent antiviral abilities and induce a very strong phase (1) response.
* During phase (2) Ribavirin is needed to prevent viral breakthrough during treatment and relapses after treatment, in patients who respond to the antiviral effect of IFN.
Without a sufficient duration of treatment to promote the Phase 2 effect until all infected cells have been cleared, HCV replication will resume shortly after treatment completion and patients will experience a relapse.”
You would have to continue BOTH INF + Ribavirin as was done in previous years with 2 drug therapy beyond 48 weeks if you are undetectable to prevent relapse. A reduced dosage of INF alone will not prevent relapse. In fact, it is the RIBAVIRIN, NOT Interferon that accelerates the clearance of infected cells to prevent viral breakthrough during treatment, and relapses following treatment.
Long-term dosage using peg-INF -(Note this is people that FAILED 2 drug treatment)
HALT-C Study
“Researchers from multiple U.S. centers conducted a randomized controlled trial in which 1050 patients with chronic hepatitis C and advanced fibrosis who were non-responders to prior therapy with pegylated interferon plus ribavirin were randomly assigned to received either 90 mcg once-weekly pegylated interferon alfa-2a (Pegasys) for 3.5 years or no further treatment. For comparison, the usual Pegasys dose in combination therapy is 180 mcg once-weekly for 24 (genotypes 2/3) or 48 (genotype 1) weeks.
Participants eligible for enrollment had an Ishak fibrosis score of > 3 on liver biopsy, a Child-Turcotte-Pugh score of >6, no history of ascites, encephalopathy, or bleeding varices, and no other identifiable cause of liver disease. Participants were stratified according to their stage of fibrosis: Ishak stage 3 or 4 (622 with fibrosis) vs 5 or 6 (428 with cirrhosis).
Participants were seen at 3-month intervals, underwent liver biopsies at 1.5 and 3.5 years after randomization, and were monitored for the occurrence of death, HCC, hepatic decompensation (variceal hemorrhage, ascites, spontaneous bacterial peritonitis, encephalopathy, or a Child-Turcotte-Pugh score of = 7), and -- for those with pre-cirrhotic fibrosis at baseline -- an increase in fibrosis score of = 2 points.”
The conclusion of the HALT-C study was - “Long-term therapy with peginterferon did not reduce the rate of disease progression (fibrosis),” the investigator concluded. “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
There has been a new study analyzing the data from the HALT-C study use of INF after SVR has failed it shows that INF REDUCES INFLAMMATION and could slow liver disease progression—notably the development of liver cancer, liver failure or death—in people living with hepatitis C virus (HCV) who weren't able to achieve an SVR using peg-IFN plus ribavirin.
Cheers!
Hector
hrsepwrguy - good discussion thread there. Didn't look like they came to a consensus on it though. Personally I think I will taper or at least extend treatment (on a lower dose). I don't have the time to wait a 2 or 3 years for plan B.
hawk - yes I agree it does seem to somewhat random. I never cleared first three times and 4th time on half-dose of INF and 1/3 Riba did clear. Of course I'm off Incivek now and have the first VL test next week so the jury is still out. I have no choice about the lower INF dosage. My WBC is low and I'm on Neopogen.
I think the more side-effects I feel the from the drugs the better they are working. :)
hawk - yes I agree it does seem to somewhat random. I never cleared first three times and 4th time on half-dose of INF and 1/3 Riba did clear. Of course I'm off Incivek now and have the first VL test next week so the jury is still out. I have no choice about the lower INF dosage. My WBC is low and I'm on Neopogen.
I think the more side-effects I feel the from the drugs the better they are working. :)
I heard about a man with decompensated cirrhosis that actually did the reverse.
They started with low doses gradually working up to full dosage of interferon.
He did successfully beat the virus but still needs a transplant.
As a small med-sensitive person, I felt I did not need to be on full dose. However, I began on full dose. At week 10, we reduced it to 135, then at week 18 it was reduced further to 90mg for the remainder of my 24 week tx.
I was und at week 4, geno 2 and felt confident that this was the best course for me. Can't say it would be for everyone as this virus is so odd in how different people respond both to the virus and the treatment.
There was a member last Fall who had to reduce dosage to 90 in his first weeks of tx yet was und at week 4. This was a big surprise but would it work for others ? Who knows.
Our doctors do what has been shown in research to be the most successful approach for the majority of patients.
I'm sure for some it is overkill.
It's a gamble but we are each responsible ultimately, for our health care. The decision is, or should be, yours to make.
They started with low doses gradually working up to full dosage of interferon.
He did successfully beat the virus but still needs a transplant.
As a small med-sensitive person, I felt I did not need to be on full dose. However, I began on full dose. At week 10, we reduced it to 135, then at week 18 it was reduced further to 90mg for the remainder of my 24 week tx.
I was und at week 4, geno 2 and felt confident that this was the best course for me. Can't say it would be for everyone as this virus is so odd in how different people respond both to the virus and the treatment.
There was a member last Fall who had to reduce dosage to 90 in his first weeks of tx yet was und at week 4. This was a big surprise but would it work for others ? Who knows.
Our doctors do what has been shown in research to be the most successful approach for the majority of patients.
I'm sure for some it is overkill.
It's a gamble but we are each responsible ultimately, for our health care. The decision is, or should be, yours to make.
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