Aa
Tailored Treatment
T. Berg, Tailored Treatment for Hepatitis C, Clin Liver Dis 12 (2008) 507-528
Excerpts from the text:
Still, there remains the intriguing question as to what the critical criteria are to be sure that relapses do not occur even when we can now anticipate (provided that sensitive tests have been applied) that the HCV RNA has become undetectable on treatment. Thus, a clear definition of the duration of the negative HCV RNA interval required to prevent any relapse is still lacking and is of the utmost importance (Fig. 2A). ...
The ability to achieve an SVR depends on the time at which HCV RNA becomes undetectable, however, and patients who have a slow virologic response have an increased risk for relapse after treatment has been discontinued, even when HCV RNA was undetectable at the end of the 48-week treatment period [8]. Obviously, the HCV RNA-negative interval was too short to clear HCV from the host tissue permanently. Extension of treatment duration may be one possibility for improving SVR rates by reducing relapse rates in these patients [23]. This concept is, however, confronted with some limitations, considering the troublesome side effects associated with this combination therapy, which, as a consequence, may be responsible for an increasing number of dropouts when treatment duration is extended. ....
Predicting relapse according to the hepatitis C virus RNA-negative interval during treatment?
Drusano and Preston [28] recently presented a mathematic model to predict whether patients may achieve an SVR or experience relapse. It was concluded that HCV type 1–infected patients require continuous absence of detectable of HCV RNA in serum for 36 weeks to attain 90% probabilities of an SVR (ie, relapse rate of 10%). These data confirm the previously mentioned findings indicating that patients with an early virologic response at week 12 hardly experienced relapse independent of treatment duration (ie, 48 or 72 weeks), with an HCV RNA-negative interval on treatment of 36 to 60 weeks. Late responders who first became HCV RNA-negative at week 24 and were treated for 72 weeks (ie, who had undetectable HCV RNA levels during the last 48 weeks of the total 72-week treatment period) still had relapse rates of approximately 30% to 40% [24], however, a finding that clearly contradicts the proposed model by Drusano and Preston [28].
Obviously, the HCV RNA-negative phase required to prevent a relapse must be calculated in a more exponential way and seems to depend on how early a patient becomes HCV RNA-negative during treatment (Fig. 6).
Excerpts from the text:
Still, there remains the intriguing question as to what the critical criteria are to be sure that relapses do not occur even when we can now anticipate (provided that sensitive tests have been applied) that the HCV RNA has become undetectable on treatment. Thus, a clear definition of the duration of the negative HCV RNA interval required to prevent any relapse is still lacking and is of the utmost importance (Fig. 2A). ...
The ability to achieve an SVR depends on the time at which HCV RNA becomes undetectable, however, and patients who have a slow virologic response have an increased risk for relapse after treatment has been discontinued, even when HCV RNA was undetectable at the end of the 48-week treatment period [8]. Obviously, the HCV RNA-negative interval was too short to clear HCV from the host tissue permanently. Extension of treatment duration may be one possibility for improving SVR rates by reducing relapse rates in these patients [23]. This concept is, however, confronted with some limitations, considering the troublesome side effects associated with this combination therapy, which, as a consequence, may be responsible for an increasing number of dropouts when treatment duration is extended. ....
Predicting relapse according to the hepatitis C virus RNA-negative interval during treatment?
Drusano and Preston [28] recently presented a mathematic model to predict whether patients may achieve an SVR or experience relapse. It was concluded that HCV type 1–infected patients require continuous absence of detectable of HCV RNA in serum for 36 weeks to attain 90% probabilities of an SVR (ie, relapse rate of 10%). These data confirm the previously mentioned findings indicating that patients with an early virologic response at week 12 hardly experienced relapse independent of treatment duration (ie, 48 or 72 weeks), with an HCV RNA-negative interval on treatment of 36 to 60 weeks. Late responders who first became HCV RNA-negative at week 24 and were treated for 72 weeks (ie, who had undetectable HCV RNA levels during the last 48 weeks of the total 72-week treatment period) still had relapse rates of approximately 30% to 40% [24], however, a finding that clearly contradicts the proposed model by Drusano and Preston [28].
Obviously, the HCV RNA-negative phase required to prevent a relapse must be calculated in a more exponential way and seems to depend on how early a patient becomes HCV RNA-negative during treatment (Fig. 6).
Not quite the verbiage I meant to use but my boss was standing behind me aNd I didn't want to be typing on the forum right then!
Well now that makes sense I just couldn't understand how the new information was so contradictory to the newer information!
Any exerpts on tx length/SVR odds if still detectible at week 24? I agree with Zazza, that the newness is suspect esp given the reference to the "recent" Drusano model. The Drusano model was presented in 2005.
Hmm, I checked the original Berg study from 2006, and parts of the excerpt above is the same word for word. That is why it seems to be old news. It seems to be rewritten from that old study.
Indeed, this is the problem. There are no other studies then 48 or 72 weeks and therefore studies like the one from Arase are a big step forward.
You mentioned Sanchez-Tapias. Times change, thanks good!
Their study had two big mistakes: First, they included genotypes 2 and 3 too, and they used a fixed dosis of only 800mg ribavirin per day. This is no good idea. TAILORED therapy is a better idea, for the riba dosis too.
You mentioned Sanchez-Tapias. Times change, thanks good!
Their study had two big mistakes: First, they included genotypes 2 and 3 too, and they used a fixed dosis of only 800mg ribavirin per day. This is no good idea. TAILORED therapy is a better idea, for the riba dosis too.
There is no study data available to propose that any other amount of weeks is beneficial - the Sanchez Tapias study was done for 72 weeks. So we have that data to look to to see the decline in odds for those of us who are between 12 - 24. It was a big amount to me and I thought worth it.
I tried originally to have my doctor order only 60 weeks (hey I'm not CRAZY) but both he and Dr. Jacobson said it's 48 or 72 nothing else is supported for having any meaning and that adding random weeks did not make any sense (and I guess 60 was random). They were not into Drusano whatsoever and considered it old data.
I tried originally to have my doctor order only 60 weeks (hey I'm not CRAZY) but both he and Dr. Jacobson said it's 48 or 72 nothing else is supported for having any meaning and that adding random weeks did not make any sense (and I guess 60 was random). They were not into Drusano whatsoever and considered it old data.
I have the fulltext as a pdf, but it is a signed copy and not allowed to share. This is the reason to send the excerpts. If you want to download the file, go to
http://www.liver.theclinics.com/article/S1089-3261(08)00032-9/abstract
I wonder why most people read the papers as a proposal to do a treatment for 90 weeks. The message is not as simple: Treatment should be TAILORED, the two groups 48 or 72 are too rough. Some are overtreated with 48, 24 weeks give similar SVR rates for a subgroup of genotype,1 as 48, some are undertreated even with 72. The second message is written there too: Obviously, the HCV RNA-negative phase required to prevent a relapse must be calculated in a more exponential way and seems to depend on how early a patient becomes HCV RNA-negative during treatment. Of course each individual strategy depends on many individual factors, especially how well one tolerates the treatment.
For people who are just diagnosed and read here, it looks as if everybody has terrible sides from TX. Some have, but some dont have. Some have problems from the hepatitis and die from it, some dont..
Again: The strategy has to be a very individual decission from patient AND skilled hepatologist as a team, and sometimes has to be adapted during therapy.
http://www.liver.theclinics.com/article/S1089-3261(08)00032-9/abstract
I wonder why most people read the papers as a proposal to do a treatment for 90 weeks. The message is not as simple: Treatment should be TAILORED, the two groups 48 or 72 are too rough. Some are overtreated with 48, 24 weeks give similar SVR rates for a subgroup of genotype,1 as 48, some are undertreated even with 72. The second message is written there too: Obviously, the HCV RNA-negative phase required to prevent a relapse must be calculated in a more exponential way and seems to depend on how early a patient becomes HCV RNA-negative during treatment. Of course each individual strategy depends on many individual factors, especially how well one tolerates the treatment.
For people who are just diagnosed and read here, it looks as if everybody has terrible sides from TX. Some have, but some dont have. Some have problems from the hepatitis and die from it, some dont..
Again: The strategy has to be a very individual decission from patient AND skilled hepatologist as a team, and sometimes has to be adapted during therapy.
That would make sense that he is trying to reiterate the fact that the 36 weeks ain't the ticket - it just didn't read clearly to me at all. Considering it's Berg he must be backing up the 'earlier you clear' concept that he saved my life with. Good ole Berg mixed with good ole sanchez tapias = SVR!
72 weeks is the way to go - so far it seems on the money for those of us who don't clear by 12...thank God they aren't doing studies now to turn the 72 into 90 or something you know? God I get the heebie jeebies just thinking about that!
72 weeks is the way to go - so far it seems on the money for those of us who don't clear by 12...thank God they aren't doing studies now to turn the 72 into 90 or something you know? God I get the heebie jeebies just thinking about that!
drofi
+If you have a link to the complete report, I would appreciate it. Remember, I am one of those fools who used the Drusano model ---- and relapsed. Perhaps Berg is trying to respond to those who still think 36 weeks clear -- and my hepatologist is one of them -- is still an acceptable solution.
NYgirl -- 72 Rocks!
Ktahy
+If you have a link to the complete report, I would appreciate it. Remember, I am one of those fools who used the Drusano model ---- and relapsed. Perhaps Berg is trying to respond to those who still think 36 weeks clear -- and my hepatologist is one of them -- is still an acceptable solution.
NYgirl -- 72 Rocks!
Ktahy
"Obviously, the HCV RNA-negative phase required to prevent a relapse must be calculated in a more exponential way and seems to depend on how early a patient becomes HCV RNA-negative during treatment".
This statement fits well with the study from Arase et al.
The date of online publication was 12 July 2008.
Regards, drofi
This statement fits well with the study from Arase et al.
The date of online publication was 12 July 2008.
Regards, drofi
Like I said when I did the 72 week extension - a 30% chance of relapse knocked the odds off the chance that not becoming UND until between 12 - 24 gave me, which was practically nil.
Althought Drusano was thrown out a while ago - not sure why Berg is making it sound like new information? 24 + 36 = 60, not 72 anyway.
Is he just backing up the Sanchez Tapias study here or trying to establish more proof that the earliest UND is the best (and thought that was week 4 not 12?)
Just confused as to why this information seems sort of old to us in here? Is there a date on this paper?
Althought Drusano was thrown out a while ago - not sure why Berg is making it sound like new information? 24 + 36 = 60, not 72 anyway.
Is he just backing up the Sanchez Tapias study here or trying to establish more proof that the earliest UND is the best (and thought that was week 4 not 12?)
Just confused as to why this information seems sort of old to us in here? Is there a date on this paper?
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