type 1b 24 weeks of Tx?

[nency]

Has anyone had 24 weeks of pegasys and riba tx  for type 1b and SVR afterall?
I hope to hear from all!
Nency

[sfbaygirl]

Good luck with this. I will run this by HR, wonder what he will say.  As I said, I wouldn't chance it, but if you are having severe sx perhaps this is best for you.  UND at 6 weeks at what sensitivity?  I sure would make sure it is at least down to <5 or <10 at 6 weeks.  I think we had someone here that went less time and got SVR. So best of luck!

linda

[nency]

Hello everyone, I am glad that we all can have this discussion, and  as I have promised I spoke to my doc today, and I MIGHT WILL GO FOR 24 weeks. I am 1b, VL before Tx 253 000, was UND at 6 weeks, on Pegasys and ribavarin. So, wish me good luck! If you could  ask your doctors opinion as well and let me know, I would appreciate very deeply! I wish you all to have the least amount of days of intoxication and svr!
Sincerely,
Nency

[sfbaygirl]

Good question. I asked the same to HR.  Why 48 weeks, or 24 weeks?  This is because the studies show these number of weeks to have worked in studies.  Just like those of us who did not clear at week 12, we have to go 72 weeks to have the best chance of SVR as geno 1's.  

[alagirl]

because nobody here like to compromise! ;) lol

Just kidding.  I know what you mean though.  I'm always the same way.  I just FEEL safer if I do this or this.  Theoretically though, it shouldn't matter.  Theoretically, if they do a retrospective study like this and identify all the prognosticators, one should be able to fit oneself in and know if one can do the 24 week stint and still have SVR.

It's kind of like that lottery deal.  They always tell me that even if I play the same numbers every week I'm no more likely to win.  Ok.  I know this is correct.  and right.  And rational.  And makes good mathematical sense.  But I still bet on the same numbers every week just to be sure.  Or I would if lived in a lottery state.  And I wasn't too lazy to drive by and pick up a ticket ;)

[sfbaygirl]

I haven't read all the studies but would be interested to know how many patients there were in the studies....

[mirceani]

How about a compromise, 36 weeks?

How come nobody talks about that?

[alagirl]

Ok, I think I did read the Illinois study correctly last night (at least in part).  It does say that baseline numbers are important not just in RVR's but in SVR's:

"HCV subtype (1b vs. 1a) was also independently associated with RVR (OR 1.8, 95%
CI 0.9-3.7; P  .0954). RVR (OR 23.7 vs. no RVR, 95% CI 9.1-61.7) and baseline HCV
RNA less than 200,000 IU/mL (OR 2.7 vs. >600,000 IU/mL, 95% CI 1.1-6.3; P < .026)
were significant and independent predictors of SVR in patients treated for 24 weeks."

Strip it down to the essentials and it says: HCV subtype was also independently associated with RVR and baseline HCV RNA less than (insert numbers here) were
significant and independent predictors of SVR in patients treated for 24 weeks.

So its saying the baseline numbers were independent predictors.

Later in the article, it says: "the overall SVR rate in genotype 1 patients with a
baseline HCV RNA level of 800,000 IU/mL or less who had a RVR at week 4 was 76% after 24 or 48 weeks of treatment."  

So according to the Illinois article, if you have the right baseline and you have 4 wk RVR, they are saying, it seems, that there is essentially no difference in the 24 or 48 wk groups.

I wouldn't want someone to miss the subtlety of that baseline factor and think that a 1b can just casually drop to 24 weeks, because the baseline seems to be a big factor as they repeat it a few times.

HOWEVER, the Illinois study says that in circumstances where there is no RVR at wk 4, there is a difference between treating for 48 wks and treating for 72 wks in SVR rates.

"SVR rates in patients who did not achieve a RVR were significantly higher in the 72-week versus the 48-week treatment groups, primarily because of a reduced rate
of virological relapse during follow-up."

Also, this wasn't a new study, the Illinois study was analyzation of older data on treated patients, who had either successfully RVR's or who had not, looking at the different factors.  Obviously, data at least 72 months old was studied.

I haven't had time to read much of the Italian research yet, however, this paragraph stood out: "The quality of the assay used to assess the rapid HCV RNA clearance may be even more important in genotype 1 patient subgroups with low baseline viraemia tested with the aim of shortening treatment duration to only 24 weeks, as demonstrated with the very sensitive real-time PCR (low detection limit 29 IU/mL) [23]."

It lets me know that this low baseline/genotype 1 is something researchers have apparently been looking at a good bit.  

[alagirl]

I only looked at the Illinois one last night, pretty late, I'll go back and look at them both this time, and with a fresher pair of eyes.

[nygirl7]

If you are going to treat you are in for the fight of your life =- trying to SAVE your life perhaps. Don't try and find an easy out. If there was one we'd all have done it. Fight for your life as hard as you possibly can. Get it into your head that you are ready and willing to do whatever it takes and then do it.

I doubt that many doctors would ever stop treatment at 24 weeks any way. What you have to remember is just because you cannot detect them in your blood stream does not mean they are not in your body...ready to stop replicating again and could become detectible without any problem.

Sure you can find small studies to support just about anything you want to - but it's up to YOU to determine what is the right move to kill this disease for good.

I opted to extend treatment to 72 weeks and am SVR.  Without extending I dont know that I would be. I didn't want to do it, but I realized I had to.

[Trish77]

Viral load and the dosage of ribavirin taken impacts the outcome of who is more likely to become RVR at 4 weeks.  But once you HAVE achieved RVR at 4 weeks, the studies indicate that everything evens out after that.  HOWEVER.  I would not recommend going only 24 weeks to anyone, simply because this is just to new.  Where it DOES come into play more, I think, is for those that are struggling with side effects to the point where they can't go on.   Perhaps they can manage another 10 weeks to 24...but not another 34 weeks to 48.  I would hang in there until 48 myself until enough studies have been done to make this darn near irrefutable as long as I was able to tolerate it.  

[alagirl]

If read carefully, the decision in the article to stop at 24 weeks and to basically call it safe for SVR is predicated on quite a few criteria.  Much more than just RVR at 4 weeks.  

Please someone jump in here if I neglect to mention everything or I read something about the study incorrectrly.  As I read it, genotype 1's can only stop at 24 weeks if at the very least, the following requirements were met:

1) Which subgroup you're in.  It's important to watch your starting or baseline viral load.  The article suggests that one of the criteria for a 24 week tx period is that you're at less than 200,000 for genotype 1a and less than 600,000 for genotype 1b
2) Whether you have RVR.  A big criteria is that you're RVR, UND by week 4 of treatment
3) How much ribavirin you take every day.  It's stated that 1000 to 1200 mg gives much better chances at SVR than smaller amounts.

[moahunter]

I was UND at 4 weeks, and also had this decision to make as I "qualified" for 24 weeks, due to low viral load at outset and RVR (or at least, my doctors had this decision, since I decided to listen and trust). They decided as I was 1A, 48 weeks was the wiser move. I deeply disliked treatment, and was doubtful and wanted it to end at 24 weeks, but I do think, this was the right decision. I am UND at end of 48 weeks, the odds are in my favour now.

Amazing how after only 2 weeks of treatment, I feel like a new man. I can actually do more than 1 activity a day, in fact, I can do multiple things, quite the change.

[sfbaygirl]

Yes,  granted that a week 4 UND is good, that doesn't mean you are cleared to go only 24 weeks as a geno 1.  I went 47 weeks, had to stop due to colitis, wanted to make it to 72 weeks as I was not clear at week 12.  Even if I were UND at week 4 as a geno 1, I would have at least gone to 48 weeks. Who wants to chance having to do this tx again?  If I had the chance, I sure wouldn't chance doing this whole tx again and longer.  Do your time and get it done as the studies dictate.  Don't chance it. My opinon.  I relapsed due to not being able to continue to 72 weeks, as I read the studies.  Don't take the chance and do the time, it will bode well for you if you do.  

Linda

[nency]

I am sorry I didn’t get update on my E-mail that I had some answers on my question as above. Thank you all for responding. I am not tolerating treatment well, so I thought  if we all get our MD's opinion on that matter and post together would be give us some new prospective in a treatment, or may be new hope... because a lot of people after 48 weeks relapsing as well, and nobody actually established  that 48 is the best NUMBER.
Thank you, I will be glad to hear what your doc's said about that, I am going to ask mine definitely.
Thank you, Nency

[Trish77]

My guess would be that your 1b went first.  It responds a bit better than 1a does so I'm not surprised Susan cleared her 1b first.  When I start tx, I'll see how that shakes out and I'll let you know.  I've been trying to find some data on that but not looking all that hard yet as other things are up on my radar screen a bit more at the moment.

[nygirl7]

I totally agree the articles are very intersting.  It's amazing how important that 4 week test really is and I remember when I came on this forum - at the time - doctors NEVER ordered it hardly unless you begged them to (and even them sometimes they said no it wasn't important until week 12).  Imagine that?

You're right there isn't enough data out there YET but maybe in time they can find us a drug that is less harsh then the current combo.  with our odds as a 1 (or in our case 1a and 1b which is rare but we both had it right?) being less than 50 - 50 to start off with...we need every extra bit of help there is out there.

I didn't do the 72 weeks because I was a combo geno I did it because for some reason I hit a plateau at week 4 having a VL of 411 and then at week 12 it was STILL 419.  I wish to God they had tested WHICH strain was the more predominant at that time...did I kill off one and not the other? That's would have interested me.

I know susan400 had two and then during treatment had only one (I believe A stuck around but might have it backwards).

Us dual people.............we are cool :)

[Trish77]

I wouldn't risk it myself at the moment, simply based on RVR at 4 weeks.  Not being 1a/1b, VL of 1.3+mil (upper limit of the assay they used so I don't really know my VL).  I would want to see more studies first.  In no way would I recommend that anyone go for 24 weeks based on RVR alone, there just isn't enough data and that would be utterly reckless of me.  However, over time....if the studies bear this out consistently enough, SOC may change and these studies are initially promising, that's all I'm really saying.  For those that are having a hard time with sx, an RVR would be at least a factor in the decision-making.  

Overall, I found these articles VERY interesting...I didn't realize the full importance of that 4 week test until I read these articles and I will be asking for a very sensitive assay to be used as well.

[sfbaygirl]

I sure wouldn't trust 24 weeks as a geno 1. Who would want to do this tx all over again and longer if you didn't get SVR?  IMO it would be best to go the 48 than chance it at 24. It sure would be nice and I am sure that with other drugs added to SOC we will see 24 weeks working well. I just wouldn't chance it.  

[nygirl7]

Is it worth the chance of relapse? Hell no.

[Trish77]

I doubt anyone did well with 24 weeks unless they were at least RVR.
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That is exactly what the studies Nency posted indicate.  That the overriding and indicating factor was RVR - UND at 4 weeks.  This also applied to those with a higher VL, which, for these studies, was considered around >600,000 IU/ml.  Even those with a higher VL, if RVR at 4 weeks, did well.   Higher VL seemed to have more of an impact on SVR if achieving UND until 12 weeks.  Even at that, the odds for SVR were increased yet again by increasing treatment to 72 weeks from 48 weeks.  Not a pleasant thought but good to know.  After reading these studies, I know if I'm not UND until 12 weeks, depending on how I handle tx, I'll be serious considering going the 72 weeks.  Will most certainly keep reading though.

[jmjm530]

Yes, there are studies and protocols that support 24 versus 48 weeks which excellent if not identical results. But keep in mind, those that did well with 24 weeks were
RVR (UND at week 4) and also -- I don't have the studies handy -- probably had low pre-treatment viral load as well. I doubt anyone did well with 24 weeks unless they were at least RVR.

-- Jim

[Trish77]

Thanks for posting these articles.  I read them exhaustively.  While I think it will take awhile for SOC for 1a/1b to change to 24 weeks, the information here shows promise.  The interesting factor and deciding factor seems to be achieving RVR at 4 weeks.  Results are better for 1b than 1a but still significant.  VL seems to factor in here as well, however no real difference regardless of factor if RVR achieved at 4 weeks.  

It would be important to ensure that the test used at 4 weeks is a sensitive enough assay, seems to me, as it would give you a more accurate picture of whether you are truly RVR at 4 weeks and if you can limit to 24 weeks.  A big chance to take without being absolutely sure.  If no appreciable difference in SVR whether going 24 weeks or 48 weeks with an RVR, it shows promise.

Very interesting, that's for sure.  Where are you at in your own treatment?

Trish

[nency]

I am referring my question to these 2 links. May be 48 weeks will not be the soc anymore. I am hopping to get 24! God luck with shorter tx!

http://www.illinois-liver.org/education/professional/documents/EarlyIdentificationofHCVGenotype1Patients-Dr.DonaldJensen.pdf


http://www.eatg.org/news/newsitem.php?id=934

[Proactive]

I'd be surprised if there are many reply posts to your question...I'm sure you probably know that standard of care treatments for 1b's is 48 weeks..