24 v 48-week treatment

[kimakay1950]

I was told yesterday I would probably only have to treat for 24 weeks. I did some research and found that UNC Chapel Hill had done a study and they were only treating for 24 weeks. I am now at week #17. Has anyone else been told this. I was UND at 4, 8 and 12 weeks. Had labs drawn again yesterday. http://news.unchealthcare.org/news/2011/september/24-week-hepatitis-c-treatment-as-effective-as-48-week-treatment

Wouldn't it be fantastic - I was a null responder 10 years ago.

[KJL]

2nd that thought!!!!

I'm also at week 16/17 (was UND 4 9 12 and 14) but still slated for 48 weeks total
due to  being a partial responder with Viral break through in 2005)

I've been very lucky with SX, and blood levels so far no "rescue" drugs needed yet
But my worst rash side effects came after the 12 weeks of Incivek was completed.

I just added Atarax to help with the rash, Starting to bleed at the bumps and have scaly patches of dry/burnt skin on back shoulders thighs.  The Atarax seems like it is keep the itching down to a "just tolerable" level of slow torture.
(I was certainly spoiled by the mild Sx during the 1st 12 weeks)

Long story short "in my darkest hours" I contemplate jumping this ship rather than
riding it out for another 36 weeks (If I even can). In my better moments I can deal with it and look forward to finishing the whole sentence. But always looking for a 12 week reprieve from the Governor .

KJL
BWell




 

[hangingin]

I relapsed in March 2011 after 6 months (26 weeks) of SOC peg/riba.  My dr says wither way I have to go 48 weeks this time.  I am on SOC + Victrellis, UND after 4 weeks of triple treats .  I get 16 week labs done this week, moving on, one day at a time.  Good luck to you guys, SVR all around.  Its time to add this  to the other extinct dinasaurs. 

[Cali]

Sounds great Kima...hope you can stop at 24 weeks!

KLJ, I'd hate to see you give up...dig way down for the strength to complete tx, the alternative really sucks.  Hang in there ok?

Thinking of you,
Cali

[kimakay1950]

I am eat us with a rash again also - horrible on my chest. The article was published in the NEJM and you should read it - it says the odds of SVR are basically the same. If this is true, I have only 2 months - yeah.

[alice]

That's interesting.... it supports the current FDA approved dosing recommendations for 24 weeks for most patients. I'm interested, however, in how they categorized the patients. The current dosing recommendations for Incivek states (and the current CCO training module for Incivek agrees) that cirrhotic patients may benefit from 48 weeks. Fixed-duration tx (i.e., 48 weeks) is recommended for cirrhotic patients instead of Response-Guided-Therapy (24 OR 48 weeks of tx, depending on patient response).

I'm coming on week 6 or so post-Incivek and none of my docs have mentioned me stopping early. Honestly, I'm still afraid to stop at 24 weeks. There just aren't any more options out there for me anytime soon and I don't want to do this again anyways. Tough decision, tho, for anyone.

thanks for posting, kim.

alice

[kimakay1950]

That's interesting.... it supports the current FDA approved dosing recommendations for 24 weeks for most patients. I'm interested, however, in how they categorized the patients. The current dosing recommendations for Incivek states (and the current CCO training module for Incivek agrees) that cirrhotic patients may benefit from 48 weeks. Fixed-duration tx (i.e., 48 weeks) is recommended for cirrhotic patients instead of Response-Guided-Therapy (24 OR 48 weeks of tx, depending on patient response).

I'm coming on week 6 or so post-Incivek and none of my docs have mentioned me stopping early. Honestly, I'm still afraid to stop at 24 weeks. There just aren't any more options out there for me anytime soon and I don't want to do this again anyways. Tough decision, tho, for anyone.

thanks for posting, kim.

alice

I would print out that article from UNC Chapel Hill and the New England Journal of Medicine and take it with you. I have stage IV cirrhosis and they told me that tests from all over the world proved the same no matter what.

[banarep]

someone  posted here a couple of weeks ago that treatment is now more response driven, so this sounds like great news.

[hepcatts]

negative at 2,4,8,and12, finish 15 on Thurs. Started as naive and after week 4 test Doc said 24 total. She is going 48 with previous nulls and relapsers and also 48 for patients at stage 4. Similar itching issues started after Incivek ended.

Kirk

[kimakay1950]

2nd that thought!!!!

I'm also at week 16/17 (was UND 4 9 12 and 14) but still slated for 48 weeks total
due to  being a partial responder with Viral break through in 2005)

I've been very lucky with SX, and blood levels so far no "rescue" drugs needed yet
But my worst rash side effects came after the 12 weeks of Incivek was completed.

I just added Atarax to help with the rash, Starting to bleed at the bumps and have scaly patches of dry/burnt skin on back shoulders thighs.  The Atarax seems like it is keep the itching down to a "just tolerable" level of slow torture.
(I was certainly spoiled by the mild Sx during the 1st 12 weeks)

Long story short "in my darkest hours" I contemplate jumping this ship rather than
riding it out for another 36 weeks (If I even can). In my better moments I can deal with it and look forward to finishing the whole sentence. But always looking for a 12 week reprieve from the Governor .

KJL
BWell


Calamine lotion - I swear I have woke up in a puddle of blood from crazed itching during the night - I am on 4 Atarax a day and Benadryl. It is slow torture. I too have had crying jags when I said I can't do this anymore, can't I get a break, but I can and will do 24 weeks if it is the last thing I do.

 

[B]

Hi,

Please excuse my ignorance, but could this rash be from riba and not from the Incivek?

[kimakay1950]

Hi,

Please excuse my ignorance, but could this rash be from riba and not from the Incivek?

no you're not ignorant - that is exactly what it is from. It is bad, bad, bad. No one on here is stupid - hey we have enough smarts to ask questions and support each other. If I don't know the answer I know where I can get it.

[B]

Thanks for those nice words!  I have to choose between telaprevir and bocepravir and my decision needs to be made by Friday...the rash issue w/telaprevir scares me enough, not to mention the riba rash!  My doc says he likes tela due to the lesser treatment time but will allow me to make the final decision.  I am undecided at this point.....but know I will start treating soon. 

KJL, I so hope you stick with it even though it is tough.  You can do it!

Bye for now,
B

[greyrocker]

negative at 2,4,8,and12, finish 15 on Thurs. Started as naive and after week 4 test Doc said 24 total. She is going 48 with previous nulls and relapsers and also 48 for patients at stage 4. Similar itching issues started after Incivek ended.

Kirk

Being tx naive and given your response, 24 weeks is definitely supported by the results of the trials. I am surprised that your doctor is grouping relapsers with null responders. They are two very distinct, different groups and relapsers are usually treated like naive, provided they respond with RVR and sustain it.

greyrocker

[alice]

OK, guys... It took me a little bit to figure this out but here's the deal:

This article this thread links to is a press release from UNC describing the results of the ILLUMINATE study, which was part of the Vertex's Phase III trials for telaprevir. The results of the ILLUMINATE study form the basis of the current recommendation that tx-naive patients who have an extended RVR with Incivek should do 24 weeks. This is not a new, separate study.

Here's the Conclusion from the NEJM article:
"Conclusions In this study, among patients with chronic HCV infection who had not received treatment previously, a regimen of peginterferon–ribavirin for 24 weeks, with telaprevir for the first 12 weeks, was noninferior to the same regimen for 48 weeks in patients with undetectable HCV RNA at weeks 4 and 12, with an extended rapid virologic response achieved in nearly two thirds of patients. (Funded by Vertex Pharmaceuticals and Tibotec; ILLUMINATE ClinicalTrials.gov number, NCT00758043.)"

What this means is that this isn't new data and current recommendations for treatment duration remain the same. Cirrhotic patients should seriously consider doing 48 weeks, following the FDA-approved tx guidelines.

I gotta tell you folks something.. It has REALLY chapped my hide the way Vertex has downplayed the potential benefit of extending tx to 48 weeks for cirrhotic patients. I have yet to see a straightforward comparison of data between cirrhotic patients who did 24 weeks and cirrhotic patients who did 48 weeks. If they lump the cirrhotic and non-cirrhotic patients together, you can't necessarily see subtle differences between two distinct groups.

I guess i can understand their motivation-- it IS a business and the prospect of cutting tx time in half is a gigantic selling point-- but still, this really, really rubs me the wrong way because the ONLY mention of this potentially huge benefit is in a stinking footnote to a table in the prescribing information!

Sorry, I'll take my wet-blanket self back to my sad little corner and suck up another 30 weeks of tx as planned.

alice