termination at week 41

I am now on the Invivek triple therapy with interferon and ribivarin.  I was put on the 48 week tract because I had been treated in 1999 with (non pegalated) interferon and ribavarin when the treatment frist received FDA approval.
I was a partial responder.

I was undetectable for HVC at weeks 4, 8, 12  and remain undetectable at week 40.  I am haveing some unirary tract problems, infection and fungal problems.  I can not find data on what possible effect termination of treatment after 40 weeks might be.  I had the rapid response and was undetectable at week 4 and have remained undetectable.  

Does anyone have any experience with this type of situation? Is there any data?  I am considering termination treatment  after week 40. Im a 63 year old male with no serious liver damage.

Jim

[pooh55811]

Jean-Michel Pawlotsky, in his AASLD presentation stressed this point (as well as others):

Treatment failure with triple combination with a direct acting antiviral is due to insufficient response to Peg-Inf and Ribavirin which leads to a growth of DAA resistant HCV variants.

In triple med treatment (current regimens with either Viv or Inc) and a person has only a moderate Inf-Riba effect then the person may be cured if treated for a sufficient length of time
OR
the person may relapse if treatment is stopped too early


The reason I mention this, and I will give the link, is because you said you are a prior partial responder. Prior partial responders have a lower SVR rate, even on the Triple Med TX with a DAA. Therefore cutting treatment length would probably not be beneficial.

This is a slide presentation. You need to register but it does not cost anything.

It would be beneficial to watch the entire program but if there is not time for that, go to slide 32 and start watching from slide 32, through to the end.

http://74.43.177.57/courses/2010/pg/pawlotsky/player.html

There is more data comparing the SVR rates and I will try to find it and post another link.

48 weeks is not easy. However, if you can make it and if your doc says you are healthy enough to treat 48 weeks you would have your best chance at success if you finish Tx.

I treated 48 weeks so I understand the 48 weeks. Plus, Tx was not easy so I do understand that aspect too. I finished Aug. 25th. I am UND at 12 weeks post EOT, so now I have 99.7% chance for SVR/cure. It was difficult, but worth it.

[Idyllic]

I know there is data on partial responders who treated 12/24 but not sure about stopping 8 weeks early. It might be OK but I am not sure about relapse so I will let others offer data and suggestions.

I know you are not soliciting ways to remain on treatment but depending on the extent of these conditions your ability to fight infection and heal is one that might need assistance either way. I was UND at week 4, 12, 18, 24 and 44. I have developed three rather alarming conditions over the past few weeks which my GI understandably could not effectively treat so I saw my PCP and a Dermatologist.  The point  is if you are handling treatment basically OK then I encourage you to find solutions to these other conditions. There are only so many symptoms and conditions that will subside once we cease taking these meds.

As a Prior partial responder with no serious liver damage myself who is on week 47 I realize this is asking a lot. I can imagine these meds are taking their toll and you are ready for this experience to be over. I encourage you to hang in there and find a way to remain treating for the entire duration or as long as you possibly can. I know it is not easy but you have come so far. I think deep down I would want others to encourage me to keep treating but ultimately this is up to what is OK with you and what you and your doctor decide.

Bast of luck

[Jel111]

I stopped after seven months and it came back. I was also a early responder. I just got back from the doc today and will start again the beginning of January, Wish me luck!

[Jim3333]

Thanks for your response.  If it were just dealing with unplesant side effects I would not consider stopping in week 41.  The treatment has been completely sucesful, and I do not want to mess that up.

A urinary tract infection, and fungus in my lungs has some potential for damage.  I am trying to do a risk / reward analysis.  That is why I am trying to get some information on the change to possible outcome in sucessful treatment for stopping 7 weeks early.  It is not just the need for some support to tough it out for the last 7 weeks

[Jim3333]

If I were to stop at 41 weeks, it would be 9 months, 2 months more than your 7 months.  No way do I want to go thru this again.
Thanks for your imput.  I think it will be very dificcult for me to get information to help me deternin if 41 weeks rather than the 48 weeks is likely to change outcome.

[pooh55811]

Jean-Michel Pawlotsky, in his AASLD presentation stressed this point (as well as others):

Treatment failure with triple combination with a direct acting antiviral is due to insufficient response to Peg-Inf and Ribavirin which leads to a growth of DAA resistant HCV variants.

In triple med treatment (current regimens with either Viv or Inc) and a person has only a moderate Inf-Riba effect then the person may be cured if treated for a sufficient length of time
OR
the person may relapse if treatment is stopped too early


The reason I mention this, and I will give the link, is because you said you are a prior partial responder. Prior partial responders have a lower SVR rate, even on the Triple Med TX with a DAA. Therefore cutting treatment length would probably not be beneficial.

This is a slide presentation. You need to register but it does not cost anything.

It would be beneficial to watch the entire program but if there is not time for that, go to slide 32 and start watching from slide 32, through to the end.

http://74.43.177.57/courses/2010/pg/pawlotsky/player.html

There is more data comparing the SVR rates and I will try to find it and post another link.

48 weeks is not easy. However, if you can make it and if your doc says you are healthy enough to treat 48 weeks you would have your best chance at success if you finish Tx.

I treated 48 weeks so I understand the 48 weeks. Plus, Tx was not easy so I do understand that aspect too. I finished Aug. 25th. I am UND at 12 weeks post EOT, so now I have 99.7% chance for SVR/cure. It was difficult, but worth it.

[frijole]

The fungal infection in the lungs may be the deal breaker.  I too did 48, but you need to deal with the lungs.  As Pooh said, I don't think you are going to find any data on 40 weeks.  Also as she stated, it is always best to continue to 48.  I assume you are doing the 48 because you were a partial responder since you say you have no serious liver damage.  

I had pneumonia (beginning) twice while treating, and it was no fun, but managed to continue and did not miss any pills or injections.  Rockymo had some serious lung issues, probably related to asthma and had to quit.  She did not clear.  In my pictures, in my profile are some spread sheets showing members mostly who started in 2011.  You can see a few members who achieved SVR even though they quit early.  My hepatologist had some patients who did.  But there really is no statistical data.

You are right -- we don't want to do this again, so staying the course would increase your odds.

I wish you much luck.
frijole

[pooh55811]

Here is a link which will give you data on treatming for 48 weeks (but no data for treating 41 weeks):

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%202.aspx

"Retreatment of previous partial or null responders with telaprevir-based triple therapy resulted in SVR rates that were lower than those achieved by previous relapsers treated with triple therapy but still higher than those reached with pegIFN/RBV alone. Previous partial responders achieved higher rates of SVR with triple therapy compared with null responders."

"Figure 3. REALIZE: SVR rates with telaprevir-based therapy according to previous response.[24"

The figure given for prior partial responders is 59% SVR rate if 48 weeks are done. However, if you look at all of the data and graphs, you will see that the percent changes depending on other factors, such as amount of liver fibrosis.

[Mark4415]

I'm week 35 sure is tough meds everyday, hope it works man

[Mark4415]

I'm hanging week 35 been long time

[yodennis]

I'm not sure I understand. Were you undetectable when you stopped your therapy after 7 months and if so how long after did you become detectable again. And if you are going to retreat again in January I presume you were on dual, e.g., Ribo. and Interferon as opposed to triple therapy which Jim3333 was referring to? Thanks and good luck in Jan. d

[quayle]

That is only a theory at the moment,not a medical fact,people have the right too choose and if you feel your life is that bad follow your gut instincts,don't persist at the risk of damaging the rest of your body.

[BoceprevirGal]

  Well, fungal infection in the lung is serious, especially at your age, and
you did say your liver damage was minor.  Like you mentioned, the whole thing needs to be weighed.
  I would take it one day at a time, and closely watch the lungs. Good luck~

[pooh55811]

"That is only a theory at the moment,not a medical fact,"
------------------------------

What is only a theory? Are you stating that the studies that the researchers did  are only a theory? They did studies. Those links go to the studies. If you have a problem with the data, the figures, the analysis, and the conclusions that the researchers came up with after doing the studies, then I suggest you take it up with the researchers. The OP asked for information and data concerning truncating treatment. I provided him with links to studies and presentations given by the researchers/experts.


"people have the right too choose and if you feel your life is that bad follow your gut instincts,don't persist at the risk of damaging the rest of your body."
----------------------------

Of course people have the right to choose what they will do. That is not the topic here. No one is discussing that aspect. The OP asked for information and data concerning truncating treatment, so I provided links to the studies and the data. The OP can then make up his own mind

[einsteinus]

That is some BRILLAINT stuff....have to take a while to digest all that but as someone that had so many issues with side effects I was always asking the question what if I quit early?

For Jim -- All I can say is that I was a Fast Responder (Viral load @ 5Mil to 12Mil at the start)  down to 400,000 on Peg + Rib alone after 4 weeks then with Bo Undetectable at 8 Weeks. I quit at 16 or so weeks with over 1 month of no detection it came back about month later first just 50,000 or so and now back to 7.5 MIl to 15 Mil.....I had to quit because I was part of a study and denied any treatments for the side effects --basically the treatment was killing me. It has been at least 3 years since the end of meds and I still suffer from side effects or maybe just Hep C--- lots of unanswered questions

[einsteinus]

Sux doesn't it! especially when you put all the effort into getting well

[einsteinus]

I can tell you have a great back round in the scientific area.  From what I have had noticed about some of the people that have this disease, is that from the standpoint of someone with a degree in the field of microbiology I have t say the people in the HCV community are some of the most intelligent people I have ever met.  The unknowns of this disease and the fact it effects so many people in so many counties has bought out the best in people helping people. I am sure we all have lots to learn including the difference between theory, study, fact and guess.  As a biologist the one thing I loved about this field is that is was a little less structured then physics and sometimes a feeling that something may or may not work often led to new discoveries....usually by accident

[Jim3333]

Good luck on your new treatment.  Hope you have success.

[Jim3333]

Good luck on your new treatment.  Hope you have success.

[BoceprevirGal]

  *high fives you, for working in the microbiology field...slap

[pooh55811]

"I am sure we all have lots to learn including the difference between theory, study, fact and guess."
----------------------------
I certainly hope all of us are not still learning "the difference between theory, study, fact and guess." The differences between theory, study, fact and guess are quite clear. However, if one is unsure about the differences, one can always consult a dictionary.


Jim ... I hope everything works out for you and that you attain SVR. Please keep us updated and let us know how you are doing.