Tele Response Rate at 92% Vs 88% 48 weeks

[nygirl7]

The patients who had undetectable virus levels after 4 weeks and 12 weeks were treated with pegylated interferon and ribavirin for either 12 more weeks or 36 more weeks. Of the patients who were treated for an additional 12 weeks — making 24 weeks of therapy in total — Vertex said 92 percent had undetectable levels of the hepatitis C virus. It said 88 percent of the patients who received 48 weeks of treatment had undetectable virus levels.

Patients' virus levels were measured 24 weeks after the end of their treatment.

http://www.google.com/hostednews/ap/article/ALeqM5g7D_XCiVd824fy4ycKjkpmfQKhsAD9HGMB1G0

[Andiamo1]

I forgot to include partial response, but I think that might be null response.  I don't have the passion to look it up though.

[Andiamo1]

The article is poorly written; the thread is excellent.

Having watched treatment protocols evolve over the last 20 years, I believe that eventually there won't be a fixed duration protocol for naive patients.  The length of time on the SOC drugs that follows the 12 weeks of triple therapy will vary depending on patient parameters.

The overall response rate for naive patients, is 72%.  The 28% that don't respond would be those patients that would have failed SOC in the different ways we have identified: Relapse, null response, and breakthrough.

As Nygirl said, if you fail treatment with a protease inhibitor, you will have increased the mutant strain that is resistant to the drug and you will not be able to use a similar PI for many years, perhaps forever.  For this reason, it is important to identify naive patients that are likely to fail with 12 + 12 week duration and treat them for longer periods with the SOC drugs.

[Cory255]

Absorbing brand new news takes a minute or two.  The article is somewhat of a starting point; it's a little confusing, but has excellent data results.    

In other words...Telaprevir results from the phase 3 study ILLUMINATE; presented that patients who RVR'd benefited with the 92% which was the shortened 24 week tx duration.  In comparison the patients who RVR'd who did 48 weeks was 88%.  

Cory.

[billm57]

the article is useless it doesnt even say first timers - it leaves the reader askiig more questions while answering none really - the results i posted are what the treatment protocol will most likely be as per expert opinion - so i will spout them because they were spouted at me from data presented at EASL 2010 - study 107 - the last phase of clinical trials before FDA approval is just a larger sampling than the previous phase - so protocol most likely will not change - and this is a worldwide disease with worldwide data - and technically the results i posted are accurate as per expert opinion - it may be mine also but only after research and documentation

[Andiamo1]

I did not get helper drugs on the trial and had to reduce the Riba at about 30 weeks.

I think the protocol for naive patients will be 12 + 12.  I think that treatment failures will be handled differently depending on the type of failure, age  and other health factors.

I am too lazy to get the numbers from the Prove 3 trial, but I remember very well that relapsers that treated for a total of 48 weeks had a higher SVR rate than those that treated for 24 weeks.  I don't remember how the other type of failures responded to the trial.  I approached Doctor D about dropping out after 30 weeks and he advised me not to do it.  He felt that my age increased the chances of relapse and didn't want me to take a risk.

The main variables for success are based on variant strains of the virus that don't respond to Telaprevir and the strength of our immune response that is necessary to help the drugs beat the virus.  Age, weight, exercise and general health all play a role in influencing our immune system.  The better our health at the start of treatment, the better our chance of SVR.

Eric

[working dog]

i can hardly wait for telaprevir...hopefully it will be approved early next year..thanks for the update and info guys.....billy

[spectda]

Although the results look great, I find the data from vertex difficult to discern, I guess they are still pinning down the protocol.

[spectda]

I thought telaprevir had a 4 week lead in of soc before the introduction of telaprevir, I guess this is only true for the boceprevir treatment.

It looks like telaprevir treatment protocol starts with tela plus soc and after 12 weeks tela is stopped and soc continues for another 12 weeks for a total 24 weeks since the 48 week extension did not improve results. great results and only 24 weeks?

Dave

[pcds]

I think Dave told me the new regime will be 12 wks tela then the rest soc?  I am hoping for the 24 week regime.  Did you get helper meds on the trial?  Neupo, procrit?
Thanks Eric..
Judy

[Andiamo1]

The rash is very rare, so that's not the problem.  I had severe anemia beyond anything I experienced with SOC and nauseaas well.  I had a general feeling of being sick that was hard to pinpoint.  Once I hit the 24 week mark and went on SOC alone, I felt much better.

No one will treat for 24 weeks again and many of the worst side effects appeared after 12 weeks, so don't worry.

Best of luck to you.
Eric

[pcds]

That's great to hear.  I was on the website for vertex and there is a podcast from a recent meeting on progress with Telaprevir, they mentioned the Sept report.  Did you have any special side effects different from SOC?  I guess I'm concerned about the rash.

[Andiamo1]

There have been earlier trials for non responders; I was in one of them.  All the numbers from Prove 3, the trial I am talking about are in.

I treated 7 times with various flavors of SOC starting in 1992.  I finally got an SVR with the 8th time I treated using Telaprevir.  I was a relapser using SOC and I treated for 48 weeks in the Prove 3 trial.

[pcds]

The final results of the last trail which had non responders, relapser, slow responders, isn't finalized until next month, so really no one should be spouting numbers. They aren't in yet except for treatment naive.  What the rec will be after those numbers are in, is not yet known.

[Andiamo1]

I don't think the article is useless at all.  It did convey the good news that the success rate is much higher with Telaprevir and the treatment for naive patients is shorter.

Treatment failures, by the nature of their failure, might have to treat longer.  After all, the failure puts them into a different -- pre-screened -- category.  You might have to treat longer if you failed prior treatment.  So what, if you get an SVR!

[Andiamo1]

Glad to see you and thanks for the good wishes.

Lucky for you, the new protocol for relapsers will likely be 12 + 36 not 24 + 24.  I could do the later standing on my head.  24 + 24 was brutal and thank goodness didn't prove any more effective than 12 + 36.

Best of luck to you.
Eric

[Bali05]

had my wk12 meeting with hepatologist and he gives me 80% SVR worst case !
for my current tx.

Since I am a plan B person I proposed trying Tela if I relapse. Now Tela is
designed for geno 1 but I brought study C210 to his attention and he agreed
It would be an "off label" use.

Just wanted to post this to let  geno 4s know that Tela is worth a try  !

b

[billm57]

12 tela + 48 peg riba for nonresponders yields best results - 12 tela + 36 peg riba for nonresponders yields comparable svr

overall svr for previous nonresponders is 37%

for previous partial responders - 55%

for previous breakthrough - 75%

for previous relapsers - 97 % - nice

[billm57]

the article you provided is useless it makes no mention of many facts needed to form a conclusion - like first timers or nonresponders or relapsers or what

from what ive read only treatment naive patients will benefit from 24 weeks

previous relapsers partial responders and breakthrough patients 12wk tela + 24 peg / riba

previous non responders 12wk tela + 48 peg/riba

[pcds]

24 weeks of treatment is long, but a huge improvement over 48 weeks.  Not to mention the higher success.  These drugs are harmful to all the systems in our body.  The less time exposed the better off you are.  My treatment stopped at 12 weeks with a VL 348, 3+ log drop during the 12 weeks but not before 12 weeks.  Still not quite right 4 wks post tx.  

[Isobella]

I love your kick-*** attitude!!

I absolutely cannot wait for Tela to be available so you can have your turn.

Isobella

[Trinity4]

To get the same results you did, sign me up, I'll do 24 + 24.  Being a relapser a shortened treatment time with a PI has never crossed my mind.  By no means is 48 weeks the longest war in HCV history but with relaspers and null responders it's got to be the deadliest.

Hope you are doing well

Trinity

[Andiamo1]

I forgot to say that the study arm I was in, 24 + 24 had no better results than 12 + 24.  In fact, the dropout rate from side effects was much higher in the 24 + 24 and for people that finished the treatment, the results were the same as the 112 + 36 group.

Only masochists should think about a 24 + 24 option.  It was brutal!

Eric

[Andiamo1]

This is an excellent drug and we are very lucky to have it.

I was randomized into 24 weeks of  triple therapy followed by 24 weeks of Interferon and Ribaviron.

The article about the latest trial is misleading in a number of ways.  First, it is for naive patients only.  Secondly, the overall response rate for the entire study was 72%.  Thirdly, it implies that 48 weeks of SOC has worse response rates than 24 weeks and that is not the case.

All the studies involving prior treatment failures with Interferon and Ribaviron were broken into groups depending on how they failed:  Null responders:  People that never became undetectable; Relapsers: people that became undetectable and remained undetectable until EOT; Break through: people that became undetectable and then relapsed while still under treatment.

People in these studies had vastly improved results when treating with 12 triple+ 12 SOC compared to 12 triple + 36 weeks with Interferon and Ribaviron only.  The improvements varied according to the type of prior failure.  People in my category, relapsers, had a 70% SVR rate in the 12 + 12 week group and people in the 12 + 36 week group had a 90% SVR rate.

Pouring through trial results can give anyone a headache trying to understand the options.  The bottom line is that if you failed prior treatment with SOC, you have better odds with 12 + 36 weeks making the total treatment 48 weeks.  I don't have the numbers for the breakthrough and null responders, but as I recall, these numbers  were not as good.

[becksta29]

thanx 4 info :) gives ppl hope.