vertex, 12 week post pcr.

STILL UND!!!!! FROM THIS DAY ON FRIDAY THE 13TH IS MY LUCKY DAY..

[pln]

one more thing. DR, Shiffman told me I am now cured?, who am I to argue??

[jmjm530]

Coooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooool !!!!

You treated 24 weeks right? Maybe you can recap your stats and tx experience when you come down off the clouds but please take your time on that :)

[pln]

1a/1b
bio 3
had hcv for 21 years, treated 12 weeks vx950 + soc, then 12 weeks soc. Had my riba cut in half at week 3, from 1200mg to 600mg.
When I became unblinded I found out I became UND at day 4, and have stayed that way.

[jmjm530]

That's great and without full riba! Be interesting to see how the Prove 2 non-riba trial arm does. Since you had less riba than the others, wondering how significant the rash problem was. Again, congratulations and hearing the word "cure" from Schiff must have really made the day. Last question -- what was your pre-tx viral load because becoming non-detectible at day 4 is really awesome. Thanks.

-- Jim

[FlGuy]

That's great. From week 3 onward...did you everr go back to increased riba?  Interesting that he'd make that proclaimation at 12 weeks post.  You've got to be one happy PLN.

[pln]

At week 13 when I stoped the vx I did go up to 800mg of riba, and stayed at 800 till week 24. my starting vl was 78,500.

Do you think he said cure to soon???

[mikesimon]

Congratulations on your great news. Good luck, Mike

[jmjm530]

No, not at all. Some doctors feel that being SVR 3 months post treatment is the new SVR, as the correlation with six months is almost the same. Remember, this came from Schiffman, a widely respected HCV clinician and researcher. Of course, you'll want to be tested at six months and one year, but it really looks like a done deal.

-- Jim

[drofi]

3 months SVR is supported by several authors.
Regards, drofi

1: J Hepatol. 2003 Jul;39(1):106-11.

Twelve weeks of follow-up is sufficient for the determination of sustained
virologic response in patients treated with interferon alpha for chronic
hepatitis C.

Zeuzem S, Heathcote EJ, Shiffman ML, Wright TL, Bain VG, Sherman M, Feinman
SV, Fried MW, Rasenack J, Sarrazin C, Jensen DM, Lin A, Hoffman JH, Sedarati
F.

Klinik fur Innere Medizin II, Universitatskliniken des Saarlandes, 66421,
Homburg/Saar, Germany

BACKGROUND/AIMS: The current standard for the determination of sustained
virologic response in patients treated for hepatitis C is undetectable
hepatitis C virus (HCV) RNA 24 weeks following the completion of therapy.
Sensitive molecular tests may permit earlier determination of sustained
virologic response following the completion of therapy in end-of-treatment
responders.METHODS: We examined this possibility in 1441 patients, who
received 48 weeks of treatment with either standard or pegylated interferon
alpha-2a. HCV RNA was determined by polymerase chain reaction assay
(Amplicor HCV Monitor vs. 2.0) at baseline and monitored at 4-week intervals
throughout the treatment and 24-week post-treatment follow-up
periods.RESULTS: End-of-treatment and sustained response were achieved in
624 and 342 patients, respectively. For all treatments, relapse was most
frequent at weeks 52 and 56 and became rare following week 60. Only six
patients out of 348 patients (2%) became HCV RNA positive between weeks 60
and 72. Analysis of baseline characteristics failed to identify a specific
set of parameters associated with early relapse.CONCLUSIONS: This finding
suggests that determination of HCV RNA levels at 12 weeks of follow-up may
be sufficient for making decisions related to the management of most
patients treated with standard or pegylated interferon alpha.



AASLD 2004

Program#/Poster#: 426
Presentation Title: THREE MONTH HCV RNA BY PCR POST IFN AND RIBAVIRIN
THERAPY FOR SUCCESSFULLY TREATED CHRONIC ACTIVE HEPATITIS C (HCV) CAN BE
USED TO DETERMINE SUSTAINED VIROLOGICAL RESPONSE (SVR)

Presentation Time: 10/30/2004 5:30:00 PM
Author Block: Lino J. De Guzman, Bradley Collins, Inland Empire
Digestive Diseases & Liver Center, Redlands, CA.
Abstract Body: AIM: The purpose of this trial was to evaluate the
earliest time point (one or three months) before patients (pts) can be
classified as having a SVR after a complete response (CR) to HCV treatment
(TX). Currently, the standard is to wait 6 months after TX before
identifying pts with a SVR. It is estimated that 98% of pts with a SVR at 6
months will remain virus free indefinitely unless re-exposed and infected.
METHODS: A total of 60 HCV pts who had a CR had quantitative HCV
RNA by PCR collected at the end of TX and at 1, 3 and 6 month intervals
thereafter. There were 33 males, 35 pts were Genotype (G)1, 11 pts G 2 and
14 pts G 3. In order to qualify, pts must have completed 24 weeks if G2 or
G3 or 48 weeks if G1 of either PEG IFN or standard IFN plus ribavirin.
Metavir scores were the following: F0 (7 pts), F1 (22 pts), F2 (14 pts ), F3
(11 pts) and F4 (6 pts). This trial also examined if any underlying
relationship existed between a pts total white blood cell count (WBC) and
amino alanine transferase (ALT) levels after cessation of therapy to predict
ultimate response or relapse.
RESULTS: HCV RNA by PCR taken at 1 and 3 months after completing
TX correlated highly with viral loads obtained at 6 months. A total of 13 of
the 60 pts (21.6%) with CR relapsed. All of the 3 month HCV RNA measurements
were in exact agreement with those taken at 6 months (100% specificity).
Only one (G 3) pt who had a CR after 24 weeks of TX became HCV RNA(+)
between the 1 and 3 month blood draws (98% specificity).
CONCLUSION: The specificity of the HCV RNA by PCR at 1 and 3
months post HCV TX for pts with a CR is similar to the viral load at 6
months. Based on the results of this data, we feel that SVR can be made with
assurance at 3 months post HCV TX. and perhaps as early as 1 month after the
end of TX. There was no significant relationships between WBC or ALT levels
in predicting SVR.

[mremeet]

Way to go pam!!! I knew it!! You're in like flint now, it's all gravy from here on out. And I agree, Friday the 13th ain't such a bad day after all huh?? LOL Anyway, this makes me feel like I have a better chance now too. Hopefully in a few months more, me and charlotte will be seeing you on the other side. Way to go, enjoy your faaaaabullouuusss weekend!

[jmjm530]

Thanks. I wonder if you could post the links to the studies, so I could bookmark them.

-- Jim

[pln]

Thanks, I see my DR is one of the ones that did the study, what a great day.

I hope when all the vx news is out we will have a new drug to CURE us all...

[Willy50]

Hooray Pam!!!  (I knew it  ; ) )  I hope these first 12 week SVR's are the first of many that we will hear.  I also believe that they will (at some point) connect the dots and construct new algorithms for defining RVR as well as what a SVR might be when one clears so quickly.  

Who said Friday the 13th was unlucky?

Willy

[chcnme]

YES!    That is marvelous news!   As long as I continue to see reports of still UND on the VX, I feel encouraged.   When I get doubts or... being to wonder what might be up with the studies is when I begin to feel ... I begin to feel an undercurrent of bad attitude coming on - lol, and so your note - while it's WONDERFUL news for you for SURE - is also wonderful for me!!  I feel better now than I did just one minute ago :)  

[missy60051]

You are the 3rd person I've read about being svr so quickly.
I hope this vertex is our answer to our prayers.
I'm truly very happy for you.

[ladybug52]

Exciting to read you were und at day 4 and still und and now SVR. Caps look like I'm shouting, AND I AM!!!!!!!!!!
This is great news for all who haven't been able to kill the virus with SOC.
You're probably one of those that made the forum famous!:)
Bug

[lab-rat]

Congratulations plm -   Good for you!  Now I'm really jealous!

[APKhaos]

I've been out all morning, and this was the first screen I looked at when I finally hit my office. COOOOOOOngratulatiuons. Superb result, especially given your Riba reduction. As others said, results like these on a consistent bases will certainly recalibrate the clinical norms for RVR and SVR.

If Dr Shiffman says the C word, that's way good enough for me, too. What a relief. Your family must be overjoyed, and so must you. Its still too good to be true, but its looking more certain every day. Plus, we have the 24 & 48 week labs to give us all the convincing we need.

Sound like we need a VX labrat weekend somewhere!

[CitizenSmith]

Great news,congratulations.I'm pretty convinced 3 months is SVR.

[Forseegood]

this is great news! wow, and they are supposed to have another trial in the fall? for relapsers and naive? hmmmm....this is just wonderful for you, and you didn't have to slog through the stuff for a whole year, just great news!

[dointime]

YES!  It's a landmark victory for virus slayers everywhere.  It could be the turn of the tide in the battle against this stinking virus which has had it's own way for far too long.

And you are the best for letting us share it with you,

dointime.

[shastri20032003]

CONGRATS!!! YOU MUST BE FEELING GREAT TODAY!
REGARDS

[goldyn]

Good for you ,you took the journey into a place where not very many people have gone before and came through with victory!!!!!!!!!!!!1

[pln]

Thanks all. A lot of talk about stock, who cares!!!!!!!!

Personally I only care about getting rid of the virus for us all.

thank you vertex.

[drofi]

It is great that you have SVR, I am happy for you! Nevertheless all discussions here about Telaprevir are without any worth, just opinions without data. There are several publications that a SOC of 24 weeks is enough to get SVR when you start with a low VL. 78,500 is low, very low.
Sorry, but we have to wait for scientific data from unblinding the VX-950 studies. Everything else is smalltalk, not more.

Regards, drofi

[mremeet]

Have to disagree with you pal. It is true we don't have a fully fleshed out story as to telaprevir's complete effectiveness under any and all circumstances at this point. But I don't think there's any doubt telaprevir contributed to pam's success, and it may have been the decisive factor in her SVR. She was undetectable by day four! Day FOUR. And possibly even earlier than that, as day four was the first day of followup testing after day one. And by UND, I mean <10 IU/ml!  Even considering her low starting VL, I don't believe SOC would have so thoroughly zapped the bugs nearly that quickly, do you? Plus pam's riba dose was cut in half by week three due to anemia. Are you so sure she would have scored an SVR with geno 1a AND 1b (she had both) in 24 weeks on only half riba? Remember, mixed 1a and 1b, on HALF riba and HALF the normally prescribed duration of treatment for geno 1 (which itself only has a ~50% SVR rate, and even much lower than that on half riba).

Plus, the Vertex realeased data (from December) revealing 88% that managed to complete the triple therapy over 12 weeks were UND by week 12. Why would it be hard to believe this drastically improved clearance rate will shorten treatment time and/or increase likelihood of SVR? Surely you don't think adding telaprevir to SOC would make either no difference, or possibly even lower existing performance?? C'mon dude, telaprevir has its problems to be sure, and it's no panacea. But barring some ominous and yet unknown long term side effect, it's the biggest/bestest thing to come along since ribavirin and possibly interferon as well.

[Willy50]

I agree that much or the posting here is anectdotal but it is not without value.

Each member here that has posted their results of their specific trial are one piece of the scientific study which I believe that you DO respect.  Some of those results will be released in under 2 hours on people who treated 12 weeks only.

You may be correct that some people with low viral loads may clear and acheive SVR in 24 weeks.  How many clear in 4 days?  Consider the log drop in 4 days with the starting viral load of 78,000 IU/ml.  I consider that noteworthy.  Another member APL had a starting viral load of around 28,000,000 IU/ml and was clear (or clear within about the amount and time) in 4 weeks.  What is the log drop on that in one month?    MREmeet had similar results inspite of dose reductions, stopping treatment and being put on steroids which depres immune response; he too is clear of the virus after 12 weeks of treatment.  I believe all these results are impressive.  

I'm not aware of other studies which correlate with these results.

In a few hours we'll have some FDA backed trial results that we can talk about but I'd remind you that these are people, individuals from those same FDA drug trials.  

Best,
Willy

[wyntre9]

Congrats, pln!  And thanks for posting.

Wyntre

[nick m]

I am delighted, keep blazing that trail. best wishes nick m

[pln]

Yes, I read several studys about 24 weeks for 1b and low starting vl being able to do 24 weeks. So that did make it easier to stop treatment at 24 weeks, also being a stage 3.

So maybe I had several factors on my side. low vl, 40/f, and vertex. I can not wait for the 24 week unblinding.

Take Care
Pam

[drofi]

whatever added to the success - it is great! My personal opinion is, that VX-950 will be on the market and will be the first of a multi-therapy-system similar to the HAART against HIV. A multi-therapy for some weeks or month, not for lifetime, HCV will be cured!
However, I learned during my professional activity in drug development during the last 20 years, to trust only on clinical facts of prospective, blinded, controlled studies, not on single cases.
Example: If we write a documentation about two (2) persons starting SOC for 48 weeks tomorrow, and both have SVR in two years. Does this mean that SOC gives SVR at 100%? No.
That's all I wanted to point out.