Incivek tx (hcv)

[johnr1]

Hi again

Does anyone know the protocol for a patient naive(I've no prior tx) who is "UND" at 4 and 12 weeks?
I know that if I'm "UND" at 24, hopefully, I'm finished with tx.
My gastro guy tells me I'm done either way. I thought if the was a bad test score, I was to continue
the rib and int for another 24 weeks.
He said after 2 "UND" tests, even if the results were bad...I'm finihed w/ tx.(I have 2 weeks to go.)
Is that correct?

Thanks again guys for your help
John

[halbev]

Thanks for the Congrats !
It took me 3 years a total of 132 weeks 84 of Int/Riba and 6 months break followed by 48 weeks of Int/Riba with the first 12 weeks including Incevik but I AM HERE and going to stay that way to Damm mean and Stubborn thats what my mom would say.

[johnr1]

Thanks a bunch...I sincerely appreciate the support.

[johnr1]

Thanks for the support and encouragement.
I am real glad to hear you're doing well..and I hope you stay that way.
wow! 48 weeks...that's a road...congrats

[Idyllic]

Wow I looked through some of your posts and you really have had a tough go of it what with your Hgb dropping so low.  Plus the Riba dose reductions coupled with nausea! Bless your heart! Hang in there just two more weeks

I agree with the others. 24 weeks is the appropriate treatment duration for a treatment naive person who is not cirrhotic (you) & who was eRVR (UND in weeks 4 & 12). The way your doctor phrased it is unusual. In order to "be done" you need to be UND at week 24.

If for some freak reason you were to have a viral breakthrough (and become detectable) you would be done since you have to be UND at week 24 to continue treating (which you don't need to do).

[halbev]

I did 48 weeks on Incevik triple with 3rd stage cirrhosis NEGATIVE from 4th week on. I finished 9 weeks ago, Be STRONG !

[johnr1]

Thank you also for what all you guys do

[johnr1]

Thank you very much

[HectorSF]

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCIVEK safely and effectively.  See full prescribing information for
INCIVEK.
INCIVEK
TM
(telaprevir) Film Coated Tablets
Initial U.S. Approval: 2011

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf


DOSAGE AND ADMINISTRATION

Table 1: Recommended Treatment Duration

Treatment-Naïve and Prior Relapse Patients  

Undetectable at Weeks 4 and 12

Total Treatment Duration

24 weeks


In clinical trials, HCV-RNA in plasma was measured using a COBAS
TaqMan assay with a lower limit  of quantification of 25 IU/mL and a limit of
detection of 10 IU/mL.  See Laboratory Tests (5.6) for a description of HCV-RNA assay recommendations.

For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA result is required; a
confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result [see Laboratory Tests (5.6)].

Treatment-naïve patients with cirrhosis who have undetectable HCV-RNA at weeks 4 and 12 of INCIVEK combination treatment may benefit from an
additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2)].
-------------------------------------------------------------------------------
Regarding what your doctor said...

Detectable (1000 IU/mL or less) at
Weeks 4 and/or 12

Total Treatment Duration

48 weeks
----------------------------------------------------------
Read the Prescribing label for complete details.

Congratulations!
Hector

[pooh55811]

Your treatment should be 24 weeks based on your UND status at weeks 4 and 12. Your doctor is correct about the stopping rules.

"Telaprevir. The prescribing information for telaprevir in treatment-naive patients recommends that all patients begin with a 12-week period of triple therapy with telaprevir 750 mg 3 times daily (every 7-9 hours) plus pegIFN/RBV.[53] Telaprevir should be administered with food, specified as standard or high fat (standard-fat meal would be 21 g, such as 2 ounces of cheese or a half cup of nuts). After 12 weeks, telaprevir should be discontinued and pegIFN/RBV continued; for individuals with an eRVR (undetectable HCV RNA at Weeks 4 and 12), pegIFN/RBV should be continued to treatment Week 24. Conversely, for individuals without an eRVR, pegIFN/RBV should be continued through treatment Week 48 (Table 6). "

"For all patients treated with telaprevir, the following futility rules should be employed:

If HCV RNA is > 1000 IU/mL at treatment Week 4 or 12, all 3 medications should be discontinued.
If HCV RNA is detectable at Week 24, pegIFN/RBV should be discontinued. "

Here is a link to the protocol:

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx

Since you were UND at weeks 4 and 12, your chances of attaining SVR are excellent.