VICTRELIS QUESTION

[zako7]

Hi Folks, I need suggestions on when to stop victrelis. According to Victrelis treatment algorithm, a treatment naive person who responded poorly to interferon during the 4 week lead of SOC with less than 1 log drop is recommended to take victrelis till week 44 (40 weeks of vic). But my NP has told me to stop victrelis at the week 36 (32 weeks of victrelis). Please has anybody in the forum been in my position or somebody you know. I need suggestions so that I can call my NP and talk to him.
ZAKO7

[Idyllic]

Wow this is great I am so glad you persisted with your doctor. I am plodding along behind you at 31 weeks and I wish I had half your energy. Great news about the Quantasure tests. I wouldn't mind having the lower detection limit so I see what you mean. But truly most off all kudos for getting your doc to spring for more frequent tests. I have been trying to have a PCR around every four weeks or so. I know I don't need them that often but the longer I treat the more worried I get and seeing those words "Not detected" is about the only thing that gives me peace of mind.♫

Keep in touch with how you are doing
Hoping & praying UND for you (for all of us!!)

[zako7]

Thank you guys. I am genotype 4f with grade1 and stage 0-1 from my biopsy last year july. Based on your suggestions and the evidence provided, I confronted my NP and he totally agreed with me, and all my submissions and apologized to me for making the mistake. He has ordered Vic for me till my 48 weeks.
I am with Kaiser and they have partnership with quest lab. I requested for quantasure >2 ul/ml initially, my NP refused to let kaiser pay for it. But after this incident he has agreed that Kaiser will pay for the quantasure tests as much many times I want to do it. SO WE WON !!!!!!!!! My 36 week test is on 8/25, after that If I am still UND, I will go for quantasure >2
I am been treated off label, the GI that added vic to my treatment has left Kiaser, so I think they are looking for anyway to cut my supply. Triple therapy is not fun, I still work 60 hours a week standing but I have a little hope of clearing this virus and I will do whatever I can within my power to do so including taking Vic to week 48.
Thanks folks for your solid support.

[willbb]

As you see one should take all three drugs until week 48 for a total of 44 weeks of Victrelis...............

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I agree with this.......

Best of luck....
Will

[Idyllic]

I based the assumption Z was Geno 4 on a prior post of his.
What I did not catch until now is that Z is African American.
And working two jobs.

http://www.medhelp.org/posts/Hepatitis-Social/WK-24-UND--56-IU-ml-GT-4-TREATING-WITH-VICTRELIS/show/1752327#post_8041750

Plus, I am sorry if this sounds nosy but are you still seeing the same GI you were seeing this time last year? If so your work is cut out for you but I think you really need to try and reason with the guy.

I would say being a Geno 4 & African American indicates you aren't doing to bad on treatment. I think you really need to be persistent and encourage your doctor to try. I mean you have come so far and you are willing to take this until the end.

If you are willing then I don't see why your doctor isn't willing to try. Maybe if he sees how determined you are he will reconsider.

[nygirl7]

Candyman is always right in my book ;)

[frijole]

I looked at cando's link and he is right . You should do 44 weeks of Vic.

[frijole]

Are you a genotype 4 or Grade 4.  I am confused. Did you get a biopsy?  I may have given you some misinformation in a pm thinking you were cirrhotic.  I have posted the pocket guides to my pictures for incevik and victrelis.

I think you fall under the protocol fo discontinuing the VIC at week 36 and continuing through 48 with SOC, but if it were me, I would ask for the VIC thru the 48 ( which is 4 week lead in and 44 weeks of vic)

[Idyllic]

can-do is right. The entire paragraph (after where I copied) says:

OR patients, who after 4-week peginterferon/ribavirin lead-in have less than ONE log virus drop (i.e., are interferon-resistant) should be treated with 4 + 44 (4-week lead-in with peginterferon/ribavirin followed by peginterferon/ribavirin/boceprevir for 44 weeks, for a total of 48 weeks of therapy).
__________________________

Based on what has happened so far it sounds as if both you and he are aware of the futility rules. I guess copying them and taking copies might help however they are based on studies for Geno 1. Still, it looks like you have been following the protocol for Geno 1 all the while so I get being perplexed that your doc wants to stop.

Ask him why he wants you to deviate from protocol you have been following until now.  The interferon resistance would be a reason too keep you on the Vic for the time you outline in your post.

Especially if you have remained UND all this time. But this time the studies about the Boceprevir treatment protocol are on your side even though you are a Geno 4. There might be some info out there that is more recent.

[can-do-man]

Here is the response guided treatment rule:

Thats the whole thing as he doesn't fall under this rule; According to the label, some treatment-naive patients should not be considered
for RGT...

[can-do-man]

This is their reason for the 4 week Lead in, and a slow response to the interferon is quite clear on a total of 48 weeks... At least thats what the drug company even says...
---------------------------------------------------------

but should receive a 4-week pegIFN/RBV lead-in plus a fixed duration of
44 weeks of triple therapy. This includes patients who are poor responders to
interferon, defined as those who do not achieve a ≥ 1 log drop in their HCV RNA
during the lead-in phase

[Idyllic]

I think the 32 weeks of Vic is consistent with the Boceprevir treatment futility rules & treatment duration.

There isn't a whole lot of data on Victrelis & Geno 4. I saw that at week 4 you had only a .64 log and you weren't UND at week 8 but you were UND at week 12.

With that being the case you are to continue Boceprevir/Peg/Riba up to treatment week 36 and then Peg/Riba only from week 37 to week 48

Here is the response guided treatment rule:
for patients who are treatment-naive, previous partial responders, or relapsers who do NOT have undetectable virus at week 8, the treatment protocol is 4 + 32 +12 (4-week lead-in of peginterferon/ribavirin followed by 32 weeks of triple therapy, followed by 12 weeks of peginterferon/ribavirin tail without boceprevir);

http://bestpractice.bmj.com/best-practice/monograph/128/treatment/step-by-step.html

Here is the table:
http://www.medhelp.org/user_photos/show/284656?personal_page_id=414409

[can-do-man]

Victreils is the most important part of your treatment, interferon is not your friend proved by the lead in, losing 12 weeks or 25% of your treatment is to much of a risk... Make sure they understand you are the one treating.

[can-do-man]

According to the label, some treatment-naive patients should not be considered
for RGT but should receive a 4-week pegIFN/RBV lead-in plus a fixed duration of
44 weeks of triple therapy. This includes patients who are poor responders to
interferon, defined as those who do not achieve a ≥ 1 log drop in their HCV RNA
during the lead-in phase, and all patients with cirrhosis. Therefore, it is
important to know if the patient has cirrhosis before beginning therapy.


http://www.clinicaloptions.com/Hepatitis/Annual%20Updates/2011%20Annual%20Update/Modules/DAA%20Naive/Pages/Page%205.aspx
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As you see one should take all three drugs until week 48 for a total of 44 weeks of Victrelis............... Best way is to print this from clinical options and  show it to him, Go to the link then follow "boceprevir in treatment - naive Patients.......... Figure 2.

Good luck