doctor screwed up treatment protocol

[em787]

I need an advice. My bf is on triple treatment with Victrelis. Originally doctor suggested 28 weeks of treatment because he read the 8 week blood test wrong. It was detected but under level of qualification.  The doctor read the results as undetected and originally submitted request to the insurance as such. All the materials we have read state that "detected but under level of quantification" should not be considered "undetected" for response guided therapy.  My understanding is that standard of care is 48 weeks of treatment, 4 weeks pegasus, riba, week 8-36 peg, riba, and Victrelis, and 12 weeks peg + riba.  After pointing out to the doctor that he read the blood test wrong (of course he hated that), he agreed that 48 weeks is needed. We are presently on week 30 and have enough meds till week 32. Insurance paid for peg and riba but denied further Victrelis and we are not sure whether we can have a quick appeal and get the Victrelis in two weeks. We are afraid that if we stop now virus will return. any suggestions?

[em787]

We are finally done with 48 weeks of treament and hoping for svr. Thanks again for support..I dont know what I whould do without this board..good luck to everyone in treatment.Treatment is hard but doable.

[em787]

Thanks again everyone for support. Yes, it gets frustrating, especially when you add doctor offices not filling the paperwork right. Anyway, we are done with Victrelis now...Yahoooo....11 weeks of riba + interferon to go.

[Dee1956]

You did great! Treating is so frustrating all by itself, when you add in the doctor and his office not handling things the right way it just blows your mind.  I  had similar problems with doctor/insurance confusion.  I was only approved for 14 of 24 week tx, did not know until I called for my next order of medication.  Then it was delivered to the wrong home on the other side of my community.  Thank God those people brought it to me..

So many things can fall through the cracks, it is awful!
Congratulations!!
Dee

[jillhepc]

go to the drug company itself and ask for help.  Patient assistance.  he can get it and they will give him the drugs free no need for your insurance.  

[flcyclist]

Great job in self-advocating Em.  Sometimes you have to push hard to get what is needed.  Tx is frustrating and difficult enough without having to fight these battles.  Many of us have had similar problems with the doctor's office staff.  I've had problems of them not sending in the authorizations to continue tx, then to find out they had to rush the meds overnight to make sure I didn't miss any days.  Best of luck for the remainder of tx and for his SVR.  

[em787]

So, the insurance denied the re -authorization appeals submitted by the doctor's twice. I put a package together including insurance requirements and blood test, and told doctor's office to re-fax them it. All the medications were approved within 24hrs. Apparently doctor's office staff wasn't filling the paperwork right. So we are on for 48 weeks.

thanks again for the support.

[can-do-man]

I really hope you can get it approved as I truly understand and agree that when you see detected you don't want to stop. I would not either.

Hoping for the best for both of you.

Can-do

[em787]

thanks for all the responses. We are appealing with the insurance, and if they do not approve another 4 weeks, then we will continue with peg and riba for another 20 weeks.

[hepcat1954]

em787,

The HCV virus was detected but at levels so low they can't be quantified.  However, you know they're < 15 IU/mL.

The Victrelis folks want to make sure he is responding!  Because if he's NOT, further treatment (and the suffering that goes along with it) is futile.

They've determined that if his VL < 15 IU/mL, then he's considered UND for treatment purposes.  It's indicative that he is responding and should continue with RGT.

Good luck!
HC
...

[can-do-man]

Even though it does read detected the level is so low that under <15 that they consider one Und by their guidelines. I fully understand when you read the word "detected" it means you are detected but Victrelis considers anything under that as Und and that is what they go by and also what my Hepa goes by. Who by the way was the lead investigator for Victrelis.

They set that standard from their trial results, do I agree with them? I'm not sure as I'm like you I see the word detected and that is all that matters.

Confusing for sure... My guess is maybe because there were so many that read that way during trials and when they re tested the same blood it came back as undetected. And that their trial results showed as long as one was under <15 their SVR rates was the same...

One thing that is for sure when it comes to treating Hep C the word confusion is always there...:)

[em787]

.why does the lab report read "detected" then?? yes it is very, very, very confusing..

[can-do-man]

This is what your going by and I agree it is confusing. But note they are going by <43 and that  should not be considered equivalent to an "Undetected" result.

"A "Detected" result with the comment "HCV RNA level is <43 IU/mL (<1.63 log IU/mL). This assay cannot accurately quantify HCV RNA below this level." indicates that the HCV RNA level is below the lower limit of quantification for this assay. When clinically indicated, follow-up testing by this assay is recommended in 1 to 2 months. For the purposes of assessing response-guided therapy eligibility, an "Undetected" result is required; a "Detected" result below the limit of quantification should not be considered equivalent to an "Undetected" result."

[can-do-man]

(1) BOC, PegIFN, and RBV that was administered for 24 weeks if, at study week 8 (week 4 of triple therapy), the HCV RNA level became undetectable (as defined in the package insert as <10-15 IU/mL), referred to as response-guided therapy (RGT)

It's in their package insert. HCV RNA level became undetectable as defined in the package insert as <10-15.

In other words anything below that level is considered Und by Victrelis guidelines.

[em787]

I have not found anything that say that less than 15 should be considered undetected though...my head is hurting from reading all this stuff :(

[can-do-man]

I totally understand that and would feel the same way as you do and would want to do the full 48. I just wanted to point out by their own guidelines they consider him Und so if it does not happen the odds are still much in your favor. Look at it has having and extra 4 weeks of Vic and 18 weeks of peg and Riba if you do the last 16 weeks with peg and Riba only.

Things will work out, wishing both of you the best...

[em787]

the doctor is leaning toward considering <15 as undetected but he did not retest 8 week results to confirm and we are afraid to stop early. we have been through all this treatment and want to do everything to achieve SVR.

[pooh55811]

You could also contact Merck and see if he qualifies for the Patient Assistance Program.

http://www.victrelis.com/boceprevir/victrelis/consumer/hepatitis-c-treatment-cost.jsp

[can-do-man]

Also keep in mind the 8 week test could have been wrong with such a low number... At week 8 I tested UND then at week 10 I tested <10 but detected. Sense I was in a trial they had enough blood from the week 10 test to redo it and it came back as UND... When were talking about such low levels this happens quite often.

[can-do-man]

You say..." All the materials we have read state that "detected but under level of quantification" should not be considered "undetected" for response guided therapy."

That is true but it is the results for test that are <43 and from a prior post your husband test was <15. The reason I bring that up is the <43 test could mean somebody had a viral load of 42 and in that case one would still be considered detected. I am surprised your doctor does not understand this.

[em787]

regarding "door" I figured...he could as well be a door so far have been useless :). I have been pretty much managing his side effects and scheduling appointments on the necessary dates.

[em787]

Thanks for your response. We are going to try to fast track appeal. But If he still continues without victrelis, he will only have 28 weeks of victrelis with 4 week lead. that is why we are worried. I am stressed out with all this..treatment is hard enough and now we are dealing with the consequences of doctor's errors.

[can-do-man]

Sorry that should be Doctor instead of "door". A door won't do you much good...:)

[can-do-man]

You have a few options, I would contact my Insurance company door should also and explain the confusion and why you should treat with Vic for the full 48 weeks. I would also ask my doctor for samples. He should either have them or be able to get them. If none of that works then I would continue on with just the peg and riba. Their were trails that included only 32 weeks of Vic after the 4 week lead in and for people that had early or low viral loads at week 8 the results were good. I was in that arm of the phase 3 trials and now I am SVR. Plus I have cirrhosis.

Don't worry so much as in their guidelines of Vic they consider anything below <10 to 15 as Und... But I can understand wanting to go on and if it is with only the interferon and Riba that would be ok to... Best to you.

For Boceprevir, (Victrelis)

All patients were first treated with PegIFN alfa-2b and weight-based RBV as lead-in therapy for a period of 4 weeks, followed by one of three regimens: (1) BOC, PegIFN, and RBV that was administered for 24 weeks if, at study week 8 (week 4 of triple therapy), the HCV RNA level became undetectable (as defined in the package insert as <10-15 IU/mL), referred to as response-guided therapy (RGT)

http://hepatitiscnewdrugs.blogspot.com/2011/09/2011-updated-hepatitis-c-practice.html