6 wks n2 treatment w pegasys and copegus and my dr wants 2 add victrella

[nikki506]

i am currently into my 6th week of treatment w pegasys and copegus and my dr wants 2 add victrella as soon as he can get my insurance 2 approve. i was wondering if any1 has already started their treatment w victrella as well as the pegasys and copegus so i may get a bit of insight as 2 what i may expect if they do approve me.

[can-do-man]

I have to agree with the others, i don't see where starting victrelis at week 6 instead of week 4 is doing anything out of line, good docs have been treating "out of the box" with soc for some time now.. Like Dave i was in a victrelis trial and it seemed different doctors had discretion in their own studies...... If it was me i would jump at this chance. Wishing you the best.

cando

[spectda]

Lynda and I were in the same victrelis trial although with different treating physicians, with different opinions and at different study centers. The doctors had some discretion within the trial guidelines.

PCRs were done every two weeks for the first 20 weeks, then at week 24,28,34,40,48. then at 4,12 and 24 weeks post.

Some of the guidelines for stopping tx:
*An increase of more then 1000 iu/ml before becoming und but after pi was added 4   weeks into tx.

*Not being und by week 12.

*once und being detected even at very low levels (under 25) would be considered a breakthrough after 4 weeks (2 pcrs)

Hi Lynda :)
Dave

[mountainair]

I concur with Dave and willing about starting the Victrelis as soon as you can after at least 4 wks of SOC, and based upon your early response, and other relevant factors etc. which your doctor needs to take into consideration. The drug labels provide guidance based on the most successful clinical trial protocols and depend heavily upon the theoretical philosophies of the researchers.  This doesn't prohibit variations in the dosing schedule prescribed by your physician (just like treatment for other conditions).

wrt to Pegasys vs PEG-Intron  -  I completed the last boceprevir (Victrelis) trial and ran into a bit of difficulty with continuity of drug supplies and switched back and forth between PEG-Intron & Pegasys as well as at least 4 different brands of riba during the course of my tx.  I am still UND at 8 wks post tx...

Good luck with getting started!!
Lynda

[spectda]

I wouldn't be concerned about adding the PI at this point unless you are having no or little response to soc so far which as willing mentioned is essential to success when adding the PI. Of course the progression of your disease would play a big part in you decision to add the PI also. Have you had a biopsy? Do you know what your stage of liver damage is?

Good information from Susie. I am certainly not a doctor or and expert, but personally I wouldn't be uncomfortable about using pegasys rather then pegintron with victrelis. Merck used pegintron in trials because it's their drug. Why would they pay for pegasys when they have virtually no cost for pegintron.

It seems that many people (not all) report less sides with pegasys then pegintron, maybe that is why your doc choose it.

Good luck,
Dave

[SusieS2010]

I have to agree with willing. You can add victrellis at any point with no problem. The possible problem I do see is that Victrellis has not been studied with Pegasys,Telaprevir has. Is there a reason your doc chose victrellis over telaprevir?

Treating with PI's is very very different than SOC. You must follow the schedule to take the drugs on time. Even one slip up can cause the treatment not to work. PCR's should be done frequently and the very minute a patient's viral load goes up, or he does not meet the viral load drop expected by a certain week, he MUST stop treatment. That minimizes the chance of resistance developing. We don't know if resistance to one of the protease inhibitors will cause resistance to all PI's. That could be problematic if you needed to treat in the future.

Good luck.

[willing]

with all respect for my friend Hector , I'd recommend reading further before assuming your Dr's plan  is ill-advised. Adding a PI later in treatment is definitely non-standard but non-standard treatment is very close to a standard in this disease.

There is  a  very, very, long list of members on this forum who reached SVR notwithstanding difficult situations by following non-standard ifn/rbv protocols : heavier dosages, lead-in, longer duration, adjuncts, etc. It worked for them, where previous "on-label" rx had failed. PIs are no different, we simply have less experience with them.
Unlike clinical trials, the objective of Drs now is to cure patients rather than conduct controlled experiments.

A critical factor is the  the extent of your ifn response so far, in particular your drop at w4 if it  was measured at that time. That is an important predictor of whether triple tx is likely to be successful,

I added Victrelis at w30 of an ifn/rbv tx with my Dr's approval. Now starting my 2nd month of triple and I'd  concur  with Dave's experience, The Hgb impact is definitely noticeable.

Good luck - if your read further you'll find that non-standard tx and/or supplements are  controversial topics.

[HectorSF]

What your doctor is proposing appears ignorant,unprofessional, possibly unsafe and maybe unethical. Doctors are suppose to follow treatment guideline and protocol not make up they own way of treating patients that has never been shown to be safe and effective as approved by the FDA for the standard treatment regiment using during clinical trials.

So your doc is going to improvise a treatment protocol based on when insurance approves paying for the DDA? When will it start? Week 7, 8, 9, 10? Why didn't he wait for a month or two to treat you according to the proper protocol.  What was the rush? Does she/he just make up there own ways of treating patients?

Victrelis is to be started after 4 weeks of SOC meds. Then depending on your response at week 8, 12, 24 determines how long you have to treat.
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http://hepatitiscnewdrugs.blogspot.com/2011/05/victrelisboceprevir-fda-approvednow.html

Prescribing Information:
• Initiate therapy with peginterferon alfa and ribavirin for 4 weeks (Treatment Weeks 1-4).
• Add VICTRELIS 800 mg (four 200-mg capsules) orally three times daily (every 7-9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment.

Dose Modification
Dose reduction of VICTRELIS is not recommended.
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued

When To Stop Treatment
*TREATMENT FUTILITY
If the patient has a (viral load)  greater than or equal to 100 IU/mL at Treatment Week 12, then discontinue three-medicine regimen.

If the patient has confirmed, detectable HCV-RNA (viral load)  at Treatment Week 24, then discontinue three-medicine regimen.
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Are you aware that they are no data that says that starting treatment at arbitrary times even is effective?
If you should fail treatment...Was it that your body didn't respond or was it that the treatment schedule was a one off, or was it something else. No one will ever know and you will have wasted up to a year of your life doing a treatment that has never been known to be safe and effective. What if you develop viral resistance because of this improvised treatment schedule. Then what will you do? Since you did not use the meds properly and there is no data about viral resistance at 7, 8, 9, etc weeks no one will be able to help you.

IMHO. This is unethical and your doctor should not be allowed to treat patients with these new treatments as there are many things that are not understood completely about these meds and it could be unsafe treating this way.

Good luck!
Hector

[spectda]

Hi and welcome-
I completed a victrelis trial and completed tx about 14 weeks ago.

When i started the victrelis I didn't really feel much of anything. A few weeks into it I had abdominal pain that was pretty tough to deal with but a few weeks more and it resolved.

Everyone is different though. I also became very anemic so I hope your doctor is on board with prescribing helper drugs like prorcrit for low HGB and neupogen for low ANC if necessary.

What was your starting viral load and what was it on your last pcr and what week was it done?

Best of luck to you with tx,
-Dave