Week 3 Dose Reduction

[HappyByChoice]

I had an early visit with my NP yesterday (a week ahead of schedule).  Been feeling very dizzy and short of breathe and face is numb/tingly.  NP was unaware that I lost 25 pounds between last visit in March and start of TX in July.  She reduced riba from 1200 to 1000 and Peg from .5 to .4.  Also discontinued spironolactone.  Just wandering if anyone has a link to a handy dandy chart that tells doses by weight for these drugs we take.  

It's a small victory, but 2 week labs showed ALT/AST within range for the first time in more years than I can count!  All other values within range.  Had 4 week VL drawn this morning.

Thanks to each of you for the kind words and advise offered when I vented earlier in the week... you rock!!

Hope all have a great weekend!
Janette

[pooh55811]

I agree with Can-do that since you are just in the lead-in phase all they are really looking for is at least a one log drop. This (4 week)  PCR has nothing to do with how long you will treat. Its the week 8 PCR that is the most important....

I agree with that. However, if the docs are counting shots and instead of the actual full weeks of treatment, they will be off by a week (1 week early) every time. When you do get to the viral loads that do count in terms of length of treatment and whether you will continue, if they continue to do the viral load tests a week early, it could make a difference.

[can-do-man]

HCV-RNA decline after 4-week PR lead-in period helped predict
likelihood of SVR
In pre-specified analyses [Poster #481], researchers evaluated
the relationship between decline in levels of virus (HCV-RNA) after
the 4-week PR lead-in period to overall SVR.
In the HCV SPRINT-2 treatment-naïve study, patients
receiving VICTRELIS who had good response after the 4-week lead-in
period, defined by a greater than or equal to 1.0-log10
decline in HCV-RNA , achieved SVR rates of 81 percent (203/252) in
the RGT arm and 79 percent (200/254) in the 48-week treatment arm
compared to 51 percent (133/260) in the PR control arm. Patients
with poor response after the 4-week lead-in, defined by a less than
1.0-log10 decline in HCV-RNA, achieved SVR rates of 28
percent (27/97) in the RGT arm and 38 percent (36/95) in the
48-week treatment arm compared to 4 percent (3/83) in the PR
control arm.
Similarly, in the HCV RESPOND-2 treatment-failure study,
patients receiving VICTRELIS who had good response after the
lead-in achieved SVR rates of 73 percent (80/110) in the RGT arm
and 79 percent (90/114) in the 48-week treatment arm compared to 25
percent (17/67) in the PR control arm. Patients with poor response
after the 4-week lead-in achieved SVR rates of 33 percent (15/46)
in the RGT arm and 34 percent (15/44) in the 48-week treatment arm
compared to 0 percent (0/12) in the PR control arm.
These analyses showed that 4-week lead-in response helped
predict SVR in all three treatment groups, and the addition of
VICTRELIS to the treatment regimen improved SVR rates regardless of
whether patients had good or poor response during the lead-in period.

http://hepatitiscnewdrugs.blogspot.com/2011/04/boceprevir-four-week-lead-in-response.html

[Idyllic]

If that is the case then maybe Happy's doctor just wants to see how she is responding to the meds. It is a little unclear what this VL was taken for.

Happy, maybe you should establish the reason for the VL labs and hear what they have to say. As it stands it seems like the timing of your doctor's office might be a week off. That way you can be sure you do not end up a week short when you get to week 8.  :)

btw the doses per weight listed above seems low to me. According to the weight-based chart my dose would be 800 rather 1000.

[can-do-man]

People get confused between the Vic and Incivek treatment, first 4 weeks of treament with Incivek is a whole lot different then the 4 week lead-in with Vic. The lead in is looking for something a whole lot different then what Incivek is.

[can-do-man]

Since your just in the lead-in phase all they are really looking for is at least a one log drop. This PCR has nothing to dowith how long you will treat. Its the week 8 PCR that is the most important... Best to you

[BoceprevirGal]

  Wow, great news about your enzymes being normal again. When that happened to me, (at the 4 wk vl test) I was also Undetected, at that time.
   If you are not Undetected at the 3 and a hal week vl count, then you should demand to be retested on August 3rd.
  Bring a spouse or smart friend, to support you, when you make your demand.
   I'm glad they saw their error, in the riba dosaging. Not sure about pega dosage~

[Idyllic]

I agree with Pooh. It does not make sense to have VL today as you will not have had four weeks worth of meds in your system. This person is a nurse practitioner so it may not be all that unusual she is unfamiliar with the treatment protocol. Don't let them tell you it does not matter since it does.

A lot of us had to educate people in the medical profession. Either way it sounds like you have all the right questions to ask. **I hope you get all this squared away now early in treatment so you can start the Vic with no disruptions :)  :)

[HappyByChoice]

Positive... read the orders myself before handing them to tech.

[jules2551]

are you sure they weren't just doing a CBC Diff and Chemistry today?

[HappyByChoice]

I agree with what everyone has said about what is considered 4 weeks...  I won't even take my 4th injection until tonight but it was insisted that I do my VL this morning.  I have a call in to NP now.  I'm all about following protocol and having the best chance.

Thanks!

[pooh55811]

"They count shots, instead of weeks" .....

They are not following treatment protocol.

Jules is correct. I looked back on your profile. You started treatment on July 6th. Today is only 3 full weeks of treatment. The 4 week VL is drawn after 4 full weeks of treatment. Treatment includes both the injections and the Ribavirin. So, yes, you have had 4 injections, but you have not had 4 weeks of Ribavirin. Your 4 week viral load should be drawn next Friday, August 3, after 4 full weeks of full treatment (Interrferon and Ribavirin).

I agree with Jules. You should ask for another VL for Aug 3rd. That will be your 4 week VL.

The doctor's office needs to get on board with the correct protocol. Drawing the Viral Loads early could potentially affect how long you treat and/or even if you can continue treatment. Therefore, drawing the VLs early could jeopardize your chance at SVR.

If your doctor won't follow correct protocol, I would suggest finding another doctor who does follow protocol.

[jules2551]

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf



Janette....print off page 6 and hand it to her and insist on another one next week

[HappyByChoice]

I'm scheduled for more labs next week so I will definitely ask for another VL!  Just want the best possible chance!!

[HappyByChoice]

I add Vic on Aug. 3rd.  Bewtween the fluid being pulled off by the spironolactone and the peg and riba dose being too high for recent weight loss there was concern about toxicity.  My chest felt like it was being crushed, I was dizzy, my face was numb, and my hands were drawn up and numb... and even though I drink 80+ oz. of water a day I am dehydrated.  Someone should have weighed me before I started TX!

I'm still concerned about the dates for VL, though!  Not sure what to say to NP to make her see my way of thinking on that.

[jules2551]

Janette, they should be counting days not shots.  I would ask for another one next week JMHO

Jules

[HappyByChoice]

willbb-
I was started on a dose that was too high for my weight... according to the chart provided by hrsepwrguy I am now on the correct dose.

jules2551-
I did start the day after you did and also thought that 4 week VL should be Aug. 3rd... wanted to have 4 full weeks of meds to have best chance at 2 log drop.  I did question this while there but was instructed to do it today... they count shots instead of weeks?!?

I knew you all would have great questions and advise... what should be my next step?

Hugs,
Janette

[Idyllic]

What was your Hgb and ANC? Why the reduction in Peg?
When do you start taking the Vic?
What is the Spironolactone connection. Did your doctor stop it because it was lowering your BP or were you taking it for oedema? If it is the latter be ware of possible rebound oedema.

I hope you feel better.  :)

[HappyByChoice]

Wow!  Thanks for the speedy response!  Just wanted to see for myself that I'm on the correct dose and not sure yet where everyone looks to find the references used.

[jules2551]

Didn't you start tx the day after I did?  Then your 4 wk VL should be next Friday August 3rd.  I am confused here

Jules

[willbb]

Riba is usually only reduced as  management of  drug induced "hemolytic anemia".Thiss is when the HGB. falls <10.

The symptoms you are describing are common with this type of anemia,however most physicians wait for lab values to make this desicion .

Reducing the PEG(INF) is not a modality early on to relieve anemia . and this could actually jeapordize your treatment.

I would want to inquire of my treating physician why the nurse made this adjustment

Good luck...
Will

[hrsepwrguy]

Dosages according to weight:
Less than 40 kg: Ribavirin 400 mg orally twice a day plus peginterferon alfa-2b 50 mcg subcutaneously once a week

40 to 50 kg: Ribavirin 400 mg orally twice a day plus peginterferon alfa-2b 64 mcg subcutaneously once a week

51 to 60 kg: Ribavirin 400 mg orally twice a day plus peginterferon alfa-2b 80 mcg subcutaneously once a week

61 to 65 kg: Ribavirin 400 mg orally twice a day plus peginterferon alfa-2b 96 mcg subcutaneously once a week

66 to 75 kg: Ribavirin 400 mg orally in the morning and 600 mg in the evening plus peginterferon alfa-2b 96 mcg subcutaneously once a week

76 to 80 kg: Ribavirin 400 mg orally in the morning and 600 mg in the evening plus peginterferon alfa-2b 120 mcg subcutaneously once a week

81 to 85 kg: Ribavirin 600 mg orally twice a day plus peginterferon alfa-2b 120 mcg subcutaneously once a week

86 to 105 kg: Ribavirin 600 mg orally twice a day plus peginterferon alfa-2b 150 mcg subcutaneously once a week

Greater than 105 kg: Ribavirin 600 mg orally in the morning and 800 mg in the evening plus peginterferon alfa-2b 1.5 mcg/kg subcutaneously once a week

This is merck (pegintron/riba) wt based dosing chart

In combination with peginterferon alfa-2a 180 mcg subcutaneously once a week:
Genotypes 1, 4:
Less than 75 kg: 1000 mg/day orally in 2 divided doses for 48 weeks
75 kg or more: 1200 mg/day orally in 2 divided doses for 48 weeks

This is genetech (pegasys/riba) dosage recommendation