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MIxed emotions - 4 weeks results in
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MIxed emotions - 4 weeks results in

Just had my 4 weeks visit.
So just to recap, G 1b, CT, started tx on 1/11 , had Telaprevir stopped on 2/11 from throwing up. One week before starting tx Hep C Viral Load: 1684315 IU/mL , HCV RNA: 6.23 log IU/mL, liver enzyme were around 128, Hemoglobin 13.4 Doctor decided to give me 4 weeks lead in with just Interferon and Riba and reintroduce Telaprevir at 4 weeks

So 4 weeks results, not completely sure how I feel about it. When I hear the results I thought is the end of the world
Viral load is 1739 IU/ml , HCV RNA: 3.24 log IU/mL , liver enzymes ALT, normal 33
Hemoglobin down to 10.4, platelets at 88, white cells dropped to 1.8, neutrophils are holding to 0.83

Restarting Telaprevir tonight
I have been told that I will have to go for the 48 weeks ( not ready for that!!!!)

To me 1739 IU/ml viral load is just huge, do I still stand a chance?

How is the Telaprevir going to influence platelets and hemoglobin? Looks like I am in line for dose reduction soon. Huge drops for 4 weeks only

18 Comments Post a Comment
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Avatar_m_tn
Not quite sure what your doctor is thinking on doing 48 weeks just yet, as you had a fantastic response with just SOC as a 4 log drop is great... If you were doing Victrelis your treatment time would depend on your 8 week viral load. And since you did the lead-in with the Incivek one would think at 8 weeks would tell the story also on your treatment time. The lead-in is mainly just to see your response, a two log drop would have been good yet you had a 4 log drop.........
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Avatar_m_tn
Also as for your blood work not really that bad, kinda what one would expect after 4 weeks as the meds are doing their job. My concern would be to watch your HGB with adding the Incivek. Have you talked with him about rescue drugs? Mainly procrit at this time... Dose reducing is not such a good ideal UNTIL one is UND.
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3093770_tn?1389742726
Thank you cando

In NZ they are not going for rescue drugs. The first step will be to reduce the Riba and second step will be blood transfusions

I will ask though next time

3 logs drop, from 6.23 to 3.24. ok, so I still have some hope. Well, I think he suggested the 48 weeks due to the fact that I have severe fibrosis.

But let's get first through the next 4 weeks. On the good side he told me that the latest studies are showing that everyone with my type of lymphoma cleared once they cleared the hep c :)))). I only have to clear now !!!!. But since week 2 some hardened lymph nodes I had on side of my neck are gone - so I think this maybe is a good sign that lymphoma maybe goes in remission !!
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1747881_tn?1358189534
8.2.2.1 Hemoglobin Laboratory Results
A mean decline of hemoglobin of 2-3 g/dL has been consistently reported in studies of Peg- IFN/RBV therapy, requiring RBV dose reductions or discontinuations in some subjects.32  Decreases in hemoglobin requiring modifications in the treatment regimen, including RBV does reductions and discontinuations, were also experienced in the telaprevir clinical development program. In a pooled analysis of hemoglobin abnormalities in the placebo-controlled Phase 2-3 telaprevir studies, grade 1 to 4 hemoglobin abnormalities were observed in 93.3% and 79.2% of subjects in the T12/PR and Pbo/PR groups, respectively. Likewise, grade 3 decreases in hemoglobin were observed in 51.1% and 24.0% of subjects in the T12/PR and Pbo/PR groups, respectively. During the first 4 weeks of treatment, mean baseline hemoglobin levels were reduced by 3.0 g/L in the T12/PR group and 2.6 g/dL in the Pbo/PR group (Figure 21). At week 12, mean baseline hemoglobin levels were reduced by 4.0 g/dL in the T12/PR group and 3.1 g/dL in the Pbo/PR group. In both groups, the hemoglobin level nadir was reached between weeks 12 to 14 of treatment. Hemoglobin nadir values below 10.0 g/dL were observed in a total of 33.7% and 13.6% of subjects in the T12/PR and Pbo/PR groups, respectively, whereas hemoglobin nadir values below 8.5 g/dL were observed in 8.3% and 2.3% of subjects in the T12/PR and Pbo/PR groups, respectively. After completion of telaprevir treatment in the T12/PR group, hemoglobin levels increased to levels observed in the Pbo/PR group over a 12-week period. There were also sharp increases in hemoglobin levels 4 weeks after completion of treatment in subjects who completed either 24 weeks of T/PR treatment or 48 weeks of T/PR or Pbo/PR treatment (Figure 22).

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562
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Avatar_f_tn
Hi Diana, I am checking my 4 week blood work (labs) and I had a "lead in" with just the Inf and the riba, and after the 4 weeks, my hgb was at 10.0
  It is usually a good sign,(the anemia) that the meds are doing their job, as is your 4 log drop.
  I'm not sure if Procrit is an option for you, because of your NHL, or even if they prescribe Procrit, in NZ.
  I started Procrit at 9 weeks, did your Doctor discuss with you, his plan, for the hemolytic anemia?
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1747881_tn?1358189534
Basically it is saying that telaprevir will add approx a 1 gr more of a drop in HGB compared to peg/riba alone.
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Avatar_m_tn
Well yes if your cirrhotic then 48 weeks would be it, BTW one doesn't just subtract the 3.24 from 6.23..... The easy way to figure it is to drop one decimal from your starting viral to your current viral load which would mean a 4 log drop..........

1684 would be right on the money but really no difference there with your at 1739
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3093770_tn?1389742726
Thank you for the info

Just great, not sure if to laugh or to cry right now!!!  I mentioned this today, the fact that a sharp drop in 4 weeks might need reduction but they did not seem to be worried about it ( not sure why :( )

They seem to be more concerned if I will get under 10. SO I will continue with weekly blood tests for now. 1 gr more drop will put me to 9 which is really low !!!
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1747881_tn?1358189534
If you follow the link posted above and look starting at page 119 it has graphs that show the difference in lab value's of tri/tx (platelets/ANC ect ect) compared to just peg/riba, they don't copy and paste
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Avatar_f_tn
  Oh, I just read your next post, congrats on your swollen lymph nodes disappearing, yay!
  Also, congrats on your normal liver enzymes. I bet you will be viral free, after just a few weeks with the Incivek!
   Think of the Incivek as your friend.  Also, you should be Und, before riba-reducing. So, if you go lower than 8, with your hgb, before going und, or just after achieving Und, I think it would be better to take the Blood Transfusion, which should help for a few weeks, and then see how things go from there.
  But hopefully, your hgb wont get too much lower, that does happen some time~
  It is also a good sign, like can-do pointed out, that you have the anemia, because it indicated that your body is very responsive to Interferon~
  Good luck with your Incivek, you can do it!
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3093770_tn?1389742726
oo, woaaa 4 logs is a pretty good drop then, let's see where I am in 4 weeks.

I was just calculating that my next 4 weeks tests will be on 26/12 - just great, everybody is in holiday !!!! I will need to find who is around at that time
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766573_tn?1365170066
Here is a viral load calculator:
http://www.hcvsociety.org/files/HCVLogDropCalc.htm

Starting VL 1684315 IU/mL
Ending VL 1739 IU/mL
drop 3.99 log

Or
Starting 6.23 log IU/mL
Ending HCV RNA: 3.24 log IU/mL
Log Drop 3.99

___________________
To me a close to 4 log drop is great! I am a Geno 1a and I never managed more than a 2 log drop after week 12 when I treated with just the Peg and Riba! Hey, as you know lots of doctors do not use Procrit/Epo with Triple and lots of people make it by dose reducing.

________________

Here is a link, "Impact of Ribavirin Dose Reductions in Hepatitis C Virus Genotype 1 Patients Completing Peginterferon Alfa-2a/Ribavirin Treatment"
http://www.cghjournal.org/article/S1542-3565%2806%2901046-9/abstract

Hang in there!!!
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766573_tn?1365170066
btw the link is related to Riba dose reduction if you should happen to remain on dual therapy♥
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548668_tn?1394190822
Congratulations Diana;  From what I can see, for a G1 on the Riba/Interferon alone, your stats are about as good as it can get and it looks as though you're well on the way!!  And glad your neuts are holding well.

BTW my naturopath gave me high strength B6 tablets for if my hgb dropped too low, which I started taking after its first major drop - I don't know whether it was the B6 or a natural consequence, but I did stabilise.  I checked with my specialist "I don't mind what you take as long as it's not milk thistle which may affect the blood tests we're doing'" was is reply, but with the extra meds you're taking, you may want to check first or do your own investigation.

It was mentioned on this site that 25% get some assistance from B-complex, but a discussion was started around either the niacin or folate possibly being toxic to the liver in high doses.

I didn't take the B6 as regularly as prescribed by the naturopath, but did use them.

Congrats again - I'm sure it wasn't exactly the news you hoped for but is still very definitely good news.
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Avatar_m_tn
good news on the viral load drop.  also the decrease in ALT shows that your liver is less inflamed.
many blessings
eric
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223152_tn?1346981971
2.99 log drop (which is very good).  American that I am, I get dates confused -- so you started on November 1 and stopped the Telaprevir on November 2 ---- is that right?  -- so you did the Telaprevir only 1 day?

I have not read back to see why you were throwing up with the Telaprevir but how is that going to be different now?  Were you sick then?  Was it the amount of fat?  I would suggest switching to Victrelis but maybe you cannot get that either and it may make you more anemic than you would be with Incevik. I think it is projected that you have a 1-2 gr drop in addition to normal SOC with the Vic.  Still, it might (only might) be easier on the stomach. I guess you have to weigh the choices.  Since you cannot get rescue drugs.

I think you are doing well, Linda.

bean
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3093770_tn?1389742726
Thank you Linda
yes, you remember correctly. What is different now? That I am already stable on Interferon and Riba without being sick. I think first time it was the shock of everyting plus the fats. This time around I have some ffods I seem to tolerate, in fat I am living on 3 times a day 2 slices of gluten free bread, boiled eggs, danish salami and avocado !!!!! 4 slices of salami - 8.4 gr, one egg 5 grms, half avocado - 8-9grms (done). Taken with a bottle of diet gingeer beer :).. This time around I also have near me 6 boxes of Ondensatrone (Zofran?) and depending on how is going today, I will start to take every 12 hours... So fingers crossed. I started last night, so far so good, I will be fine today, but tonight is injection night so Fri I have headaches which does not help..
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1986676_tn?1329866071
Will have to read all this a couple times
Glad the big guns chimed in on your tx.
I knew they would help as much as they could.

Reva

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