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-- Jim
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I'm unaware such a study exists, but please surprise me :) You are aware of the recent "Black Box" warnings on Procrit. Also, if your hgb goes up too much there can be cardiac issue.
-- JIm
Just don't want you to go down that road without confirming that you didn't misread the article, which if I were a betting man, I'd bet you did.
All the best,
-- Jim
Pre-TX WBC was 5.9, HgB was 14.7 and ANC was 3.7.
Less than a month into TX WBC was 1.7, HgB was 11.5 and ANC was 0.8.
WBC and ANC were flagged as ALERT on the lab report.
My Dr. made me see a hemotologist immediately and started me on neupogen.
I've been taking it twice a month for the past 52 weeks. My WBC and ANC never rose close to their pre-TX levels untill last month when I was on antibiotics for a couple of weeks.
My Dr. was very concerned with low WBC and ANC. I hate taking the neupogen but he says it has kept those numbers from tanking to the point meds would have to be reduced.
HgB has nevr dropped below 11. Although that's a large decrease compared to my pre-TX numbers, procrit has never been suggested. I understand it's not offered until HgB drops below 10.
wyntre
ps - I'm on the 72 week extended TX, too.
Regarding the timing for when to start epoetin alfa in patients with HCV therapy-associated anemia, most study protocols have used a hemoglobin level of 12 g/dL as a threshold for starting epoetin alfa. One expert recommends starting epoetin alfa 40,000 U sq weekly for hemoglobin levels less than 12 g/dL in men and less than 11 g/dL in women [14]. In our opinion, initiating epoetin alfa for a hemoglobin less than 12 g/dL seems reasonable, especially if the patient has anemia-related symptoms such as fatigue or dyspnea. After starting epoetin alfa, if the hemoglobin increases less than 1 g/dL during the next four weeks, we recommend increasing the dose to 60,000 U sq weekly. If there is still less than 1 g/dL increase in hemoglobin during the subsequent month, then epoetin alfa support should be stopped. For those with acceptable response, epoetin alfa should be held while the hemoglobin level exceeds 16 g/dL in men and 14 g/dL in women.
Guidelines from the American Society for Clinical Oncology [15] state that epoetin alfa should definitely be started for hemoglobin less than or equal to 10 g/dL, and that clinicians should consider the clinical circumstances if the patient has a hemoglobin level between 10 and 12 g/dL.
My pre-tx hgb was 14.8. Two weeks later it was 11.4 and I ended up in the ER with anemia.
The reason for the ER wasn't because of the absolute number (11.4) but because of the rate of drop (over 3 points in two weeks). Later in treatment -- mid treatment -- I was functioning fine (as far as anemia went) with hemoglobin in the 11's. I think this is consistent with the article you quote and with what I posted. What happens over time is that the body adjusts to lower levels of hemoglobin.
-- Jim
My HgB dropped more than 3 points in 3 weeks. Reading that you ended up in the ER coz of that (after 2 weeks) helps put some things in perspective for me.
Despite many posts that might indicate the contrary (*LOL*), I'm not a huge complainer and am more the sort of person that keeps thinking either everything's gonna improve quickly or things aren't as bad as they seem.
Granted, a lot of other people have had much bigger decreases in blood counts than me, but reading that a similar HgB drop caused severe SX in you somehow makes me feel better.
Not that I'm glad you ended up in the ER, you understand! :)
Boy, I can't wait for the next 20 weeks to be over. I'm ready for hibernation.
wyn
Nothing to prove on either end -- I just want to make sure that if you're going to base a decision to go on rescue drugs on the premise that the rescue drugs -- in and of themselves foster SVR -- that your premise is correct. I don't think it is.
-- Jim
Good Luck
"AP
Amgen Discussing Aranesp Label Changes
Friday December 7, 8:32 am ET
Amgen Discussing Aranesp Safety Label Changes With the Food and Drug Administration
THOUSAND OAKS, Calif. (AP) -- Biotechnology company Amgen Inc. said late Thursday it is discussing potential safety updates for its anemia drugs with the Food and Drug Administration and there will be a panel review during the first quarter.
ADVERTISEMENT
The drugs are part of a class of drugs called erythropoiesis stimulating agents, or ESAs, used to treat anemia in chemotherapy and kidney-failure patients. They include Aranesp and Epogen, made by Amgen, and Johnson & Johnson's Procrit.
Earlier this year, the FDA issued requirements for stronger warnings on the drugs and asked for additional studies. The FDA issued a "black box" warning on the drugs, the most serious warning a drug can carry, emphasizing that cancer patients had increased risk of death and showed accelerated tumor growth when treated with high doses of the drug.
The company is conducting studies to further determine the possible safety risks.
The Centers for Medicare and Medicaid Services changed the reimbursement policy for Aranesp and other drugs in the same class during the quarter. Now doctors will only be paid for using a low dose of the drug.
Additional safety label changes will likely be based on data from a breast cancer patient study and follow-up data from a cervical cancer patient study, Amgen said.
The FDA's Oncologic Drugs Advisory Committee will meet during the first quarter as part of its ongoing review for ESA therapies, the company said."
I can't imagine getting that low as it's been difficult enough for me with the measly 3 point drop I've had.
Congrats on your early UND and best of luck with SVR. Sounds like you're gonna hear those magic words very soon.
wyntre
-- Jim
I think the action at play in the 'rescue drugs help SVR' concept is that by needing the Procrit you are showing that your body is getting a whallop from the Riba. Don't need procrit? Maybe you're not getting whalloped hard enough. Whallop some more until you need procrit. We don't all matabolize and clear the riba at the same rates.
I'ts kinda like drinking enough until the ugly girls start looking pretty.Or maybe not....
PS - a safer approach might be to ribafy right to the threshold of needing the procrit... just random musings....
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That would only be the case if the "low SVR" group didn't need Procrit. I don't believe the studies were structured that way. What happened is that two groups were compared -- those where Procrit was made avaliable. And those where Procrit was not made available. The difference was in compliance, not hgb drop.
I do agree however, with amping up ribavirin until the non- Procrit "theshold" is met and then adding Procrit until the maxium Procrit threshold is met. That is if you decide it's in your best interest to fight as agressive as possible and you and your doc accept the risks that go with the xtra toxicity.
-- Jim
http://www.hivandhepatitis.com/2005icr/aasld/docs/112305_a.html
I think your point valid in a population where everyone was offered Epo, but only a subgroup accepted it. That subgroup no doubt had more anemia and therefore and argument could be made they had better ribavirin absorption. My point was simply that the studies in question were not structured that way and therefore compliance was the deciding factor.
-- Jim
Your body will learn to live in the 11s with no problem eventually - taking it once a week got me up into the mid 10s and I was ok after a while with that. I guess your body is just able to do about anything, it's really so cool.
I am a big believer in using the stuff space - it really did help me a LOT.
Mine dropped @ 4 points in 2 weeks and I kept thinking I was being a woos! " I can't feel THIS bad already???" Total body shock!
Hence the reductions as can't do the epogen, procrit. I would never make it thru 48-72 weeks!
In my no where near as 'educated' in all this as everyone above.......I just don't see why trials don't get rescue drugs as per the 'compliance' factor making a difference in the outcome??
LL