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Avatar universal

Appt. with Dr. on 9-15-03

15 weeks into tx,my WBC is 1.2 and ANC is 516 but Dr. is still not keen on Neupogen because of the Leukemia risk. He said "Trouble is there's little data on hepatitis C patients.  The ultimate risk could be the same as for congenital neutropenic patients.  Neupogen hasn't been used nearly as long in hepatitis C patients as for congenital neutropenia. Data suggests infection risk not real until ANC drifts down to 200." Other questions and answers may be of interest to you folks also. I asked him; 1. "Why 52 week treatment instead of 48? Is there any data to suggest it is helpful or even harmful?" "48 weeks will suffice; no additional benefit to 52 weeks." 2. When you say you use the qualitative assay after treatment to look for early recurrence, do you mean relapse? If we find early recurrence,then what do you typically do next? "Yes, I mean relapse. If you relapse, there is no alternative treatment at this time. Long-term suppressive interferon therapy is being studied." 3. What is the low end of the qualitative assay test reportable range? I know the HEPTIMAX reportable range is down to 5 IU/ml. "10-50 copies/ml" 4. Does Procrit have any impact on SVR rates? "No"
5. Do HGB, HCT, RBC, WBC and ANC typically stabilize at some point during treatment? "Yes, at week 15 you probably won't go any lower" 6. Does Pegasys cross the blood brain barrier and can the Hep C virus reside in other parts of the body and remain unaffected by interferon? "HCV may reside in lymphocytes; interferon does enter lymphocytes.  I don't
believe interferon crosses the blood-brain barrier."
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Avatar universal
Hi Layla - my Dr. was neutral - he just said there was no data to support a benefit from extended tx. He's also not a hepatologist/GI and thus more likely to stay within the "standard of care". Personally, I would be really surprised if upcoming studies don't report reduced relapse %s for 1s on 72-week tx - the question is going to be how much..

ps - the bottom of the 9/2 amantadine thread has some notes on including links in a post.
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Avatar universal
Is your doc saying there is no benefit to 52 weeks vs 48 weeks or any amount of weeks of prolonged therapy, because there are studies that show other info. Here is an article that says prolonged therapy can be helpful. There is another article we had looked at in recent past post of another study that indicates prolonged therapy can be helpful in certain situations. I can't find the other articles address . Sorry you will have to copy this to read it as I am not sure how to creat the link.  LL

http://hivandhepatitis.com/hep_c/news/060603a.html
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Avatar universal
Hi - sounds like one of the points of that comment is the agreement between their own small, 14 person, study and a larger 119 person study (Soza etc., their 1st ref) which reported "Documented or suspected bacterial infections developed in 22 patients (18%), but in no patient with neutropenia".

I agree it seems strange - you'd expect infection to be highly associated with a low neutrophil count...but apparently in the case of  combo-induced changes, low neutrophils may not be a reliable predictor of susceptibility to infection. Anyway, I'm  paranoid about taking meds in general so my outlook is definitely biased.
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Avatar universal
Do interferon dosage reductions affect SVR rates like ribavirin dosage reductions do?  mofo, like you, I wonder how much dr. decision making is really driven by cost saving and insurance regulations. I have MEDICARE/BCBS fully covered, no HMO.  Sometimes you have to wonder if they really know what they are talking about and if they are telling you the real story, or is it 15 minutes of face time, out the door and on to the next patient?
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Avatar universal
I've been on Procrit and Neupogen since week 9.  I stabilized for a while then at week 30 my hemoglobin started dropping and they upped the Procrit.  
As to your last question, I am copying a link that says otherwise about the blood/brain barrier.

http://www.retroconference.org/2002/Abstract/13652.htm

From that report, "HCV RNA negative strands were detected in brain tissue in 3 out of 6 patients (1 was HIV+). In 2 of these patients, serum- and brain-derived viral sequences were different and belonged to different genotypes."
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Avatar universal
I'm pretty  fogged in today - apologies if this rambling makes no sense. Raheem - thanks for posting the update. The leukemia link seems pretty alarming. In support of foregoing the neupogen here's a <a href="http://hepatology2.aasldjournals.org/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=letter&id=ajhep50122">comment</a>that argues that combo-induced neutropenia is a neutropenia of a  different color and that the current 750/500 thresholds for reduction/discontinuation are too high. Reluctance to prescribe may very well be caution.

"No additional benefit to 52-weeks" seems a bit strong. For 2-3s data showed that SVR % didn't increase by going from 24->48 or by upping the riba past 800. However for 1s we really don't yet know (with the exception of a couple of small studies) the benefits/risks of pushing past 48. I also saw my Dr. today, asked him about the flatness of my vl curve during the  5-8 week range, and what he thought about extending tx and he basically said there was no data to support pushing past 48.

Having the meds cross the blood-brain barrier is a different issue than havng the virus replicate in the CNS. The presence of RNA-negative strands in CNS cells just tells us the little buggers are busy replicating there. By size, even tiny riba is too big to cross the blood-brain barrier let alone ifn with its big honking peg, yet  high SVR rates imply there is some mechanism for clearing infected CNS cells.

Also, I believe the 80/80 "adherence" clause applies to both ifn and riba.. cheers.
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Avatar universal
It's a damned if you do and damned if you don't situation isn't it? I suggested to my nurse I take it every other week -- thinking that it worked, brought my WBC way up, and that the WBC would not be able to drop in just a week's time -- at a half dose; he agreed. I have 11 weeks of 48 left.

If I didn't, or anyone on tx, didn't take the Neupogen we could develop some nasty infections and then be taken off tx and then what? HCV would take over. Grim prospect from my perspective but then again so is developing leukemia.

Take care and thanks again,

Scott
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Avatar universal
Yes scott, I had posted this a few weeks ago; I found this information in one drug database regarding Neupogen blood
adverse effects:

C. MYELODYSPLASTIC SYNDROME
1. INCIDENCE
a. 5.5% to 16.5%
(1) Analysis of post-marketing surveillance data of 531 patients with
severe chronic neutropenia, reveals that the development of
myelodysplastic syndrome (MDS) or acute myeloid leukemia appears to be
confined to patients with congenital neutropenia. The cumulative risk of
developing MDS by end of the eighth year is 16.5%, representing an
annual rate of 2% (Prod Info Neupogen(R), 2000).

(2) Four of 72 patients with aplastic anemia who were treated with
filgrastim developed myelodysplastic syndrome (Kaito et al, 1998).

2. OUTCOME
a. Severe (mortality reported).
(1) Of 4 patients, 2 died without leukemic transformation and 2
developed acute leukemia (Kaito et al, 1998).

3. ASSOCIATED SYMPTOMS
a. Monosomy 7 (Kaito et al, 1998).

4. ONSET DURATION
a. EARLIEST ONSET: 12 months (Kaito et al, 1998).
b. LATEST ONSET: 20 months (Kaito et al, 1998).
c. DURATION OF SYMPTOMS (without treatment): permanent (Kaito et al,
1998).

5. CLINICAL MANAGEMENT
a. PROPHYLACTIC MEASURES:
(1) Avoid long-term administration (more than 1 year) of filgrastim to
prevent the evolution of aplastic anemia to myelodysplastic syndrome
(Kaito et al, 1998).

6. PREDISPOSING RISK FACTORS
a. DOSE-RELATED: Yes.
(1) Patients receiving a mean cumulative dose of filgrastim 822
micrograms/kilogram (mcg/kg) developed myelodysplastic syndrome, whereas
patients receiving a mean cumulative dose of 205 mcg/kg did not (p less
than 0.05) (Kaito et al, 1998).

b. DURATION-RELATED: Yes.
(1) Patients developing myelodysplastic syndrome were administered
filgrastim for a mean of 487 days, whereas those who did not received
filgrastim for a mean of 72 days (p less than 0.002) (Kaito et al,
1998).
c. AGE GROUP: Older age did not relate to myelodysplastic syndrome
development (Kaito et al, 1998).
d. GENDER RELATED: Gender did not relate to myelodysplastic syndrome
development (Kaito et al, 1998).
e. DISEASE STATES:
(1) The risk of developing myelodysplastic syndrome or acute myeloid
leukemia appears to be confined to patients with congenital neutropenia
(Prod Info Neupogen(R), 2000).
(2) The severity of aplastic anemia did not relate to myelodysplastic
syndrome development (Kaito et al, 1998).
f. OTHER: The administration of cyclosporine with filgrastim was a
significant risk factor for developing myelodysplastic syndrome. The
odds of developing myelodysplastic syndrome was about 20 times greater
for patients receiving both drugs compared to those who did not (Kaito
et al, 1998).
*******

Essentially, I think  this says that the risk of developing leukemia is low except for those taking Neupogen for congentital leukopenia, and for those who take it over a long period of time. However, my doc and oncologists he works with are timid about using it on Hep C patients because there is little data on Neupogen and Hep C tx.
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Avatar universal
I didn't know there was a risk of leukemia from Neupogen. Do you have some data/study/link to confirm that?

I've been taking it every other week since July; it was either that or stop treatment. My WBC had dropped, not to 200, but low. The nurse lowered my Pegasys dose by 25% for three weeks while we waited for the Neupogen to arrive.

Good luck to you.

Scott
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