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HR: Predosing with NTZ

Hi HR,

In one study, patients predosed with NTZ for 12 weeks then introduced SOC.  Do you have an opinion on whether one could predose with NTZ for less time, say 6 weeks or a month?

All three drugs are on hand and tx is imminent.  I'll report VL as often as I can, however, I'll be paying out of pocket so it may not be weekly.  Thanks for you assistance.

Kittyface
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86075 tn?1238115091
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Avatar universal
MEDICAL PROFESSIONAL
Predosing the Alinia before SOC has been done by Romark in its Egypt studies more as a result of happenstance than intentional design....
As a principal stance, Simulstart is the proper concept for antiviral cocktails,.exceptions are possible, and Alinia might be one of them, since resistance is likely to develop slowly., if ever.

BTW also mentioned here before, if someones VL is already very low or UND, adding the Alinia holds no risk of Alinia resistance and future use is NOT precluded/hampered. On the contrary, it might add a DECIDING  level of protection against relapse - this is a good theory at this point in time nothing more, but if you consider the benefit/risk equation it is something to consider.
Off to the airport in a few hours - so no more communication possible.
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131817 tn?1209529311
I remember this post from a long time ago...don't know the date. I believe it and would never take Alinia as a monotherapy, but would predose for perhaps a week or so. I am not positive, but I think HR thinks this is okay. MO is on Alinia for parasites, so she has to take it prior to tx and hasn't started yet. HR didn't say much regarding that as far as SVR.
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Avatar universal
Thanks for the clarification.  

KF
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144210 tn?1273088782
Any predose time with Alinia is 1 or 2 weeks prior to tox just to see how one handles it so to speak. Simulstart has been HRs' advice in the past. Adding it later in tox for those who have already started? Well, a lot would have to be considered such as slow response, non response, etc. The last thing I would want to do is build up a viral resistance to Alinia rendering it less or non effective if a re-tox becomes necessary. If I was a very slow responder at 12 wks plus, the rather than add alinia, I would probably stop treatment, regroup, and add it on the next round. This is only my opinion though!  Sometimes you just have to follow you gut on these decisions.
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Avatar universal
Strange, I went through Alinia archives and found a post by HR suggesting that Alinia predosing isn't a good idea: (see last paragraph)

". . .Considering the incredible adaptive power of HCV any kind of monotherapy is likely to fail. If you followed carefully what was previously presented here, one of the "official" new HCV antivirals supressed the virus by 99% after 4 days and yet after a mere 2 weeks , under ccontinuous dosing, all trial participants returned to baseline VLs- total resistance in all participants! And the AASLD abstract 92 by Tara Keiffer of Vertex showed that out of 8 patients receiving 950 Monotherapy, 4 experienced viral breakthrough or plateau response after two weeks, all with respective resistance mutations.



While the resistance propensity of antivirals differs widely due to mechanism, suppressive power, molecular target and the ease with which HCV can produce mutants fit enough to suceed, the working hypothesis must be that no mono and likely no simple dual therapy can retain this virus from adapting. Note that IFN is not just a " monotherapy" but has multiple , complex activity against HCV, classifying it a priori as " pseudocombotherapy).Apparantly not comboish enough, however. Thats why riba helps and more elaborate cocktails will help even more, if used properly.



The second problem with monotherapy - and that goes most likely for Alinia as well - is that, once resistance has set in, even in the past and even after no drug was given for prolonged periods of time its future use in a combo is clouded with a quick return of the resistant variant that has been" archived" as Doug Richman puts it. Same for HCV and HBV and HIV.



A combo treatment cocktail needs to be given in combo from the start and ideally the virus has never seen any of the drugs before.

Thus any of the official helper drugs or the Alinia or perhaps the oxymatrine should never be used without the IFN/riba combo, started simultaneously and should never be used before in mono form.  

Rapid supression of the adaptive evolutionary power of HCV must be the guiding concept to combat HCV. The mutants that eventually stage the HCV combeback when treaters relapse after a full year of therapy with even "UND" for 6 month are PROBABLY CREATED WITHIN THE FIRST DAYS AFTER THE IFN/RIBA WAS STARTED, in tiny amounts. If you cut -by using additional replication reducing drugs("helpers") - the adaptive power by a factor of 100 or 1000, then these early mutants probably never come to live.

HCV is an incredible sophisticated huge molecular machine that has a milion times a million! offspring and mutants per day. There is nothing trivial about that and we must use all levels of sophistication to combat it. No mistakes are forgiven.



Re Alinia, with all due respect, the approach by the company to pretreat for three month and then add Pegasys for 6 month is prone to breed Alinia resistance. . ."
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Avatar universal
BTW, I meant I am paying out of pocket for the VL blood tests and they are very expensive ($400-$500).  However, the laboratories also have financial assistance programs for uninsured people below a certain income.  I'm not sure I fit that criteria.

Kittyface
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Avatar universal
Hi!

Alinia is one of the easiest drugs to obtain for free.  Romark has a one page application and no supporting docs are required.  They don't even ask for the diagnosis.

I don't understand why a doc wouldn't write a rx for it and if it were me I'd find another doc.

I'll be glad to forward anyone the Romark application, just PM me.

Best regards,

Kittyface
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131817 tn?1209529311
You are lucky to get that Alinia!  From what I have gathered from past threads of HR's, he thinks that predosing is good to do with Alinia. Look in the archives or ask MO. She is going to predose as well.  I am not current on how much predosing is good...maybe look in the archives if HR doesn't respond.

Where are you getting your Alinia from? You say you are paying out of pocket. From Mexico?  I sure wish we could all get our Dr's to give us a script for it, so we wouldn't have to do pay out of pocket!  

Good luck...hope to hear of your tx!  

Lidna
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