I need some encouragement and hope. As you may know I am starting Infergen, Riba and Alinia in exactly 1 week from now and would like to hear what your personal opinion is about Alinia working for geno 1A's as well as it worked for the people with different genotypes in the Egyptian study. Any bit of insight into the mechanics of the drug and your proffesional opinion would be great. Do you think I may be wasting my time with the addition of Alinia?
While i could not recommend Alinia at any time it is not fully FDA approved for this indication, there are indications that it is possibly at this moment the most meaningful addition to the available SOC options, for those patients whose doctors feel they should treat NOW..
Three lines of thought are important:
1. Do we have reason to believe that the reports and results from the Egyption study, as reported at the AASLD are truthful and therefore meaningful, at least within the Genotyoe 4 context?
The answer is yes, see my previous detailed report re the actual presentation at the AASLD, who spoke, who did the study, how were the methods to ensure patient compliance.
One further aspect that is not typically fully understood by many, is that the 90% 12wkSVR rate achieved was an intention to treat - ITT- analysis. This means that all the failures that constitute in toto the missing 10% INCLUDE the failures that are not related to the inherent capacity of this regimen to work when properly administered. Thus, for example, a deadly accident after EOT preventing a likely SVR patient to bre counted as such made this patient a "nonSVR" statistic.Similarly, all the ones who skipped Riba pills and failed therefore are failures in this ITT count, while they could have been SVRs, if taken their meds properly. The conclusion from this aspect is, that whoever does everything properly, will have a better than ITT chance for SVR.
2. The fact that Nitazoxanide also has effectivness against HBV and rotavirus, combined with the undisputable DDW 2006 reported ( #1821 and # 1852) in vitro results against HCV ( genotype not mentioned in abstract) and HBV and the
suspected mechanism of impairment of viral protein folding,
possibly resulting in an increased "damaged viral protein salvage processing pathway", that in turn is likely to mean an increased presentation of viral peptide fragments/epitopes on the hepatocyte surface for T-cell recognition/enhanced response for rare HCV proteins normally invisible to the Tcell system (because of a rarety of synthesized numbers for nonstructural proteins) (this is of course just a good theory at this point in time!)
lend meaningful support to the putative assumption
that it will be effective against other genotypes as well.
3. All the Egyption trial date will have been scrutinized by the FDA before an IND necessary to begin the US trial using NTZ and SOC was successfully processed ( A planned trial needs to be as such approved before start for basis and design and toxicity issues etc).
While the NTZ monotherapy ( 12wk"lead in") VL reduction results were meager, just barely better than ribavirin on its own (riba monotherapy) in earlier trials, it seems to have, similar to riba, but with a somewhat different, synergistic mechanism, the capacity to enhance the IFN dependent immune clearance mechanisms.
Thank You for the information. I feel more confident already. Is it safe to assume(hypothetically) that the Alinia will probably work just as well synergistaclly with Infergen as it did in the study with the pegasys or is Alinia's antiviral activity strictly linked with the chemical composition ( amino acid structure) of the pegasys? Basically will it (Alinia) kick as much viral butt with Infergen as it has with the Peg?
By the way, my doctor was excited about me trying the Alinia. He hadn't heard the study on it but was pleased with information I dug up on it. He was so excited that he said if it worked for me he would have me speak formally with him at a meeting in front of his Yale colleagues. Also, would it be prudent( hypothetically) to stay on the Alinia the entire 48 weeks or just 36 , like in the study? Oh and should the alinia be taken at the same time (fatty meal) as the Riba or seperately?
Infergen acts as stimulator of innate and also mostly indirectly immune processes. Thre is no reason to belive that it will work differnetly with NTZ than Pegasys - but there can always be surprises.
In the Egypt trial, all participants stayed on the NTZ for the full duration - 48wks.
With respect to the effect of food administration the public domain FDA files from the Alinia registration trials state that the Cmax of NTZ was slghtly higher (2%) , the Tmax was significantly delayed and the elimination half life was slightly longer following administration of NTZ with food. Overall bioavailibility of tizoxanide was 48% higher when administered with a high fat, high caloric meal.
Best to space riba and NTZ apart to avoid theoretical resorption/bioavailibility competition.
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