Tuesday, September 15, 2009

 

When Treatment Can Be Most Effective. Helping to Develop an Informed Decision



Researchers are focusing in on "when treatment can be most effective" sometimes without knowing it. Following, for your good information, are comments regarding the studies making big news on the HCV Industry News Wire.

(This is a fictitious label. Your suggestions are welcome on an official label [think acronym] that should be adopted!).


http://content.nejm.org/cgi/content/abstract/361/6/580

In this comparison study published in the New England Journal of Medicine (NEJM), the focus was to uncover if one pharmaceutical brand of HCV treatment was better than another. The answer was no but the results are halting. Where we have been told there is a 50% "clear rate" (or SVR = Sustained Viral Response) in current treatment we find now that there is only an overall 30% to 40% SVR in the treatment success. That epiphany dragged kicking and screaming aside, here is the reference to the finding of when treatment is most effective: "Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response [SVR] was achieved in 86.2% and 78.7%, respectively."

http://www3.interscience.wiley.com/journal/122457376/abstract

In this Australian study (The Chariot Study) the initial focus was to test SVR results if higher doses of medicine were given for a shorter duration of time. That result was wholly negative however what was learned:

1) Patients with no or little liver fibrosis present before treatment began obtained SVR up 64% of the time.

2) As in the 'Comparison Study' (NEJM), landmarks were noted in specific periods of time during the treatment. Specifically, weeks 4, 8 and 12. If HCV RNA was not detectable in these weeks, the patient was most likely to achieve SVR up to 74% of the time.*

This study incites a real push in the need to treat early. The challenge may lay in the fact that insurers have criteria of when to treat. The current model is built on a 'wait to treat' expenditure. Studies like the below attempt to change that ideology.

http://www.nature.com/nature/journal/vaop/ncurrent/abs/nature08309.html#a2

This a study released by Duke University. It identifies the IL28B gene and points to proof that patients with the gene have more than a two fold chance for achieving SVR than those without it. The most exciting news discovered is that this helps explain the reason people of African decent do not respond to the standard treatment (30% SVR is normal compared to the 40-50% norm).**








This image was offered for download within the text of the study



The IL28B gene is found to only exist mainly in people of European decent. The lesson learned here helps people make an informed decision of whether to treat or not. Natalie Cole recently was forced to stop treatment after only approximately 8 weeks (standard treatment length is 48 weeks) when she suffered complete kidney failure. She received a kidney transplant in May of this year. Speculation can be made, if Miss Cole, who should have been informed she had only a 30% chance of SVR, also knew she did not have the IL28B gene would she have still chosen to attempt treatment? Would you?

!! Important to note that the Duke Univ study was financially underwritten largely by the pharmaceutical company, Schering-Plough. Also seven different consultants and other advisors of this study are inventors of a patent application based on the final result of the study.*** !!

In conclusion, the below quotation from an article (http://tinyurl.com/kughn5) published in Canada 9 months ago, sums up nicely why the subject of focusing future funding on more studies surrounding successful treatment landmarks is an intelligent approach to serving the sufferers of Hepatitis C.

"The side effects of the medicines to treat hepatitis C are terrible," Tavis said. "Why beat on a patient for a year if the treatment isn't going to work anyway?

"On the other hand, if we know the medicine is likely to work, we can coax patients to stick with the therapy [through the side effects]. It would help doctors to positively support their patients through trying times."


Disclaimers:

~All treatment data offered above is related to the Geno types 1~

~Debbullan Inc. is not a medical institution. Debbullan Inc. does not recommend particular treatments for specific individuals under any circumstance. In all cases we strongly recommend that you consult your physician to develop a well-informed decision before pursuing any course of treatment.~

Footnotes:

*Make note: News of The Chariot Study was obtained by a constituent in Australia, who responded to our post of The Comparison Study in NEJM with the Chariot article published by Hepatitis Central [dot com].

**Nod to the new statistic offered by The Comparison study. Check back for updates.

***This Australian study also mentions amazing new information found because of the IL28B gene. We are looking into the coincidence.
**Update - Regarding our repeated requests of affiliated funding via Shering Plough addressed to the Univ of Australia went unanswered. We were directed to one of the leaders of the study, Dr. David Booth who had since left the University. Following new contact directions, we were told by the recipient that they were unable to help us directly contact Dr. Booth. Having exhausted reasonable expense and time to achieve a definitive answer, we leave the disclaimer above.

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