PPC study as adjunct to SOC

PubMed study at:  http://tinyurl.com/6jmsey



PROLONGED PPC THERAPY GIVEN TO RESPONDERS BEYOND THE CESSATION
OF INTERFERON THERAPY TENDED TO INCREASE THE RATE OF SUSTAINED RESPONDERS AT WEEK
48 IN PATIENTS WITH HEPATITIS C (41% VERSUS 15% IN THE CONTROL GROUP; p = 0.064).

BACKGROUND/AIMS: Polyunsaturated phospatidyl-choline (PPC) has been shown to
reduce serum aminotransferases in experimental hepatitis. This multi-center,
randomized, double-blind, placebo-controlled trial evaluated the effects of PPC
in patients with chronic hepatitis B and C in combination with interferon alpha
2a or 2b. The diagnosis of chronic viral hepatitis was based on an abnormal serum
alanine aminotransferase (ALT) value (more than twice the upper value of normal),
viral replication and chronic hepatitis found on liver biopsy. METHODOLOGY:
Patients received 5 million I.U. (Hepatitis B) and 3 million I.U. (hepatitis C)
interferon s.c. thrice weekly for 24 weeks, respectively, and were randomly
assigned to additional oral medication with either 6 capsules of PPC (total daily
dose: 1.8 g) or 6 capsules of placebo per day for 24 weeks. Biochemical response
to therapy was defined as a reduction of ALT by more than 50% of pre-treatment
values. The responders were treated for further 24 weeks after cessation of
interferon therapy with either PPC or placebo. RESULTS: 176 patients completed
the study protocol (per-protocol population: 92 in the PPC and 84 in the placebo
group). A biochemical response (> 50% ALT reduction) was seen in 71% of patients
who were treated with PPC, but only in 56% of patients who received placebo (p <
0.05). PPC increased the response rate in particular in patients with hepatitis
C: 71% of those patients responded in the PPC group versus 51% in the placebo
group (p < 0.05). PROLONGED PPC THERAPY GIVEN TO RESPONDERS BEYOND THE CESSATION
OF INTERFERON THERAPY TENDED TO INCREASE THE RATE OF SUSTAINED RESPONDERS AT WEEK
48 IN PATIENTS WITH HEPATITIS C (41% VERSUS 15% IN THE CONTROL GROUP; p = 0.064).
In contrast, PPC did not alter the biochemical response to interferon in patients
with hepatitis B. PPC did not accelerate elimination of HBV-DNA, HBeAg and
HCV-RNA.
CONCLUSIONS:

In conclusion,
PPC may be recommended in patients with
chronic hepatitis C in combination with interferon and after termination of
interferon in order to reduce the high relapse rate.

PPC may not be recommended
for patients with chronic hepatitis B. In contrast to IFN and other antiviral
agents PPC does not carry major risks and is tolerated very well.
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It would be naive to assume that PPC by itself can halt the progression of fibrosis. But it certainly is one very useful component of a multiprong/complex approach in that direction.  HR
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If my child had cirrhosis I would advise him to take 4 of these capsules a day (as part of quite a few other things that I would advise to take/do ( better do/take!) my child in that setting). I would of course advise him to understand that this is just a nutritional supplement possibly beneficial to his general health and that no claim can or should be made that it has any capacity to cure or mitigate his cirrhotic liver disease at this point in time, until, by randomized, properly powered clinical trials whose results have been analyzed and scrutinized by an expert advisory panel a decision is made by the proper authority that such disease specific claims can be attached to such a substance.I would explain to him, that while he is in need of immediate treatment, the strict rules to attach such claims must be followed in  a world that is filled with quackery claims by people trying to financially profit from the need of the despaired. HR
--------------------------------------------------------------The knowledge regading PPC is mainly from Dr. Charles Liebers work, he has published several animal studies on the antifibrotic effect of this compound. It is also from abstracts at prior liver meetings, posters viewed there and a personal, over an hour discussion wit Dr. Lieber which allowed me to better judge his qualifications, trust his conclusions and get his ovrall " feel" for this compound. The rest is from what publications are available on Pubmed and the overall trend re lack of any toxicity, likelihood of contribution to liver health by concept and role in membrane biology. There are no further large human trials, since none will pay for those, since this is not an item where you can charge $20 per pill as with the antivirals and if you did, patients would obtain it from other sources once you would have spent the money to further prove its usefulness. I fully realize that this is not enough to convince any authorities in Germany or here ("evidence based medicine") to allow it to be officially labeled and indicated as antifibrotic , indeed, its contribution in this regard might be smaller that we think or even worst case, nonexistent. However, weighing all the available evidence, combined with the virtually nonexistent toxicity, the availability and its low cost it seems a valuable component to someone with inflammatory liver and/or  fibrosis. Please also note, that the above PPC trial tested its efficac y re SVR%  improvement, not antifibrosis, and it seemed well conducted to me. HR