<<Does anyone know if any companies other than SGP are working on PEGylated IFN? Roche??>>
Rick, here are today news from Roche on their PEG-IFN (Pegasys):
biz.yahoo.com
Monday November 8, 9:02 am Eastern Time
Company Press Release
SOURCE: Hoffmann-La Roche
Pegasys(TM) Posts Positive Results in Chronic Hepatitis C Patients With Cirrhosis
-- First Large Prospective Study Performed Exclusively In Difficult-to-Treat Patient Population --
Casaubon:
<<So far, I do not consider the data proof of concept.>> and
<<I'm not sure it's "a good thing" to reduce the ALT levels without a concommitant reduction in viral load.>>
If pathology of the liver cirrhosis from *ANY* HV infection (HCV versus HBV versus ...) is the some (and I do not see reason why it shouldn't be, based on medline search), than today news from Glaxo explain rule of the pre-treatment ALT level and clinical response (not surogate end-point like plasma viral RNA) as seroconversion:
biz.yahoo.com
...At one year, the overall e antigen seroconversion (defined as loss of hepatitis B e antigen and gain of antibody to e antigen, an indicator of loss of HBV replication) rate in four studies was 8% for placebo and 19% for lamivudine. Seroconversion increased with increasing baseline ALT in both treatment groups. In patients with a pre-treatment ALT more than two times above the normal limit, e antigen seroconversion was 12% for placebo and 28% for lamivudine at one year. When pre-treatment ALT was more than five times above the normal limit, e antigen seroconversion was 14% for placebo and 47% for lamivudine. In the one clinical trial where a standard course of interferon was included as a treatment arm (n=68 patients), the results based on ALT levels were similar. In the patients treated with lamivudine, the effect of pre-treatment ALT level on the rate of e antigen seroconversion appeared similar between Asians and Caucasians, the two major ethnic groups in the four trials....
...''The results from these four large studies suggest that pre-treatment ALT level predicts the likelihood of e antigen seroconversion when patients with chronic hepatitis B are treated with lamivudine,'' said Robert Perrillo, M.D., Director of Gastroenterology and Hepatology at Ochsner Clinic in New Orleans and presenter of these study results. ''Seroconversion may predict sustained suppression of HBV and improved clinical prognosis.''...
As you already known, not every HCV/HBV infected person develop liver disease, but ALT level is marker for progress in liver inflammation and cirrhosis. So, HCV pts who didn't responded to INF or are relapsed do have high ALT level and reduction of the ALT level is indication of liver inflammation stabilization, or HCV RNA level in liver (not plasma) is reduced and viral replication suppressed. Also, non-responded pts have very high HCV plasma level (from 10exp5 to 10exp7) and significant plasma viral RNA reduction for short treatment period wasn't expected.
So far 497 data are comparable in efficiency with Ribovirin, but without side effects. Will see what will expanded 3 months study bring?
Miljenko
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