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STEALTH C 3 Trials
Has anyone here signed on for the Stealth C trial starting soon? If you have, I'd like to know exactly what the inclusion criteria is. I've been watching Alinia carefully and so far am real happy with what I see. I know it's early but one can hope.
Susie
Susie
Thanks for the info. Actually I feel I have no choice but to go the study route because my insurance company has denied me the use of Peg/Riba since I never got a 2 log drop. They've paid for the many 100's of injections I've taken since 1992 and just last year cut me off. I appealed it twice and lost both times. I hate BC/BS. And I also get calls constantly from others inquiring about these drugs and I need to know what the deal is for them. I'm meeting with Romark and Dr. Keeffe in mid June but don't want to wait that long to find out what is going on with this drug. I didn't realize there was a romarktrials.com. Good to know and thanks again.
Susie
Susie
alinia/ntz does look quite promising. If I need to retreat soon I will definitely try to include it. However not sure why anyone for whom the clock ticking is getting kinda loud (and my apologies if I'm mistakenly including you here) would bother with a clinical trial and the associated placebo risk. Finding a dr who will write the rx would seem the more direct route.
Anecdotally, I also took the fact that Emmet Keeffe hepatology head at the stanford transplant unit was persuaded to join romark as a promising sign. Interestingly, one of the messages from the Korba study of ntz (easl'08 presentation) seems to be that it may be an effective means of reducing ifn dosing "8-fold decrease in concentration of interferon required to inhibit virus replication by 90%".
Also, not sure whether this has been discussed already, but there appears to be a new, existing, med with a strong anti-viral effect : injections of silibinin, a milk-thistle extract:
From the easl'08 presentation by Ferenci, et al:
"SILIBININ IS A POTENT ANTIVIRAL AGENT IN PATIENTS WITH CHRONIC HEPATITIS C NOT RESPONDING TO ANTIVIRAL COMBINATION THERAPY.
P. Ferenci, T.M. Scherzer, H. Hofer, M. Schöniger-Hekele, P. Steindl-Munda
Internal Medicine 3, Medical University Of Vienna, Vienna, Austria
Background: Silibinin (SIL) is the main flavonoid extracted from milk thistle (Silibum marianum G.). This compound is used for treatment of a variety of liver diseases without a precise knowledge of its mode of action. Because of its potential antioxidative action pre-treatment with SIL may improve the response to interferon. Furthermore, SIL inhibits viral replication in the Replicon® system (Gastro 2007;132:1925). As part of this investigation we discovered that SIL is a potent antiviral agent active against the hepatitis C virus in vivo.
Methods: 16 pedigreed nonresponders to full dose peginterferon-alfa2a /ribavirin combination therapy (12 male/4 female; age 49.9±9.7; genotype 1: 14, genotype 4:2; liver histology: F3/4: 13, F1/2:3) were pretreated with 10 mg/kg i.v. SIL (Legalon Sil®, Madaus, Köln)/d for 7 days before starting treatment with 180µg peginterferon-alfa2a (PEGASYS® ;Roche, Basel)/week ,1-1.2 g/d ribavirin (COPEGUS ® ;Roche, Basel) and 140 mg silymarin (Legalon®, Madaus, Köln) TID per os. HCV-RNA was quantified by the TaqMan® assay (Roche Diagnostics) at baseline, after 7 infusions of SIL, and every 2 weeks on PEGIN/RBV.
Results: Within one week iv. SIL-monotherapy lead to a decrease in the viral load in all patients (baseline: 6.2±5.82 [SD] MIU/mL; day 8: 0.96±1.88; p=0.00005). The mean log decline in viral load was 0.82±0.43. ALT decreased from 162±133 to 118±107 (p=0.004). At present, viral kinetics are available only in 3 patients. Viral decline started on day 3 of SIL and showed a linear decline over the next days. Treatment was well tolerated. On antiviral treatment HCV-RNA tended to further decline (2 weeks: 0.81±1.59, 4 weeks 0.96±1.49; both p 2. At the meeting data for iv. SIL doses of 5 mg/kg and 15 mg/kg will be available.
Conclusions: SIL has a marked antiviral activity against the hepatitis C virus. This effect was unrelated to the action of IFN/RBV. Thus this drug may be a useful for treatment of chronic hepatitis C, especially in nonresponders. The potential of SIL for combination with new antivirals needs to be explored."
Legalon SIL is manufactured by Manaus and has been granted interim emergency approval by the FDA for mushroom poisoning. I doubt it can be purchased in the US but shouldn't be hard to obtain in Europe.
Anecdotally, I also took the fact that Emmet Keeffe hepatology head at the stanford transplant unit was persuaded to join romark as a promising sign. Interestingly, one of the messages from the Korba study of ntz (easl'08 presentation) seems to be that it may be an effective means of reducing ifn dosing "8-fold decrease in concentration of interferon required to inhibit virus replication by 90%".
Also, not sure whether this has been discussed already, but there appears to be a new, existing, med with a strong anti-viral effect : injections of silibinin, a milk-thistle extract:
From the easl'08 presentation by Ferenci, et al:
"SILIBININ IS A POTENT ANTIVIRAL AGENT IN PATIENTS WITH CHRONIC HEPATITIS C NOT RESPONDING TO ANTIVIRAL COMBINATION THERAPY.
P. Ferenci, T.M. Scherzer, H. Hofer, M. Schöniger-Hekele, P. Steindl-Munda
Internal Medicine 3, Medical University Of Vienna, Vienna, Austria
Background: Silibinin (SIL) is the main flavonoid extracted from milk thistle (Silibum marianum G.). This compound is used for treatment of a variety of liver diseases without a precise knowledge of its mode of action. Because of its potential antioxidative action pre-treatment with SIL may improve the response to interferon. Furthermore, SIL inhibits viral replication in the Replicon® system (Gastro 2007;132:1925). As part of this investigation we discovered that SIL is a potent antiviral agent active against the hepatitis C virus in vivo.
Methods: 16 pedigreed nonresponders to full dose peginterferon-alfa2a /ribavirin combination therapy (12 male/4 female; age 49.9±9.7; genotype 1: 14, genotype 4:2; liver histology: F3/4: 13, F1/2:3) were pretreated with 10 mg/kg i.v. SIL (Legalon Sil®, Madaus, Köln)/d for 7 days before starting treatment with 180µg peginterferon-alfa2a (PEGASYS® ;Roche, Basel)/week ,1-1.2 g/d ribavirin (COPEGUS ® ;Roche, Basel) and 140 mg silymarin (Legalon®, Madaus, Köln) TID per os. HCV-RNA was quantified by the TaqMan® assay (Roche Diagnostics) at baseline, after 7 infusions of SIL, and every 2 weeks on PEGIN/RBV.
Results: Within one week iv. SIL-monotherapy lead to a decrease in the viral load in all patients (baseline: 6.2±5.82 [SD] MIU/mL; day 8: 0.96±1.88; p=0.00005). The mean log decline in viral load was 0.82±0.43. ALT decreased from 162±133 to 118±107 (p=0.004). At present, viral kinetics are available only in 3 patients. Viral decline started on day 3 of SIL and showed a linear decline over the next days. Treatment was well tolerated. On antiviral treatment HCV-RNA tended to further decline (2 weeks: 0.81±1.59, 4 weeks 0.96±1.49; both p 2. At the meeting data for iv. SIL doses of 5 mg/kg and 15 mg/kg will be available.
Conclusions: SIL has a marked antiviral activity against the hepatitis C virus. This effect was unrelated to the action of IFN/RBV. Thus this drug may be a useful for treatment of chronic hepatitis C, especially in nonresponders. The potential of SIL for combination with new antivirals needs to be explored."
Legalon SIL is manufactured by Manaus and has been granted interim emergency approval by the FDA for mushroom poisoning. I doubt it can be purchased in the US but shouldn't be hard to obtain in Europe.
Did you try this site? They have info on inclusion and exclusiong criteria for STEALTH C
http://www.romarktrials.com/
http://www.romarktrials.com/
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