Guest guest Posted June 3, 2000 Report Share Posted June 3, 2000 In a message dated 6/4/00 12:23:38 AM Eastern Daylight Time, LEST2001@... writes: << During my treatment I was doing 5 million IU daily for the first 6 months, and the went to 3 million IU daily for the last 5 months >> I stand corrected! I forgot that...and I know you wrote it, previously. Well, I am on heavy medication - doncha know?! lol. BTW - do you know the studys' results? Or is it too early? Just curious. Peace, Jane Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 4, 2000 Report Share Posted June 4, 2000 Dear Les, I've heard that the earlier you go undetectable the better chance you have of sustaining that response. I'd say things are looking good for you! Good luck! Claudine >From: LEST2001@... > No, I don't know the results form my study yet. I do know that I went >undetectable the first two weeks of treatment, and have stayed same ever >sense. >Take care, >Les ________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 4, 2000 Report Share Posted June 4, 2000 Dear Les, I've heard that the earlier you go undetectable the better chance you have of sustaining that response. I'd say things are looking good for you! Good luck! Claudine >From: LEST2001@... > No, I don't know the results form my study yet. I do know that I went >undetectable the first two weeks of treatment, and have stayed same ever >sense. >Take care, >Les ________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 4, 2000 Report Share Posted June 4, 2000 No, I don't know the results form my study yet. I do know that I went undetectable the first two weeks of treatment, and have stayed same ever sense. Take care, Les Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 4, 2000 Report Share Posted June 4, 2000 No, I don't know the results form my study yet. I do know that I went undetectable the first two weeks of treatment, and have stayed same ever sense. Take care, Les Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 5, 2000 Report Share Posted June 5, 2000 Alley, Probably wouldn't even run out because there is an extra dose in the pens to compensate for air bubbles and the removal of them. so you could still go the full treatment course. I have been using my extra and it really helped because a pen fell out of refrigerator and so i lost it all as my company set it on top of the frig!! I have wondered the same thing but mostly because on the 3 day of the weeks i usually feel really bad maybe because i've gone so long without an injection? dOESN'T ALWAYS WORK THAT WAY SOMETIMES FEEL WORSE wED but heck its worth a shot and you already have the med. somepeople are already doing it every other day or even every day for those fortunate to have docs that will treat them aggressively. Good Luck Suzy ________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 5, 2000 Report Share Posted June 5, 2000 Alley, Probably wouldn't even run out because there is an extra dose in the pens to compensate for air bubbles and the removal of them. so you could still go the full treatment course. I have been using my extra and it really helped because a pen fell out of refrigerator and so i lost it all as my company set it on top of the frig!! I have wondered the same thing but mostly because on the 3 day of the weeks i usually feel really bad maybe because i've gone so long without an injection? dOESN'T ALWAYS WORK THAT WAY SOMETIMES FEEL WORSE wED but heck its worth a shot and you already have the med. somepeople are already doing it every other day or even every day for those fortunate to have docs that will treat them aggressively. Good Luck Suzy ________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 6, 2000 Report Share Posted June 6, 2000 The drug's name you refer to is Amantidine...mzgee " We can do no great things; only small things with great Love. " Mother Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 6, 2000 Report Share Posted June 6, 2000 ---------- >From: " gorski " <gorski@...> > There is a study in progress with the above three. The one study I know of > has four arms as follows: > > Randomized PEG study (ROCHE) with four arms > for relapsers: > > 1) PEG plus Ribavirin > 2) PEG plus Amantidine > 3) PEG plus Ribaviron & Amantidine > 4) PEG plus Cellcept > > > > What's cellcept? Gail Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Thanks for pointing that out Sharon. I know here in Dallas.. they are doing 3 yr long PEG maintenance studies for nonresponders. I've also read that the time release only actually works for 4 - 5 days. Yeah... if more people can tolerate the sides, then more will continue treatment and more will hopefully go into remission alley/ ICQ 12631861 alleypat@... http://www.flash.net/~alleypat http://community.dallasnews.com/dmn/dfwliver Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Dear Sharon, I went to your article regarding pegylated interferon. You state: **At this time, the clinical trials for PEG-INTRON in the US and Canada should begin this year. However, there are several differing opinions on exactly which dates this product will be available for use on Hepatitis C patients. There were reports released that Clinics around the North American region could expect product availability by September 2000, however that date has now been postponed, possibly to December 2000. Please do not be confused regarding the upcoming clinical trials of PEG. This is using the coated interferon product only. For the year 2000, the clinical trials will not include the Ribavirin (PEG combo) therapy. This singular product might decrease the overall effectiveness of treatment for those who might respond to the current Combination Rebetron therapy. After the US PEG clinical trials, Schering-Plough will apply to the FDA again for the use of PEG in conjunction with the Ribavirin product. This is the more promising combination, because it will allow the interferon more effective and lasting capabilities in the body, and be easier for the patient. Quoting a member of the Schering-Plough research team, " We hope to have the PEG Combo therapy available for clinical trails by 2002, FDA willing! " ** While I agree with you that Schering's pegylated monotherapy results are not as good as current interferon combo therapy, I disagree with your information about peg with ribavirin. The trials for Schering's Peg-Intron WITH ribavirin are ALREADY into phase III. In fact, in the report Schering-Plough presented on May 1, 2000 at the EASL meeting Schering stated: PEG-INTRON PLUS REBETOL COMBINATION THERAPY Results of a Phase II dose-ranging study of PEG-INTRON in combination with REBETOL (Ribavirin, USP) Capsules were presented by Esteban Mur, M.D., professor of medicine, Servei de Medicina Interna-Hepatologia, Hospital Vall d’Hebron, Barcelona, Spain, at a satellite symposium sponsored by Schering-Plough. " The results of this study indicate that REBETOL enhances the antiviral activity of PEG-INTRON and that sustained virologic response with the combination therapy is dose dependent, " Esteban Mur said. " While preliminary, these results are encouraging. " The combination of PEG-INTRON and REBETOL is currently being studied in Phase III trials to further define its clinical profile. They then go on to report the results of the phase II study. Trials on Roche's version of the pegylated interferon with ribavirin are also well under way. Since ribavirin is already approved for use with interferon in the treatment of hepatitis C I don't think there will be much delay in an approval of the pegylated-ribavirin combination. After all, it's still just interferon. There are NO NEW medications involved here. (I think that Schering's pegylated would already have been approved if it weren't for the law suits between Schering and Roche.) However, ribavirin can be prescribed NOW for use with other interferons, such as Roferon or Infergen, and can also be prescribed with a pegylated interferon when available, if you have a doctor that is willing to do so. It can be obtained through Fisher's pharmacy (for now) and shipped to you. I have already discussed with my doctor that I want to take ribavirin with the Roche brand of pegylated interferon, and he didn't seem to think this would be a problem (and he is NOT a doctor too willing to stick his neck out either.) He also thinks Schering will be pressured into 'unlocking' their ribavirin from their interferon so it will be more easily available for use with medications other than those manufactured by Schering. I hope he is right, but I will have to see it to believe it. I really don't think you can trust the word of the Schering reps 100%. I have heard of other things they have said which were not true. It is NOT in their best interests to have anyone wait for a pegylated interferon to become available. They want people on treatment NOW. Waiting costs them money, and I don't believe they would mind at all if you relapse and need to take treatment all over again (buying more of their products, of course). Also, they have what just about amounts to a monopoly on treatments for hepatitis C at this time, but that may change when Roche's version of the pegylated interferon is out, since studies so far seem to show that the Roche version of pegylated interferon is more effective than Schering's version. So again, it's NOT in Schering's best interests to have anyone postpone treatment now. For myself, I will look at the published studies, news releases, etc., and NOT what the Schering reps have to say. Besides, my fibrosis is only stage 1, and at the rate this disease progresses I could wait several years if I needed to. Being a genotype 1b non-responder, even if I was stage three, or already had cirrhosis, I still think (after all the research I've been doing) that I would wait for something more better than this combo treatment, even if it was only pegylated monotherapy, since the latest news out is that pegylated monotherapy is more effective than standard interferon for improving liver histology, and that would be a real concern of mine. Depending on individual circumstances, I still think waiting for the pegylated is the best option for many people. Claudine ________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Schering-Plough Announces European Union Approval Of PEGINTRON for Treatment of Hepatitis C >>> First Pegylated Interferon Approved in the World <<< MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to PEGINTRON (peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult patients with chronic hepatitis C. PEGINTRON is the first pegylated interferon approved for marketing in the world. In clinical studies, once-weekly administration of PEGINTRON has been shown to be twice as active and just as well tolerated as Schering-Plough's INTRON® A (interferon alfa-2b, recombinant) Injection, the world's largest-selling alpha interferon, administered three times weekly as monotherapy for hepatitis C. PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J. Schering-Plough holds an exclusive worldwide license to PEGINTRON. Commission approval of the centralized application for PEGINTRON results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The Commission's decision follows the product's unanimous recommendation for approval in February 2000 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). PEGINTRON will be introduced upon receiving pricing approvals, where necessary, from individual EU countries. PEGINTRON is indicated as monotherapy in case of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C who have serum markers indicating virus replication, e.g., those patients who have elevated transaminases(1) without liver decompensation and who are positive for serum HCV-RNA(2) or anti-HCV(3). The approved labeling in the EU for PEGINTRON indicates that the optimal treatment for chronic hepatitis C is considered to be the administration of a combination of interferon alfa-2b with ribavirin. The safety and efficacy of the combination of PEGINTRON and ribavirin has not yet been documented. PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or 1.0 mcg/kg once weekly for at least six months. In patients showing loss of HCV-RNA at six months, treatment is continued for an additional six months, i.e. for a total course of treatment of one year. A worldwide, controlled clinical study designed to establish the activity and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult patients with previously untreated chronic hepatitis C and compensated liver disease. A total of 1,219 patients, who were positive for serum HCV-RNA and who had elevated liver enzymes (serum alanine aminotransferase), were treated with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The primary efficacy endpoint of the study was sustained loss of detectable HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all three doses studied was shown to be superior to, and as safe as, INTRON A in treating all HCV genotypes. The study results showed that sustained virologic responses were achieved in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON A. In patients having genotype 2 or 3 and low viral load (<2 million copies/ml), sustained virologic responses were achieved in 62% of patients treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON 0.5 mcg/kg, compared to 36% of patients treated with INTRON A. The demographic/disease characteristics of patients in this study were similar to those in previous Schering-Plough hepatitis C registration studies, with a majority of patients having genotype 1, the most difficult genotype to treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml). Adverse events (AEs) for all doses of PEGINTRON were similar to those for INTRON A. Most AEs were mild to moderate and were manageable with dose adjustment. Discontinuation of therapy due to AEs was similar for all treatment groups (6-11%). Dose reductions were similar for INTRON A and PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%, 14% and 19%, respectively). The most common side effects occurring with PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and fever, which appeared to decrease in severity as treatment continued. Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as 5 million Europeans (1 to 2 percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. In the United States, Schering-Plough on Dec. 23, 1999, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of chronic hepatitis C. Some 4 million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDC). INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A worldwide for 16 major antiviral and anticancer indications. REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. (1) Elevated enzyme levels indicating ongoing liver inflammation. (2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid). (3) Anti-HCV: antibodies to hepatitis C virus. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Sharon Nicholson Hepatitis Education & Patient Coalition (H. E. P. C. in AZ) Executive Director <A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B, C's - editor Suite101.com</A> http://www.suite101.com/welcome.cfm/hepatitis_abc Join our e-group mailing list online! <A HREF= " ArizonaHepatitis C " >eGroups : ArizonaHepatitis C</A> ArizonaHepatitis C Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Schering-Plough Announces European Union Approval Of PEGINTRON for Treatment of Hepatitis C >>> First Pegylated Interferon Approved in the World <<< MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to PEGINTRON (peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult patients with chronic hepatitis C. PEGINTRON is the first pegylated interferon approved for marketing in the world. In clinical studies, once-weekly administration of PEGINTRON has been shown to be twice as active and just as well tolerated as Schering-Plough's INTRON® A (interferon alfa-2b, recombinant) Injection, the world's largest-selling alpha interferon, administered three times weekly as monotherapy for hepatitis C. PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J. Schering-Plough holds an exclusive worldwide license to PEGINTRON. Commission approval of the centralized application for PEGINTRON results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The Commission's decision follows the product's unanimous recommendation for approval in February 2000 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). PEGINTRON will be introduced upon receiving pricing approvals, where necessary, from individual EU countries. PEGINTRON is indicated as monotherapy in case of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C who have serum markers indicating virus replication, e.g., those patients who have elevated transaminases(1) without liver decompensation and who are positive for serum HCV-RNA(2) or anti-HCV(3). The approved labeling in the EU for PEGINTRON indicates that the optimal treatment for chronic hepatitis C is considered to be the administration of a combination of interferon alfa-2b with ribavirin. The safety and efficacy of the combination of PEGINTRON and ribavirin has not yet been documented. PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or 1.0 mcg/kg once weekly for at least six months. In patients showing loss of HCV-RNA at six months, treatment is continued for an additional six months, i.e. for a total course of treatment of one year. A worldwide, controlled clinical study designed to establish the activity and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult patients with previously untreated chronic hepatitis C and compensated liver disease. A total of 1,219 patients, who were positive for serum HCV-RNA and who had elevated liver enzymes (serum alanine aminotransferase), were treated with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The primary efficacy endpoint of the study was sustained loss of detectable HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all three doses studied was shown to be superior to, and as safe as, INTRON A in treating all HCV genotypes. The study results showed that sustained virologic responses were achieved in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON A. In patients having genotype 2 or 3 and low viral load (<2 million copies/ml), sustained virologic responses were achieved in 62% of patients treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON 0.5 mcg/kg, compared to 36% of patients treated with INTRON A. The demographic/disease characteristics of patients in this study were similar to those in previous Schering-Plough hepatitis C registration studies, with a majority of patients having genotype 1, the most difficult genotype to treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml). Adverse events (AEs) for all doses of PEGINTRON were similar to those for INTRON A. Most AEs were mild to moderate and were manageable with dose adjustment. Discontinuation of therapy due to AEs was similar for all treatment groups (6-11%). Dose reductions were similar for INTRON A and PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%, 14% and 19%, respectively). The most common side effects occurring with PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and fever, which appeared to decrease in severity as treatment continued. Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as 5 million Europeans (1 to 2 percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. In the United States, Schering-Plough on Dec. 23, 1999, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of chronic hepatitis C. Some 4 million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDC). INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A worldwide for 16 major antiviral and anticancer indications. REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. (1) Elevated enzyme levels indicating ongoing liver inflammation. (2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid). (3) Anti-HCV: antibodies to hepatitis C virus. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Sharon Nicholson Hepatitis Education & Patient Coalition (H. E. P. C. in AZ) Executive Director <A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B, C's - editor Suite101.com</A> http://www.suite101.com/welcome.cfm/hepatitis_abc Join our e-group mailing list online! <A HREF= " ArizonaHepatitis C " >eGroups : ArizonaHepatitis C</A> ArizonaHepatitis C Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Schering-Plough Announces European Union Approval Of PEGINTRON for Treatment of Hepatitis C >>> First Pegylated Interferon Approved in the World <<< MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to PEGINTRON (peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult patients with chronic hepatitis C. PEGINTRON is the first pegylated interferon approved for marketing in the world. In clinical studies, once-weekly administration of PEGINTRON has been shown to be twice as active and just as well tolerated as Schering-Plough's INTRON® A (interferon alfa-2b, recombinant) Injection, the world's largest-selling alpha interferon, administered three times weekly as monotherapy for hepatitis C. PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J. Schering-Plough holds an exclusive worldwide license to PEGINTRON. Commission approval of the centralized application for PEGINTRON results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The Commission's decision follows the product's unanimous recommendation for approval in February 2000 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). PEGINTRON will be introduced upon receiving pricing approvals, where necessary, from individual EU countries. PEGINTRON is indicated as monotherapy in case of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C who have serum markers indicating virus replication, e.g., those patients who have elevated transaminases(1) without liver decompensation and who are positive for serum HCV-RNA(2) or anti-HCV(3). The approved labeling in the EU for PEGINTRON indicates that the optimal treatment for chronic hepatitis C is considered to be the administration of a combination of interferon alfa-2b with ribavirin. The safety and efficacy of the combination of PEGINTRON and ribavirin has not yet been documented. PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or 1.0 mcg/kg once weekly for at least six months. In patients showing loss of HCV-RNA at six months, treatment is continued for an additional six months, i.e. for a total course of treatment of one year. A worldwide, controlled clinical study designed to establish the activity and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult patients with previously untreated chronic hepatitis C and compensated liver disease. A total of 1,219 patients, who were positive for serum HCV-RNA and who had elevated liver enzymes (serum alanine aminotransferase), were treated with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The primary efficacy endpoint of the study was sustained loss of detectable HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all three doses studied was shown to be superior to, and as safe as, INTRON A in treating all HCV genotypes. The study results showed that sustained virologic responses were achieved in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON A. In patients having genotype 2 or 3 and low viral load (<2 million copies/ml), sustained virologic responses were achieved in 62% of patients treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON 0.5 mcg/kg, compared to 36% of patients treated with INTRON A. The demographic/disease characteristics of patients in this study were similar to those in previous Schering-Plough hepatitis C registration studies, with a majority of patients having genotype 1, the most difficult genotype to treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml). Adverse events (AEs) for all doses of PEGINTRON were similar to those for INTRON A. Most AEs were mild to moderate and were manageable with dose adjustment. Discontinuation of therapy due to AEs was similar for all treatment groups (6-11%). Dose reductions were similar for INTRON A and PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%, 14% and 19%, respectively). The most common side effects occurring with PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and fever, which appeared to decrease in severity as treatment continued. Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as 5 million Europeans (1 to 2 percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. In the United States, Schering-Plough on Dec. 23, 1999, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of chronic hepatitis C. Some 4 million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDC). INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A worldwide for 16 major antiviral and anticancer indications. REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. (1) Elevated enzyme levels indicating ongoing liver inflammation. (2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid). (3) Anti-HCV: antibodies to hepatitis C virus. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Sharon Nicholson Hepatitis Education & Patient Coalition (H. E. P. C. in AZ) Executive Director <A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B, C's - editor Suite101.com</A> http://www.suite101.com/welcome.cfm/hepatitis_abc Join our e-group mailing list online! <A HREF= " ArizonaHepatitis C " >eGroups : ArizonaHepatitis C</A> ArizonaHepatitis C Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2000 Report Share Posted June 25, 2000 Schering-Plough Announces European Union Approval Of PEGINTRON for Treatment of Hepatitis C >>> First Pegylated Interferon Approved in the World <<< MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to PEGINTRON (peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult patients with chronic hepatitis C. PEGINTRON is the first pegylated interferon approved for marketing in the world. In clinical studies, once-weekly administration of PEGINTRON has been shown to be twice as active and just as well tolerated as Schering-Plough's INTRON® A (interferon alfa-2b, recombinant) Injection, the world's largest-selling alpha interferon, administered three times weekly as monotherapy for hepatitis C. PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J. Schering-Plough holds an exclusive worldwide license to PEGINTRON. Commission approval of the centralized application for PEGINTRON results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The Commission's decision follows the product's unanimous recommendation for approval in February 2000 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). PEGINTRON will be introduced upon receiving pricing approvals, where necessary, from individual EU countries. PEGINTRON is indicated as monotherapy in case of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C who have serum markers indicating virus replication, e.g., those patients who have elevated transaminases(1) without liver decompensation and who are positive for serum HCV-RNA(2) or anti-HCV(3). The approved labeling in the EU for PEGINTRON indicates that the optimal treatment for chronic hepatitis C is considered to be the administration of a combination of interferon alfa-2b with ribavirin. The safety and efficacy of the combination of PEGINTRON and ribavirin has not yet been documented. PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or 1.0 mcg/kg once weekly for at least six months. In patients showing loss of HCV-RNA at six months, treatment is continued for an additional six months, i.e. for a total course of treatment of one year. A worldwide, controlled clinical study designed to establish the activity and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult patients with previously untreated chronic hepatitis C and compensated liver disease. A total of 1,219 patients, who were positive for serum HCV-RNA and who had elevated liver enzymes (serum alanine aminotransferase), were treated with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The primary efficacy endpoint of the study was sustained loss of detectable HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all three doses studied was shown to be superior to, and as safe as, INTRON A in treating all HCV genotypes. The study results showed that sustained virologic responses were achieved in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON A. In patients having genotype 2 or 3 and low viral load (<2 million copies/ml), sustained virologic responses were achieved in 62% of patients treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON 0.5 mcg/kg, compared to 36% of patients treated with INTRON A. The demographic/disease characteristics of patients in this study were similar to those in previous Schering-Plough hepatitis C registration studies, with a majority of patients having genotype 1, the most difficult genotype to treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml). Adverse events (AEs) for all doses of PEGINTRON were similar to those for INTRON A. Most AEs were mild to moderate and were manageable with dose adjustment. Discontinuation of therapy due to AEs was similar for all treatment groups (6-11%). Dose reductions were similar for INTRON A and PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%, 14% and 19%, respectively). The most common side effects occurring with PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and fever, which appeared to decrease in severity as treatment continued. Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as 5 million Europeans (1 to 2 percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. In the United States, Schering-Plough on Dec. 23, 1999, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of chronic hepatitis C. Some 4 million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDC). INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A worldwide for 16 major antiviral and anticancer indications. REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. (1) Elevated enzyme levels indicating ongoing liver inflammation. (2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid). (3) Anti-HCV: antibodies to hepatitis C virus. SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Sharon Nicholson Hepatitis Education & Patient Coalition (H. E. P. C. in AZ) Executive Director <A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B, C's - editor Suite101.com</A> http://www.suite101.com/welcome.cfm/hepatitis_abc Join our e-group mailing list online! <A HREF= " ArizonaHepatitis C " >eGroups : ArizonaHepatitis C</A> ArizonaHepatitis C Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 9, 2000 Report Share Posted October 9, 2000 Ruth, As far as I know here in the USA, it has not been released for us. I talked to my Dr. today and asked him the same ? If anyone knows, please let us know. Also I heard a weird thing, actually read it. That Ribivirin is RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this please. Janet xoxoxo Ps. Best to you Ruth! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2000 Report Share Posted October 10, 2000 Ruth, I also have more problems now than before combo... it was good just to get a confirmation that that can happen though I am sorry for you and your husband. What problems does he have as a result of treatment? I have extremely sensitive skin and emotional agitation... Always, Mesa >From: " Ruth White " <rwhite@...> >Reply-Hepatitis Cegroups ><Hepatitis Cegroups> >Subject: Re: PEG >Date: Tue, 10 Oct 2000 09:50:15 -0500 > >Thanks for your reply Janet. As far as the Ribavirin being radioactive, I >wouldn't be a bit surprised. I don't have much faith in doctors lately. My >husband did the combo and has more problems now that he had before. >Anxiously await the outcome of the PEG trials. Take care. Ruth > > >>> jlyjan@... 10/09/00 03:32PM >>> >Ruth, As far as I know here in the USA, it has not been released for us. I >talked to my Dr. today and asked him the same ? If anyone knows, please let >us know. Also I heard a weird thing, actually read it. That Ribivirin is >RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this >please. Janet xoxoxo Ps. Best to you Ruth! > > > > > > _________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com. Share information about yourself, create your own public profile at http://profiles.msn.com. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2000 Report Share Posted October 10, 2000 Thanks for your reply Janet. As far as the Ribavirin being radioactive, I wouldn't be a bit surprised. I don't have much faith in doctors lately. My husband did the combo and has more problems now that he had before. Anxiously await the outcome of the PEG trials. Take care. Ruth >>> jlyjan@... 10/09/00 03:32PM >>> Ruth, As far as I know here in the USA, it has not been released for us. I talked to my Dr. today and asked him the same ? If anyone knows, please let us know. Also I heard a weird thing, actually read it. That Ribivirin is RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this please. Janet xoxoxo Ps. Best to you Ruth! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2000 Report Share Posted October 10, 2000 He had extremely sensitive skin before doing the combo because he also has a medical condition called PCT (Porphyria Cutanea Tarda) which in short means sensitive to the sun, it's also a liver/blood disorder. The combo aggravated this previous condition making his skin blister and sensitive, it's getting a little better now as long as he gets phlebotomized every 4 months, keeping his iron levels down. He also developed a rash that won't go away as a result of the combo and has a hard time remembering things. He also has a short fuse, very little patience. Such fun. >>> wintermesa@... 10/10/00 02:38PM >>> Ruth, I also have more problems now than before combo... it was good just to get a confirmation that that can happen though I am sorry for you and your husband. What problems does he have as a result of treatment? I have extremely sensitive skin and emotional agitation... Always, Mesa >From: " Ruth White " <rwhite@...> >Reply-Hepatitis Cegroups ><Hepatitis Cegroups> >Subject: Re: PEG >Date: Tue, 10 Oct 2000 09:50:15 -0500 > >Thanks for your reply Janet. As far as the Ribavirin being radioactive, I >wouldn't be a bit surprised. I don't have much faith in doctors lately. My >husband did the combo and has more problems now that he had before. >Anxiously await the outcome of the PEG trials. Take care. Ruth > > >>> jlyjan@... 10/09/00 03:32PM >>> >Ruth, As far as I know here in the USA, it has not been released for us. I >talked to my Dr. today and asked him the same ? If anyone knows, please let >us know. Also I heard a weird thing, actually read it. That Ribivirin is >RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this >please. Janet xoxoxo Ps. Best to you Ruth! > > > > > > _________________________________________________________________________ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com. Share information about yourself, create your own public profile at http://profiles.msn.com. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2000 Report Share Posted October 10, 2000 HI..... When you all talk about the " combo " treatment, what exactly is that? I have just now gone to a GI Dr. that is talking about some kind of new treatment he wants me to try. I think he mentioned the word 'combo' but I can't remember exactly what he called it. It was where I would go to his office once a week to get an injection, for 3-6 months. Can anyone offer any info on this? He was shocked that my Drs. have known of my HepC for over 4 yrs, and had not referred me to a specialist. Thanks for any help..... Sherry from NC Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 11, 2000 Report Share Posted October 11, 2000 At 03:19 PM 10/10/2000 -0500, you wrote: > He also developed a rash that won't go away as a >result of the combo and has a hard time remembering things. He also has a >short fuse, very little patience. Such fun. > Right there with you, Ruth and Mesa. My husband's always had extremely dry skin in winter, and this year it's cracking open and bleeding if I don't slather his back with lotion at least 2-3 times a day. He had some success with Zoloft for his depression and irritability, but combined with the taste changes from the combo it completely eliminated his ability to taste anything. Since he's already lost 30 pounds, this was a problem so he quit taking the zoloft and is back to snapping my head off if I hesitate when speaking or answer yes/no questions with too much explanation. It's like he can't stand the sound of my voice. (He'd become very affectionate again on the zoloft.) He's been given another prescription to try, but keeps saying he's not depressed, he can manage it himself. At least his blood work says his viral load is undetectable -- now if we can just get through 6 more months without our relationship becoming undetectable . . . Hepatitis Neighborhood just had a chat on anxiety and mood disorders - they had some technical problems, so there's not as much info as usual but you can see the transcript in the Town Hall archive. According to the physician who hosted, the depression is caused by the combo's effect on seratonin in the brain. I hadn't read that before. That's why it's usually treated with zoloft, paxil or another seratonin uptake inhibitor. Last night was a chat on side effects, the transcript should be up by Friday. (I never go to the chats, but I like to read the transcripts.) Belinda Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 11, 2000 Report Share Posted October 11, 2000 At 09:17 PM 10/10/2000 -0400, you wrote: >HI..... >When you all talk about the " combo " treatment, what exactly is that? I have >just now gone to a GI Dr. that is talking about some kind of new treatment he >wants me to try. I think he mentioned the word 'combo' but I can't remember >exactly what he called it. It was where I would go to his office once a week >to get an injection, for 3-6 months. Can anyone offer any info on this? Hi Sherry - Sounds like he might be putting you in a trial for pegalated Interferon and Ribivirin, although that's usually a 36 or 48 week program. Right now people taking the Combo (interferon & ribivirin) usually take 3 interferon shots a week, plus ribivirin pills every day. (There are some studies doing daily shots.) " Pegalated " (and I'm probably misspelling it) is a time-release process that only requires one shot a week. Peg interferon is supposed to have FDA approval early next year, but peg plus ribivirin as a combo is still in clinical trials. I really, really recommend you go to www.hepatitis-central.com for info on combo therapy, and talk, talk, talk to your doctor until you're comfortable with what he's planning. It's a hard course of treatment, you need to know what to expect (both in terms of how you're going to feel while on it and what you may or may not gain from it) and YOU need to make an active decision about whether to do it or not. www.hepatitisneighborhood.com is another useful site (you have to register). And of course, ask lots of questions here - there are wonderful, compassionate people on this list and between us we've accumulated lots of resources. Wishing you the best, Sherry - Belinda Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 11, 2000 Report Share Posted October 11, 2000 Thanks Belinda! I know that the Dr. said this treatment was new. He also mentioned a study he is still conducting in Columbia, SC. Apparently, I was one of his first " official " patients....the day he saw me was his first day practicing as a Dr. He told me that he had studied in Columbia, SC and all of his clinical work has been on the liver. He says he specializes in liver disorders. I asked a lot about the side effects. He said that in the 70 patients he has been following, one has suffered severe depression (to the point of being suicidal; but this patient was already on anti-depressants before starting the treatment), and one lady lost all her hair. He also mentioned the possibility of flu like symptoms, bone marrow problems, and a few other things. He told me he was trying to be as up-front about the side effects as possible. He says that in 65-70 percent of the cases reported, the virus is undetectable after treatment. Like I said, I am still in the learning process. It is scary to think of all these possible side effects, when I am having no problems at the moment. I have never been on any meds, and have had no ill effects from the HepC as far as I can tell so far. I will check out those places you mentioned, and I appreciate your help!! Thanks again...... Sherry from NC Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 12, 2000 Report Share Posted October 12, 2000 Something you all might like to consider participating in. I did. http://www.hepcchallenge.org/HTML/SURVEY.htm Re: PEG > At 09:17 PM 10/10/2000 -0400, you wrote: > >HI..... > >When you all talk about the " combo " treatment, what exactly is that? I have > >just now gone to a GI Dr. that is talking about some kind of new treatment he > >wants me to try. I think he mentioned the word 'combo' but I can't remember > >exactly what he called it. It was where I would go to his office once a week > >to get an injection, for 3-6 months. Can anyone offer any info on this? > > Hi Sherry - > > Sounds like he might be putting you in a trial for pegalated Interferon and > Ribivirin, although that's usually a 36 or 48 week program. > > Right now people taking the Combo (interferon & ribivirin) usually take 3 > interferon shots a week, plus ribivirin pills every day. (There are some > studies doing daily shots.) " Pegalated " (and I'm probably misspelling it) > is a time-release process that only requires one shot a week. Peg > interferon is supposed to have FDA approval early next year, but peg plus > ribivirin as a combo is still in clinical trials. > > I really, really recommend you go to www.hepatitis-central.com for info on > combo therapy, and talk, talk, talk to your doctor until you're comfortable > with what he's planning. It's a hard course of treatment, you need to know > what to expect (both in terms of how you're going to feel while on it and > what you may or may not gain from it) and YOU need to make an active > decision about whether to do it or not. www.hepatitisneighborhood.com is > another useful site (you have to register). And of course, ask lots of > questions here - there are wonderful, compassionate people on this list and > between us we've accumulated lots of resources. > > Wishing you the best, Sherry - > > Belinda > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 18, 2003 Report Share Posted December 18, 2003 <<<<<I'm thinking about, first seeing if I can find other AS families in the area that are interested, and then purchasing a set of social skills curriculum to use at our meetings. I also need to check around and see if I can find a place where we can hold our meetings (our place is pretty small and cramped). >>> Nothing like a Borg Mom in action! Good luck ,Peg!! F Quote Link to comment Share on other sites More sharing options...
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