Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
This is posted by request, for those who's Doctor wanted proof of shorter therapy on genotype 1.
In my opinion, the therapy should be as I had heard a few years back, adding 36 weeks to the 4th week of being cleared of the virus, as per PCR test, but Schering, are encouraging therapy to be cut at week 24, but I wouldn't go that far if it was in my case.
I should also mention, that I was on peg/riba from Schering-Plough medications when I did my journey, and have been cured from hep c, genotype 1a.
Mckenzie
Shorter course of treatment approved for cetain HCV patients with genotype 1 and low viral load.
Shorter Course Combination Therapy Approved in European Union for Certain Hepatitis C Patients with Genotype 1 and Low Viral Load
Schering-Plough Corporation today announced that the European Commission has approved revised dosing instructions allowing for a shorter, 24-week course of Pegitron(R) (1.5 mcg/kg once weekly) and Rebetol(R) (800 - 1,200 mg daily) combination therapy among a subgroup of patients with chronic hepatitis C virus (HCV) genotype 1 infection and low viral load (less than 600,000 IU/ml) who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week 4 of treatment that is maintained through week 24. The approval follows a positive opinion granted on July 28, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
Approval of this shorter combination treatment regimen cuts by half the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load. This is the only treatment regimen approved in the European Union (EU) for a 24-week course of therapy in certain genotype 1 patients. In clinical studies supporting the approval, 92 percent of patients who met the criteria for early response achieved a sustained virologic response (SVR) with 24 weeks of treatment.
"Physicians now have the opportunity to consider a shorter course of therapy for their patients with hepatitis C genotype 1 who meet specific criteria," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, and lead investigator of the study supporting the approval. "Tailoring treatment so that those with an early response are treated for only 24 weeks rather than 48 weeks may make therapy more appealing to patients, providing comparable efficacy with better tolerability," he said.
"Approval of this shorter course of Pegitron and Rebetol combination therapy reflects the ongoing commitment of Schering-Plough to define optimal dose and treatment schedules to better meet the needs of hepatitis C patients," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The Commission approval results in Marketing Authorization with unified labeling that is valid in the current EU 25 member states as well as in Iceland and Norway. Pegitron and Rebetol combination therapy was previously approved in the EU for a 48-week course of therapy for all patients with genotype 1 who exhibit virological response at week 12.
Study Results
The approved labeling change is based on results of a clinical study involving 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with Pegitron (1.5 mcg/kg once weekly) and Rebetol (800 - 1,400 mg daily); only two patients weighing more than 105 kg received the 1,400 mg dose. In the study, 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week 4 and week 24 of therapy. Patients in this subgroup achieved a 92 percent (89/97) rate of sustained virological response. The high SVR in this group of patients was identified in an interim analysis and prospectively confirmed.
Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall, varying by geography. For patients with HCV genotypes 2 or 3, the EU labeling for Pegitron recommends that all patients be treated for 24 weeks. Patients infected with HCV genotype 4 are considered harder to treat and generally 48 weeks of therapy is recommended.
In my opinion, the therapy should be as I had heard a few years back, adding 36 weeks to the 4th week of being cleared of the virus, as per PCR test, but Schering, are encouraging therapy to be cut at week 24, but I wouldn't go that far if it was in my case.
I should also mention, that I was on peg/riba from Schering-Plough medications when I did my journey, and have been cured from hep c, genotype 1a.
Mckenzie
Shorter course of treatment approved for cetain HCV patients with genotype 1 and low viral load.
Shorter Course Combination Therapy Approved in European Union for Certain Hepatitis C Patients with Genotype 1 and Low Viral Load
Schering-Plough Corporation today announced that the European Commission has approved revised dosing instructions allowing for a shorter, 24-week course of Pegitron(R) (1.5 mcg/kg once weekly) and Rebetol(R) (800 - 1,200 mg daily) combination therapy among a subgroup of patients with chronic hepatitis C virus (HCV) genotype 1 infection and low viral load (less than 600,000 IU/ml) who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week 4 of treatment that is maintained through week 24. The approval follows a positive opinion granted on July 28, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
Approval of this shorter combination treatment regimen cuts by half the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load. This is the only treatment regimen approved in the European Union (EU) for a 24-week course of therapy in certain genotype 1 patients. In clinical studies supporting the approval, 92 percent of patients who met the criteria for early response achieved a sustained virologic response (SVR) with 24 weeks of treatment.
"Physicians now have the opportunity to consider a shorter course of therapy for their patients with hepatitis C genotype 1 who meet specific criteria," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, and lead investigator of the study supporting the approval. "Tailoring treatment so that those with an early response are treated for only 24 weeks rather than 48 weeks may make therapy more appealing to patients, providing comparable efficacy with better tolerability," he said.
"Approval of this shorter course of Pegitron and Rebetol combination therapy reflects the ongoing commitment of Schering-Plough to define optimal dose and treatment schedules to better meet the needs of hepatitis C patients," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The Commission approval results in Marketing Authorization with unified labeling that is valid in the current EU 25 member states as well as in Iceland and Norway. Pegitron and Rebetol combination therapy was previously approved in the EU for a 48-week course of therapy for all patients with genotype 1 who exhibit virological response at week 12.
Study Results
The approved labeling change is based on results of a clinical study involving 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with Pegitron (1.5 mcg/kg once weekly) and Rebetol (800 - 1,400 mg daily); only two patients weighing more than 105 kg received the 1,400 mg dose. In the study, 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week 4 and week 24 of therapy. Patients in this subgroup achieved a 92 percent (89/97) rate of sustained virological response. The high SVR in this group of patients was identified in an interim analysis and prospectively confirmed.
Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall, varying by geography. For patients with HCV genotypes 2 or 3, the EU labeling for Pegitron recommends that all patients be treated for 24 weeks. Patients infected with HCV genotype 4 are considered harder to treat and generally 48 weeks of therapy is recommended.
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I gave my 2 week notice last Friday 13th. Now to join you fine people in a life of leisure and nothing else to do but to look out for myself....is it just me or does that sound pretty boring? My goal was to live to retire and I guess having to take early retirement because of health reasons wasn't exactly the way I had planned things. I just can't stay in that building that is reeking mildew...
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I'm trying to exercise daily. I was doing fairly well until I sprained my ankle 2 weeks ago but now I'm getting back on the horse. Today I walked over a mile with my arm weights that are about 22lbs total. I was out of shape and it was hard on my arms. I also did my 30 situps. I'm also going to drink a lot of water and try to eat healthy. I do tend to have a sweet tooth but I'm cutting...
You're a doll Mckenzie!