Aa
clevudine(revovir)
how do you ***** this anti-virals?????????
all other drugs are too weak and lead to resistance on the contrary hbsag decrease by tenofovir projections take 17 years only with 0%resistance
clarification about clevudine ban, i used the wrong word the drug maker stopped its development in 2009 because the severe sides and because high resistance rates vs tenofovir (av. since 2000) with 0% resistance, no relevant sides
first line drugs for hbv on all guidelines are only peginterferon ,tenofovir, entecavir.all other drugs are too weak and lead to resistance on the contrary hbsag decrease by tenofovir projections take 17 years only with 05 resistance
http://www.verusmed.com/articles/view/60039/
Pharmasset stops Phase III trials for clevudine HBV treatment candidate
Monday, April 20 2009 | Comments
Evidence Grade 0 What's This?
Pharmasset Inc. terminated its Phase III QUASH studies of clevudine as a treatment for chronic hepatitis B infection after learning that patients being treated with the drug in South Korea had developed more serious cases of myopathy than the mild to moderate cases seen among QUASH participants.
The decision came after discussions with the independent Data and Safety Monitoring Board and the Food and Drug Administration.
The international, double-blind, randomized QUASH trials were comparing clevudine 30 mg/day with Gilead Sciences Inc.'s Hepsera (adefovir dipivoxil) 10 mg/d during a 96-week treatment regimen in patients with chronic hepatitis B who had not been treated with nucleoside agents. The primary objective was to assess clevudine's ability to reduce serum levels of the virus and to normalize liver function at 48 weeks after starting therapy.
Pharmasset noted that a small number of mild to moderate cases of myopathy, or muscle weakness linked to elevated levels of creatine kinase, had occurred among QUASH participants. However, the company became aware that more serious cases of the condition had been reported by patients being treated with the drug in South Korea, where clevudine is approved and marketed as Levovir by Bukwang Pharmaceutical Co. Ltd. Pharmasset said those patients have been exposed to the drug for longer periods relative to the trial participants.
"Although the number of cases of myopathy in the QUASH trials was low and the severity was mild, more severe reports from other trials and postmarketing surveillance led us to believe the risk-benefit ratio for clevudine was insufficient to continue development," said Dr. Michelle Berrey, Pharmasset's chief medical officer.
The firm said it plans to continue collecting safety data and will monitor patients after the trials have stopped, but it will not submit the research results to regulators as pivotal studies. The company added that it will now focus on its hepatitis C pipeline.
first line drugs for hbv on all guidelines are only peginterferon ,tenofovir, entecavir.all other drugs are too weak and lead to resistance on the contrary hbsag decrease by tenofovir projections take 17 years only with 05 resistance
http://www.verusmed.com/articles/view/60039/
Pharmasset stops Phase III trials for clevudine HBV treatment candidate
Monday, April 20 2009 | Comments
Evidence Grade 0 What's This?
Pharmasset Inc. terminated its Phase III QUASH studies of clevudine as a treatment for chronic hepatitis B infection after learning that patients being treated with the drug in South Korea had developed more serious cases of myopathy than the mild to moderate cases seen among QUASH participants.
The decision came after discussions with the independent Data and Safety Monitoring Board and the Food and Drug Administration.
The international, double-blind, randomized QUASH trials were comparing clevudine 30 mg/day with Gilead Sciences Inc.'s Hepsera (adefovir dipivoxil) 10 mg/d during a 96-week treatment regimen in patients with chronic hepatitis B who had not been treated with nucleoside agents. The primary objective was to assess clevudine's ability to reduce serum levels of the virus and to normalize liver function at 48 weeks after starting therapy.
Pharmasset noted that a small number of mild to moderate cases of myopathy, or muscle weakness linked to elevated levels of creatine kinase, had occurred among QUASH participants. However, the company became aware that more serious cases of the condition had been reported by patients being treated with the drug in South Korea, where clevudine is approved and marketed as Levovir by Bukwang Pharmaceutical Co. Ltd. Pharmasset said those patients have been exposed to the drug for longer periods relative to the trial participants.
"Although the number of cases of myopathy in the QUASH trials was low and the severity was mild, more severe reports from other trials and postmarketing surveillance led us to believe the risk-benefit ratio for clevudine was insufficient to continue development," said Dr. Michelle Berrey, Pharmasset's chief medical officer.
The firm said it plans to continue collecting safety data and will monitor patients after the trials have stopped, but it will not submit the research results to regulators as pivotal studies. The company added that it will now focus on its hepatitis C pipeline.
The most important things is to get your doctor's opinion when selecting the right medication for Hepatitis B. No two human beings react to a drug in exactly the same way. The only good medication is the one that works well for you.
hbvdna undetactable in the blood doesn t mean undetactable in the liver, replication goesn on both as hbvdna, intraepatic hbvdna, cccdna
yes antivirals makes impossible to develop cirrhosis and fibrosis increase is extremely rare but hepatitistechnologies products have a stronger effect regressing or blocking liver damage and probably preventing liver cancer too
antivirals lower risk of liver cancer but liver cancer can happen anyway even if hbvdna is und
if you can afford tenofovir+hepatitistechnologies products is the best choice
but it the virus reach on undetectable level could you consider the patient safe for the possible worse case scenario for the liver, i mean safe from cancer or cirrhosis?
and tenofovir is the most potent
of course these antivirals are useless on hbv infection they only lower replication to block liver damage but no effect on hbv
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