AASLD eNews: October 21, 2010
By Morgan Fincham, AASLD Staff
Paul J. Pockros, MD, head of the Division of Gastroenterology/Hepatology and Director of the SC Liver Research Consortium at the Scripps Clinic and Adjunct Associate Professor at The Scripps Research Institute, provides a look at the first ever Hepatitis Debrief being launched at The Liver Meeting® 2010.
Telapravir and Boceprevir have completed phase 3 trials and are both being formally presented at the meeting. “We expect widespread use of these drugs in the US and the EU,” Dr. Pockros cautions, “but there is a significant concern that there will be improper use of these drugs because of a poor understanding of treatment regimens, treatment of special populations, and monitoring for antiviral resistance. “The focus group developed by AASLD earlier this year decided to establish the viral hepatitis debrief as a way to address these concerns,” Dr. Pockros explains. AASLD is worried that physicians with improper education will use these new drugs in a casual manner, resulting in antiviral resistance to the class of drug, as happened with HIV. Dr. Pockros elucidates that HIV treatment and subsequent antiviral drug resistance is the model of caution used to formulate this debrief.
The rate of antiviral drug development will increase rapidly in the next 12-24 months. “What we are discussing this year is the first era of antivirals to be out in 2011,” Dr. Pockros elaborates. “Many of the other drugs presented at The Liver Meeting® won’t be approved by the FDA until 2014 or later.” The Hepatitis Debrief will be held every year, rapidly synthesizing the new data and keeping medical professionals current and correctly educated.
The clinical task force collaborating with Dr. Pockros as chair is comprised of Douglas Dieterich, MD; Fred Poordad, MD; Kirti Shetty, MD; and Donald Jensen, MD. They have designed the program to cover changes in pre-treatment predictors of response, monitoring of resistance during treatment, treatment of special populations, lessons from the phase 3 trials, and an overarching theme of what will be different about therapy that doctors can expect next year. There is also a list of new acronyms of antivirals and virology that doctors will have to learn.
To aid medical professionals in learning this new information, an enduring document will be made available for reference a few short months following the meeting, both online and in print. “We cannot make true AASLD guidelines,” Dr. Pockros elaborates, “until the drugs are labeled by the FDA. However, we can provide a set of rules to follow for anyone treating patients with hepatitis C.” The slides of the Hepatitis Debrief will be available as part of the Best of The Liver Meeting®.
“All hepatologists don’t know about these antivirals yet,” Dr. Pockros expounds. “These rules are new and our knowledge in special populations such as HIV-coinfected patients and decompensated cirrhosis patients is lacking. This program will benefit anyone who is seeing patients in the next year, hepatologists and non-hepatologists alike.” Attendees will walk away from this half-hour presentation with up-to-date information they may use in treating hepatitis C patients in 2011.
By Morgan Fincham, AASLD Staff
Paul J. Pockros, MD, head of the Division of Gastroenterology/Hepatology and Director of the SC Liver Research Consortium at the Scripps Clinic and Adjunct Associate Professor at The Scripps Research Institute, provides a look at the first ever Hepatitis Debrief being launched at The Liver Meeting® 2010.
Telapravir and Boceprevir have completed phase 3 trials and are both being formally presented at the meeting. “We expect widespread use of these drugs in the US and the EU,” Dr. Pockros cautions, “but there is a significant concern that there will be improper use of these drugs because of a poor understanding of treatment regimens, treatment of special populations, and monitoring for antiviral resistance. “The focus group developed by AASLD earlier this year decided to establish the viral hepatitis debrief as a way to address these concerns,” Dr. Pockros explains. AASLD is worried that physicians with improper education will use these new drugs in a casual manner, resulting in antiviral resistance to the class of drug, as happened with HIV. Dr. Pockros elucidates that HIV treatment and subsequent antiviral drug resistance is the model of caution used to formulate this debrief.
The rate of antiviral drug development will increase rapidly in the next 12-24 months. “What we are discussing this year is the first era of antivirals to be out in 2011,” Dr. Pockros elaborates. “Many of the other drugs presented at The Liver Meeting® won’t be approved by the FDA until 2014 or later.” The Hepatitis Debrief will be held every year, rapidly synthesizing the new data and keeping medical professionals current and correctly educated.
The clinical task force collaborating with Dr. Pockros as chair is comprised of Douglas Dieterich, MD; Fred Poordad, MD; Kirti Shetty, MD; and Donald Jensen, MD. They have designed the program to cover changes in pre-treatment predictors of response, monitoring of resistance during treatment, treatment of special populations, lessons from the phase 3 trials, and an overarching theme of what will be different about therapy that doctors can expect next year. There is also a list of new acronyms of antivirals and virology that doctors will have to learn.
To aid medical professionals in learning this new information, an enduring document will be made available for reference a few short months following the meeting, both online and in print. “We cannot make true AASLD guidelines,” Dr. Pockros elaborates, “until the drugs are labeled by the FDA. However, we can provide a set of rules to follow for anyone treating patients with hepatitis C.” The slides of the Hepatitis Debrief will be available as part of the Best of The Liver Meeting®.
“All hepatologists don’t know about these antivirals yet,” Dr. Pockros expounds. “These rules are new and our knowledge in special populations such as HIV-coinfected patients and decompensated cirrhosis patients is lacking. This program will benefit anyone who is seeing patients in the next year, hepatologists and non-hepatologists alike.” Attendees will walk away from this half-hour presentation with up-to-date information they may use in treating hepatitis C patients in 2011.
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