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Possible Clinical Trials during the next ten years
by dointime, Oct 03, 2007 06:02AM
http://clinicaloptions.com/Hepatitis/Treatment%20Updates/Small%20
Molecule%20HCV%20Agents/Modules/Chung.aspx
Interesting article. Especially what is foreseen in the next ten years:-
Possible Clinical Trials During the Next 10 Years
During the next 5 years, we can expect to see the completion of add-on trials examining STAT-C compounds plus standard of care vs standard of care to identify the best treatment regimen (Figure 4). We can also expect to see trials of standard of care plus STAT-C in difficult-to-treat populations, such as those with HCV/HIV coinfection and those who are postliver transplantation recipients. It is hoped that several regimens will demonstrate superiority to standard of care and be approved as the new standard of care.
In the following 5 years, studies may be more realistically designed to improve the quality rather than the efficacy of therapy, since with higher baseline SVR rates, the bar for demonstrating superiority will be set even higher than at present. Therefore, studies to define shorter regimens, as well as strategies to substitute a less toxic STAT-C agent for another agent such as ribavirin, will likely be conducted using noninferiority study designs.
This same period will also likely see the development of multidrug (at least 3 drugs) combination regimens to attempt to produce SVR without dependence on interferon with or without ribavirin backbones. These combinations could include 3 or more STAT-C agents or 2 or more STAT-C agents plus a host cofactor inhibitor. These studies would most reasonably be tested first in populations with active contraindications or historical intolerance to interferon-based therapy.
Molecule%20HCV%20Agents/Modules/Chung.aspx
Interesting article. Especially what is foreseen in the next ten years:-
Possible Clinical Trials During the Next 10 Years
During the next 5 years, we can expect to see the completion of add-on trials examining STAT-C compounds plus standard of care vs standard of care to identify the best treatment regimen (Figure 4). We can also expect to see trials of standard of care plus STAT-C in difficult-to-treat populations, such as those with HCV/HIV coinfection and those who are postliver transplantation recipients. It is hoped that several regimens will demonstrate superiority to standard of care and be approved as the new standard of care.
In the following 5 years, studies may be more realistically designed to improve the quality rather than the efficacy of therapy, since with higher baseline SVR rates, the bar for demonstrating superiority will be set even higher than at present. Therefore, studies to define shorter regimens, as well as strategies to substitute a less toxic STAT-C agent for another agent such as ribavirin, will likely be conducted using noninferiority study designs.
This same period will also likely see the development of multidrug (at least 3 drugs) combination regimens to attempt to produce SVR without dependence on interferon with or without ribavirin backbones. These combinations could include 3 or more STAT-C agents or 2 or more STAT-C agents plus a host cofactor inhibitor. These studies would most reasonably be tested first in populations with active contraindications or historical intolerance to interferon-based therapy.
Member Comments (1)
by GrandmaA, Oct 03, 2007 09:09AM
To: dointime
Thanks for sharing this. It's very interesting. And gives patients hope.
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