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No new therapy has been approved for the treatment of chronic hepatitis C in the last 5 years in the USA since the approval of pegylated interferon (IFN)-alpha(2a) and ribavirin. Multiple new drugs are currently in development and are expected to be approved for use in the USA and/or the EU by 2011-2013. Although the mechanism of action of pegylated IFN and ribavirin are not completely known, it is likely that they will continue to be used in combination regimens for a number of years. Direct antivirals are likely to be the first new drugs to be used in combination with pegylated IFN and ribavirin. Viral resistance will prove to be a significant barrier and require that consolidation therapy with at least 24 weeks of pegylated IFN and ribavirin be used to successfully prevent the selection or emergence of resistant variants. Numerous other compounds, such as ribavirin analogs, long-acting IFNs, hepatoprotectants and immunomodulators, are in development and may replace the drugs that are used currently. The combination of direct antivirals, such as protease and polymerase inhibitors, may rapidly follow in development, as has occurred in HIV drug therapy.
No new therapy has been approved for the treatment of chronic hepatitis C in the last 5 years in the USA since the approval of pegylated interferon (IFN)-alpha(2a) and ribavirin. Multiple new drugs are currently in development and are expected to be approved for use in the USA and/or the EU by 2011-2013. Although the mechanism of action of pegylated IFN and ribavirin are not completely known, it is likely that they will continue to be used in combination regimens for a number of years. Direct antivirals are likely to be the first new drugs to be used in combination with pegylated IFN and ribavirin. Viral resistance will prove to be a significant barrier and require that consolidation therapy with at least 24 weeks of pegylated IFN and ribavirin be used to successfully prevent the selection or emergence of resistant variants. Numerous other compounds, such as ribavirin analogs, long-acting IFNs, hepatoprotectants and immunomodulators, are in development and may replace the drugs that are used currently. The combination of direct antivirals, such as protease and polymerase inhibitors, may rapidly follow in development, as has occurred in HIV drug therapy.
Chronic hepatitis C virus infection occurs worldwide and affects over 2.7 million adults in North America. Current standard of care is the combination of pegylated (peg) interferon and ribavirin for 24 weeks in hepatitis C virus genotypes 2 or 3 and at least 48 weeks in chronic hepatitis C virus infection genotypes 1 or 4. Peginterferon-α2a is a 40-kDa linear pegylated molecule that alters the pharmacokinetic properties of unmodified interferon-α. In clinical trials evaluating the combination of peginterferon-α2a and ribavirin in chronic chronic hepatitis C virus infection, sustained virologic response rates have been achieved in 46–52% of patients with genotype 1 and 76–80% of patients with genotypes 2 or 3. Studies on the role of longer treatment duration and retreatment in prior nonresponders are in progress. The main toxicities of peginterferon-α2a are flu-like symptoms and neuropsychiatric disorders, especially depression and cytopenias, and are found in similar rates to those observed with regular inteferon. Future areas of study include the role of peginterferon-α2a in combination with the newer oral chronic hepatitis C virus infection active agents in development.
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