Medical societies launch new hepatitis C treatment guidelines
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02.02.2014
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http://www.eatg.org/news/169645/US_medical_societies_launch_new_hepatitis_C_treatment_guidelines
The American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA) and International Antiviral Society-USA (IAS-USA) yesterday announced the first new hepatitis C treatment guidelines to include next-generation direct-acting antiviral agents recently approved by the US Food and Drug Administration (FDA).
The guidelines are intended for use by both hepatologists and infectious disease doctors who have traditionally treated people with hepatitis C, as well as by other types of providers who will be called on to treat the growing number of people seeking care due to expanded screening and availability of better treatments.
Recommendations for initial therapy for people with hepatitis C virus (HCV) who have decided to start treatment include the following:
For initial treatment of genotype 1 hepatitis C, the panel recommends the recently approved HCV polymerase inhibitor sofosbuvir (Sovaldi) plus weight-based ribavirin and pegylated interferon for 12 weeks, regardless of HCV subtype 1a or 1b.
An alternative is the HCV protease inhibitor simeprevir (Olysio) for 12 weeks plus pegylated interferon and ribavirin for 24 weeks for people with genotype 1b or those with 1a who do not carry the Q80K resistance mutation.
For people with genotype 1 who cannot take interferon, the panel recommends sofosbuvir plus simeprevir, with or without ribavirin, for 12 weeks. This off-label regimen has not been through phase 3 testing, but performed very well in the phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for people with liver cirrhosis.
For people with easier-to-treat HCV genotype 2, the panel recommends first-line treatment using sofosbuvir plus weight-based ribavirin for 12 weeks.
For people with HCV genotype 3, the recommendation is sofosbuvir plus weight-based ribavirin for 24 weeks, with an alternative of sofosbuvir plus ribavirin plus pegylated interferon for 12 weeks.
For people with HCV genotype 4 which has not been as extensively studied the panel chose sofosbuvir plus weight-based ribavirin and pegylated interferon for 12 weeks, or sofosbuvir plus ribavirin alone for 24 weeks for patients who cannot use interferon. An alternative is simeprevir for 12 weeks plus pegylated interferon/ribavirin for 24-48 weeks.
For people with HCV genotype 5 or 6 about which even less is known the recommendation is sofosbuvir plus weight-based ribavirin for 12 weeks, with an alternative of pegylated interferon/ribavirin for 48 weeks.
Recommendations for re-treating people who did not respond to prior interferon-based therapy include:
For re-treatment of people with HCV genotype 1, the panel recommends sofosbuvir plus simeprevir, with or without weight-based ribavirin, for 12 weeks. Alternative regimens combine sofosbuvir or simeprevir with pegylated interferon and ribavirin for 24 to 48 weeks.
The panel recommends sofosbuvir plus weight-based ribavirin for 12 or 24 weeks for re-treatment of prior non-responders with genotype 2 or 3, respectively. Again, alternative regimens include pegylated interferon and ribavirin.
The recommended second-line treatment for HCV genotypes 4, 5, and 6 is sofosbuvir plus weight-based ribavirin and pegylated interferon for 12 weeks, with an alternative of 24 weeks of sofosbuvir plus ribavirin alone for those who cannot take interferon.
Recommendations for people with HIV/HCV co-infection include:
For co-infection with HCV genotype 1 either treatment-naive or prior relapsers the panel recommends sofosbuvir, weight-based ribavirin plus pegylated interferon for 12 weeks.
For people with HIV/HCV co-infection who are unwilling or unable to take interferon, alternatives include sofosbuvir plus ribavirin alone for 24 weeks. Another option is sofosbuvir plus simeprevir, with or without ribavirin, but simeprevir can interact with several HIV drugs.
The panel's recommendations for people with HIV/HCV co-infection with genotypes 2 or 3 are the same as for those with HCV alone, that is, sofosbuvir plus ribavirin for 12 or 24 weeks, respectively.
For almost all patients, the panel specifically recommends against the old standard of care, pegylated interferon plus ribavirin alone. They also advise against regimens containing the first-generation HCV protease inhibitors boceprevir (Victrelis) or telaprevir (Incivo), which can improve cure rates compared to interferon/ribavirin alone but come with added side-effects and potential for drug interactions.
