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Sofosbuvir + simeprevir shows good results for hepatitis C in real-world use
Liz Highleyman, 2014-12-02 08:10:00
Regimens containing sofosbuvir
(Sovaldi) – including sofosbuvir plus
simeprevir (Olysio) – work well for people
with hepatitis C genotype 1 in real-world use, which to date has included some
of the patients most urgently in need of treatment at the dawn of the
interferon-free era, according to a pair of presentations at the American
Association for the Study of Liver Diseases (AASLD) Liver Meeting last month in
Boston, United States. Sofosbuvir plus ribavirin alone is highly effective for
people with genotype 2.
The advent of
direct-acting antivirals (DAAs) that target different steps of the hepatitis C
virus (HCV) lifecycle has brought about a revolution in treatment. While these
drugs can improve effectiveness and shorten treatment duration when added to
interferon-based therapy, many patients and providers have held out for
all-oral regimens that avoid interferon and its difficult side-effects.
Researchers with the
HCV-TARGET Study Group and the TRIO Health network presented findings on
real-world use of currently approved new DAAs suitable for use in all-oral
regimens. (The first-generation HCV protease inhibitors boceprevir [Victrelis] and telaprevir [Incivo or Incivek] must be used with interferon.)
nucleotide HCV polymerase inhibitor sofosbuvir is among the most effective of
these new drugs. While sofosbuvir plus ribavirin alone works well for people
with easier-to-treat HCV genotype 2, those with harder-to-treat genotypes
including 1 or 3 may need to add interferon or other DAAs.
next-generation HCV protease inhibitor simeprevir (Olysio) was approved around the same time as sofosbuvir – late 2013
in the US and the first half of 2014 in Europe. These drugs were not initially
indicated for combined use and this regimen has not been through phase 3 trials.
However, the phase 2 COSMOS trial showed that sofosbuvir plus simeprevir taken with
or without ribavirin for 12 weeks cured more than 90% of previously untreated and treatment-experienced
genotype 1 patients with or without cirrhosis.
developed by both European experts and American specialists recommend sofosbuvir plus simeprevir
for people with HCV genotype 1 who are unwilling or unable to take interferon.
This combination was included in the European approval of simeprevir and this
month received supplemental approval from the US Food and Drug
Administration (FDA). However, the recent approval of Gilead's
sofosbuvir/ledipasvir coformulation (Harvoni)
offers an at least equally effective and less expensive option for people with
HCV genotype 1.