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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.)

Gilead Sciences' 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.

Janssen's 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. 

Guidelines 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.