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Sofosbuvir + simeprevir dual therapy shows high cure rates for hepatitis C patients with or without cirrhosis
Liz Highleyman, 2014-04-14 10:20:00
A 12-week oral regimen of sofosbuvir (Sovaldi) plus simeprevir (Olysio) without pegylated interferon or ribavirin led to sustained virological response in 93% of genotype 1 hepatitis C patients with either absent to moderate liver fibrosis or with advanced fibrosis or cirrhosis, according to data from the COSMOS trial presented last week at the 49th EASL International Liver Congress in London.
Researchers are still learning about predictors of response to direct-acting antivirals for hepatitis C, but some of the traditional factors that predicted good response to interferon no longer play a major role, and some may become unimportant.
The phase 2a COSMOS trial enrolled two cohorts of genotype 1 chronic hepatitis C patients traditionally considered hard to treat. Cohort 1 included 80 prior null responders - people who saw little or no drop in HCV RNA with previous interferon-based therapy - who had absent to moderate fibrosis. Cohort 2 included 87 previously untreated patients and prior null responders with advanced fibrosis or compensated cirrhosis.
In this open-label study participants were randomly assigned to receive sofosbuvir (150mg once daily) plus simeprevir (400mg once daily), taken either with or without weight-based ribavirin, for either 12 or 24 weeks.
Gilead Sciences' nucleotide HCV polymerase inhibitor sofosbuvir was approved in the European Union in January 2014 and in the US in December 2013. Janssen's HCV protease inhibitor simeprevir, also approved in the US late last year, is expected to receive European Union approval next month.
Although the drugs' official indications do not include use together in interferon-free regimens, recent guidelines issued by both European (EASL) and US (AASLD/IDSA/IAS-USA) liver disease experts recommend this combination for people with HCV genotypes 1 or 4 who are unable or unwilling to take interferon.
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