Gilead presents data highlighting progress and efficacy in liver and hepatitis C therapies

pharmafile | April 20, 2016 | News story | Research and Development, Sales and Marketing Gilead, harvoni, hepatitis, liver, sofosbuvir 

Gilead (NASDAQ: GILD) has presented a broad range of results on its current and potential therapeutics at the International Liver Congress 2016 in Barcelona Spain.

The company presented the results from several Phase II and Phase III studies evaluating its two investigational, fixed-dose combination therapies for the treatment of chronic hepatits C virus infection, as well as new data highlighting the potential use of Harvoni (ledipasvir/sofosbuvir) in adolescents aged 12 to 17. Harvoni is currently available to a broad range of patients in the US, after several expansions of its indication.

The data presented shows that Gilead’s treatment achieved high SVR12 (i.e. that hepatitis C is undetectable for twelve or more weeks after the end of treatment) rates, reaching as high as 100% in patients with cirrhosis.

Norbert Bischofberger, chief scientific officer at Gilead, says: “The data presented this week continue to underscore the high cure rates and tolerability of our sofosbuvir-based HCV therapies, and support their utility across all patient HCV genotypes and disease stages.”

Other data presented by Gilead relates to their development of three investigational agents for the treatment of non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The former is a serious liver condition resulting from metabolic dysfunction that is associated with fat within the liver, inflammation and fibrosis, which may eventually progress to cirrhosis. The latte is a disease characterised by inflammation and structuring of the bile ducts. It can eventually lead to cirrhosis and other complications, including bile duct cancer.

The potential agents, simtuzumab, GS-4997 and GS-9674 all showed positive signs in Phase I and Phase II studies.

Bischofberger adds: “The data presented enhance our understanding of the pathogenesis of NASH and PSC – two progressive liver diseases for which there are no approved treatment options. We are encouraged by the data presented and look forward to applying the scientific insights from these and other ongoing studies to enhance our clinical programs.”

Sean Murray

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