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ARTICLE | Clinical News

Medivir reports more simeprevir data

October 19, 2013 12:29 AM UTC

Medivir AB (SSE:MVIR B) presented data on Friday at the European AIDS meeting in Brussels from an open-label Phase III trial evaluating simeprevir ( TMC435) in 106 patients with HCV genotype 1 infection co-infected with HIV-1. In the trial, once-daily oral simeprevir plus peginterferon and ribavirin for 12 weeks led to a sustained virologic response (SVR) 12 weeks after the end of treatment, the primary endpoint, in 74% of patients. Additionally, SVR12 rates were 79% for treatment-naïve patients (n=53), 87% for prior relapsers (n=15), 70% for prior partial responders (n=10) and 57% for prior null responders (n=28).

Last month, Japan's Ministry of Health, Labor and Welfare (MHLW) approved simeprevir as Sovriad to treat HCV genotype 1 infection. FDA's Antiviral Drugs Advisory Committee is scheduled to meet next Thursday to discuss an NDA from the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) for the HCV NS3/4A protease inhibitor to treat HCV genotype 1 infection in adults with compensated liver disease. The NDA is under Priority Review with an undisclosed PDUFA date; a six-month Priority Review would place the PDUFA date in November. Simeprevir is also under review in the EU. ...