Medivir Shares Results from Simeprevir


announces data two phase III studies with in hepatitis C subpopulations – HCV/HIV co-infected and genotype 4 infected patients

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced preliminary data from two phase III studies conducted by Janssen R&D Ireland evaluating simeprevir in genotype 4 chronic hepatitis C in adult patients with compensated liver disease, and in genotype 1 hepatitis C and HIV-1 co-infected adult patients. The data were presented today at the ongoing European AIDS Conference (EACS), October 16-19 in Brussels.

“Based on these encouraging data with the high cure rates seen in patients co-infected with HCV genotype 1 and HIV-1 we believe that simeprevir could provide a new treatment option in this specific patient group” says Charlotte Edenius, EVP Development, Medivir AB. “We are also delighted to see the positive interim from patients infected with HCV genotype 4, a strain of virus which currently have limited treatment options.”

HCV/HIV co-infected patients – Study Design
This phase III, open-label trial evaluated the safety and efficacy of simeprevir (150 mg QD) with peginterferon and ribavirin (PR) for 12 weeks in patients co-infected with HCV genotype-1 and HIV-1 (N=106). Treatment-naïve patients (N=53) and prior relapsers (N=15) (without cirrhosis) received response-guided therapy (RGT) with PR up to 24 or 48 weeks. All other patients (prior null responders [N=28], partial responders [N=10] and all patients with cirrhosis) received PR up to 48 weeks. The primary endpoint was sustained virologic response (SVR) rate 12 weeks after end of treatment. In the study 93 patients were receiving antiretroviral therapy (ART), 12% of patients had cirrhosis, 82% had genotype 1a subtype and 73% had an IL28B CT or TT genotype.

HCV/HIV co-infected patients – Summary Primary Results
High SVR12 rates…Read more

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