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Medivir announce data from phase III studies

The Swedish company has 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.

“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. “We are also delighted to see the positive interim results from patients infected with HCV genotype 4, a strain of virus which currently have limited treatment options.”

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.

High SVR12 rates were observed regardless of prior HCV treatment response with 79% in HCV treatment-naive patients, 87% in prior relapsers, 70% in partial responders and 57% in null responders. Most patients eligible for shorter duration of treatment met the RGT criteria (89%; 54/61), of whom 87% (47/54) achieved SVR12.

The SVR12 rate in genotype 1b was 89% (16/18) and in genotype 1a 70% (62/88) where genotype 1a patients with Q80K polymorphism at baseline achieved SVR12 rates of 67% (20/30). SVR12 rates were high irrespective of baseline METAVIR fibrosis score (80% and 64% for patients with of F0-F2 and F3-F4 respectively).

 

Simeprevir once daily with PR was well tolerated with a safety profile similar to that observed in studies of mono-infected patients.

Primary efficacy endpoint with 150 mg simeprevir for 12 weeks with peginterferon and ribavirin (PR) for up to 24 or 48 weeks). Intent-to-treat (ITT) population.

In this phase III study, 107 patients with chronic HCV genotype 4 received simeprevir once daily with peginterferon and ribavirin (PR) for 12 weeks. Treatment-naïve patients and prior relapsers received response-guided therapy (RGT) with PR up to 24 or 48 weeks. Prior partial responders and prior null responders received PR up to 48 weeks.

At the time for this interim analysis only data from patients eligible to shorten therapy and who had reached study visit W28 (SVR4) and W36 (SVR12) were included. In these patients SVR4 rates of 89-91% (N=20) and SVR12 of 67-100% (N=9) were achieved. Overall simeprevir was well tolerated and most AEs were grade 1 or 2.