News on Wellness

Clinical Research on Gilead Hep C Combo Drug Shows Encouraging Results in Japan


Gilead Sciences Inc. proclaimed great results of a Phase 3 clinical research in Japan, assessing sofosbuvir in amalgamation with ribavirin for treating genotype-2 chronic HCV infections.


The trial met its key efficiency endpoint compared to a predefined chronological control SVR rate. Around 97-percent of the patients affected by genotype-2 HCV, who took part in the research, received twelve weeks of an all-oral dosage of sofosbuvir plus RBV, and accomplished a SVR twelve weeks post therapy completion (SVR12).

The SVR of 12 amongst the treatment-experienced and treatment-naïve patients were 95% and 98% respectively. Out of the 153 people who got treated, 11-percent of them had recorded cirrhosis.

The rate of liver cancer in Japan is higher when compared to any other industrialized nation and most of the cases are because of chronic HCV infection. Around 2 million individuals in Japan suffer from this infection and around 20-30% of them have the virus strain of genotype 2.

The present treatment choices for this infection in Japan require around 48 weeks of therapy alongside interferon injections and there are chances that this may not suit several patients who need urgent treatment.

Norbert Bischofberger, the Chief Scientific Officer and Executive Vice President of research and development of Gilead Sciences stated that this research confirmed the high efficiency of all-oral treatment with sofosbuvir among the patients infected by genotype 2 hepatitis C in Japan irrespective of whether they are new to the treatment or are experienced.

Depending upon the results of this research, Gilead hopes to submit a new sofosbuvir Drug Application to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) before mid-2014, Bischofberger stated.  Gilead started its Japanese operations with the establishment of Gilead K.K. during September 2013 in Tokyo.


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