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This update comes at the heels of the announcement made on January 20, 2017, under which the Company announced that the MAA for the single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients, was fully validated by the EMA and was under further assessment.
The MAA for SOF/VEL/VOX is supported by data from four Phase-3 studies, which included two studies, namely POLARIS-1 and POLARIS-4, evaluated under 12 weeks of the single tablet regimen in patients with genotypes of 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Under these two tests, 97% of the treated patients achieved the primary efficacy endpoint of SVR12.
The other two tests, namely POLARIS-2 and POLARIS-3, evaluated 8 weeks of SOF/VEL/VOX in DAA-naive patients with genotypes 1-6 HCV infection. In POLARIS-2 test, 95% of the patients treated with SOF/VEL/VOX achieved the primary efficacy endpoint of SVR-12. The final test, i.e., POLARIS-3, reported 93% of the patients with genotype-3 infection and cirrhosis treated with SOF/VEL/VOX, achieved the primary efficacy endpoint of SVR12.
Sofosbuvir was granted marketing authorization, as a single agent, in the European Union on January 16, 2014, under the trade name Sovaldi, for use in combination with other agents. Also, the single tablet regimen of sofosbuvir and ledipasvir received marketing authorization in the European Union, under the trade name Harvoni, on November 18, 2014. The single tablet version of sofosbuvir and velpatasvir received marketing authorization in the EU on July 08, 2016, under the trade name Epclusa.
Gilead HCV Treatment Portfolio
According to the Company, the direct-acting antiviral treatment has transformed the ability to treat hepatitis C. However, some patients were unable to be cured with these regimens, effective and well-tolerated therapies are still necessary for them. The Company viewed the submission of this application as a step to deliver enhanced treatment options for the life-threatening disease to the maximum possible patients in Europe and around the world.
Gilead Sciences, Inc. announced on January 12, 2017, a $22 million fund for the HIV cure grants program, which will support 12 new HIV cure research projects. These tests focus on three key segments, namely, translational research, efficacy studies in animal models, and community perspectives of HIV cure.