The European Commission ( EC ) has granted marketing authorization for Vosevi ( Sofosbuvir 400mg / Velpatasvir 100mg / Voxilaprevir 100mg ), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus ( HCV ) infection.
Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen.
A 12-week regimen was also authorized for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3.
For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
Sofosbuvir-based regimens are recommended by global guidelines across HCV genotypes and disease severities and have been used to treat more than 1.5 million patients worldwide.
Vosevi is fourth Sofosbuvir-based treatment to be granted marketing authorization by the European Commission for the treatment of chronic HCV infection.
The marketing authorization of Vosevi follows an accelerated review procedure by the European Medicines Agency ( EMA ), reserved for medicinal products expected to be of major public health interest.
The approval of Vosevi is supported by data from four phase 3 studies. Two studies ( POLARIS-1 and POLARIS-4 ) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies ( POLARIS-2 and POLARIS-3 ) evaluated 8 weeks of Vosevi in DAA-naïve patients with hepatitis C genotypes 1-6.
Across POLARIS-1 and POLARIS-4, 97% of patients treated with Vosevi ( n=431/445 ) achieved the primary efficacy endpoint of SVR12.
In POLARIS-2, 95% of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi ( n=477/501 ) achieved the primary efficacy endpoint of SVR12.
In POLARIS-3, 96% of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi ( n=106/110 ) achieved the primary efficacy endpoint of SVR12.
The most common adverse drug reactions among patients who received Vosevi in the POLARIS studies were headache, diarrhea and nausea.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi, for use in combination with other agents for the treatment of adults with chronic HCV infection.
The single tablet regimen, Harvoni, received marketing authorization in the European Union on November 18, 2014.
The single tablet regimen of Sofosbuvir ( 400mg ) and Velpatasvir ( 100mg ) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa for the treatment of adults with chronic HCV infection.
Vosevi was approved by the U.S. Food and Drug Administration ( FDA ) on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection. ( Xagena )
Source: Gilead, 2017