Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 301

The European Commission has granted marketing authorization for Vosevi® for the treatment chronic hepatitis C

Posted by fidest press agency su giovedì, 7 settembre 2017

voseviFOSTER CITY, Calif.–BUSINESS WIRE–Gilead Sciences, Inc. (NASDAQ:GILD) announced that the European Commission 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.
Gilead also announced an extension of the marketing authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg). Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.
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 european commissionhepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent 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 percent 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.
Vosevi was approved by the U.S. Food and Drug Administration on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection.
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) are contraindicated. Co-administration with strong OATP1B inhibitors (e.g. ciclosporin), rosuvastatin, dabigatran etexilate and ethinylestradiol-containing medicinal products is also contraindicated.Patients co-infected with hepatitis C and hepatitis B are at risk of hepatitis B virus reactivation and should therefore be monitored and managed according to current clinical guidelines. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral treatments (e.g. tenofovir disoproxil fumarate- and efavirenz-containing regimens). Safety has not been established in patients with severe renal impairment (glomerular filtration rate <30ml/min).
Full European Summary of Product Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are available from the EMA website at http://www.ema.europa.eu. (photo: vosevi)

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