Press Releases
July 28, 2017
European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C
-- Vosevi is the First and Only Single Tablet Regimen for Patients Who Have Previously Failed Therapy with Direct-Acting Antivirals --
-- European Commission Also Extends Marketing Authorization for Harvoni® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients --
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.
“DAA-based therapies have transformed our ability to treat hepatitis C.
However, until now we have had limited options for patients who have
failed to achieve cure with these regimens,” said Professor
Gilead also today 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
“The authorization of Vosevi and the extended indication for Harvoni
demonstrate our ongoing commitment to bring therapies with high cure
rates to all HCV-infected patients,” said
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 Gilead’s fourth
sofosbuvir-based treatment to be granted marketing authorization by the
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 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.
Sofosbuvir as a single agent was granted marketing authorization in the
Vosevi was approved by the
Important Safety Information for Vosevi
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).
Monitoring of digoxin and amiodarone is recommended when used with sofosbuvir/velpatasvir/voxilaprevir.
The “interaction with other medicinal products and other forms of interaction” section of the Vosevi EU Summary of Product Characteristics (SmPC) should be consulted before starting therapy with sofosbuvir/velpatasvir/voxilaprevir.
Sofosbuvir/velpatasvir/voxilaprevir should not be administered concomitantly with other medicinal products containing sofosbuvir.
In clinical studies, headache, diarrhoea and nausea were the most commonly reported adverse drug reactions.
Important Safety Information for Harvoni
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with rosuvastatin or St. John’s wort (Hypericum perforatum) is contraindicated. Co-administration with certain P-glycoprotein (P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is not recommended. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken.
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 regimens. Safety has not been established in patients with severe renal impairment.
Monitoring of digoxin and dabigatran is recommended when used with ledipasvir/sofosbuvir.
Ledipasvir/sofosbuvir should not be administered concomitantly with other medicinal products containing sofosbuvir.
In clinical studies headache, fatigue and nausea were more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
About
ForwardLooking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing Vosevi for the
treatment of adults with chronic HCV infection or Harvoni for the
treatment of adolescents with chronic HCV infection. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended
Full European Summary of Product Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are available from the EMA website at www.ema.europa.eu.
Vosevi, Sovaldi, Harvoni and Epclusa are trademarks or registered
trademarks of
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Gilead Sciences, Inc.
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