July 08, 2016
European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
– Epclusa is the First and Only All-Oral, Single Tablet Regimen for all Genotypes (1-6) of Chronic Hepatitis C Virus Infection and is Gilead’s Third Sofosbuvir-Based Treatment –
The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.
The Marketing Authorization follows an accelerated review procedure by
SOF/VEL is Gilead’s third sofosbuvir-based treatment to be granted
Marketing Authorization by the
“Built on the foundation of sofosbuvir, SOF/VEL offers a highly
effective and tolerable choice which is protease inhibitor free and
ribavirin free for the majority of patients. For the first time we have
a once-daily single tablet treatment option which works across all
genotypes including genotype 3, which is often the least responsive to
treatment,” said Professor
The authorization of SOF/VEL is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of SOF/VEL. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of SOF/VEL with or without RBV or 24 weeks of SOF/VEL alone. The primary endpoint for all studies was the sustained viral response rate 12 weeks after treatment (SVR12).
Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving SOF/VEL with RBV for 12 weeks achieved a higher SVR12 rate (94 percent) compared to those who received SOF/VEL for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively.) The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.
Sofosbuvir as a single agent was granted marketing authorization in the
Epclusa was approved by the
Important Safety Information
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with potent P-glycoprotein (P-gp) or potent cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) is contraindicated.
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, dabigatran and amiodarone is recommended when used with sofosbuvir/velpatasvir. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken.
The “interaction with other medicinal products and other forms of interaction” section of the Epclusa EU Summary of Product Characteristics (SmPC) should be consulted before starting therapy with sofosbuvir/velpatasvir.
Sofosbuvir/velpatasvir should not be administered concomitantly with other medicinal products containing sofosbuvir.
In clinical studies, adverse events were comparable to placebo, with fatigue, headache and nausea the most commonly reported side effects.
Please refer to the SmPC for further details. The SmPC is available at www.ema.europa.eu.
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 Epclusa.
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 Sovaldi, Harvoni and Epclusa are available from the EMA website at www.ema.europa.eu.
Sovaldi, Harvoni and Epclusa are registered trademarks of
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Gilead Sciences, Inc.
Sung Lee, +1-650-524-7792
Arran Attridge, +44 208-587-2477
Mark Snyder, +1-650-522-6167