January 17, 2014
European Commission Grants Marketing Authorization for Gilead’s Sovaldi® (Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection
– Sovaldi Approved For Use in Genotypes 1-6 –
– High Cure Rates and Shortened, 12-Week Course of Therapy for Treatment-Naïve Patients –
– First All-Oral Treatment Option for Patients Who Cannot Take Interferon –
– First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence –
Sovaldi has been studied in hepatitis C virus (HCV) genotypes 1-6. The efficacy of Sovaldi has been established in patients with genotypes 1-4, in those awaiting liver transplantation and those with HCV/HIV-1 co-infection. The clinical data supporting the use of Sovaldi in patients with genotypes 5 and 6 is limited. Recommended regimens and treatment duration for Sovaldi combination therapy in HCV mono-infected or HCV/HIV-1 co-infected patients follow:
|Genotype 1, 4, 5 or 6 CHC||
Sovaldi + RBV + peg-IFN
Sovaldi + RBV
Only for use in patients ineligible
|Genotype 2 CHC||Sovaldi + RBV||12 weeks|
|Genotype 3 CHC||
Sovaldi + RBV + peg-IFN
Sovaldi + RBV
Patients with CHC
awaiting liver transplantation
|Sovaldi + RBV||Until liver transplantation|
Monotherapy is not recommended. The Summary of Product Characteristics is available at www.ema.europa.eu.
“Unlike many chronic diseases, hepatitis C can be cured. However, for a
number of reasons, many HCV patients have not currently achieved a cure
and often progress to end-stage liver disease or liver cancer,” said
Approximately nine million people in
“The marketing authorization of Sovaldi is an important step forward in
the management of hepatitis C in
During the regulatory review, data from two additional Phase 3 studies, VALENCE and PHOTON-1 were added to the marketing authorization application. In the VALENCE study, patients with genotype 3 HCV infection were treated with Sovaldi and RBV for 24 weeks. The PHOTON-1 study evaluated Sovaldi and RBV for 12 weeks in patients with genotype 2 or 3 HCV infection co-infected with HIV-1 and for 24 weeks in patients with genotype 1 HCV co-infected with HIV-1. In all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.
To date, nearly 3,000 patients have received at least one dose of Sovaldi in Phase 2 or 3 studies. Sovaldi was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse events occurring in at least 10 percent of patients were consistent with the safety profiles of peg-IFN and RBV and included fatigue, headache, nausea, insomnia, dizziness, pruritis (severe itching) and anemia.
Sovaldi was approved in
Important Safety Information
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use: The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with Sovaldi. When Sovaldi is used in combination with RBV or peg-IFN/RBV, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin. Refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with potent P gp inducers: Medicinal products that are potent P glycoprotein (P gp) inducers in the intestine (e.g. rifampicin, St. John’s wort [Hypericum perforatum], carbamazepine and phenytoin) may significantly decrease Sovaldi plasma concentration leading to reduced therapeutic effect of Sovaldi. Such medicinal products should not be used with Sovaldi.
For the Summary of Product Characteristics please visit 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 and patients may not see advantages of Sovaldi over
other therapies and may therefore be reluctant to prescribe the product
and the risk that government reimbursement and pricing approval may take
longer than anticipated. In addition, pending marketing applications for
Sovaldi in other territories may not be approved in the currently
anticipated timelines or at all, and marketing approval, if granted, may
have significant limitations on its use. 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
Sovaldi is a registered trademark of
Gilead Sciences, Inc.
Patrick O’Brien (Investors, U.S.)
Cara Miller (Media, U.S.)
Arran Attridge (Media, Europe)
+44 208 587 2477