Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Sovaldi® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)). Today's marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union (EU).
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:
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 Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. "With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured."
Approximately nine million people in Europe are infected with HCV, a major cause of liver cancer and liver transplantation. The societal, clinical and economic burden of untreated HCV is substantial, with HCV-related healthcare costs directly related to disease severity. The current standard of care for HCV involves up to 48 weeks of therapy with a peg-IFN/RBV-containing regimen, which may not be suitable for certain types of patients.
"The marketing authorization of Sovaldi is an important step forward in the management of hepatitis C in Europe, enabling many more patients the opportunity of cure," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible."
The European Commission marketing authorization for Sovaldi is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with the currently available treatment options RBV/peg-IFN or historical controls, based on the proportion of patients who had a sustained virologic response (where HCV becomes undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full study details, see the Summary of Product Characteristics at www.ema.europa.eu.
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 the United States on December 6, 2013 and in Canada on December 13, 2013. Applications are pending in Australia and New Zealand, Switzerland and Turkey.