CHMP Recommends Hepatitis C Treatment Sofosbuvir for EU

Miriam E. Tucker

November 22, 2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for sofosbuvir, a first-in-class treatment for chronic hepatitis C virus (HCV) infection.

Used in combination with ribavirin (RBV), sofosbuvir (Sovaldi, Gilead Sciences, Inc) would allow for the first all-oral interferon-free HCV treatment regimen and is thereby expected to improve compliance and reduce toxicity compared with current therapies.

The prevalence of HCV infection ranges from 0.4% to 3.5% among the European member states.

In the United States, an advisory panel to the US Food and Drug Administration has unanimously recommended sofosbuvir in combination with RBV for the treatment of adults with chronic HCV infections (genotypes 2 and 3) and in combination with pegylated interferon (pegIFN) and RBV for treatment-naive adults infected with genotypes 1 and 4.

Current HCV treatment includes a combination of pegIFN and RBV with or without a protease enzyme inhibitor. Interferon causes significant adverse effects for many patients. These are difficult to manage, and a large proportion of patients cannot take the treatment at all, including many with advanced liver disease. "For these patients, there is a very clear unmet medical need for new HCV treatment regimens," the European Medicines Agency said in a statement.

Sofosbuvir demonstrated good safety and efficacy in clinical trials in which it was used in combination with RBV, with many patients clearing the virus in 12 to 24 weeks after the end of treatment. When used in combination with pegIFN, viral clearance was achieved in 12 weeks compared with 24 to 48 weeks with current treatment.

Sofosbuvir combined with RBV also prevented reinfection of liver grafts, suggesting it may be a treatment option for patients awaiting transplantation.

Last month, the CHMP had advised early access to sofosbuvir for compassionate use programs. Now, the panel has also said that the combination of sofosbuvir and Bristol-Myers Squibb's daclatasvir should be available for compassionate use in patients who are at high risk for loss of liver function or death without treatment.

Several new therapies are currently being developed for treating chronic HCV. The European Medicines Agency "is actively supporting the development of these new treatment options for patients through provision of scientific advice and drafting of guidance to developers of these medicines."


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