EU regulators back new Hep C combo pills

Two new hepatitis C combination drugs from Gilead and Merck Sharp and Dohme (MSD), that negate the need for interferon therapy and its hated side effects, have been recommended for approval by European regulators.

The European Medicines Agency’s CHMP scientific committee gave the green light for Gilead’s Epclusa (sofosbuvir+velpatasvir) and MSD’s Zepatier (grazoprevir+elbasvir) – daily tablets that allow for a 12-week treatment programme.

Clinical trials have shown that Epclusa has a high cure rate in all six genotypes, including patients with decompensated cirrhosis. Zepatier can be used in patients with genotypes 1 and 4, including those with compensated cirrhosis and severe kidney disease.

In the likely event of approval in Europe in the next few months, Gilead will be able to cover every hepatitis C genotype without need for interferon.

This has unpleasant side effects, including flu-like symptoms, which rule out treatment in a considerable number of hepatitis C patients.

These medicines block the action of proteins which are essential for viral replication. Epclusa targets the proteins NS5B and NS5A, while Zepatier targets the proteins NS3/4A and NS5A.

Epclusa contains sofosbuvir, already approved under the name Sovaldi and as a combination therapy with ledipasvir under the name Harvoni, and velpatasvir which is a novel HCV protein inhibitor.

Both drugs produced sustained virologic response – in effect a cure – in around 90% of patients, 12 weeks after end of treatment.

Side effects were similar, with the most common reported for both drugs being headache, fatigue and nausea.

Following a fast review for drugs that improve on existing therapies, the US Food and Drug Administration (FDA) is set to make a regulatory decision on Epclusa next month. The FDA approved Zepatier in January.

Merck said earlier this month that Zepatier’s European launch may be delayed until late 2016 or 2017, after European regulators cited inadequate record-keeping by a third-party manufacturer.

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