Gilead's latest hep C therapy approved in EU

Gilead’s pan-genotype hepatitis C treatment has been approved in Europe, offering a course of treatment without many of the unpleasant side effects of previous combinations.

Epclusa (sofosbuvir+velpatasvir) offers a single tablet regimen for adults with genotype 1-6 chronic hepatitis C virus infection.

Gilead has been refining its treatments for hepatitis C and previous drugs based around sofosbuvir, first eliminating the need for interferon. This often causes severe flu-like side effects, which can deter or lead some patients to stop taking the treatment.

Now Gilead has eliminated the need for ribavirin, unless patients have genotype 3 infection with compensated cirrhosis.

This is the first approved treatment for patients with genotypes 2 and 3 without the need for ribavirin.

The drug was granted an accelerated review by the European Medicines Agency, reserved for treatments expected to be of major public health interest.

It is the third combination treatment approved based around sofosbuvir, after Sovaldi (sofosbuvir) and Harvoni (sofosbuvir+ledipasvir).

Also approved in the US, Gilead hopes the drug will revive flagging sales in its multi-billion dollar hepatitis C franchise.

Sales of Sovaldi and Harvoni have levelled off because of rivals from AbbVie and Merck & Co.

Although Gilead gave no pricing details for Europe, the drug will cost just under $75,000 for a 12-week course in the UK, less than the list price for Sovaldi and Harvoni and lower than AbbVie’s Viekira Pak (ombitasvir, paritaprevir+ritonavir).

Gilead could face competition as AbbVie began phase 3 trials of its own pan-genotypic, single pill combination in January.

But for now Gilead looks to have the advantage again, with Leerink analyst Geoffrey Porges predicting peak sales of $10.3 billion in 2017, dropping tp $2.2 billion in 2021 because of competition.

Professor Stefan Zeuzem, Professor of Medicine and Chief of the Department of Medicine at the J.W. Goethe University Hospital, Frankfurt, Germany, and phase 3 trial lead investigator, said: “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.”