Impressive data for once-daily sofosbuvir and ledipasvir treatment of HCV genotype 1

Strong results from three Phase III clinical trials (ION-1, ION-2 and ION-3) evaluating the investigational once-daily fixed-dose combination of the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400mg and the NS5A inhibitor ledipasvir (LDV) 90mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection have been presented at the International Liver Congress2014, held by the European Association for the Study of Liver Disease (EASL) in London, UK.

This was further good news for US anti-viral specialist Gilead Sciences (Nasdaq: GILD), which has also reported results of trails with its potential blockbuster hepatitis C drug Sovaldi (sofosbuvir) in other setting at this meeting, and had already seen its shares jump 4% to $68.11 on Friday (The Pharma Letters passim).

The previous day, Gilead reported that co-formulation of sofosbuvir and ledipasvir successfully treated a variety of difficult-to-treat patient populations including people with hepatitis C virus (HCV) genotype 3, patients with decompensated cirrhosis and people who were not cured with previous sofosbuvir-containing therapy.

Cure rates exceeding 90%

“With cure rates well in excess of 90% with as little as eight weeks of treatment for some patients, these data represent a significant advance in the race to develop a new, all-oral treatment for hepatitis C,” said Markus Peck-Radosavljevic, secretary general of the EASL and Associate Professor of Medicine, University of Vienna, Austria.

“The results of the ION studies demonstrated highly satisfactory cure rates with a fixed dose combination of sofosbuvir/ledipasvir among patients with genotype 1 HCV infection without the use of either injectable interferon, which causes miserable flu-like symptoms, or ribavirin, an antiviral pill associated with a variety of troublesome side effects, including anemia and rash," Prof Peck-Radosavljevic continued. “As a result of this marked improvement in tolerability, many more people are likely to seek treatment with this ribavirin-free regimen, which involves just one pill once a day.”

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