European regulators have given the green light to Gilead Sciences' hepatitis C combination treatment Harvoni.
European regulators have given the green light to Gilead Sciences’ hepatitis C combination treatment Harvoni.
The European Commission has approved Harvoni, which combines Gilead’s mega-blockbuster Sovaldi (sofosbuvir), a nucleotide analogue polymerase inhibitor, with the firm’s the NS5A inhibitor ledipasvir, for HCV genotype 1 and 4 infection, reports PharmaTimes.
The thumbs-up, which comes a month after approval in the US, is significant as Harvoni offers a once-daily, all-oral interferon- and ribavirin-free treatment option for HCV. The green light is based on three Phase III studies which showed that Harvoni achieved cure rates – sustained virologic response – (SVR 12) of 94%-99%.
Graham Foster of Queen Mary University in London said that genotype 1 patients "and the physicians who treat them have been waiting for a treatment advance like this for decades". He added that "with Harvoni, we have the potential to change the way we treat people living with the most prevalent form of HCV in Europe".
However, the approval of Harvoni in Europe will reignite the debate over the price of HCV treatments. Across the Atlantic, it costs $94,500 for 12 weeks.