Gilead is getting closer to the holy grail of hepatitis C treatment – a therapy that offers effectiveness against all six strains of the disease.
The group has unveiled clinical data from its dual therapy combining blockbuster Sovaldi (sofosbuvir) with experimental drug velpatasvir in four clinical trials, which showed high cure rates across all six genotypes of the disease.
In three of the studies, the combination cured 98% of patients after 12 weeks of therapy. In the fourth, patients with decompensated cirrhosis taking Gilead’s therapy plus ribavirin experienced higher cure rates (SVR12 94%) compared with those taking the combo alone (83%).
And on the safety side, patients treated with sofosbuvir/velpatasvir for 12 weeks had similar adverse events compared with placebo-treated patients, the most common being headache, fatigue and nausea.
On the back of the results Gilead said it is planning US and European submissions for the fourth quarter, and, if successful, the combination would be the first all-oral pan-genotypic single pill regimen approved for chronic HCV.
Barclays analyst Geoff Meacham said the 12-week regimen will likely target patients with genotype 2-6 patients, “while Harvoni will remain the key regimen for GT1 given its commercial success and shorter 8 week treatment duration,” according to FierceBiotech.
AbbVie and Merck are also currently working on new therapies targeting all HCV genotypes.
