Odalasvir/Sovaldi yields 100% SVR in HCV genotype 1
Achillion announced additional interim results of its phase 2 pilot study of odalasvir in combination with Sovaldi, in which 100% of patients with hepatitis C virus genotype 1 infection treated with this regimen achieved a sustained virologic response.
The clinical trial is investigating a combination regimen of odalasvir (ACH-3102, Achillion), a HCV NS5A inhibitor, and Sovaldi (sofosbuvir, Gilead Sciences) without ribavirin for 6 or 8 weeks in 18 treatment-naive patients with HCV genotype 1, along with six observational patients. The results mentioned in this release were of six patients treated with 50 mg of ACH-3102 and 400 mg of sofosbuvir for 6 weeks. Of these patients, all remained HCV RNA-negative 12 weeks post-treatment, according to the release.
Earlier results mentioned in the release indicated 12 patients underwent therapy with 50 mg of odalasvir and 400 mg of sofosbuvir per day for 8 weeks. The observational patients did not receive any drug during this time. All treated patients achieved SVR at 24 weeks. After this trial, the six observational patients plus six more patients were enrolled and underwent 6 weeks of the same treatment regimen of ACH-3102 and sofosbuvir. All 12 of these patients achieved SVR at 12 weeks.
In May, Achillion entered into a licensing agreement with Janssen to develop and commercialize HCV products and regimens containing one or more of Achillion’s HCV assets, including ACH-3102. A goal of the collaboration is to “develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV,” according to the release.