Bristol-Myers, Gilead hep C combo shines in late-stage trial
- Bristol-Myers Squibb presented data at the International Liver Congress showing that its drug daclatasvir, combined with Gilead's Sovladi (sofosbuvir) and with ribavirin, cured 94% of patients who still had hepatitis C after a liver transplant.
- In addition, the trial also showed that the combination cured 83% of patients with hepatitis C who had severe scarring.
- BMS had previously decided not to move forward with marketing asunaprevir, another hep C drug, in the U.S. in light of intense competition from Sovaldi and AbbVie's Viekira Pak.
While treatment options for hepatitis C patients have improved dramatically for infected patients over the last year and a half, the competitive landscape has become increasingly difficult to navigate.
In February, the FDA revoked BMS's breakthrough designation status for its daclatasvir-based hep C treatment, because other drugs beat it to the finish line. And last November, the FDA outright denied BMS approval for daclatasvir in combo with other drugs, asking for more data.
Well, the data is here and it looks good. BMS is adhering to a strategy of focusing on sub-populations for their hep-C treatment protocols. This strategy seems to be working and may help BMS nab an indication for daclatasvir in the U.S. Daclatasvir is already approved in Europe, Japan and Brazil for use in combo hep C therapy.