Phase III ALLY-1 trial of Sovaldi + Daklinza meets endpoint in Hepatitis C-BMS/Gilead

BMS and Gilead have announced that primary endpoints were successfully met in ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of Sovaldi + Daklinza (daclatasvir and sofosbuvir) once-daily with ribavirin for the treatment of patients with chronic Hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. Among all ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure (sustained virologic response 12 weeks after treatment; SVR12).

The ALLY-1 trial included 16 patients with decompensated cirrhosis Child-Pugh class C; nine (56%) achieved SVR12. Over the course of the study, four advanced cirrhotic patients received a liver transplant during treatment; 3 of 4 extended treatment post-transplant, and all 4 achieved SVR12. In the study, there were no serious adverse events related to study medications throughout the treatment phase. Nine patients in the cirrhosis cohort relapsed post-treatment, and one had detectable HCV RNA at the end of treatment; there were no on-treatment virologic breakthroughs. Three patients (genotypes 1a, 1b, 3) in the post-transplantation cohort relapsed. The data was presented as a late-breaker at The International Liver Congress 2015.

Comment: The ALLY-1 study is the third study to report out of the Phase III ALLY program, which evaluates daclatasvir in combination with sofosbuvir in multiple high-unmet need patient populations. Meanwhile no marketing agreement exists at yet between BMS and Gilead for this combination.