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ALLY trial demonstrates 97% hepatitis C cure rates among patients coinfected with HIV after ribavirin-free investigational 12-week regimen of daclatasvir and sofosbuvir

Posted: 27 February 2015 |

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection…

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Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection.

“The results of ALLY-2 signal that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D., ALLY-2 Lead Investigator and Associate Professor of Medicine in the Department of Medicine, Division of Infectious Diseases at the University of California San Diego. “The trial demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications because of potential drug-drug interactions. This is a paramount consideration for clinicians treating this patient population.”

Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.

“While substantial strides have been made in the battle against hepatitis C, a significant number of patients with complicated disease and treatment histories need additional treatment options to help them achieve hepatitis C cure,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype.”

According to the Centers for Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States – approximately 300,000 people – are also infected with hepatitis C, and HCV infection progresses more rapidly to liver damage in people living with HIV.

In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. African-American patients comprised 34% of study participants; in this patient demographic, SVR12 rates were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.

Additional safety data demonstrated a low rate of Grade 3/4 lab abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%), Lipase (3%).

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