Bristol-Myers Squibb Canada Announces Hepatitis C Cure Rate of 97% in Study of Patients Co-infected with HIV Given 12-week Combination Treatment of Daclatasvir and Sofosbuvir in ALLY-2 Trial

A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with human immunodeficiency virus (HIV). This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection. Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks (HCV treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment, or SVR12). "The data showed results that are very promising in patients that are well known as being both difficult to treat and at higher risk for developing serious liver disease, making the results all the more significant," said Dr. Stephen Shafran , Professor of Medicine (Infectious Diseases) at the University of Alberta . "It's also important to note that we are seeing high cure rates with the daclatasvir and sofosbuvir combination regardless of the genotype of the hepatitis C infection." The ALLY-2 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. Hepatitis C and HIV co-infection is not rare because both viruses can be transmitted by blood-to-blood contact. Approximately 13,000 Canadians have both infections, or about 20 per cent of the total of 65,000 with HIV and 5.2 per cent of the 250,000 with hepatitis C. Currently, liver disease related to hepatitis C is the leading cause of death among people with co-infection. Hepatitis C 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. 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 for Grade 3 / 4 lab abnormalities in the study: INR (1%), AST (0.5%), Total bilirubin (4%), Lipase (3%).