Hepatitis C cure rate of 97 per cent announced in study of patients co-infected with HIV given 12-week combination treatment of daclatasvir and sofosbuvir in ALLY-2 trial

• Patient population with both infections historically challenging to treat due to drug-drug interactions.

MONTREAL, March 3, 2015 /CNW/ - 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%).

About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151 HCV treatment-naïve and 52 HCV treatment-experienced patients infected with HCV (genotypes 1-4) who were co-infected with HIV-1 on a broad range of antiretroviral regimens, into 3 cohorts. Among HCV treatment-naïve patients, one cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for concomitant antiretroviral therapy) plus sofosbuvir 400 mg once daily for 12 weeks and another received the same dosage and combination for 8 weeks.

The HCV treatment-experienced cohort also received daclatasvir 30, 60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the SVR12 rate among genotype 1 treatment-naïve patients after 12 weeks of treatment. Patients with cirrhosis were included.

About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Sexual transmission is rare among heterosexuals, however it has been increasingly observed in HIV-positive men who have sex with men. It is estimated that 74 per cent of those infected with hepatitis C will not spontaneously clear the virus and become chronically infected. According to the World Health Organization, up to 20 per cent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 per cent may progress to liver cancer.

About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.

SOURCE Bristol-Myers Squibb Canada

Monica Flores, Senior Manager, Public Affairs, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]