Results from ALLY-2 confirm drug was well tolerated and effective across genotypes 1-4

April 23, 2015, Vienna, Austria: Phase III results revealed today at The International Liver Congress™ 2015 show that once-daily treatment with daclatasvir (DCV) plus sofosbuvir (SOF) resulted in an overall 97% sustained virologic response (SVR) at 12 weeks post-treatment in patients with hepatitis C virus (HCV) and HIV co-infection, including cirrhotic patients.

HIV co-infection more than triples the risk of hepatitis C-related liver disease, liver failure and liver-related death. Co-infection can also complicate the management of HIV infection.

In the ALLY-2 randomised, open-label study, the combination of DCV+SOF was well tolerated and effective across the four different genotypes. Importantly, due to their limited pharmacokinetic interactions with other agents, DCV+SOF was able to work effectively across a broad range of concomitant combination antiretroviral therapy (cART) regimens without compromising HIV virologic control (98% of patients were on cART).

The study included treatment-naive (n = 151) and treatment-experienced (n = 52) adults co-infected with HIV and HCV. Treatment-naive patients were randomised 2:1 to receive 12 or 8 weeks of SOF 400 mg + DCV 60 mg (dose adjusted for cART); experienced patients received DCV+SOF for 12 weeks. The primary endpoint was SVR at post-treatment week 12 in treatment-naive genotype-1 patients who received 12 weeks of DCV+SOF.

A total of 98% of patients completed the study treatment. In genotype-1 patients, SVR was achieved by 96% of treatment-naive and 98% of experienced patients after 12 weeks of DCV+SOF. These positive results were also seen in genotype-2, -3 and -4 patients, with SVR at post-treatment week 12 reaching 100% (13/13), 100% (10/10) and 100% (3/3), respectively. Eight weeks of treatment appeared less effective with an SVR at 12 weeks post treatment of 76% in genotype-1 patients.

There were no treatment-related serious adverse events (AEs) and none of the patients stopped treatment due to AEs.

The results show that 12 weeks of DCV-SOF is a highly effective and well-tolerated treatment regimen for HCV in patients with HIV co-infection, including cirrhotic patients.

About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

About EASL (www.easl.eu)
Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact
For more information, please contact the ILC Press Office at:
• ilc.press@easloffice.eu or
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