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news.Bristol-Myers Squibb has reported late-breaking data from two Phase III UNITY trials evaluating a 12-week regimen of its all-oral daclatasvir (DCV) Trio regimen in a broad range of patients with genotype 1 hepatitis C virus (HCV).
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DCV is a fixed-dose combination of daclatasvir 30mg with asunaprevir 200mg (ASV) and beclabuvir 75mg (BCV).
Primary endpoint for the two trials was the percentage of patients who achieved cure, defined as HCV RNA<LLOQ TD/TND at post-treatment week 12 for treatment-naïve and treatment-experienced patients.
The UNITY-II trial, which evaluated cirrhotic patients in a 12-week regimen of the DCV-TRIO, showed sustained virologic response 12 weeks after treatment (SVR12) among 98% of treatment-naïve and 93% of treatment-experienced cirrhotic patients with ribavirin (RBV) and 93% of treatment-naïve and 87% of treatment-experienced cirrhotic patients without ribavirin.
Duke Gastroenterology associate professor of Medicine clinical director, Gastroenterology & Transplant Hepatology Andrew Muir: "Even with the most recent HCV treatment advances, genotype 1 patients with cirrhosis remain difficult to treat.
"Currently, treatment-experienced cirrhotic patients still require a 24-week regimen to achieve high SVR rates.
"The data from this clinical trial using the DCV-TRIO regimen showed high cure rates for this population in a 12-week regimen, and has the potential to aid treatment adherence and provide a shorter treatment duration to achieve cure."
The Phase III UNITY clinical trial program is an ongoing study investigating 12-week regimens of the DCV-TRIO fixed-dose combination in non-cirrhotic and cirrhotic genotype 1 patients.
Bristol-Myers Squibb head of Specialty Development Douglas Manion said: "The Phase 3 UNITY results for the daclatasvir TRIO fixed-dose combination are particularly compelling for genotype 1 patients with cirrhosis, whose treatment is often harder to manage than non-cirrhotic patients.
"BMS continues to recognize that HCV is an extremely complicated disease with no ‘one-size-fits-all’ treatment solution, and the UNITY results are especially promising for serving patients with cirrhosis, a specific but significant portion of genotype 1 patients."