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[交流] [转自药渡网]Bristol-Myers Squibb公司在AASLD会议上，公布最新临床3期研究进展

Bristol-Myers Squibb公司在AASLD会议上更新了临床3期的研究数据，关于 Daklinza (daclatasvir，DCV) 联合使用sofosbuvir (SOF) 和ribavirin (RBV)治疗基因型 3 肝炎 C (HCV) 晚期患者并伴随肝纤维化或肝硬化。Daclatasvir，sofosbuvir和ribavirin联合用药持续时间的 12 和 16 周，SVR12反应率分别是88% 和92%。

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Data from ALLY-3+ Trial Investigating Daklinza (daclatasvir) in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C Genotype 3 Patients with Advanced Fibrosis or Cirrhosis Presented at AASLD
Daclatasvir+sofosbuvir+ribavirin regimen for 12 or 16 weeks achieved SVR12 rates of 88% and 92%, respectively, in genotype 3 patients with advanced fibrosis or cirrhosis

Bristol-Myers Squibb Company (NYSE:BMY) today announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza (daclatasvir, DCV) in combination with sofosbuvir (SOF) and ribavirin (RBV) in genotype 3 hepatitis C (HCV) patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response (SVR) rates, or cure, have proved harder to achieve.

The results show that 100% of patients in the advanced fibrosis (F3) cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively. Results will be presented today at The Liver Meeting® 2015, the annual meeting of The American Association for the Study of Liver Diseases (AASLD), in San Francisco, CA, November 13 – 17.

Daklinza is an NS5A replication complex inhibitor approved by the U.S. Food and Drug Administration (FDA) for use with sofosbuvir for the treatment of adults with HCV genotype 3. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks. Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, as this may lead to lower exposure and loss of efficacy of Daklinza. Daklinza must not be administered as a monotherapy.

“High cure rates for patients with genotype 3 with advanced fibrosis or cirrhosis have remained elusive, so we are encouraged by these results,” said Dr. Alex Thompson, Professor, St. Vincent's Hospital and the University of Melbourne, Australia. “Our hope with the ALLY-3+ trial was to study this investigational regimen in the most difficult-to-cure genotype 3 patients, and to improve cure rates for this patient population.”

In the ALLY-3+ study, the daclatasvir+sofosbuvir+ribavirin combination regimen had no discontinuations due to adverse events (AEs) or treatment-related serious AEs. The most frequent AEs were insomnia (30%), fatigue (26%) and headache (24%). Additionally, relapse occurred in four patients (two in the 16-week and two in the 12-week arm). There was one death (12-week arm; not treatment-related). There were no virologic breakthroughs.

“Our continued scientific exploration of the potential for Daklinza used in combination with other direct-acting antivirals for HCV patients has yielded these encouraging results,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “We remain committed to delivering therapeutic options to HCV patients with unmet needs around the globe, including those with more complicated disease and other difficult-to-treat groups such as genotype 3 patients with more advanced liver disease who still need help to achieve cure.”

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