Bristol-Myers Squibb Co (NYSE:BMY) presented the first completed all-oral hepatitis C regimen’s late stage trial data at the Asian Pacific Association for the Study of the Liver conference (APASL) in Japan. The trial included a Chinese patient population and involved daclatasvir in association with asunaprevir for 24 weeks in patients other than Japanese with genotype 1b HCV. In China, Genotype 1b is widespread.
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Primary Endpoint
Bristol-Myers Squibb said that the trial’s primary endpoint was a sustained virologic response post-treatment at 24 weeks, or SVR24. The company indicated that 91% of the patients from China have achieved SVR24 in the trial and that it increased to 98% of patients without any resistant variants at baseline. The company said that SVR24 results were high in all subgroups with genotype 1bHCV. That includes cirrhosis patients, and patients from Korea and Taiwan.
The biotech firm said that the SVR24 rate was higher in all patients irrespective of the baseline NS5A resistant associated variants (RAVs) irrespective of cirrhosis presence or absence. The SVR24 rates were lower in patients with a baseline of NS5A RAVs as those variants were present in 12% of patients. The company indicated that HCV NS5A RAVs survive naturally and could integrate following the failure of virologic response. Physicians could screen the presence of the particular NS5A mutations to discover the best patients for treatment. That would be possible by spotting the most likely to achieve a cure with the help of an NS5A-containing regimen.
Management Comments
Bristol-Myers’ Head of Specialty Development, Douglas Manion, said that there has been enormous progress in the fight against hepatitis C globally. However, he said that the battle was not yet over. Therefore, the company seeks to know the patient populations that are in need of fresh solutions for treatment like the Chinese. The world’s most populous nation has a minimum of 13 million affected by the disease.
Hepatology & Medicine and Director and Professor Lai Wei said that Bristol-Myers’ results signaled that daclatasvir and asunaprevir regimens have the capacity to offer an effective all-oral treatment for several patients affected by the genotype 1b infection in China.