Drug Trial Brings China Closer to Getting Access to HCV Antivirals


An estimated 10 million people in China have hepatitis C but the only treatment available there is interferon/ribaviron. Though the drug-approval process in China is slower than in other nations, a phase 3 trial of two Bristol-Myers Squibb direct-acting antivirals has been completed, putting access to DAAs closer.

Direct acting antivirals (DAAs) effectively treat hepatitis C and have rapidly become the standard of care in the US and many developed countries. But in China, where there are an estimated 10 million people with HCV infections, interferon/ribavirin treatment is still the standard therapy.

Reporting at the 2015 Liver Meeting in San Francisco, CA, researchers from China and Bristol-Myers Squibb announced that China has completed its first DAA trial.

Patients who got daclatasvir (Daklinza) and asunaprevir (Sunpreva) achieved a sustained viral response at 12 weeks at a rate varying from 91% to 99%. The trial data were presented at the meeting.

The prevalent HCV genotype in China is GT1b, seen in about 57% of people with HCV, said Jia Jidong, a professor and director of the Liver Research Center at Beijing Friendship Hospital and co-investigator of the study. "With this new data, we are hopeful that we are one step closer to bringing all oral DAA therapy to Chinese HCV patients."

Interferon treatment can be hard on patients, and is often ineffective in HCV GT-1b. Daclatasvir has been recommended in China's official HCV Prevention and Treatment Guideline, but the drug is not yet approved.

In a conference session on global access issues held Monday, panelists said China will likely not get access to DAAs until 2018.

There is a particularly high prevalence of HCV in Mongolia where an estimated 15% of the population or a half million people have the virus, said Osamu Yokosuka, MD, of Chiba University, Chiba, Japan, presenting at that panel.

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