China has approved the first all-oral, interferon, and ribaven-free-direct-acting antiviral treatment alternative against chronic hepatitis C virus (HCV) infection.

"The burden of HCV in China is extremely high, and now for the first time, we have an all-oral treatment option in combination of Daklinza and Sunvepra, which is a significant step forward for patients and doctors alike," Hui Zhuang, a professor from Beijing University Medical School, said in a press release.

Daclatasvir (Daklinza), which is a potent, pan-genotypic NS5A replication complex inhibitor, and asunaprevir (Sunvepra), which is an NS3/4A protease inhibitor, are both products of Bristol-Myers Squibb Company. They are used to treat treatment-naïve or treatment-experienced patients, with or without the presence of compensated cirrhosis, infected with genotype 1b HCV, MedScape reported.

"This new option helps to address many of the unmet needs for our HCV genotype 1b patients, and is also included in the latest edition of China's HCV Prevention and Treatment Guideline," Hui said.

The decision to approve the drugs is based on the results of a multicenter Asian phase 3 clinical trial of patients with genotype 1b chronic HCV infection. The study involved 159 patients; 127 of them were from China. The patients were given daclatasvir once a day and asunaprevir twice a day for 24 weeks. All patients were ineligible for or intolerant to interferon.

The researchers found that sustained virologic response at 24 weeks (SVR24) was 91 percent and was nearly similar in cirrhotic patients at 90 percent. The researchers recorded one death during the trial, five on-treatment serious adverse events, and three grade 4 laboratory anomalies. However, none was related to the drugs being studied.

 "Until now, standard of care in China has been interferon- and ribavirin-containing regiments which have left some patient groups with unmet needs," the study wrote. HCV is the fourth most commonly reported infectious disease in China.