China Clears First All-Oral Chronic Hepatitis C Regimen

Megan Brooks


April 28, 2017

The China Food and Drug Administration (CFDA) has approved the country's first all-oral, interferon- and ribavirin-free direct-acting antiviral regimen for chronic hepatitis C virus (HCV) infection.

The combination of daclatasvir (Daklinza) and asunaprevir (Sunvepra), both from Bristol-Myers Squibb Company, is indicated for the treatment of treatment-naive or treatment-experienced patients, with or without compensated cirrhosis, infected with genotype 1b HCV, the company said in a news release.

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

Daclatasvir is a potent, pan-genotypic NS5A replication complex inhibitor, and asunaprevir is a NS3/4A protease inhibitor.

Approval of the daclatasvir–asunaprevir combination in China was based largely on results of a multicenter Asian phase 3 clinical trial of patients with genotype 1b chronic HCV infection who received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. Of the 159 patients enrolled, 127 were from mainland China. All patients were ineligible for or intolerant to interferon.

In the overall study population, sustained virologic response at 24 weeks (SVR24) was 91% (145/159), and was similarly high in cirrhotic patients (90%, 47/52), the company said. SVR24 rates were higher in patients without baseline NS5A resistance-associated variants (99%, 137/139) and lower in patients with baseline NS5A resistance variants (42%, 8/19).

There was one death (0.6%) in the trial, five on-treatment serious adverse events (3%), and three grade 4 laboratory abnormalities (2%), but none were considered related to the study drugs.

Two patients (1%) discontinued the daclatasvir/asunaprevir regimen because of adverse events. The most common grade 1 to 4 on-treatment adverse events (>5% of patients) were platelet count decrease (9%); upper respiratory tract infection (8%); alanine aminotransferase elevation (7%); a decrease in neutrophil count (7%), monocyte count (6%), and white blood cell count (6%); thrombocytopenia (6%); and pruritus (6%). Most of these adverse events were mild or moderate in intensity. Treatment was generally well-tolerated regardless of cirrhosis status, the company said.

"HCV represents a significant public health burden in China and is now the fourth most commonly reported infectious disease countrywide, with an estimated 10 million people currently living with the disease. Until now, standard of care in China has been interferon- and ribavirin-containing regimens which have left some patient groups with unmet needs," they note in the release.

Daclatasvir has also been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection, according to the company.

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