Bristol-Myers Squibb Company announced that the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV). This is China’s first all-oral, interferon- and ribavirin-free HCV treatment regimen. In addition, Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection. This is the only all-oral pan-genotypic regimen recommended by China’s HCV Prevention and Treatment Guideline. Daklinza must not be administered as monotherapy. Sofosbuvir is under review by the CFDA, and is not currently licensed in China.
Daklinza (daclatasvir) Sunvepra (asunaprevir)
In more than 60 countries, Daklinza is approved as part of a regimen with either Sunvepra or sofosbuvir. In China, Daklinza-based regimens provide a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with previously approved regimens. The Daklinza and Sunvepra regimen is already approved by regulatory authorities in multiple countries across the Asia Pacific, Latin America, and Eastern Europe regions. Sunvepra is not approved in the United States.
“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,” said Hui Zhuang, a professor at the Beijing University Medical School and a member of the Chinese Academy of Engineering. “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.”
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. The cure rate for interferon- and ribavirin- containing regimens varies in a number of recent Chinese studies. In CCgenos, a real-world observation study, the cure rate for interferon- and ribavirin- containing regimens among GT-1b naïve patients is 62.4%.
Karl Lintel, MD, President of Bristol-Myers Squibb (China) Investment Co. Ltd and the Sino-American Shanghai Squibb Pharmaceutical Co., commented, “Today’s approval of Daklinza and Sunvepra is great news for patients in China, as we continue the global fight against chronic hepatitis C. This milestone is testament to our ongoing collaboration with multiple stakeholders, and aligning with government policies to provide continuing support to HCV patients at the community level.”
Bristol-Myers Squibb is committed to working with stakeholders to seek timely reimbursement for Daklinza and Sunvepra at the national and provincial levels, to ensure patients have access to these important products.