Gilead announced on May 30 that China’s State Drug Administration approved Epclusa (sophobavir 400 mg/Vepatavir 100 mg, Chinese brand name BingTongSha) for the treatment of the gene type 1-6 chronic hepatitis C virus (HCV). Adult infected patients. The State Drug Administration also approved that Epclusa combined with ribavirin (RBV) can be used for adult patients with cirrhosis and decompensated liver cirrhosis. Epclusa is China’s first approved pan-genotype HCV Single Tablet Solution (STR).
Epclusa is approved in China and is based on five international multicenter Phase 3 clinical studies, namely ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5. The overall rate of achievement of SVR12 (defined as week 12 after completion of treatment, no detectable HCV RNA) in a refractory patient population (including treated patients, and compensated or decompensated cirrhotic patients) Higher, 92%-100%.
“Epclusa’s safety and effectiveness have been confirmed by a large number of clinical trials and real-world data,” said Professor Wei Lai, Institute of Liver Diseases, Peking University People’s Hospital. “Since Epclusa has a high cure rate for all genotypes of hepatitis C patients, We are expected to dispense with genotyping during treatment, which has positive implications for the expansion of hepatitis C therapy.”
In China, HCV is the fourth most common infectious disease, and about 10 million people are infected. Among them, HCV genes 1, 2, 3, and 6 accounted for more than 96% of all cases.
In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 naive and treated patients with HCV genotype 1-6 infection without cirrhosis/compensative cirrhosis received 12 weeks of BingTongSha ® treatment. 98% (1,015/1,035) of patients achieved SVR12. In the ASTRAL-5 study, 106 untreated and treated patients with HCV genotypes 1-6 without cirrhosis/compensatory cirrhosis received a 12-week treatment with Epclusa, who were also infected. HIV is undergoing stable antiretroviral treatment. Among them, 95% (101/106) of patients achieved SVR12.
ASTRAL-4 study evaluated 267 patients with decompensated cirrhosis (Child-Pugh B grade) with HCV genotype 1-4 and genotype 6 receiving 12 weeks of Epclusa with/without ribavirin (RBV) therapy Or 24 weeks of Epclusa treatment safety and effectiveness. Among them, patients with decompensated cirrhosis who received 12 weeks of Epclusa combined with RBV achieved 94% (82/87) of SVR12.
In ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-5, the most common adverse reactions (≥10%) in patients receiving BingTongSha® included headache and fatigue. In the ASTRAL-1 study, patients in the placebo group had similar headaches and fatigue. In ASTRAL-4, the most common adverse reactions (≥10%) in HCV-infected patients with decompensated cirrhosis after treatment with Epclusa and ribavirin (RBV) included fatigue, anemia, nausea, headache, insomnia, and diarrhea. Four patients taking Epclusa combined with RBV stopped treatment due to adverse reactions.
“As the first single-tablet treatment program that does not need to consider the genotype and liver fibrosis in HCV patients, Epclusa simplifies Chinese physicians’ treatment of hepatitis C patients to a large extent, and it is expected to reduce HCV at the public health level. The enormous burden it brings,” said Dr. John F. Milligan, President and CEO of Gilead Sciences. “Gilead has launched two direct antiviral treatment options in China, and we are always committed to screening patients and Treatment support is provided to help solve the HCV epidemic in China.”
In 2016, Epclusa received marketing approval from the US Food and Drug Administration (FDA) and the European Commission, becoming the first pan-genotype single tablet solution for HCV infection. In addition, Epclusa has also been approved in 54 countries.
Sovaldi (Sofoszvir), as a monolithic preparation, was approved by the China Food and Drug Administration in 2017 and is an important component of a joint antiviral treatment for the treatment of genes 1,2,3,4,5 or Type 6 adults and adolescents (12-18 years old, genotypes 2 and 3) infected with HCV.