▎This article is reposted from the “Gilead Sciences” WeChat Official Account
Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus – Epclusa Approved in China
Epclusa is the first pan-genotypic, once-daily, single-tablet regimen approved in China for the treatment of chronic hepatitis C virus infection.
Gilead Sciences, Inc. (NASDAQ: GILD) announced today thatThe National Medical Products Administration has approved Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1–6 infection.National Medical Products AdministrationConcurrently, the combination of Epclusa and ribavirin (RBV) was approved for use in adult patients with hepatitis C virus (HCV) infection compensated by decompensated cirrhosis. Epclusa is the first pangenotypic HCV single-tablet regimen (STR) approved in China.
The approval of Epclusa in China was primarily based on five international, multicenter Phase 3 clinical trials: ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4, and ASTRAL-5. In patient populations that are difficult to cure (including treatment-experienced patients, as well as those with compensated or decompensated cirrhosis),SVR12(defined as undetectable HCV RNA at week 12 after completion of treatment) had a high overall achievement rate,92%–100%.
Professor Wei Lai from the Institute of Hepatology at Peking University People's Hospital said: "The safety and efficacy of Epclusa have been confirmed by extensive clinical trials and real-world data.“Given that Epclusa achieves high cure rates in patients with hepatitis C across all genotypes, we anticipate that genotype testing may be omitted during treatment, which holds positive implications for expanding access to hepatitis C therapy.”
In China, HCV is the fourth most common infectious disease, with approximately 10 million people infected. Among these cases, HCV genotypes 1, 2, 3, and 6 account for more than 96% of all cases.[1]
In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 treatment-naïve and treatment-experienced patients with genotype 1–6 HCV infection, without cirrhosis or with compensated cirrhosis, received 12 weeks of Epclusa treatment. SVR12 was achieved in 98% (1,015/1,035) of patients. In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced patients with genotype 1–6 HCV infection, without cirrhosis or with compensated cirrhosis, who were also coinfected with HIV and receiving stable antiretroviral therapy, received 12 weeks of Epclusa treatment. SVR12 was achieved in 95% (101/106) of these patients.
The ASTRAL-4 study evaluated the safety and efficacy of 12 weeks of Epclusa with or without ribavirin (RBV), or 24 weeks of Epclusa, in 267 patients with decompensated cirrhosis (Child-Pugh class B) infected with HCV genotypes 1–4 and genotype 6. Among patients with decompensated cirrhosis who received 12 weeks of Epclusa plus RBV, 94% (82/87) achieved SVR12.
In ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-5, the most common adverse reactions (≥10%) in patients treated with Epclusa included headache and fatigue. In the ASTRAL-1 study, the incidence of headache and fatigue in the placebo group was similar. In ASTRAL-4, the most common adverse reactions (≥10%) in patients with HCV infection and decompensated cirrhosis treated with Epclusa and ribavirin (RBV) included fatigue, anemia, nausea, headache, insomnia, and diarrhea. Four patients treated with Epclusa in combination with RBV discontinued therapy due to adverse reactions.
John F. Milligan, Ph.D., President and Chief Executive Officer of Gilead Sciences, Inc., stated, “As the first once-daily, single-tablet regimen for HCV patients that does not require consideration of genotype or degree of liver fibrosis,”Epclusa has largely simplified the treatment of hepatitis C patients by physicians in China, while holding promise for alleviating the substantial public health burden posed by HCV.“Gilead has launched two direct-acting antiviral (DAA) regimens in China, and we remain committed to providing corresponding support for patient screening and treatment to help address the HCV epidemic in China.”
In 2016, Epclusa received marketing authorization from the U.S. Food and Drug Administration (FDA) and the European Commission.It became the first pan-genotypic single-tablet regimen for HCV infection.In addition, Epclusa has also beenApproved in 54 countries.
Sovaldi (sofosbuvir), as a single-tablet formulation, was approved by the China Food and Drug Administration in 2017. It is a key component of combination antiviral regimens for the treatment of adult and adolescent patients (aged 12–18 years with genotype 2 or 3) infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, or 6.
References
[1] China HCV Guidelines 2015.