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乙肝治愈再现新的曙光?这款药物二期临床研究可实现乙肝灭菌性治愈
Di Yi Cai Jing·2025-05-11 08:53

Group 1 - Hepatitis B virus (HBV) infection is a significant global public health issue, with chronic HBV potentially leading to cirrhosis and liver cancer if not controlled [1][2] - Current treatments for chronic HBV do not achieve a complete cure, with existing drugs unable to eliminate the virus entirely [2][4] - HepaPlus, a drug developed by Shanghai HepaPlus Pharmaceutical, is one of the few candidates aiming for sterilizing cure in hepatitis B treatment [1][4] Group 2 - The recent Phase II clinical trial results presented at the 2025 European Association for the Study of the Liver (EASL) conference showed that HepaPlus significantly improved the response rate of HBV DNA when combined with PEG interferon [1][5] - The trial included 96 patients, with an average age of 35.3 years, and demonstrated response rates of 78.3%, 87.5%, and 70.8% for different doses of HepaPlus compared to 58.3% for the placebo group [5][6] - The study indicated that a portion of participants achieved cccDNA clearance after 24 weeks of treatment, meeting the criteria for sterilizing cure [1][6] Group 3 - HepaPlus works by blocking HBV infection through the NTCP receptor and preventing rcDNA from forming cccDNA, while PEG interferon enhances immune response to deplete cccDNA [5][6] - The trial showed good tolerability for HepaPlus, with most adverse effects attributed to interferon, and serious adverse events not exceeding grade 2 [6] - The company plans to initiate a global Phase III clinical trial with over 500 participants to further validate the sterilizing cure potential by the end of 2027 [7]