Al Mahtab Mamun, Akbar Sheikh Mohammad Fazle, Aguilar Julio Cesar, Yoshida Osamu, Khan Sakirul, Gerardo Guillen Nieto, Hiasa Yoichi
Department of Hepatology, Interventional Hepatology Division, Bangabandhu Sheikh Mujib Medical University, BSMMU, Dhaka, Bangladesh.
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Japan.
Front Med (Lausanne). 2023 Feb 8;10:1032531. doi: 10.3389/fmed.2023.1032531. eCollection 2023.
There is a pressing need to develop novel drugs for treating patients with chronic hepatitis B (CHB), as commercially available antiviral drugs are endowed with safety and efficacy concerns.
A phase III clinical trial was conducted with a therapeutic vaccine containing two antigens of the hepatitis B virus (HBV; named NASVAC) in 78 patients with CHB expressing both HBV DNA and elevated levels of alanine aminotransferase (ALT) in the blood. Five years after the end of treatment (EOT), 60 NASVAC-recipient patients were enrolled in this long-term follow-up study to evaluate the safety, antiviral potential, and liver-protective capacity of NASVAC.
NASVAC exhibited an excellent safety profile 5 years after EOT. The levels of HBV DNA in the sera were reduced in 55 of the 60 patients, and 45 of them were negative for HBV DNA in the sera. ALT levels were also normalized in 40 of the 60 patients 5 years after EOT. None of the patients receiving NASVAC developed liver cirrhosis or cancer.
The present study is the first to exhibit long-term follow-up data of a finite immune therapy for CHB that is safe and endowed with potent antiviral and liver-protecting capacities.
由于市售抗病毒药物存在安全性和有效性问题，因此迫切需要开发治疗慢性乙型肝炎（CHB）患者的新型药物。
对78例血液中同时表达乙肝病毒（HBV）DNA和丙氨酸转氨酶（ALT）水平升高的CHB患者进行了一项III期临床试验，该试验使用了一种含有两种HBV抗原的治疗性疫苗（名为NASVAC）。治疗结束（EOT）五年后，60名接受NASVAC治疗的患者被纳入这项长期随访研究，以评估NASVAC的安全性、抗病毒潜力和肝脏保护能力。
EOT五年后，NASVAC显示出优异的安全性。60例患者中有55例血清中HBV DNA水平降低，其中45例血清中HBV DNA呈阴性。EOT五年后，60例患者中有40例的ALT水平也恢复正常。接受NASVAC治疗的患者均未发生肝硬化或癌症。
本研究首次展示了一种针对CHB的有限免疫疗法的长期随访数据，该疗法安全且具有强大的抗病毒和肝脏保护能力。
