THE IMPACTS OF BASELINE CLINICAL CHARACTERISTICS
AND HEPATITIS B VIRUS MUTATIONS ON CURATIVE
EFFECTS OF CHRONIC HEPATITIS B TREATED WITH
NOVAFERON
Wu Daxian, Tan Deming*, China
Novaferon is a new proprietary protein drug developed by Genova Biotech which can be used to treat a variety of malignant tumors and viral diseases. Its highly potent anti-tumor and anti-virus activities have been proven by National Institute for the Control of Pharmaceutical and Biological products: its anti-tumor and anti-virus activities are 246.7 times and 10 times higher than that of similar products, respectively!
Novaferon的是由热那亚Biotech公司开发了一种新的专有蛋白质药物,可用于治疗多种恶性肿瘤和病毒性疾病。其高度有效的抗肿瘤和抗病毒的活动已经证明了中国药品生物制品检定所:其抗肿瘤和抗病毒的活动是246.7倍,比同类产品高10倍,分别为!作者: 咬牙硬挺 时间: 2015-4-7 16:40
Background and Aims: Background and aims: Novaferon,which is a new type of IFN, had approved by State Food and Drug Administration (SFDA) for clinical trials of new drugs on CHB therapy in 2009.To assess the impacts of baseline clinical characteristics of patients with chronic hepatitis B (CHB) and baseline hepatitis B virus (HBV) gene mutations on curative effects of CHB treated with Novaferon.
Methods: Methods Enrolled patients accepted Novaferon monotherapy for 24 weeks and follow up for 12 weeks. Body mass index (BMI) of patients ,genotype ,basal core promoter (BCP) and precore (PC) , reverse transcriptase(RT), S region variants of HBV were determined prior to Novaferon treatment . Aminotransferase (ALT), Hepatitis B e antigen (HBeAg), HBV DNA, Hepatitis B surface antigen (HBsAg) were determined at the beginning of treatment and 12 weeks after treatment. Then the present study evaluated the influence of age , gender, genotype , BMI, baseline ALT, HBeAg, HBV-DNA, HBsAg titer as well as BCP,PC,RT and S region variants on curative effects of chronic hepatitis B treated with Novaferon。
Results: Results In total of 126 CHB patients who finished the treatedment and follow-up, 38.9% obtained virological response and 32.5%, 25.4%, 44.4%, 23.8% obtained HBeAg clearence, HBeAg seroconversion, biochemical response and combined response respectively. The baseline DNA level of virological response group was significantly lower than no-virological response group; the baseline ALT level were significantly higher in HBeAg clearence group and HBeAg seroconversion group; female and lower BMI level was prone to acquired biochemical response. Stepwise logistic regression analysis showed that PC-P159T(ntC2288A), BCP-N118T(ntA1726C), BCP-L134L (ntA1775C/G/T) were independent influence factors for virological response. The frequencies of PC-G182C (ntG2357T) was significantly higher in groups with HBeAg clearance group and PC-S64A/T(ntT2003G/A), PC-W28STOP (ntG1896A) was significantly higher in HBeAg seroconversion groups , combined response respectively.
Conclusions: Conclusions Novaferon was an effective therapeutic drug for CHB patients, different response type was influenced by different clinical characteristics and mutations. Baseline mutations screening could predict curative effect of Novaferon efficiently and offered the optimal drugs for CHB patients.