Department of Infectious Disease, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe District, Guangzhou, 510630, Guangdong Province, China.
First Department of Liver Disease, Guangzhou Eighth People's Hospital, Guangzhou, 510000, Guangdong Province, China.
BMC Infect Dis. 2020 Dec 7;20(1):931. doi: 10.1186/s12879-020-05642-y.
Evaluate the safety and efficacy of 104-week regimen of Telbivudine(LdT)-based optimization strategy for Chinese patients who have chronic hepatits B(CHB) with HBeAg-negative.
This multi-center, open-label, prospective study enrolled 108 HBeAg-negative CHB patients who received LdT (600 mg/day) for 24 weeks, Adefovir (ADV) was added if HBV DNA remained detectable at week 24, otherwise LdT was maintained to use until 104 weeks. HBV DNA, alanine amino transferase (ALT), hepatitis B surface antigen(HBsAg), creatinine kinase(CK), and estimated glomerular filtration rate (eGFR) were measured, safety was assessed.
Eighty-eight patients (81%) had HBV-DNA undetectable at 24 weeks and maintained to receive LdT monotherapy until 104 weeks, whereas the other 20 patients had HBV-DNA detectable and ADV was used in combination. For all patients, 72% of patients reached ALT normalization at 24 weeks, which increased to 80% at 52 weeks and 104 weeks, respectively.. 81% of total patients had undetectable HBV-DNA at 24 weeks, 92% at 52 weeks, and 94% at 104 weeks. The HBsAg titre declined steadily from baseline to 104 weeks (3.62 vs. 2.98 log10 IU/mL, p < 0.05), and the eGFR increased steadily from baseline to 104 weeks (92.9 vs. 104.4 mL/min/1.73 m, p < 0.05). Although 79 patients (73%) had at least one time of elevated CK, most of these patients had CK elevated in Grade 1/2.
LdT was well tolerated and effective, and 94% of patients achieved virological suppression after 104 weeks.
This study was registered in clinicaltrials.gov on January 31, 2012 and the ID No. was NCT01521975 .
评估替比夫定（LdT）为基础的优化策略治疗乙型肝炎 e 抗原阴性的慢性乙型肝炎患者 104 周疗程的安全性和疗效。
这项多中心、开放性、前瞻性研究纳入了 108 例乙型肝炎 e 抗原阴性的慢性乙型肝炎患者，他们接受替比夫定（600mg/天）治疗 24 周，如果第 24 周时 HBV DNA 仍可检测到，则加用阿德福韦酯（ADV），否则继续使用替比夫定治疗，直至 104 周。检测 HBV DNA、丙氨酸氨基转移酶（ALT）、乙型肝炎表面抗原（HBsAg）、肌酸激酶（CK）和估计肾小球滤过率（eGFR），评估安全性。
88 例（81%）患者在 24 周时 HBV-DNA 不可检测，并继续接受替比夫定单药治疗至 104 周，而其余 20 例患者 HBV-DNA 可检测，联合使用 ADV。所有患者中，72%的患者在 24 周时达到 ALT 正常化，在 52 周和 104 周时分别增至 80%和 100%。81%的患者在 24 周时 HBV-DNA 不可检测，92%的患者在 52 周时 HBV-DNA 不可检测，94%的患者在 104 周时 HBV-DNA 不可检测。HBsAg 滴度从基线到 104 周稳步下降（3.62 对 2.98 log10 IU/mL，p<0.05），eGFR 从基线到 104 周稳步升高（92.9 对 104.4 mL/min/1.73 m，p<0.05）。尽管 79 例（73%）患者至少有一次 CK 升高，但大多数患者的 CK 升高为 1/2 级。
替比夫定耐受性良好，疗效显著，94%的患者在 104 周后实现病毒学抑制。
本研究于 2012 年 1 月 31 日在 clinicaltrials.gov 注册，注册号为 NCT01521975。
