富马酸替诺福韦二吡呋酯治疗基线病毒载量高的慢性乙型肝炎患者 240 周的疗效。
Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load.
机构信息
Henry Ford Health System, Detroit, MI, USA.
出版信息
Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.
UNLABELLED
We evaluated the antiviral response of patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as having hepatitis B virus (HBV) DNA ≥ 9 log10 copies/mL, after 240 weeks of tenofovir disoproxil fumarate (TDF) treatment. A total of 641 hepatitis B e antigen (HBeAg)-negative and HBeAg-positive patients (129 with HVL) received 48 weeks of TDF 300 mg (HVL n = 82) or adefovir dipivoxil (ADV) 10 mg (HVL n = 47), followed by open-label TDF for an additional 192 weeks. Patients with confirmed HBV DNA ≥ 400 copies/mL on or after week 72 had the option of adding emtricitabine (FTC). By week 240, 98.3% of HVL and 99.2% of non-HVL patients on treatment achieved HBV DNA <400 copies/mL. Both groups had similar rates of histologic regression between baseline and week 240. Patients with HVL generally took longer to achieve HBV DNA <400 copies/mL than non-HVL patients, but by week 96, the percentages of patients with HBV DNA <400 copies/mL were similar in both groups. Among HVL patients, time to achieving HBV DNA <400 copies/mL was shorter among those initially receiving TDF, compared to ADV. No patient with baseline HVL had persistent viremia at week 240 or amino acid substitutions associated with TDF resistance.
CONCLUSION
CHB patients with HVL can achieve HBV DNA negativity with long-term TDF treatment, although time to HBV DNA <400 copies/mL may be longer, relative to patients with non-HVL.
目的
评估基线高病毒载量（HBV DNA≥9log10 拷贝/ml）的慢性乙型肝炎（CHB）患者在接受替诺福韦酯（TDF）治疗 240 周后的抗病毒应答。
方法
共有 641 例乙型肝炎 e 抗原（HBeAg）阴性和 HBeAg 阳性（HBeAg 阳性患者 129 例，HBV DNA≥9log10 拷贝/ml）患者接受 48 周 TDF 300mg（HBV DNA≥9log10 拷贝/ml 患者 82 例）或阿德福韦酯（ADV）10mg（HBV DNA≥9log10 拷贝/ml 患者 47 例）治疗，然后接受开放标签 TDF 治疗 192 周。在第 72 周或之后确认 HBV DNA≥400 拷贝/ml 的患者可选择加用恩曲他滨（FTC）。在第 240 周时，98.3%的 HBV DNA≥9log10 拷贝/ml 和 99.2%的 HBV DNA<400 拷贝/ml 的患者接受治疗。两组在基线至第 240 周的组织学缓解率相似。HBV DNA≥9log10 拷贝/ml 的患者通常比 HBV DNA<400 拷贝/ml 的患者需要更长时间达到 HBV DNA<400 拷贝/ml，但在第 96 周时，两组患者的 HBV DNA<400 拷贝/ml 的比例相似。在 HBV DNA≥9log10 拷贝/ml 的患者中，初始接受 TDF 治疗的患者达到 HBV DNA<400 拷贝/ml 的时间较短，而初始接受 ADV 治疗的患者达到 HBV DNA<400 拷贝/ml 的时间较长。在第 240 周时，没有基线 HBV DNA≥9log10 拷贝/ml 的患者持续病毒血症或与 TDF 耐药相关的氨基酸替代。
结论
HBV DNA≥9log10 拷贝/ml 的 CHB 患者可通过长期 TDF 治疗实现 HBV DNA 阴性，但与 HBV DNA<400 拷贝/ml 的患者相比，实现 HBV DNA<400 拷贝/ml 的时间可能更长。
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