台湾地区慢性丙型肝炎与乙型肝炎合并感染患者接受雷迪帕韦/索磷布韦治疗：治疗后 108 周随访结果。
Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment.
机构信息
Department of Internal Medicine, Hepatitis Research Center, and Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine and Hospital, Taipei City, Taiwan.
Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.
出版信息
Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971.
BACKGROUND
For patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV), HCV treatment with direct-acting antivirals can lead to HBV reactivation. We evaluated HBV reactivation during ledipasvir/sofosbuvir treatment and 108-week follow-up.
METHODS
In Taiwan, 111 patients with HCV genotype 1 or 2 and HBV received ledipasvir/sofosbuvir (90mg/400mg) once daily for 12 weeks. HBV virologic reactivation was defined as postbaseline increase in HBV DNA from either less than the lower limit of quantification (LLOQ, 20 IU/mL) to equal to or more than LLOQ or equal to or more than LLOQ to >1 log10 IU/mL. HBV clinical reactivation was HBV virologic reactivation with alanine aminotransferase (ALT) >2× upper limit of normal. Factors associated with development of HBV virologic or clinical reactivation were evaluated with logistic regression analysis.
RESULTS
All patients (100%, 111/111) maintained HCV suppression through 108 weeks after treatment. HBV virologic reactivation occurred in 73% of patients (81/111). Clinical reactivation occurred in 9% (10/111). The majority of HBV virologic reactivations (86%, 70/81) occurred by follow-up week 12, whereas clinical reactivation was generally more delayed. Eight (7%, 8/111) initiated HBV therapy. In regression analyses, baseline HBV DNA and hepatitis B surface antigen (HBsAg) levels were associated with HBV virologic reactivation and baseline ALT and HBV DNA, and HBsAg levels were associated with HBV clinical reactivation.
CONCLUSION
Among HCV/HBV coinfected patients treated with direct-acting antivirals for HCV, HBV virologic reactivation occurred in a majority of patients during treatment and follow-up. In most patients, HBV virologic reactivation was asymptomatic; only a small proportion initiated HBV treatment. Notably, clinical reactivation may still occur >3 months after end of therapy.
CLINICAL TRIALS REGISTRATION
NCT02613871.
背景
对于丙型肝炎病毒 (HCV) 和乙型肝炎病毒 (HBV) 合并感染的患者，直接作用抗病毒药物治疗 HCV 可导致 HBV 再激活。我们评估了 ledipasvir/sofosbuvir 治疗期间和 108 周随访期间的 HBV 再激活情况。
方法
在台湾，111 例 HCV 基因型 1 或 2 合并 HBV 的患者接受 ledipasvir/sofosbuvir（90mg/400mg）每日 1 次治疗 12 周。HBV 病毒学再激活定义为基线后 HBV DNA 从低于定量下限（LLOQ，20IU/ml）增加到等于或大于 LLOQ，或等于或大于 LLOQ 到>1 log10 IU/ml。HBV 临床再激活是指 HBV 病毒学再激活伴丙氨酸氨基转移酶（ALT）>2×正常值上限。采用 logistic 回归分析评估与 HBV 病毒学或临床再激活相关的因素。
结果
所有患者（100%，111/111）在治疗后 108 周均维持 HCV 抑制。73%（81/111）的患者发生 HBV 病毒学再激活。9%（10/111）的患者发生临床再激活。大多数 HBV 病毒学再激活（86%，70/81）发生在随访第 12 周，而临床再激活通常更延迟。8 例（7%，8/111）开始 HBV 治疗。在回归分析中，基线 HBV DNA 和乙型肝炎表面抗原（HBsAg）水平与 HBV 病毒学再激活相关，基线 ALT 和 HBV DNA、HBsAg 水平与 HBV 临床再激活相关。
结论
在接受直接作用抗病毒药物治疗 HCV 的 HCV/HBV 合并感染患者中，大多数患者在治疗和随访期间发生 HBV 病毒学再激活。在大多数患者中，HBV 病毒学再激活无症状；只有一小部分患者开始接受 HBV 治疗。值得注意的是，治疗结束后仍可能发生>3 个月的临床再激活。
临床试验注册
NCT02613871。
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