Department of Liver Diseases, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Liver Int. 2021 Jun;41(6):1254-1264. doi: 10.1111/liv.14786. Epub 2021 Jan 19.
About 20% of patients receiving nucleos(t)ide analogues treatment experienced low-level viraemia (LLV), which is associated with progression of liver fibrosis and high risk of hepatocellular carcinoma. We aimed to evaluate the effectiveness and safety of switching from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in ETV-treated patients with LLV.
In this prospective study, ETV-treated patients with LLV, presented to our hospital from December 2018 to October 2019, were enrolled. Switching to TAF or continuing ETV was given. The primary effectiveness endpoint was complete virological response (CVR) at 24 weeks, and the safety endpoint was the first occurrence of any clinical adverse event during the treatment.
Totally, 211 patients were recruited and propensity score matching (PSM) generated 75 patients in either TAF or ETV group. After PSM, baseline characteristics were balanced in two groups. After 24-week treatment, the CVR and ALT normalization in TAF group were 62.7% and 47.6%, which were higher than 9.3% and 10.5% in ETV group (OR 16.4, 95% CI 6.6-40.0, P < .001) respectively. Subgroup analysis showed that switching to TAF achieved favours CVR regardless of the status of sex, age, CHB family history, HBV DNA, HBeAg and cirrhosis, whereas alcohol consumption and diabetes mellitus might compromise the CVR of switching to TAF. Both therapies were well tolerated and had satisfying renal safety.
For ETV-treated patients with LLV, switching to TAF is safe enough and superior compared with continuing ETV monotherapy regarding both virological and biochemical benefits.
约 20%接受核苷（酸）类似物治疗的患者出现低水平病毒血症（LLV），这与肝纤维化进展和肝细胞癌发生的高风险相关。我们旨在评估拉米夫定（ETV）治疗的 LLV 患者转换为替诺福韦艾拉酚胺富马酸酯（TAF）的有效性和安全性。
在这项前瞻性研究中，纳入了 2018 年 12 月至 2019 年 10 月期间因 LLV 就诊于我院的 ETV 治疗患者。给予转换为 TAF 或继续 ETV 治疗。主要有效性终点为 24 周时完全病毒学应答（CVR），安全性终点为治疗期间首次发生任何临床不良事件。
共纳入 211 例患者，采用倾向评分匹配（PSM）生成 TAF 或 ETV 组各 75 例患者。PSM 后，两组的基线特征均衡。经过 24 周治疗，TAF 组的 CVR 和 ALT 正常化率分别为 62.7%和 47.6%，高于 ETV 组的 9.3%和 10.5%（OR 16.4，95%CI 6.6-40.0，P<0.001）。亚组分析显示，无论性别、年龄、HBV 家族史、HBV DNA、HBeAg 和肝硬化状态如何，转换为 TAF 均可带来 CVR 获益，而饮酒和糖尿病可能会影响转换为 TAF 的 CVR。两种治疗方法均耐受良好，具有满意的肾脏安全性。
对于 ETV 治疗的 LLV 患者，与继续 ETV 单药治疗相比，转换为 TAF 不仅安全，而且在病毒学和生化方面均具有优势。
