Chung Sung Won, Chang Young, Lee Hyo Young, Cho Eun Ju, Lee Jeong-Hoon, Yu Su Jong, Yoon Jung-Hwan, Kim Yoon Jun
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Republic of Korea.
Gastroenterol Res Pract. 2018 Dec 16;2018:6948235. doi: 10.1155/2018/6948235. eCollection 2018.
The efficacy of tenofovir disoproxil fumarate (TDF) monotherapy as maintenance therapy in multidrug-resistant (MDR) hepatitis B virus (HBV) patients after complete virologic suppression (CVS) has not been well evaluated. We evaluated the efficacy of maintenance TDF monotherapy compared with conventional TDF plus entecavir combination therapy after CVS of MDR HBV.
In this single-center retrospective study, patients with MDR HBV who were previously treated with entecavir plus TDF combination therapy and achieved CVS were included. Patients were either maintained on entecavir plus TDF combination therapy or switched to TDF monotherapy after CVS. The primary endpoint was the virologic breakthrough, and secondary outcomes were liver cirrhosis (LC) or hepatocellular carcinoma (HCC) development. To overcome immortal time bias, time-varying Cox proportional hazard regression analysis was performed.
A total of 201 patients were included, and 153 patients were maintained on entecavir plus TDF combination therapy (combination group); 48 patients were converted from combination therapy to TDF monotherapy (single group) after CVS. Five patients experienced a virologic breakthrough, one patient in the single group owing to poor transient compliance and four patients in the combination group ( = 0.51). One new case of LC developed in the single group; five cases of LC developed in the combination group ( = 0.35). No new HCC development occurred in the single group, while seven cases of HCC developments were noted in the combination group. However, these results were not statistically significant ( = 0.54).
For patients with suppressed HBV DNA, the efficacy of TDF monotherapy as maintenance therapy is comparable to that of entecavir plus TDF combination therapy.
富马酸替诺福韦二吡呋酯（TDF）单药疗法作为多药耐药（MDR）乙型肝炎病毒（HBV）患者在病毒学完全抑制（CVS）后维持治疗的疗效尚未得到充分评估。我们评估了MDR HBV患者CVS后维持TDF单药疗法与传统TDF加恩替卡韦联合疗法的疗效。
在这项单中心回顾性研究中，纳入了先前接受恩替卡韦加TDF联合疗法并实现CVS的MDR HBV患者。患者在CVS后要么继续接受恩替卡韦加TDF联合疗法维持治疗，要么改用TDF单药疗法。主要终点是病毒学突破，次要结局是肝硬化（LC）或肝细胞癌（HCC）的发生。为克服永生时间偏倚，进行了时变Cox比例风险回归分析。
共纳入201例患者，153例患者继续接受恩替卡韦加TDF联合疗法（联合组）；48例患者在CVS后从联合疗法转换为TDF单药疗法（单药组）。5例患者发生病毒学突破，单药组1例因短暂依从性差，联合组4例（P = 0.51）。单药组出现1例新的LC；联合组出现5例LC（P = 0.35）。单药组未出现新的HCC发生，而联合组有7例HCC发生。然而，这些结果无统计学意义（P = 0.54）。
对于HBV DNA被抑制的患者来说，TDF单药疗法作为维持治疗的疗效与恩替卡韦加TDF联合疗法相当。
