Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
Korean J Intern Med. 2019 Jul;34(4):802-810. doi: 10.3904/kjim.2019.037. Epub 2019 Apr 8.
BACKGROUND/AIMS: The optimal management of chronic hepatitis B (CHB) patients with partial virologic response (PVR) to tenofovir disoproxil fumarate (TDF) remains unclear. We aimed to evaluate the long-term efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF therapy in real practice.
We retrospectively investigated the efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA over 2 log10 IU/mL from baseline, with detectable HBV DNA by real-time polymerase chain reaction at week 48.
We included 232 patients who underwent TDF therapy for over 48 weeks. Forty-two patients (18.1%) showed PVR. In multivariate analysis, hepatitis B e antigen (HBeAg) positivity, and high levels of serum HBV DNA at baseline and week 12 were independent predictive factors for PVR during TDF therapy. Out of 42 patients with PVR, 39 (92.9%) achieved virologic response (VR) during continuous TDF treatment; the cumulative VR rates at 24, 36, and 48 months were 79.8%, 88.2%, and 95.6%, respectively. With an additional 12 months of therapy, VR was achieved in 28/31 (90.3%) patients with HBV DNA < 100 IU/mL, compared to 5/11 (45.5%) patients with HBV DNA ≥ 100 IU/mL, at week 48.
The vast majority of patients achieved VR through prolonged TDF therapy, thus TDF treatment can be maintained in nucleos(t)ide-naïve patients with PVR at week 48, especially in those with low viremia.
背景/目的：对于接受替诺福韦酯（TDF）治疗后部分病毒学应答（PVR）的慢性乙型肝炎（CHB）患者，其最佳管理仍不清楚。我们旨在评估在真实实践中，对 PVR 接受 TDF 治疗的初治 CHB 患者延长 TDF 治疗的长期疗效。
我们回顾性调查了 PVR 接受 TDF 治疗的初治 CHB 患者延长 TDF 治疗的疗效。PVR 定义为基线时血清乙型肝炎病毒（HBV）DNA 下降超过 2 log10 IU/mL，且在第 48 周时通过实时聚合酶链反应检测到 HBV DNA。
我们纳入了 232 例接受 TDF 治疗超过 48 周的患者。42 例（18.1%）患者出现 PVR。多变量分析显示，HBeAg 阳性和基线及 12 周时血清 HBV DNA 高水平是 TDF 治疗期间 PVR 的独立预测因素。在 42 例 PVR 患者中，39 例（92.9%）在连续 TDF 治疗中达到病毒学应答（VR）；24、36 和 48 个月时的累积 VR 率分别为 79.8%、88.2%和 95.6%。在额外的 12 个月治疗后，与第 48 周时 HBV DNA<100 IU/mL 的 28/31 例（90.3%）患者相比，HBV DNA≥100 IU/mL 的 11 例患者中有 5 例（45.5%）达到 VR。
通过延长 TDF 治疗，绝大多数患者实现了 VR，因此在第 48 周时，对于 PVR 接受 TDF 治疗的初治核苷（酸）类似物治疗患者，特别是低病毒血症患者，可以维持 TDF 治疗。
