治疗结束时“双阴性”HBV患者不太可能复发

StephenW

Patients with ‘double negative’ HBV at treatment end less likely to relapse

Fan R, et al. Clin Gastroenterol Hepatol. 2019;doi:10.1016/j.cgh.2019.07.046.
August 27, 2019

Results from two independent cohorts revealed that patients who had negative test results for both hepatitis B DNA and hepatitis B RNA at the end of nucelos(t)ide analogue therapy were more likely to have continued response for 4 years or more.

Rong Fan, MD, from the Southern Medical University in Guangzhou, China, and colleagues wrote that while off-treatment response was suboptimal in patients with HBV e-antigen positive chronic HBV, “double negative HBV nucleic acid” status at treatment end could provide a potent biomarker for guiding nucleos(t)ide (NA) discontinuation.


The evaluation cohort comprised 130 patients who met the stopping criteria. After 4 years, patients with HBV DNA of “target not detected” at treatment end had lower incidence of clinical relapse compared with those with either HBV DNA less than 20 IU/mL (20% vs. 39.8%; P = .036) or higher than 20 IU/mL (40%; P = .036).

Similarly, patients with negative HBV RNA levels at treatment end had a lower risk for clinical relapse (15.3% vs. 37%; P = .029).

However, the lowest incidence of clinical relapse occurred in patients with double negative status compared with patients positive for either HBV DNA or RNA (8% vs. 31.4%; P = .018), with a negative predictive value of 92%.

Multivariate analysis confirmed that HBV DNA and RNA level at treatment end was the strongest independent predictor of clinical relapse (HR = 4.54; 95% CI, 1.08-19) and virologic relapse (HR = 11.1; 95% CI, 2.69-45.8).

While not statistically significant, analysis of a smaller validation cohort showed that patients with a double negative status had numerically lower relapse rates compared with patients positive for either HBV DNA or RNA (15.4% vs. 33.3%).

“Based on these findings, we propose that the overall HBV nucleic acid level (that is HBV DNA and RNA) could be used as a reliable biomarker for guiding NA discontinuation decisions,” Fan and colleagues wrote. “Meanwhile, there is a need to develop a new kit that can directly detect overall HBV nucleic acid levels for better, simpler monitoring of treatment response and guidance for withdrawal.” – by Talitha Bennett

Disclosures: Fan reports no relevant financial disclosures. Please see the full study for all other author’s relevant financial disclosures.

StephenW

治疗结束时“双阴性”HBV患者不太可能复发

Fan R，et al。 Clin Gastroenterol Hepatol。 2019; DOI：10.1016 / j.cgh.2019.07.046。
2019年8月27日

两个独立队列的结果显示，在nucelos（t）ide类似物治疗结束时对乙型肝炎DNA和乙型肝炎RNA检测结果均为阴性的患者更有可能持续4年或更长时间的反应。

来自中国广州南方医科大学的荣范医师及其同事写道，虽然HBV e抗原阳性慢性HBV患者的治疗后反应不是最理想，治疗结束时“双阴性HBV核酸”状态可能提供用于引导核苷（t）ide（NA）中断的有效生物标志物。


评估队列包括符合停止标准的130名患者。 4年后，治疗结束时“未检测到目标”的HBV DNA患者临床复发率低于HBV DNA低于20 IU / mL的患者（20％vs。39.8％; P = .036）或高于20 IU / mL（40％; P = .036）。

同样，治疗结束时HBV RNA水平为阴性的患者临床复发风险较低（15.3％对37％; P = .029）。

然而，与HBV DNA或RNA阳性的患者相比，双重阴性患者的临床复发率最低（8％对31.4％; P = .018），阴性预测值为92％。

多变量分析证实，治疗结束时HBV DNA和RNA水平是临床复发的最强独立预测因子（HR = 4.54; 95％CI，1.08-19）和病毒学复发（HR = 11.1; 95％CI，2.69-45.8）。

虽然没有统计学意义，但对较小验证队列的分析显示，与HBV DNA或RNA阳性的患者相比，双阴性患者的复发率在数值上更低（15.4％对33.3％）。

“根据这些发现，我们提出整体HBV核酸水平（即HBV DNA和RNA）可用作指导NA中止决定的可靠生物标志物，”Fan及其同事写道。 “同时，需要开发一种新的试剂盒，可以直接检测HBV的总体核酸水平，以便更好，更简单地监测治疗反应和退出指导。” - 作者：Talitha Bennett

披露：Fan报告没有相关的财务披露。有关所有其他作者的相关财务披露，请参阅完整的研究。

Zhao85

有必要   （）开发一种新的试剂盒，可以直接检测HBV的总体核酸水平
期待！