Implications of HCV RNA level at week 4 of direct antiviral treatments for hepatitis C.
Implications of HCV RNA level at week 4 of direct antiviral treatments for hepatitis C.
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DOI：
10.1111/jvh.12731
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发表时间：
2017-11
影响因子：
2.5
通讯作者：
Ioannou GN
中科院分区：
文献类型：
--
作者：
Johnson K;Green PK;Ioannou GN
我们旨在确定在现实临床环境中，使用直接作用抗病毒药物（DAAs）治疗四周后的丙型肝炎病毒（HCV）载量（W4VL）是否可预测持续病毒学应答（SVR）。
我们确定了21095名在2014年1月1日至2015年6月30日期间在国家退伍军人事务（VA）医疗保健系统中开始基于DAA的抗病毒治疗的患者。W4VL被分类为检测不到、低于定量下限可检测（DBQ）、病毒载量≤42 IU/mL的高于定量下限可检测（DAQ≤42）以及病毒载量>42 IU/mL的高于定量下限可检测（DAQ>42）。
W4VL在36.1%的患者中检测不到，DBQ占45.6%，DAQ≤42占9.3%，DAQ>42占9.1%。与使用罗氏COBAS AmpliPrep/COBAS TaqMan Version 2检测方法相比，使用雅培实时HCV检测方法时，DAQ更为常见，而检测不到的W4VL则少见得多。与W4VL检测不到的患者（SVR = 93.5%）相比，DBQ患者（SVR = 91.8%，调整后的优势比[AOR]为0.79，p值 = 0.001）、DAQ≤42患者（SVR = 90.0%，AOR为0.63，p值<0.001）以及DAQ>42患者（SVR = 86.2%，AOR为0.52，p值<0.001）在调整基线特征和治疗持续时间后，获得SVR的可能性逐渐降低。在可能符合8周索磷布韦/来迪派韦单药治疗条件的基因1型感染患者中，我们没有发现证据表明12周治疗而非8周治疗与更高的SVR相关，即使在DAQ患者中也是如此。
在现实临床实践中，DBQ和DAQ的W4VL非常常见，这与临床试验中所报道的情况相反，并且强烈预示着在不同基因型和临床相关患者亚组中SVR降低。W4VL结果是否以及如何影响治疗决策需要进一步研究。
We aimed to determine whether the HCV viral load after four weeks of treatment (W4VL) with direct-acting antiviral agents (DAAs) predicts sustained virologic response (SVR) in a real-world clinical setting. We identified 21,095 patients who initiated DAA-based antiviral treatment in the national Veterans Affairs (VA) healthcare system from 01/01/2014 to 06/30/2015. W4VL was categorized as undetectable, detectable below quantification (DBQ), detectable above quantification (DAQ) with viral load ≤42 IU/mL (DAQ≤42) and DAQ with viral load > 42 IU/mL (DAQ>42). W4VL was undetectable in 36.1%, DBQ in 45.6%, DAQ≤42 in 9.3%, DAQ>42 in 9.1%. DAQ was much more common and undetectable W4VL much less common when tested with the Abbott RealTime HCV assay versus the Roche COBAS AmpliPrep/COBAS TaqMan Version 2 assay. Compared to patients with undetectable W4VL (SVR=93.5%), those with DBQ (SVR=91.8%, adjusted odds ratio [AOR] 0.79, p-value=0.001), DAQ≤42 (SVR=90.0%, AOR 0.63, p-value<0.001) and DAQ>42 (SVR=86.2%, AOR 0.52, p-value<0.001) had progressively lower likelihood of achieving SVR after adjusting for baseline characteristics and treatment duration. Among genotype 1-infected patients who were potentially eligible for 8-week sofosbuvir/ledipasvir monotherapy, we did not find evidence that treatment for 12 weeks instead of 8 weeks was associated with higher SVR, even among those with DAQ. DBQ and DAQ W4VL are very common in real-world practice, contrary to what was reported in clinical trials, and strongly predict reduced SVR across genotypes and clinically-relevant patient subgroups. Whether and how W4VL results should influence treatment decisions requires further study.
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