NEJM：抗病毒组合疗法后或可有效治疗肝病晚期丙肝患者

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NEJM：抗病毒药物组合性疗法后或可有效治疗肝病晚期的丙肝患者

近日，一项来自以色列贝司医学中心等处研究人员进行了一项多中心的临床试验，结果表明，抗病毒药物的组合可以帮助消除90%以上肝病晚期患者机体中的丙肝病毒感染，这项名为ASTRAL-4的临床试验研究结果刊登于国际杂志NEJM上。

文章中研究者Michael Curry指出，本文研究中超过一半的患者都在此前治疗丙肝的疗法中失败了，而本文试验中研究者将抗病毒药物索非布韦（Sofosbuvir）和Velpatasvir相结合，同时添加或不添加药物利巴韦林进行为期12周或24周的治疗，结果发现抗病毒药物的组合性疗法可以成功治疗83%至94%的丙肝患者。

目前丙肝病毒(HCV)在全球大约感染了1.3亿至1.5亿人，而且丙肝病毒感染是引发肝脏衰竭及肝硬化的主要原因，肝硬化的发生即是以疤痕组织来代替肝脏健康组织，最终抑制肝脏发挥正常的代谢功能，本文研究中研究者对来自美国47个地方的267名因感染病毒病毒引发肝脏衰竭的患者进行了随机的3期临床研究。

目前很少有疗法可以治疗已经发生肝硬化和肝衰竭的丙肝患者，而本文研究中研究者在早期的一部分研究中发现了患者的肝脏功能可以得到部分改善，他们利用蔡尔兹普得分来评估患者肝硬化的程度，同时以MELD评分来用于确定可以优先进行肝脏移植的患者。肝脏是机体中的大型实体器官，其在人类健康中扮演着多种功能，包括制造血液蛋白来帮助进行血凝和免疫功能的发挥，消化食物等等。

最后研究者Curry表示，目前由于感染丙肝导致患肝衰竭的患者的数量在未来10年里会出现持续性的增长，本文研究表明，患肝病晚期的患者可以在组合性抗病毒疗法的帮助下获得持续性的肝脏功能改善，从而可以有效消除患者机体中的病毒感染，帮助恢复机体的健康。（生物谷Bioon.com）

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doi:10.1056/NEJMoa1512614
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Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.

Curry MP1, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators.

Background As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase. Methods We conducted a phase 3, open-label study involving both previously treated and previously untreated patients infected with HCV genotypes 1 through 6 who had decompensated cirrhosis (classified as Child-Pugh-Turcotte class B). Patients were randomly assigned in a 1:1:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily for 12 weeks, sofosbuvir-velpatasvir plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. Results Of the 267 patients who received treatment, 78% had HCV genotype 1, 4% genotype 2, 15% genotype 3, 3% genotype 4, and less than 1% genotype 6; no patients had genotype 5. Overall rates of sustained virologic response were 83% (95% confidence interval [CI], 74 to 90) among patients who received 12 weeks of sofosbuvir-velpatasvir, 94% (95% CI, 87 to 98) among those who received 12 weeks of sofosbuvir-velpatasvir plus ribavirin, and 86% (95% CI, 77 to 92) among those who received 24 weeks of sofosbuvir-velpatasvir. Post hoc analysis did not detect any significant differences in rates of sustained virologic response among the three study groups. Serious adverse events occurred in 19% of patients who received 12 weeks of sofosbuvir-velpatasvir, 16% of those who received 12 weeks of sofosbuvir-velpatasvir plus ribavirin, and 18% of those who received 24 weeks of sofosbuvir-velpatasvir. The most common adverse events were fatigue (29%), nausea (23%), and headache (22%) in all patients and anemia (31%) in the patients receiving ribavirin. Conclusions Treatment with sofosbuvir-velpatasvir with or without ribavirin for 12 weeks and with sofosbuvir-velpatasvir for 24 weeks resulted in high rates of sustained virologic response in patients with HCV infection and decompensated cirrhosis. (Funded by Gilead Sciences; ASTRAL-4 ClinicalTrials.gov number, NCT02201901 .).

来源：生物谷