口服, 毋干扰素, C型肝炎治疗

StephenW

All-Oral Interferon-Free Treatment for Patients with Hepatitis C

Responses were impressive in some subgroups.

For patients with hepatitis C virus (HCV) infections, interferon-containing drug regimens require subcutaneous injections and can cause serious adverse effects. Two new reports suggest that all-oral drug regimens for treating HIV-negative patients with chronic HCV infection might be close at hand.

One study involved sofosbuvir, an oral nucleotide polymerase inhibitor. Of 10 patients with genotype 2 or 3 infections who received 12-week courses of oral sofosbuvir plus ribavirin, all exhibited sustained virologic responses (no detectable serum HCV RNA) at 24 weeks after completing treatment. Of 10 patients who received sofosbuvir monotherapy, 6 had sustained virologic responses. The researchers also studied sofosbuvir plus ribavirin in 35 patients with genotype 1 infections: 24-week sustained virologic responses occurred in 21 of 25 previously untreated patients but in only 1 of 10 nonresponders to previous therapies.

In a second study, researchers examined 12-week courses of all-oral drug combinations consisting of ABT-450 (an HCV NS3 protease inhibitor), ritonavir (a protease inhibitor that increases blood levels of ABT-450), ABT-333 (a nonnucleoside NS5B polymerase inhibitor), and ribavirin in patients with genotype 1 infections. Among 33 previously untreated patients, 29 had undetectable blood HCV RNA levels at 48 weeks after treatment. Among 17 poor responders to previous therapies, 8 had undetectable HCV RNA levels at 36 weeks after treatment.

Comment: These phase II, industry-sponsored studies of interferon-free oral regimens achieved impressive response rates in all patients, except those with genotype 1 infections who responded poorly to previous treatments. Although the new drugs have various side effects, nearly all patients completed treatment. The regimens are not yet FDA-approved, but if further research confirms their efficacy and safety, they will represent major advances in therapy for hepatitis C.

— Allan S. Brett, MD

StephenW

响应优秀，在某些子群。

丙型肝炎病毒（HCV）感染的患者，干扰素的药物治疗方案需要皮下注射，并可能导致严重的不良影响。两个新的报告表明，口服药物疗法，用于治疗慢性丙型肝炎病毒感染的HIV阴性的患者可能近在咫尺。

一个的研究涉及sofosbuvir，口服核苷酸聚合酶抑制剂。 10例患者的基因型2或3感染12周的课程的口头sofosbuvir的联合利巴韦林，都表现出持续的病毒学应答（没有检测到血清HCV RNA），在24周后完成治疗。收到sofosbuvir单药治疗的10例患者中，有6人持续病毒学应答。研究人员还研究sofosbuvir联合利巴韦林治疗基因1型感染35例发生在21 25个先前未经治疗的患者，但只有10既往治疗无反应，以24周的持续病毒学应答。

在第二项研究中，研究人员检测了12个星期的课程，所有的口服药物组合组成的A​​BT-450（HCV NS3蛋白酶抑制剂），利托那韦（一种蛋白酶抑制剂，增加血药浓度的ABT-450），ABT-333（一个非核苷NS5B聚合酶抑制剂），和利巴韦林治疗基因1型感染的病人。在33以前未经治疗的患者中，有29例检测不到​​的血液HCV RNA水平在治疗48周后。在17以前的治疗反应差，检测不到HCV RNA水平在36周后治疗。

评论：这些第二阶段的无干扰素口服疗法，行业赞助的研究取得了令人印象深刻的反应率在所有患者中，除了那些基因1型感染对以前的治疗反应不佳。尽管新的药物有不同的副作用，几乎所有的患者完成治疗。的治疗方案尚未获得FDA批准，但如果进一步的研究证实其疗效和安全性，他们将代表C型肝炎治疗的重大进展，

- 艾伦·S.布雷特，MD

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