FDA Chronic Hepatitis C Virus Infection Developing Direct-Acting Antiviral Drugs for Treatment
标准简介
Chronic Hepatitis C Virus Infection Developing Direct-Acting Antiviral Drugs for Treatment[附网盘链接]是于不久之前发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Chronic Hepatitis C Virus Infection Developing Direct-Acting Antiviral Drugs for Treatment[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-
investigational new drug application (pre-IND) stage through the new drug application (NDA) 2
and postmarketing stages. For the purposes of this guidance, the Food and Drug Administration (FDA) defines direct-acting hepatitis C virus (HCV) antivirals as drugs that interfere with specific steps in the HCV replication cycle through direct interaction with the HCV genome, polyprotein, or polyprotein cleavage products. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support DAA drugs. The organization of this guidance parallels the drug development plan. This guidance does not address the development of drugs that target host functions necessary for viral replication or of immune-based drugs for the treatment of HCV infection such as new interferon (IFN) drugs. This guidance also does not address treatment of acute hepatitis C or the use of therapeutics without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes of CHC, such as prevention of hepatocellular carcinoma (HCC) or reversal of fibrosis. The main focus of this guidance is on development of DAAs as part of IFN-
free regimens. Because safe and highly effective FDA-approved IFN-free treatment options are available, the Division of Antiviral Products (DAVP) recommends against studying an IFN-
containing regimen in a DAA treatment-naïve population. 1
This guidance has been prepared by the Division of Antiviral Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products regulated in CDER unless otherwise specified.
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