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临床试验/NCT02799355
NCT02799355已完成不适用

Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 1,203 人开始时间: 2016年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,203
试验地点
1
主要终点
Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.

研究概览

简要总结

Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to receive FDA approval-boceprevir, telaprevir, and simeprevir-do not currently have a role in the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents, daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 - 100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks. Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development of agents that directly target various stages of HCV replication are likely to provide HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis, and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2 infection.Moreover, patients with HCV genotype 3 infection are less responsive to peginterferon based treatment than are patients with HCV genotype 2 infection.

详细描述

Sofosbuvir is an oral nucleotide analogue inhibitor of the HCV NS5B polymerase that is effective against HCV genotypes 2 and 3 when it is administered in combination with weight based ribavirin for 24 weeks. In Genotype 1, a combination of Pegylated Interferon alpha 2 a with oral Sofosbuvir and weight based Ribavirin for 12 weeks resulted in 90 -100 % sustained virological response rates (SVR). These SVR rates for chronic hepatitis C genotypes 1,2 and 3 are all based on Western studies. The investigators plan to conduct a retrospective study in Northern India region on patients treated with Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and Peginterferon alpha 2a. The purpose of the investigators study is to assess the percentage of patients with sustained virologic response.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more then 18 years.
  • Patient who on treatment of either Sofosbuvir and Ribavirin (24 weeks) or Sofosbuvir, Ribavirin and peginterferon (12 weeks).

排除标准

  • Patient who are lost to follow up.

结局指标

主要结局

Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.

时间窗: 3 month

Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)

次要结局

  • Side effect(3 month)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Sandeep S Sidhu

Professor

Dayanand Medical College and Hospital

研究点 (1)

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