Patterns of Resistance-associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct Acting Antiviral Agents in the Public Health Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Achievement of sustained virological response
研究概览
简要总结
Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). Pre-existence of resistance associated substitutions (RASs) to direct antiviral agents (DAAs) reduces sustained virologic response (SVR) rates by 3-53% in hepatitis C virus (HCV) genotype 3 infected patients depending on different predictors and the DAA regimen used. This study will prospectively analyze data from the MukhMantri Punjab Hepatitis C Relief Fund (MMPHCRF) to determine the posttreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with daclatasvir-sofosbuvir or sofosbuvir-ledipasvirin patients with chronic HCV.
The study aims to assess the prevalence and effect of RASs on sustained virological response (SVR) rates in patients with treatment failure to a regimen containing sofosbuvir and ledipasvir/daclatasvir.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All viremic chronic hepatitis C
排除标准
- •People with disseminated malignancy, advanced cardiovascular, 18 pulmonary, or neurological disease with short life expectancy were not enrolled
研究组 & 干预措施
Viremic Person living with HCV
All persons enrolled in the MMPHCRF treatment programme are provided free of charge direct acting antiviral agents and followed up for outcomes.
干预措施: Direct Acting Antivirals (Drug)
结局指标
主要结局
Achievement of sustained virological response
时间窗: 12 weeks after treatment completion
SVR12
Assessment of RAS
时间窗: 12 weeks after treatment completion
12 weeks after treatment completion
次要结局
- Assessment of RAS in treatment failures(12 weeks after treatment completion)
研究者
Radha K Dhiman
Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
