REduced duration of Eight versus twelVe weeks of SOfosbuvir-VeLpatasvir in treatment naive non-cirrhotic patients with chronic hepatitis C virus infection: A Multicentric, Open labeled, Randomized, Non-inferiority trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 880
- 试验地点
- 5
- 主要终点
- Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir
研究概览
简要总结
HCV is a hepatotropic virus and all those with active HCV infection have need treatment. Though, several pangenotypic drug combinations are approved for HCV treatment, India has access to only two of them- sofosbuvir/daclatasvir and sofosbuvir/velpatasvir. Use of either of these combinations need 12 weeks of treatment. Recent studies have shown that the treatment duration can be reduced for from 12 weeks to 8 weeks for several anti-HCV drug combinations without compromising the response. The data are limited on effectiveness of 8 weeks of sofosbuvir/velpatasvir combination. Research question
Can anti-HCV treatment duration be reduced from 12 weeks to 8 weeks without compromising the virological response?
The primary objective is tocompare the sustained virological response at week 12 (SVR12) after stopping 8 weeks or 12 weeks of sofosbuvir/velpatasvir in non-cirrhotic patients with chronic hepatitis C virus infection. The secondaryobjective is tocompare the proportion of participants completing their planned 8 weeks or 12 weeks of treatment.
Methodology
This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 x 440) treatment naïve, viraemic, non-cirrhotic HCV patients. Participants will be randomized to receive either 8- or 12-week treatment followed by HCV RNA testing at 12 weeks after treatment completion for sustained virological response (SVR12) to define treatment success or failure. A blood specimen will be collected at baseline (for HCV genotype determination) and at 4 weeks of treatment (for early virological response).
Proposed outcome The study will provide data on the efficacy of 8 weeks of treatment as compared to standard of care (12 weeks) in non-cirrhotic patients with active HCV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age >18 years 2.HCV mono-infection or HCV-HIV coinfection 3.Detectable HCV RNA (>10,000 IU/mL) in serum 4.Chronic HCV infection 5.No evidence of cirrhosis based upon a combination of history, examination, ultrasound, Transient elastography, APRI, FIB-4, Upper GI endoscopy.
排除标准
- •1.Presence of cirrhosis 2.HCV-HBsAg coinfection 3.Prior exposure to oral anti-HCV drugs, i.e, DAAs 4.Hepatocellular carcinoma or any other malignancy 5.Portal vein thrombosis 6.High-risk population such as people on maintenance hemodialysis, talassaemic or haemophiliacs, people who inject drugs, men have sex with men, high risk sexual behaviour.
结局指标
主要结局
Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir
时间窗: Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir
次要结局
- The proportion of participants who have completed their planned anti-HCV treatment(Eight (intervention arm) or twelve weeks (standrad arm) after start of anti-HCV drugs)