A Phase IV Open-label, Multicentre, International Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir ±Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection and Recent Injection Drug Use or Receiving Opioid Substitution Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12)
研究概览
简要总结
A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.
详细描述
A total of 100 people with recent injection drug use or recipients of opioid substitution therapy will be enrolled from drug and alcohol clinics, tertiary liver and infectious diseases clinics and community health centres across Canada, Europe, New Zealand, France, and Australia. This will include at least 30 participants with F3/F4 liver disease. Participants will be considered recent injection drug users if they have used injection drugs in the 6 months prior to consent. Participants receiving stable opioid substitution therapy (stable dose for >2 weeks) will also be included. Patients with frequent drug use that is judged by the treating physician to compromise treatment safety will be excluded. The study drugs consisting of two tablets of the co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, ribavirin (1000 mg) daily in two divided doses (genotype 1a only and/or cirrhosis). Electronic blister packs will be used to improve and monitor treatment adherence. This innovative strategy with the "3D" interferon-free regimen could considerably enhance the capacity to scale-up HCV treatment among PWID, and is therefore being evaluated in this phase IV study within a well-defined PWID population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
"3D" regimen
The "3D" regimen contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, and one dasabuvir tablet (250 mg) twice daily for genotype 1b without cirrhosis. Treatment will be 12 weeks.
干预措施: "3D" regimen (Drug)
"3D" regimen with ribavirin
The "3D" regimen with ribavirin contain two tablets of co-formulated paritepravir/ritonavir/ombitasvir (75/50/12.5 mg) once daily, one dasabuvir tablet (250 mg) twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a (with/without) and genotype 1b with cirrhosis. Treatment will be for 12 weeks.
干预措施: "3D" regimen with ribavirin (Drug)
结局指标
主要结局
The proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12)
时间窗: 12 weeks post treatment
To evaluate the proportion of participants with undetectable HCV RNA 12 weeks post end of treatment (SVR12) following the "3D" regimen with or without ribavirin for 12 weeks in people with chronic HCV genotype 1 infection.
次要结局
- The proportion of participants with undetectable HCV RNA at 24 weeks post end of treatment (SVR24)(24 weeks post treatment)
- Change in injecting drug use and injecting risk behaviour(Baseline to week 12)
- Change in health-related quality of life Questionnaire(Baseline to week 12)
- Treatment adherence(Baseline to week 12)
- Impact of mixed HCV infection on treatment response(Baseline to SVR12)
- The proportion of participants with undetectable HCV RNA at the end of treatment - week 12(End of treatment week 12)
- Change in mental health(Baseline to week 12)
- Change in opioid substitution therapy(Baseline to week 12)
- Utility of HCV core antigen testing as a simple method for HCV monitoring(Week 108)
- The proportion of participants with undetectable HCV RNA at 2 weeks following the initiation of treatment - week 2(2 weeks following the initiation of treatment)
- The proportion of participants with undetectable HCV RNA at 4 weeks following the initiation of treatment - week 4(4 weeks following the initiation of treatment)
- Association between adherence and response to treatment(Early (0-3 weeks), mid (4-7 weeks), late (8-11 weeks) during treatment)
- Safety and tolerability (number and type of adverse events and serious adverse events)(Baseline to week 24 (SVR24))
- HCV reinfection rate(Week 108)
- Emergence of viral resistance-associated variants (RAVs)(Baseline to week 12)