Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of people who inject drugs (PWIDs) with HCV who were recruited and retained
研究概览
简要总结
This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥18 years of age;
- •2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;
- •HCV genotype 1;
- •HCV RNA <6 million copies by Roche TaqMan Assay
- •No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25-an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]);
- •Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),
- •injected with others in past 12 months by self-report;
- •Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN);
- •Able to speak English;
- •No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly;
- •for women of childbearing age, pregnancy test negative, not actively nursing, and agree to use birth control during treatment (although LDV-SOF has a "B" rating, consistent with no known evidence of harm, treatment is not urgent for these patients so we will err on the side of caution).
排除标准
- •HIV+ by rapid test or pooled viral load;
- •HBV surface antigen +;
- •Non-definitive HCV genotype results;
- •Previously received treatment for HCV (interferon, ribavirin, or DAA);
- •Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]);
- •History of any of the following:
- •Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- •History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
- •History of solid organ or bone marrow transplantation.
- •Current treatment for cancer
- •Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);
- •Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and
- •Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.
- •No other conditions that preclude study involvement as determined by PI.
结局指标
主要结局
Number of people who inject drugs (PWIDs) with HCV who were recruited and retained
时间窗: 44 weeks
To determine the feasibility of treating active PWIDs for HCV with LDV-SOF by mDOT versus unobserved dosing based on proportion eligible and enrolled among those screened and completion rates overall and by arm.
Medication adherence to study drug
时间窗: 44 weeks
To evaluate the acceptability of mDOT versus unobserved dosing, the percent of treatment medication adherence to LDV-SOF, as measured by the percent of doses taken overall (observed and unobserved), will be assessed using DOT doses and weekend Wise Pill data for the mDOT arm, and WisePill data for the unobserved dosing arm.
Challenges of medication adherence
时间窗: 44 weeks
To assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT versus unobserved dosing for PWIDs treated with LDV-SOF.
次要结局
- SVR (end-of-treatment response)(12 weeks)
- SOF/metabolite levels(8 weeks)
- Social and injector networks of participants(44 weeks)
- HCV relapse and reinfection(36 weeks)
研究者
Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
San Francisco Department of Public Health