Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Sustained virologic response
研究概览
简要总结
The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment.
The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.
详细描述
Scientific rationale
It's estimated that 0.7% of the Brazilian population is infected with hepatitis C virus (HCV). In March 2018, the Ministry of Health defined all patients with HCV to be able to receive direct-acting antivirals (DAAs) from the public health system without any charges. Though this "universal-access policy", frequently there are still many obstacles for patients to actually get at the treatment: patients living in cities distant from big centres and underserved by specialized physicians in the country, lack of medical doctors experienced in HCV treatment in the public system, delay between prescription and starting of medications because of administrative issues, and socioeconomic vulnerability among people.
Telemedicine tools are powerful ways of reaching people living distant from big centres, and there are some successful international experiences with hepatitis C treatment in this field, like Project ECHO® (Extension for Community Healthcare Outcomes). In Brazil, there is a national program, geographically located in Porto Alegre, that uses telemedicine to improve healthcare quality in primary care by offering continuous education and teleconsultations (by text or toll-free hotline) to community physicians and other healthcare professionals working in public primary care institutions all over the country.
Primary objective
To address the applicability of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Have voluntarily signed the informed consent form;
- •Chronic hepatitis C confirmed by positive HCV-RNA;
- •Have been referred to specialized consultation in gastroenterology or infectious disease in the Brazilian Public Health System in Porto Alegre;
- •Have previous fibrosis staging (eg. liver biopsy, Fibroscan®) or laboratory tests for APRI score calculation.
排除标准
- •Suspicion or diagnosis of cirrhosis based on:
- •Hepatic elastography ≥12.5 kPa on Fibroscan®;
- •APRI score ≥2.0;
- •Clinical, ultrasound or endoscopic evidence of cirrhosis or portal hypertension;
- •Previous HCV treatment with direct acting antivirals;
- •HIV coinfection with antiretroviral treatment incompatible with HCV antivirals;
- •Previous solid organ transplant;
- •Significant comorbidity that may interfere with the HCV treatment
- •Creatinine clearance < 30 mL/min;
- •Platelets < 150.000/mL;
- •Pregnant or breastfeeding female;
- •Woman of childbearing age without use or that does not accept to use effective contraception during treatment and during the 30 days after treatment end;
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
研究组 & 干预措施
Telemedicine
Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support
干预措施: Telemedicine (Other)
Telemedicine
Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support
干预措施: Velpatasvir/Sofosbuvir (Drug)
结局指标
主要结局
Sustained virologic response
时间窗: 12 weeks post end of antiviral therapy (SVR12)
Proportion of treated patients with undetectable hepatitis C virus RNA levels measured by a real time polymerase chain reaction (PCR) with a lower limit of detection ≤ 12 IU/mL
次要结局
- Adherence to antiviral treatment(12 weeks after antiviral treatment initiation)
- Patient satisfaction with the treatment(12 weeks post end of antiviral therapy (SVR12))
- Adverse effects(12 weeks post end of antiviral therapy (SVR12))
- Severe adverse effects(12 weeks post end of antiviral therapy (SVR12))