Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- CKD at 12 months
研究概览
简要总结
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.
The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.
详细描述
Antiviral therapy with nucleos(t)ide analogues (NAs) has revolutionized the management of chronic hepatitis B (CHB) in the last two decades.1 Entecavir (ETV), a nucleoside analogue, is one of the first-line NAs recommended by all international treatment guidelines.2-4 As hepatitis B surface antigen (HBsAg) seroclearance rarely occurs, most patients require long-term, if not life-long, NA therapy. Hence, the safety of NAs requires careful scrutiny. In clinical trials, nephrotoxicity may occur in a small proportion of patients receiving nucleotide analogues. We previously demonstrated that tenofovir disoproxil fumarate (TDF) was associated with mild renal impairment in a minority of patients; those treated with entecavir (ETV) had a similar risk compared to untreated patients.5
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
- •On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
- •On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)
排除标准
- •Previous NA treatment prior to TAF or ETV
- •Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
- •Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
- •Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
- •Non-hepatic cancer undergoing chemotherapy within last 6 months
研究组 & 干预措施
TAF-treated Chronic hepatitis B patients
Chronic hepatitis B patients that treated with Tenofovir alafenamide
干预措施: Tenofovir alafenamide (Drug)
ETV-treated Chronic hepatitis B patients
Chronic hepatitis B patients that treated with Entecavir
干预措施: Entecavir (Drug)
结局指标
主要结局
CKD at 12 months
时间窗: 12 months
To evaluate chronic kidney disease (CKD) progression at 12 months. The CKD progression is defined as an increase in CKD stage for at least 1 stage for at least 3 consecutive months during follow-up.
次要结局
- Change in eGFR(12 months)
研究者
Grace Lai Hung Wong
Professor
Chinese University of Hong Kong
