Current Treatment of HCV Infection After HSCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Description of treatment approach of HCV infection
研究概览
简要总结
The availability of novel therapies with DAAs might prompt clinicians caring for HSCT recipients with HCV infection to prescribe the treatment more frequently and possibly earlier after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most appropriate one is not straightforward. It depends not only on its efficacy, toxicity and rate of pharmacological interactions, but also on availability (both through healthcare system and in expanded access programs), and cost.
This observational prospective study will focus on treatment strategies in HSCT recipients with HCV infection. The main focus will be the therapeutic approach, the combination of drugs chosen, the length of treatment and the outcome. The main reasons for treating or not treating HSCT recipients with HCV infection will be also explored. Compared to previous cohorts, this study might provide additional data in the area of non-invasive assessment of fibrosis, HCV-RNA levels and genotyping.
In order to get as much data as possible on HCV treatment, patients with chronic HCV infection transplanted during the last 10 years will be included.
Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016 will be reported.
详细描述
Introduction:
According to previous EBMT studies, approximately 6% of HSCT recipients were HCV-positive (Locasciulli et al. Transplantation 1999). Despite the fact that HSCT recipients with chronic HCV infection are prone to HCV-morbidity (end stage liver disease, hepatocellular carcinoma, the need for liver transplant), only about half (44% and 61%) of long term survivors of HSCT were offered specific treatment (Ljungman et al. BMT 2012; Peffault de Latour et al. BMT 2005). The median time from HSCT to treatment was long and the efficacy was far from satisfactory (approximately 50%) (Ljungman et al. BMT 2012). Since 2011 novel oral directly acting antiviral agents (DAA) have been developed and marketed. DAAs offer the advantage of higher efficacy, shorter duration and reduced treatment toxicity; together with the possibility of exclusively oral, interferon- or interferon/ribavirin-free regimens.
Short description of the study:
The availability of novel therapies with DAAs might prompt clinicians caring for HSCT recipients with HCV infection to prescribe the treatment more frequently and possibly earlier after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most appropriate one is not straightforward. It depends not only on its efficacy, toxicity and rate of pharmacological interactions, but also on availability (both through healthcare system and in expanded access programs), and cost.
This observational prospective study will focus on treatment strategies in HSCT recipients with HCV infection. The main focus will be the therapeutic approach, the combination of drugs chosen, the length of treatment and the outcome. The main reasons for treating or not treating HSCT recipients with HCV infection will be also explored. Compared to previous cohorts, this study might provide additional data in the area of non-invasive assessment of fibrosis, HCV-RNA levels and genotyping.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HSCT recipients (allogeneic and autologous) with HCV infection
- •Transplanted from anytime until May 2017, followed from December 2015 to November 2017.
排除标准
- 未提供
结局指标
主要结局
Description of treatment approach of HCV infection
时间窗: 6 months
The type of treatment (drugs, doses) for HCV will be described.
次要结局
- SVR at week 12 and 24 after the EOT, yes/no(24 weeks)
