慢性腎臟病患C型肝炎根除計畫之研究

研究背景臺灣採納世界衛生組織於2030年消除病毒性C型肝炎之全球規劃，預計於2025年治療25萬名慢性C肝病人。有鑑於此，彰化縣於2019年4月建立彰化縣C肝根除計畫（Changhua-Integrated Program to Stop Hepatitis C Infection，CHIPS-C）架構，以縣市層級整合公共衛生、醫事檢驗，以及臨床醫療等跨科部會整合全縣照護與管理資源推動C型肝炎根除，並且於半年期間，完成彰化洗腎族群C型肝炎根除。為維持洗腎族群之C型肝炎根除狀態，確保洗腎單位C型肝炎感染控制成效，以及降低洗腎族群之C型肝炎疾病負擔，進一步將C型肝炎根除目標族群由洗腎族群往前推進至末期腎臟病前期 ( pre-ESRD ) 族群，運用CHIPS-C整合照護模式對此高風險族群由偵測、確診、治療及治癒之連續性照護指標 ( care cascade ) C型肝炎根除照護進行介入以達到根除之目的。研究目的本研究針對彰化縣C型肝炎根除計畫之高風險族群，慢性腎臟病族群 (彰化縣慢性腎臟病照護計畫個案)，進行C型肝炎篩檢及治療成效評估，將洗腎族群C肝根除模式推展至末期腎臟病前期族群，以大數據實證方法驗證彰化C肝根除照護模式執行成效，並評估根除計畫對於該族群進入末期腎臟病以及洗腎後降低機構內C型肝炎感染發生之效益。研究方法運用CHIPS-C之C型肝炎根除整合性照護架構，由衛生局整合各醫療健康照護場域並連結慢性腎臟病照護計畫。本研究以大數據資料建構末期腎臟病前期族群名冊繼之以C型肝炎根除由篩檢到治療以及治癒之多重照護階段，將C型肝炎根除往前推進至末期腎臟疾病前期族群，並且運用此大數據資料以世界衛生組織提出之根除實證評估指標進行即時評估。運用C型肝炎連續性照護指標 (care cascade) 包括診斷率、確診率、治療率、完治率以及C型肝炎治癒持續率 (sustained virologic response rate for 12 weeks，SVR12) 之結果指標。本研究運用多項式邏輯斯迴歸模型 (Polytomous logistic regression model) 對於影響根除實證指標之相關因素進行系統性評估，以標定影響不同根除服務階段之相關因子。研究結果本研究納入參與慢性腎臟病照護計畫之慢性腎臟疾病世代共8,921名，C型肝炎抗體檢測率達94.5% (n = 8,426名)，C型肝炎抗體陽性率為7.5% ( n = 628名)，之後接受以C型肝炎核糖核酸 (HCV RNA) 檢測率為87.1% ( n= 547名)，再考慮過去曾經抗病毒治療者 ( n =150名) C型肝炎核酸陽性率為68.2% ( n = 373名)，共有97.8% 適用接受治療 ( n = 218名)，接受口服抗病毒藥物治療率為85.3% ( n = 186名)，12週治癒率達97.2% ( n = 176名)。針對C型肝炎抗體陽性率性別間之差異，女性抗體陽性率高於男性。以年齡進行分析，C型肝炎抗體陽性率於50歲以後隨年齡層逐漸上升，顯示C型肝炎疾病負擔隨年齡層逐漸增加。就研究族群之共病高危險因子包含糖尿病及高血壓為變項評估其疾病負擔，其C型肝炎抗體陽性率分別為7.6%及7.5%與未罹患糖尿病 (7.3%) 或高血壓 (7.2%) 相近。結論本研究運用彰化CHIPS-C之C型肝炎根除整合性照護架構，將慢性C型肝炎根除由彰化洗腎族群推展至末期腎臟病前期族群，並運用慢性C型肝炎根除品質指標進行實證評估。以接受口服抗病毒藥物治療率與完治率以及12週病毒持續清除率之實證評估指標，顯示彰化末期腎臟病前期族群已達到C型肝炎根除標準。在此實證資料的支持下，彰化末期腎病前期繼洗腎族群後成為C型肝炎根除的族群。藉由彰化洗腎族群C型肝炎持續監測評估，此末期腎病前期族群的根除，將預期進一步可降低新發生洗腎個案的C型肝炎疾病負擔，維持洗腎族群之C肝根除狀態。就C肝根除整合照護計畫觀點來看，彰化縣以世界衛生組織提出之根除實證連續性照護指標並運用系統性方法-彰化縣C肝根除計畫，擴大C型肝炎根除族群，涵蓋腎病前期世代，這一成就降低了彰化縣洗腎族群中C型肝炎盛行率。

關鍵字

C型肝炎；根除；末期腎臟病變；彰化整合式C型肝炎根除模式

並列摘要

Background The elimination of HCV among HD (hemodialysis) population has been achieved in Changhua in 2018. To move forward to the ultimate goal of HCV elimination in Changhua following the target population of HD, HCV elimination for the pre-ESRD population is necessary. Materials and Methods For a better containment of HCV among the high-risk population of CKD, the elimination of HCV has been launched through so-called Changhua-Integrated Program to Stope HCV Infection (CHIPS-C) program during 2019-2021. A systematic approach by integrating health administrative and the health care facilities from primary to medical center guided by CHIPS-C was utilized to broaden the target population from HD to pre-ESRD population. The care cascade indicators including screening rate, confirmation rate, treatment rate, compliance rate to treatment, and sustained virologic response rate for 12 weeks (SVR12) were utilized for assessment. A polytomous regression model was used to assess the factors associated with the cascade of HCV elimination. The ultimate effectiveness of HCV elimination for pre-ESRD cohort in reducing HCV risk for HD population was further assessed. Result Following the initiation of CHIPS-C for pre-ESRD cohort in Changhua in 2019, a total of 8,921 subjects were enrolled during the study period. The HCV antibody (HCV Ab) status was tested among 94.5% (n=8,426) of Changhua pre-ESRD cohort with a positive rate of 7.5% (n=628) . The HCV status among these per-ESRD subjects were further confirmed by using HCV RNA test (n=547, 87.1%) . Taking into account the history of antiviral therapy (n=150) , the HCV RNA positive rate was 68.2% (n=373) . A total of 218 subjects (97.8%) were eligible for DAA therapy, which was initiated in 85.3% (n=186) of these infected cases. The HCV cure rate verified by SVR12 (sustained virologic response at 12 week) was 97.2% (n=176). The HCV prevalence for the incident HD cohort decreased more than half because of the clearance of HCV in the pre-ESRD cohort. By using the polytomous regression model, a series of factors associated the indicators of care cascade were elucidated. Females had a higher positive rate for HCV Ab compared with males. There was an increasing trend in the HCV Ab positive rate for the population aged 50 years and older, suggesting an increasing disease burden among this subgroup. The HCV Ab positive rates were similar for those with (7.6%) and without (7.3%) diabetes. Regarding the hypertension, the HCV positive rates were similar for those with (7.5%) and without (7.2%) the comorbidity. Conclusion Guided by the indicators of WHO care cascade, the target population of HCV elimination was expanded to cover the pre-ESRD cohort in Changhua by using the systemic approach of CHIPS-C. This achievement further reduced HCV prevalence among the incident HD cohort in Changhua.

並列關鍵字

Hepatitis C Virus ； Elimination ； Pre-ESRD ； CHIPS-C

參考文獻

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