Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3

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索磷布韦/达拉他韦治疗慢性丙型肝炎患者疗效及安全性分析：一项真实世界研究

目的 观察应用索磷布韦/达拉他韦联合或不联合利巴韦林治疗慢性丙型肝炎（CHC）和丙型肝炎肝硬化（LC）患者的疗效和安全性。方法 2016年5月~2017年5月收治的丙型肝炎LC患者129例和CHC患者311例,分别给予索磷布韦/达拉他韦联合利巴韦林或索磷布韦/达拉他韦治疗12周,停药后随访12周。观察停药后12周持续性病毒学应答（SVR12）、生化学应答、肝硬度测量（LSM）和治疗期间不良反应发生情况。结果 治疗2周时,LC组血清TBIL、ALT 和AST 水平分别为（18.10±3.46） μmol/L、（32.48±9.97） IU/L和（31.99±6.65） IU/L,显著低于基线时水平【分别为（20.98±28.64） μmol/L、（97.76±106.43） IU/L和（72.47±80.81） IU/L,P<0.05】,CHC组分别为（20.15±3.48） μmol/L、（35.18±18.47） IU/L和（35.05±13.22） IU/L,显著低于基线时水平【分别为（24.07±18.12） μmol/L、（91.42±54.56） IU/L和（81.06±40.45） IU/L,P<0.05】;CHC组血清HCV RNA为（1.83±2.88） lg IU/ml,LC组为（1.67±2.34） lg IU/ml,显著低于基线时水平【分别为（6.12±1.19） lg IU/ml和（5.91±1.17）lg IU/ml,P<0.01】;CHC组LSM为（8.09±0.90）kPa,LC组为（13.32±1.47） kPa,显著低于基线时水平【分别为（11.81±3.33） kPa和（17.56±9.86） kPa,P<0.01】;两组不同基因型感染者SVR均在94%以上;多因素回归分析显示基线肝硬化或复治是不能获得SVR12的高危因素;主要不良反应为乏力和头痛。讨论 应用索磷布韦/达拉他韦联合利巴韦林治疗丙型肝炎病毒感染患者可获得极高的SVR12和生化学应答率,显著改善肝纤维化程度,且具有良好的安全性。     

Hepatitis C virus genotype 3: Meta-analysis on sustained virologic response rates with currently available treatment options

AIM: To address the therapeutic efficacy of various treatment regimens in genotype 3 selecting randomized clinical trials and prospective National Cohort Studies.METHODS:(1) PEG-INF-based therapy including sofosbuvir(SOF) + RBV for 12 wk vs SOF + RBV 24 wk;(2) SOF + RBV therapy 12 wk/16 wk vs 24 wk; and(3) the role of RBV in SOF + daclatasvir(DCV) and SOF + ledipasvir(LDV) combinations. This metaanalysis provides robust information with the intention of addressing treatment strategy for hepatitis C virus genotype 3.RESULTS: A combination treatment including SOF + RBV + PEG-IFN for 12 wk notes better SVR than with only SOF + RBV for 12 wk, although its association with more frequent adverse effects may be a limiting factor. Longer duration therapy with SOF + RBV(24 wk) has achieved higher SVR rates than shorter durations(12 or 16 wk). SOF + LDV are not an ideal treatment for genotype 3. CONCLUSION: Lastly, SOF + DCV combination is probably the best oral therapy option and the addition of RBV does not appear to be needed to increase SVR rates substantially.     

应用索磷布韦/维帕他韦治疗门诊和住院筛查的丙型肝炎患者疗效研究

目的 调查真实世界丙型肝炎病毒感染情况,并探讨应用索磷布韦/维帕他韦治疗慢性丙型肝炎(CHC)患者病毒学应答情况。方法 2017年9月～2019年9月行血清抗-HCV检测的3966例住院和门诊患者,应用索磷布韦/维帕他韦治疗CHC患者12 w。结果 在3966例患者中,检出血清抗-HCV阳性80例(2.0%);在80例抗-HCV阳性者中,同期进行了血清HCV RNA检测者42例,结果40例(95.2%)血清HCV RNA阳性;在40例CHC患者中,12例无明显症状和体征,18例有腹胀、乏力、纳差,10例有蜘蛛痣、肝病面容、肝掌、脾肿大;35例血清AST＞90 U/L,4例AST轻度异常,1例AST正常;3例存在HBV/HCV混合感染;B超检查14例正常,26例提示肝内光点增粗;40例CHC患者接受索磷布韦/维帕他韦治疗,结果RVR、EVR、ETVR、SVR、NR和复发率分别为75.0%、80.0%、82.5%、72.5%、10.0%和10.0%;在治疗12 w末,血清TBIL水平为(30.7±4.3)μmol/L,显著低于治疗前【(80.4±15.6)μmol/L,P＜0.05】,血清AST水平为(72.5±18.6)U/L,显著低于治疗前【(247.7±110.4) U/L,P＜0.05】,血清ALB水平为(49.2±11.5)g/L,显著高于治疗前【(35.9±9.2)g/L,P＜0.05】;不良反应发生率为22.5%。结论 真实世界丙型肝炎发病率较高,对患者进行HCV感染筛查很有必要。应用索磷布韦/维帕他韦治疗CHC患者疗效显著,血清病毒学应答率高,能显著改善肝功能,且具有一定的安全性。     

索非布韦联合雷迪帕韦治疗慢性丙型肝炎患者疗效研究*

目的 探讨应用索非布韦(SOF)联合雷迪帕韦(LDV)治疗慢性丙型肝炎(CHC)患者的疗效。方法 2017年8月～2020年8月我院诊治的CHC患者116例,给予SOF联合LDV治疗3个月。计算肝纤维化四指数(FIB-4),采用RT-PCR法检测HCV RNA,采用单因素和多因素Logistic回归分析影响CHC患者获得持续病毒学应答(SVR)的影响因素,应用受试者工作曲线(ROC)分析指标的预测效能。结果 在治疗结束后随访6个月,116例CHC患者血清ALT、AST和外周血PLT计数分别为(32.4±6.8)U/L、(36.5±9.2)U/L和(224.6±31.9)×10⁹/L,显著低于治疗结束时【分别为(56.6±11.7)U/L、(64.7±11.8)U/L和(262.3±41.7)×10⁹/L,P＜0.05】或治疗前【分别为(204.3±41.6)U/L、(131.2±26.5)U/L和(313.7±53.6)×10⁹/L,P＜0.05】;FIB-4和HCV RNA水平分别为(0.9±0.1)和(1.1±1.2)lgU/mL,显著低于治疗结束时【分别为(1.2±0.2)和(1.9±1.1)lgU/mL,P＜0.05】或治疗前【分别为(1.4±0.2)和(6.4±1.3)lgU/mL,P＜0.05】;本组CHC患者获得快速病毒学应答率(RVR)为75.0%,治疗结束时病毒学应答率(ETVR)为89.7%,SVR为82.0%;多因素Logistic回归分析显示,FIB-4和血清HCV RNA是影响CHC患者获得SVR的独立影响因素(P＜0.05);联合治疗前FIB-4＜1.65和血清HCV RNA载量为(6.6±0.8)lgU/mL为截断点,其预测CHC患者在治疗后获得SVR的AUC为0.875,敏感性为83.2%,特异性为90.5%。结论 SOF联合LDV治疗CHC患者可获得很好的治疗效果,FIB-4水平低和血清HCV RNA载量低的患者可能获得更好的抗病毒效果。     

索非布韦联合达卡他韦治疗慢性丙型肝炎:真实世界临床研究

目的 评价直接抗病毒药物(DAAs)索非布韦(SOF)联用达卡他韦(DCV)治疗慢性丙型肝炎(CHC)患者真实世界研究(RWS)的疗效和安全性。方法 2015年9月～2017年9月广州市第八人民医院肝病门诊诊治的CHC患者43例,接受SOF联用DCV治疗12 w,随访12～48 w。结果 43例均完成12 w疗程及停药12 w观察,23例完成停药24 w观察、18例完成停药48 w观察;在治疗2 w、4周 w和12 w时,血清HCV RNA转阴率分别77.0％(33/43)、93.0％(40/43)和100.0％(43/43);在停药12 w时,持续病毒学应答率(SVR12)为100.0%,23例停药24周HCV RNA仍阴性,18例停药48周HCV RNA仍阴性;在治疗2 w、4 w和12 w及停药12 w时,血清ALT水平分别为(28.3±14.4)U /L、(25.4±12.9)U /L、(22.5±9.4)U /L和(21.8±8.6) U /L,显著低于治疗前水平,血清AST水平分别为(25.4±10.4)U /L、(24.7±9.6)U /L、(22.8±7.7)U /L和(22.3±6.5)U /L,也显著低于治疗前水平; 在停药12 w时,血生化学应答率为100.0%,23例停药24 w、18例停药48 w时,肝功能仍持续正常,8例基线估算的肾小球滤过率(eGFR)小于90 ml·min^-1·1.73 m²,治疗期间部分有不同程度的下降(eGFR最低降至60.76 ml·min^-1·1.73 m²),停药后恢复至治疗前水平,未因eGFR下降而需调整用药或停药情况;用药期间发生失眠3例、恶心2例、乏力1例、头痛1例、脱发1例,均发生于治疗的早期,未特殊处理,均自行缓解,无严重不良事件发生。结论 采用SOF联合DCV治疗CHC患者可获得极高的SVR12和生化学应答率,且安全性良好。长期疗效仍需观察。     

慢性丙型肝炎患者感染病毒基因型对抗病毒治疗应答的影响

目的：探讨丙型肝炎病毒基因型与抗病毒治疗后病毒学应答之间的关系。方法113例慢性丙型肝炎患者接受聚乙二醇干扰素（PEG-IFNα-2a）联合利巴韦林治疗48周。采用 Simmonds 基因分型法进行 HCV 基因分型。结果在113例患者中,基因1型88例（78.0%）,非基因1型25例（22.0%）;非基因1型患者快速病毒学应答率（RVR）明显高于基因1型患者（80%对48.8%,P＜0.05）;非基因1型患者持续病毒学应答率（SVR）明显高于基因1型患者（80.0%对64.8%,P＜0.05）;低病毒载量患者RVR 明显高于高病毒载量患者（78.9%对46.7%,P＜0.05）。结论 HCV 基因型和 HCV RNA 复制水平对 PEG-IFNα-2a 联合利巴韦林抗病毒治疗的疗效有一定的影响,提示 HCV 基因分型有重要的临床意义。     

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Novel direct‐acting antivirals (DAAs) are now the standard of care for the management of hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post‐completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real‐life clinical scenario. Consecutive patients with known HCV infection who were treated with generic‐oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. Four hundred and ninety patients (mean age: 38.9 ± 12.7 years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n = 372, 75.9%) followed by genotype 1 (n = 97, 19.8%). Treatment naïve and treatment‐experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%), respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n = 175), daclatasvir alone (n = 149), ribavirin and peginterferon (n = 80), ledipasvir alone (n = 43), daclatasvir and ribavirin (n = 37), and ledipasvir and ribavirin (n = 6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58), respectively, P = .005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real‐life clinical scenario.     

索磷布韦维帕他韦治疗慢性丙型肝炎患者疗效和安全性观察:一项单中心真实世界回顾性分析

目的 回顾性分析索磷布韦维帕他韦(SOF/VEL)联合利巴韦林(RBV)治疗慢性丙型肝炎(CHC)患者真实世界研究(RWS)的疗效和安全。方法 2018年5月～2020年4月初治/PR经治的CHC患者32例和代偿期丙型肝炎肝硬化(CHC-CLC)患者36例,接受SOF/VEL治疗12 w,失代偿期丙型肝炎肝硬化(CHC-DLC)或合并肝细胞癌(HCC)患者31例,接受SOF/VEL联合利巴韦林(RBV)治疗12 w。部分患者合并存在高血压、糖尿病、肿瘤和慢性乙型肝炎。采用RT-PCR法检测HCV基因型(GTs)。结果 本组HCV 感染患者以GT 2a(55.6%)和GT1b(34.3%)为主;CHC、CHC-CLC和CHC-DLC患者早期病毒学应答(EVR4)分别为90.6%、86.1%、83.9%,治疗结束病毒学应答(EOT)均为100.0%,CHC组和CHC-CLC组SVR12和SVR24均为100.0%,CHC-DLC组 SVR12和SVR24均为93.5%,三组间EVR4、EOT、SVR12、SVR24均无显著性差异(P>0.05);所有患者SVR12和SVR24均为97.8%,除GT3b型外其他GTs感染患者SVR12和SVR24均为100.0%;三组血生化学应答率分别为87.5%、83.3%和74.2%;本组总体不良反应(AE)发生率为12.1%,无严重AE或因AE停药和死亡事件发生。结论 应用SOF/VEL或联合RBV治疗CHC或相关的肝硬化患者,无论何种基因型感染,均有良好的效果,且安全。     

Simeprevir,daclatasvir and sofosbuvir for hepatitis C virus‐infected patients with decompensated liver disease

Approximately three million individuals in the United States are chronically infected with hepatitis C virus (HCV). Chronic HCV infection may lead to the development of compensated as well as decompensated liver cirrhosis. The Phase II IMPACT study was conducted in HCV genotype 1‐ or 4‐infected cirrhotic patients with portal hypertension or decompensated liver disease and assessed for the first time the combination of the three direct‐acting antivirals simeprevir, daclatasvir and sofosbuvir. Treatment‐naïve or treatment‐experienced adults with Child‐Pugh (CP) score <7 (CP A) and evidence of portal hypertension, or CP score 7–9 (CP B), received 12 weeks of simeprevir 150 mg, daclatasvir 60 mg and sofosbuvir 400 mg, once daily. The primary efficacy endpoint was sustained virologic response 12 weeks after end of treatment (SVR12). Pharmacokinetics and safety were also assessed. Overall, 40 patients were enrolled (CP A: 19; CP B: 21). All 40 patients achieved SVR12. At week 8, the mean pharmacokinetic exposure to simeprevir, sofosbuvir, daclatasvir and GS‐331007 (sofosbuvir metabolite) was 2.2‐, 1.5‐, 1.2‐ and 1.2‐fold higher in patients with CP B than CP A, respectively. Grade 1/2 adverse events (AEs) occurred in 26 of 40 (65%) patients. One CP B patient had a Grade 3 AE (gastrointestinal haemorrhage), which was reported as a serious AE but not considered related to study drugs. Treatment for 12 weeks with simeprevir, daclatasvir and sofosbuvir was generally safe and well tolerated, and resulted in 100% of cirrhotic patients with portal hypertension or decompensated liver disease achieving SVR12.     

快速病毒学应答对干扰素治疗慢性丙型肝炎疗效的预测分析

目的 探讨干扰素治疗慢性丙型肝炎的快速病毒学应答(RVR)对疗效的预测及其相关因素.方法 对139例慢性丙型肝炎患者,根据其临床特点,给予标准干扰素(IFN)或聚乙二醇干扰素(PEG-IFN)治疗.IFN α3～5MU隔日注射1次;PEG-IFNα-2a 135～180 μg,或PEG-IFNα-2b 50～80 μg,每周注射1次.并根据患者的体质量给予600～1500 mg/d的利巴韦林,在治疗的0、4,12周和以后每间隔12周、治疗结束后的24周进行HCV RNA含量检测,根据患者治疗过程中的病毒学应答情况给予24～72周的疗程,以持续病毒学应答(SVR)作为疗效的评判指标.根据资料不同采用χ2检验或t检验.结果 132例患者完成了全程观察,其中4例治疗无效(3.0%),12例复发(9.1%),获得SVR有116例(87.9%).120例在治疗4周时检测了病毒学指标,101例(84.2%)获得了RVR,治疗前病毒载量为(5.883±1.246)lg拷贝/ml,19例无RVR,治疗前病毒载量为(6.502±0.693)lg拷贝/ml,两组比较,t:2.15,P=0.034,差异有统计学意义.97例完成全程观察的RVR患者中,88例(90.7%)获得SVR,17例无RVR的患者,14(82.4%)例获得了SVR,x3=0.371,P=0.543,差异无统计学意义.基因1型HCV感染患者的RVR为80.7%(46/57),非基因1型HCV感染患者的RVR率为92.6%(25/27),两组间比较,χ2=6.00,P=0.112,差异无统计学意义.初治患者的RVR率为87.8%,干扰素再治疗者的RVR率为65.0%,两组比较,χ2=4.651,P=0.031,差异有统计学意义. 结论 干扰素个体化抗病毒治疗慢性丙型肝炎,有较高的RVR获得率.RVR的获得与治疗前HCV RNA载量和患者是否为初次治疗相关,与基因型无关,RVR的获得可预测SVR的获得.     

Treatment of chronic hepatitis C in patients with chronic kidney disease with Sofosbuvir-basead regimes

BackgroundTo analyze the effectiveness and the safety of Sofosbuvir-based regimens to treat patients with chronic hepatitis C virus (HCV) infection and chronic kidney disease (CKD).MethodsA retrospective, observational study in patients with chronic HCV infection and CKD treated with Sofosbuvir-based regimens was performed. Liver fibrosis, comorbidities, HCV genotype and sustained virological resposnse (SVR) at 12th week post-treatment were evaluated. Kidney function was accessed by serum creatinine and glomerular filtration rate (GFR). The assumed level of significance was 5 %.ResultsThirty-five patients were treated. The mean age was 52.1 ± 10.9 years, 19 (54.3 %) were women, 32 (91.4 %) were already kidney transplanted and 3 (8.6 %) were on hemodialysis. The SVR by intention to treat was 88.6 %. The mean GFR was 65.8 ± 28.6 and 63.7 ± 28.3 ml/min pre- and post-treatment respectively (p > 0.05). Treatment was interrupted in 1 (2.85 %) patient due to anemia and in 2 (5.7 %) due to loss of kidney function.ConclusionSofosbuvir-based regimens are effective to treat HCV in patients with CKD. In patients with mild CKD this type of therapy seems to be safe.     

索磷布韦/维帕他韦联合利巴韦林治疗慢性丙型肝炎患者疗效临床研究

目的 探讨应用索磷布韦/维帕他韦联合利巴韦林治疗慢性丙型肝炎(CHC)患者的疗效及血清细胞毒性T淋巴细胞相关抗原4(CTLA-4)、肿瘤坏死因子α诱导蛋白8样分子2(TIPE2)和白介素-12(IL-12)水平的变化。方法 2018年5月~2019年5月我院肝病科就诊的105例CHC患者,采用随机数字表法将所选患者分为对照组51例和观察组54例,分别给予利巴韦林联合干扰素α-2b或者索磷布韦/维帕他韦联合利巴韦林治疗观察3个月。采用ELISA法检测血清CTLA-4、TIPE2和IL-12水平。结果 观察组快速病毒学应答(RVR)率为(88.9%,显著高于对照组(43.1%,P<0.05),早期病毒学应答(EVR)率为90.7%,显著高于对照组(52.9%,P<0.05),治疗结束时应答率为96.3%,显著高于对照组(76.5%,P<0.05),持续病毒学应答(SVR)率为92.6%,显著高于对照组(60.8%,P<0.05);外周血白细胞水平为(5.2±2.0)×10⁹/L,显著高于对照组【(3.4±1.8)×10⁹/L,P<0.05】,红细胞水平为(4.9±0.5)×10⁹/L,显著高于对照组【(4.6±0.7)×10⁹/L,P<0.05】,血小板计数为(113.2±38.6)×10⁹/L,显著高于对照组【(94.7±41.2)×10⁹/L,P<0.05】;血清CTLA-4水平为(1.1±0.4)ng/mL,显著低于对照组【(1.6±0.7)ng/mL,P<0.05】,血清IL-12水平为(29.6±7.3)pg/mL,显著低于对照组【(41.5±11.7)pg/mL,P<0.05】,而血清TIPE2水平为(0.8±0.1)μg/L,显著高于对照组【(0.6±0.3)μg/L,P<0.05】;在治疗期间,观察组不良反应发生率为25.9%,显著低于对照组(94.1%,P<0.05)。结论 应用索磷布韦/维帕他韦联合利巴韦林治疗CHC患者疗效好,除强大的抗病毒作用外,可能与该治疗能降低血清CTLA-4和IL-12水平,升高血清TIPE2水平有关。     

抗丙型肝炎病毒治疗中的病毒学应答对持续应答的预测价值

慢性HCV感染极易发展成肝硬化和肝癌,抗病毒治疗是惟一有可能延缓或阻止其进程的有效方法.目前最理想的抗病毒治疗方案为聚乙二醇干扰素(PEG-IFN)联介利巴韦林.获得持续病毒学应答(SVR)是评价其疗效的主婴指标,但多种宿主因索和病毒因素都可能影响其疗效.近年来有研究者认为治疗过程中病毒的应答情况能够综合反应这些因素的影响,可更好地预测其治疗效果~([1-2]).为了解不同基因型HCV感染者在抗病毒治疗过程中的病毒学应答情况对SVR的预测价值,为对不同基因型HCV感染者制定更加合理的个体化治疗方案提供参考,本研究对近年来在本院接受PEG-IFN联合利巴韦林治疗的慢性HCV感染者的相关资料做了回顾性分析.     

The association of cryoglobulinaemia with sustained virological response in patients with chronic hepatitis C

Previous reports suggest cryoglobulinemia might influence the hepatitis C virus (HCV) infection clinical course and treatment response but this association has not been thoroughly evaluated. We aimed to assess the relationship between cryoglobulinemia and sustained viral response (SVR) in patients treated for HCV infection. We included patients with HCV infection treated from January 2003 through December 2006. Biochemical analyses, detection cryoglobulinemia, and liver biopsies were performed prior to treatment. Genotype 1 or 4 infections received Peg-interferon (IFN) alpha-2a or -2b for 48 weeks; genotypes 2 or 3 received IFN alpha for 24 weeks. All patients also received ribavirin. Of 329 enrolled patients, 242 (73%) were male and the median age was 43 years. Cryoglobulinemia was detected in 196 (59.6%) patients; liver biopsy was performed in 301. Multivariate analysis showed an association of cryoglobulinemia with severe active necroinflammation (A3) (adjusted odds ratio [AOR] = 9.48; 95% confidence interval [CI]: 1.50-59.92) and rheumatoid factor (RF) level (AOR = 1.01; 95% CI: 1.00-1.02). Variables associated with advanced fibrosis were age, aspartate aminotransferase and alkaline phosphatase levels, alcohol use, and presence of diabetes. Variables independently associated with SVR were cryoglobulinemia (AOR = 2.33, 95% CI: 1.26-4.32), absence of cirrhosis (AOR = 4.5, 95% CI: 1.4-14.80), and RF level (AOR = 1.008, 95% CI: 1.001-1.014). Our findings suggest cryoglobulinemia is associated with severe necroinflammatory activity in HCV-infected patients. We also provide the first evidence for an association between cryoglobulinemia and higher SVR rates, highlighting its potential role as a prognostic factor for treatment response.     

Development of a risk score to guide targeted hepatitis C testing among human immunodeficiency virus patients in Cambodia

BACKGROUNDThe World Health Organization recommends testing all human immunodeficiency virus (HIV) patients for hepatitis C virus (HCV). In resource-constrained contexts with low-to-intermediate HCV prevalence among HIV patients, as in Cambodia, targeted testing is, in the short-term, potentially more feasible and cost-effective. AIMTo develop a clinical prediction score (CPS) to risk-stratify HIV patients for HCV coinfection (HCV RNA detected), and derive a decision rule to guide prioritization of HCV testing in settings where ‘testing all’ is not feasible or unaffordable in the short term. METHODSWe used data of a cross-sectional HCV diagnostic study in the HIV cohort of Sihanouk Hospital Center of Hope in Phnom Penh. Key populations were very rare in this cohort. Score development relied on the Spiegelhalter and Knill-Jones method. Predictors with an adjusted likelihood ratio ≥ 1.5 or ≤ 0.67 were retained, transformed to natural logarithms, and rounded to integers as score items. CPS performance was evaluated by the area-under-the-ROC curve (AUROC) with 95% confidence intervals (CI), and diagnostic accuracy at the different cut-offs. For the decision rule, HCV coinfection probability ≥1% was agreed as test-threshold. RESULTSAmong the 3045 enrolled HIV patients, 106 had an HCV coinfection. Of the 11 candidate predictors (from history-taking, laboratory testing), seven had an adjusted likelihood ratio ≥ 1.5 or ≤ 0.67: ≥ 50 years (+1 point), diabetes mellitus (+1), partner/household member with liver disease (+1), generalized pruritus (+1), platelets < 200 × 10⁹/L (+1), aspartate transaminase (AST) < 30 IU/L (-1), AST-to-platelet ratio index (APRI) ≥ 0.45 (+1), and APRI < 0.45 (-1). The AUROC was 0.84 (95%CI: 0.80-0.89), indicating good discrimination of HCV/HIV coinfection and HIV mono-infection. The CPS result ≥0 best fits the test-threshold (negative predictive value: 99.2%, 95%CI: 98.8-99.6). Applying this threshold, 30% (n = 926) would be tested. Sixteen coinfections (15%) would have been missed, none with advanced fibrosis. CONCLUSIONThe CPS performed well in the derivation cohort, and bears potential for other contexts of low-to-intermediate prevalence and little onward risk of transmission(i.e. cohorts without major risk factors as injecting drug use, men having sex with men), and where available resources do not allow to test all HIV patients as recommended by WHO. However, the score requires external validation in other patient cohorts before any wider use can be considered.