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Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study

机译:多人研究在人类免疫缺陷病毒-丙型肝炎病毒合并感染患者中的直接作用抗病毒治疗的有效性

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BackgroundDirect-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated DAA effectiveness across a broad spectrum of patients with human immunodeficiency virus (HIV)–hepatitis C virus (HCV) coinfection in routine clinical care, including those with psychosocial comorbid conditions.MethodsThe primary end point was sustained virologic response (SVR), defined as HCV RNA not detected or 25 IU/mL ≥10 weeks after treatment. We calculated SVR rates and 95% confidence intervals (CIs) in a modified intent-to-treat analysis. We repeated this analysis after multiply imputing missing SVR values.ResultsAmong 642 DAA-treated patients, 536 had SVR assessments. The median age was 55 years; 79% were men, 59% black, and 32% white. Cirrhosis (fibrosis-4 index3.25) was present in 24%, and 17% were interferon treatment experienced; 96% had genotype 1 infection and 432 (81%) had received ledipasvir-sofosbuvir. SVR occurred in 96.5% (95% CI, 94.5%–97.9%). Patients who were black, treatment experienced, or cirrhotic all had SVR rates 95%. Patients with depression and/or anxiety, psychotic disorder, illicit drug use, or alcohol use disorder also had high SVR rates, ranging from 95.4% to 96.8%. The only factor associated with lower SVR rate was early discontinuation (77.8%; 95% CI, 52.4%–93.6%). Similar results were seen in multiply imputed data sets.ConclusionsOur study represents a large multicenter examination of DAA therapy in HIV/HCV-coinfected patients. The broad treatment success we observed across this diverse group of patients with significant comorbid conditions is highly affirming and argues for widespread implementation of DAA therapy.
机译:背景技术在临床试验和观察性研究中已显示出直接作用抗病毒(DAA)治疗非常成功,但对患有精神疾病和药物滥用等合并症的高负担患者的治疗成功知之甚少。我们评估了DAA在常规临床护理(包括患有心理社会合并症的患者)中对广泛的人类免疫缺陷病毒(HIV)-丙型肝炎病毒(HCV)合并感染患者的有效性。方法主要终点为持续病毒学应答(SVR),定义为因为未检测到HCV RNA或治疗后<25 IU / mL≥10周。在改良的意向治疗分析中,我们计算了SVR率和95%置信区间(CI)。在多次估算缺失的SVR值后,我们重复了此分析。结果在642位接受DAA治疗的患者中,有536位接受了SVR评估。中位年龄为55岁;男性为79%,黑人为59%,白人为32%。肝硬化(纤维化-4指数> 3.25)占24%,经历过干扰素治疗的占17%; 96%的患者患有基因1型感染,其中432例(81%)接受了ledipasvir-sofosbuvir的治疗。 SVR发生率为96.5%(95%CI,94.5%–97.9%)。黑人,有治疗经验或肝硬化的患者的SVR率均> 95%。患有抑郁症和/或焦虑症,精神病性疾病,非法药物使用或酒精滥用疾病的患者的SVR率也很高,从95.4%到96.8%。降低SVR率的唯一因素是早期停用(77.8%; 95%CI,52.4%–93.6%)。在多个估算数据集中也看到了相似的结果。结论我们的研究代表了对HIV / HCV合并感染的患者进行DAA治疗的大型多中心检查。我们在患有严重合并症的各种不同患者中观察到的广泛治疗成功是高度肯定的,并主张广泛实施DAA治疗。

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