1 Department of Medicine, Veterans Affairs Greater Los Angeles Health Care System.
2 Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, and.
Clin Infect Dis. 2017 Jun 15;64(12):1711-1720. doi: 10.1093/cid/cix111.
BACKGROUND.: Large cohorts are needed to assess human immunodeficiency virus (HIV)/hepatitis C virus (HCV) real-world treatment outcomes. We examined the effectiveness of ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF ± RBV) and ombitasvir/ paritaprevir/ritonavir plus dasabuvir (OPrD) ± RBV in HIV/HCV genotype 1 (GT1)-coinfected patients initiating HCV therapy in clinical practice.
METHODS.: Observational intent-to-treat cohort analysis using the Veterans Affairs Clinical Case Registry to identify HIV/HCV GT1-coinfected veterans initiating 12 weeks of LDV/SOF ± RBV or OPrD ± RBV. Multivariate models of sustained virologic response (SVR) included age, race, cirrhosis, proton pump inhibitor (PPI) prescription, prior HCV treatment, body mass index, genotype subtype, and HCV treatment regimen.
RESULTS.: Nine hundred ninety-six HIV/HCV GT1-coinfected veterans initiated therapy: 757 LDV/SOF, 138 LDV/SOF + RBV, 28 OPrD, and 73 OPrD + RBV. Overall SVR was 90.9% (823/905); LDV/SOF 92.1% (631/685), LDV/SOF + RBV 86.3% (113/131), OPrD 88.9% (24/27), and OPrD + RBV 88.7% (55/62). SVR was 85.9% (176/205) and 92.4% (647/700) in those with and without cirrhosis (P = .006). SVR was similar between African Americans (90.5% [546/603]) and all others (91.7% [277/302]). PPI use with LDV/SOF ± RBV did not affect SVR (89.7% [131/146] with PPI and 91.5% [613/670] without PPI). Cirrhosis was predictive of reduced SVR (0.51 [95% confidence interval {CI}, .31-.87]; P = .01). Median creatinine change did not differ among patients receiving LDV/SOF and tenofovir disoproxil fumarate (TDF) without a protease inhibitor (PI) (0.18 [interquartile range {IQR}, 0.08-0.30]; n = 372), LDV/SOF and TDF/PI (0.17 [IQR, 0.04-0.30]; n = 100), and LDV/SOF without TDF (0.15 [IQR, 0.00-0.30]; n = 423).
CONCLUSIONS.: SVR rates in HIV/HCV GT1-coinfected patients were high. African American race or PPI use with LDV/SOF ± RBV was not associated with lower SVR rates, but cirrhosis was. Renal function did not worsen on LDV/SOF regimens with TDF.
需要大样本队列来评估人类免疫缺陷病毒（HIV）/丙型肝炎病毒（HCV）的真实世界治疗结局。我们检测了 ledipasvir/sofosbuvir 联合或不联合利巴韦林（LDV/SOF ± RBV）以及 ombitasvir/paritaprevir/ritonavir 加 dasabuvir（OPrD）± RBV 在接受 HCV 治疗的 HIV/HCV 基因型 1（GT1）合并感染患者中的有效性在临床实践中。
使用退伍军人事务临床病例登记处进行观察性意向治疗队列分析，以确定开始接受 12 周 LDV/SOF ± RBV 或 OPrD ± RBV 治疗的 HIV/HCV GT1 合并感染的退伍军人。持续病毒学应答（SVR）的多变量模型包括年龄、种族、肝硬化、质子泵抑制剂（PPI）处方、既往 HCV 治疗、体重指数、基因型亚型和 HCV 治疗方案。
996 例 HIV/HCV GT1 合并感染的退伍军人开始治疗：757 例 LDV/SOF、138 例 LDV/SOF + RBV、28 例 OPrD 和 73 例 OPrD + RBV。总的 SVR 率为 90.9%（823/905）；LDV/SOF 92.1%（631/685），LDV/SOF + RBV 86.3%（113/131），OPrD 88.9%（24/27），OPrD + RBV 88.7%（55/62）。肝硬化患者 SVR 率为 85.9%（176/205）和 92.4%（647/700）（P =.006）。非裔美国人（90.5% [546/603]）和其他人（91.7% [277/302]）之间 SVR 相似。LDV/SOF ± RBV 联合使用 PPI 不会影响 SVR（有 PPI 者为 89.7%[131/146]，无 PPI 者为 91.5%[613/670]）。肝硬化是 SVR 降低的预测因素（0.51 [95%置信区间 {CI}，.31-.87]；P =.01）。接受 LDV/SOF 和替诺福韦二吡呋酯（TDF）而无蛋白酶抑制剂（PI）的患者（n = 372）、接受 LDV/SOF 和 TDF/PI 的患者（n = 100）和接受 LDV/SOF 而未接受 TDF 的患者（n = 423）的肌酐变化中位数无差异。
HIV/HCV GT1 合并感染患者的 SVR 率较高。非裔美国人或 LDV/SOF ± RBV 联合使用 PPI 与较低的 SVR 率无关，但肝硬化有关。TDF 联合 LDV/SOF 方案不会导致肾功能恶化。
