Ojha Rohit P, MacDonald Brooke R, Chu Tzu-Chun, Fasanmi Esther O, Moore Jonathan D, Stewart Rachel A
Center for Outcomes Research, JPS Health Network, Fort Worth, TX, USA.
Department of Biostatistics and Epidemiology, UNT Health Science Center School of Public Health, Fort Worth, TX, USA.
Antivir Ther. 2018;23(7):585-592. doi: 10.3851/IMP3249. Epub 2018 Jul 3.
Real-world studies have aimed to compare the effects of 8- and 12-week ledipasvir/sofosbuvir regimens on sustained virological response (SVR) among HCV infection genotype-1 (HCV-1) treatment-naive patients. Nevertheless, real-world comparative effectiveness studies pose unique challenges, such as confounding by indication, that were not adequately addressed in prior studies. We thus aimed to address limitations in prior studies and compare overall- and subgroup-specific effectiveness of 8- and 12-week ledipasvir/sofosbuvir regimens among HCV-1 treatment-naive patients.
Patients eligible for our study were aged ≥18 years and initiated 8- or 12-week ledipasvir/sofosbuvir regimens for treatment-naive HCV-1 at an urban public hospital network. We excluded patients with HIV or cirrhosis. We used marginal structural models to estimate overall and subgroup-specific risk ratios (RRs) and 95% confidence limits (CL) comparing the effect of 8- and 12-week ledipasvir/sofosbuvir regimens on 12-week SVR.
Our study population comprised 191 patients. Among both regimens, the majority were aged >50 years, non-Hispanic White and uninsured. The overall risk of SVR was comparable between the 8- and 12-week regimens (RR=1.01, 95% CL: 0.92, 1.11). The risk of SVR did not vary by race/ethnicity (non-Hispanic Black: RR=1.01, 95% CL: 0.84, 1.21; non-Hispanic White: RR=1.01, 95% CL: 0.89, 1.04).
Our real-world results suggest that 8- and 12-week ledipasvir/sofosbuvir have comparable effects on SVR among HCV-1 patients without cirrhosis or HIV. In addition, the comparable effectiveness of 8- and 12-week regimens among non-Hispanic Black individuals adds to the growing body of evidence that supports the removal of race-based treatment guidelines.
真实世界研究旨在比较8周和12周的来迪派韦/索磷布韦治疗方案对初治丙型肝炎病毒1型（HCV-1）感染患者持续病毒学应答（SVR）的影响。然而，真实世界的比较疗效研究带来了独特的挑战，如指征性混杂，而先前的研究并未充分解决这一问题。因此，我们旨在解决先前研究中的局限性，并比较8周和12周的来迪派韦/索磷布韦治疗方案在初治HCV-1患者中的总体及亚组特异性疗效。
符合我们研究条件的患者年龄≥18岁，在城市公立医院网络开始接受8周或12周的来迪派韦/索磷布韦治疗方案，用于初治HCV-1。我们排除了合并HIV或肝硬化的患者。我们使用边际结构模型来估计总体及亚组特异性风险比（RR）和95%置信区间（CL），以比较8周和12周的来迪派韦/索磷布韦治疗方案对12周SVR的影响。
我们的研究人群包括191名患者。在两种治疗方案中，大多数患者年龄>50岁，为非西班牙裔白人且未参保。8周和12周治疗方案的SVR总体风险相当（RR=1.01，95%CL：0.92，1.11）。SVR风险在不同种族/民族间无差异（非西班牙裔黑人：RR=1.01，95%CL：0.84，1.21；非西班牙裔白人：RR=1.01，95%CL：0.89，1.04）。
我们的真实世界研究结果表明，8周和12周的来迪派韦/索磷布韦对无肝硬化或HIV的HCV-1患者的SVR影响相当。此外，8周和12周治疗方案在非西班牙裔黑人个体中的疗效相当，这进一步增加了支持取消基于种族的治疗指南的证据。
