Mangia Alessandra, Milligan Scott, Khalili Mandana, Fagiuoli Stefano, Shafran Stephen D, Carrat Fabrice, Ouzan Denis, Papatheodoridis George, Ramji Alnoor, Borgia Sergio M, Wedemeyer Heiner, Losappio Ruggero, Pérez-Hernandez Francisco, Wick Nicole, Brown Robert S, Lampertico Pietro, Doucette Karen, Ntalla Ioanna, Ramroth Heribert, Mertens Michael, Vanstraelen Kim, Turnes Juan
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Trio Health Analytics, La Jolla, CA, USA.
Liver Int. 2020 Aug;40(8):1841-1852. doi: 10.1111/liv.14537. Epub 2020 Jun 9.
Achieving sustained virological response (SVR; cure) in hepatitis C patients using a simple regimen is key to making elimination by 2030 possible. In the largest real-world analysis to date, the effectiveness of pangenotypic, panfibrotic, single-tablet, sofosbuvir/velpatasvir (SOF/VEL) once-daily for 12 weeks was assessed in 12 clinical real-world cohorts from various geographical areas, settings and treatment practices. Factors affecting risk of not achieving SVR were assessed.
Adults treated with SOF/VEL 400/100 mg, without ribavirin, were included. All HCV patients reaching Week 12 or 24 post-treatment were assessed for SVR12/24. Factors associated with not achieving SVR12/24 for virological reasons were evaluated using logistic regression analysis.
Overall, 5552 patients were included: 13.3% treatment-experienced; 20.7% compensated cirrhotic; 30.2% genotype 1; 29.5% genotype 2; 32.9% genotype 3; 4.7% genotype 4; 3.7% HIV coinfection; 13.4% current/former intravenous drug use. Of the 5196 patients evaluated for effectiveness, 98.9% achieved SVR12/24. High SVR12/24 rates occurred in all genotypes including genotype 3 (98.3%; 1649/1677) and in those with compensated cirrhosis (97.9; 1055/1078). Only 55 patients did not achieve SVR12/24 due to a virological reason; the only factor statistically significantly associated with an increased risk of not achieving SVR12/24 was compensated cirrhosis (P = .002). Overall, 6% (332/5552) of patients did not achieve SVR12/24 for non-virological reasons (67% lost to follow-up; 26.5% early treatment discontinuation).
In this large cohort, representative of clinical practice, a simple 12-week regimen of SOF/VEL without ribavirin resulted in high SVR12/24 rates in diverse patient populations, even among those with compensated cirrhosis.
采用简单治疗方案使丙型肝炎患者实现持续病毒学应答（SVR；治愈）是2030年实现消除丙型肝炎的关键。在迄今为止最大规模的真实世界分析中，评估了泛基因型、全纤维化、单片剂的索磷布韦/维帕他韦（SOF/VEL）每日一次、疗程12周在来自不同地理区域、环境和治疗实践的12个临床真实世界队列中的有效性。评估了影响未实现SVR风险的因素。
纳入接受400/100mg SOF/VEL治疗且未使用利巴韦林的成年人。对所有治疗后达到第12周或第24周的HCV患者评估SVR12/24。使用逻辑回归分析评估与因病毒学原因未实现SVR12/24相关的因素。
总体而言，共纳入5552例患者：13.3%有治疗史；20.7%为代偿期肝硬化患者；30.2%为基因1型；29.5%为基因2型；32.9%为基因3型；4.7%为基因4型；3.7%合并HIV感染；13.4%目前或既往有静脉注射毒品史。在评估有效性的5196例患者中，98.9%实现了SVR12/24。所有基因型包括基因3型（98.3%；1649/1677）以及代偿期肝硬化患者（97.9%；1055/1078）均有较高的SVR12/24率。仅55例患者因病毒学原因未实现SVR12/24；与未实现SVR12/24风险增加在统计学上显著相关的唯一因素是代偿期肝硬化（P = 0.002）。总体而言，6%（332/5552）的患者因非病毒学原因未实现SVR12/24（67%失访；26.5%提前终止治疗）。
在这个代表临床实践的大型队列中，简单的为期12周的不含利巴韦林的SOF/VEL治疗方案在不同患者群体中，甚至在代偿期肝硬化患者中，都产生了较高的SVR12/24率。
