Sacco Rodolfo, Messina Vincenzo, Gentilucci Umberto Vespasiani, Adinolfi Luigi Elio, Ascione Antonio, Barbarini Giorgio, Barlattani Angelo, Cariti Giuseppe, Cozzolongo Raffaele, Fimiani Basilio, Francavilla Ruggiero, Furlan Caterina, Garrucciu Giovanni, Iovinella Vincenzo, Rinaldi Luca, Marignani Massimo, Begini Paola, Palitti Valeria Pace, Pellicelli Adriano M, Scifo Gaetano, Facciorusso Antonio, Giacomelli Luca, Shah Aashni, Bertino Gaetano, Perazzo Serena, Bresci Giampaolo, Izzi Antonio
Gastroenterology and Metabolic Diseases Unit - Pisa University Hospital, Pisa, Italy.
Infectious Disease Unit Sant'Anna e San Sebastiano Hospital Caserta, Italy.
Drugs Context. 2020 Dec 15;9. doi: 10.7573/dic.2020-4-11. eCollection 2020.
The once-daily oral combination of daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is effective and well tolerated in patients with hepatitis C virus (HCV). However, further field-practice studies are necessary to investigate the effectiveness and safety of the DCV+SOF combination in diverse subpopulations of patients with HCV, including those who are more challenging to treat such as patients with a genotype 3 (G3) infection. The aim of this retrospective, multicenter, field-practice study was to investigate the therapeutic efficacy and safety of the oral combination of DCV and SOF, with or without RBV (DCV+SOF±RBV), in a large unselected cohort of patients with chronic HCV infection (CHC).
Consecutive patients received DCV+SOF±RBV for 12 or 24 weeks. The efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12). Safety factors were also considered.
A total of 620 patients were included in this study; the predominant genotype was G3 (55.3%). Of the total sample, 248 (40%) patients were treated with DCV+SOF+RBV and 372 (60%) did not receive RBV. The majority of patients assessed at week 12 (98%, 596/608) achieved SVR12. Among G3 patients, 98.8% (335/339) achieved SVR12. The most common adverse event was elevated bilirubin (30.6%), recorded in 4.9% of cases as a grade 3-4 adverse event.
This study shows the high pan-genotypic effectiveness and safety of the DCV+SOF±RBV combination in a large, unselected sample of CHC patients with G1-4, including a wide proportion of G3 CHC patients.
每日一次口服达卡他韦（DCV）和索磷布韦（SOF）联合用药，无论是否联用利巴韦林（RBV），对于丙型肝炎病毒（HCV）患者均有效且耐受性良好。然而，有必要开展进一步的实际应用研究，以调查DCV+SOF联合用药在不同HCV患者亚群中的有效性和安全性，包括那些治疗难度较大的患者，如基因型3（G3）感染患者。这项回顾性、多中心、实际应用研究的目的是调查DCV和SOF口服联合用药，无论是否联用RBV（DCV+SOF±RBV），在一大群未经选择的慢性HCV感染（CHC）患者中的治疗效果和安全性。
连续入选的患者接受DCV+SOF±RBV治疗12周或24周。疗效终点为治疗结束后12周的持续病毒学应答（SVR12）。同时也考虑了安全因素。
本研究共纳入620例患者；主要基因型为G3（55.3%）。在全部样本中，248例（40%）患者接受DCV+SOF+RBV治疗，372例（60%）未接受RBV治疗。在第12周评估时，大多数患者（98%，596/608）实现了SVR12。在G3患者中，98.8%（335/339）实现了SVR12。最常见的不良事件是胆红素升高（30.6%），4.9%的病例记录为3-4级不良事件。
本研究表明，DCV+SOF±RBV联合用药在一大群未经选择的G1-4型CHC患者样本中具有高度泛基因型有效性和安全性，其中包括很大比例的G3型CHC患者。
