Paolucci Stefania, Novazzi Federica, Piralla Antonio, Maserati Renato, Gulminetti Roberto, Novati Stefano, Barbarini Giorgio, Sacchi Paolo, Fratini Alice, Bellotti Laura, Baldanti Fausto
Molecular Virology Unit, Microbiology and Virology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico, San Matteo, Pavia, Italy.
Institute of Infectious Diseases, University of Pavia, Pavia, Italy.
Infect Drug Resist. 2019 Jul 8;12:1975-1984. doi: 10.2147/IDR.S205282. eCollection 2019.
New hepatitis C virus (HCV) therapies have improved efficacy, allowed pangenotypic applications, increased barriers to drug resistance and shortened therapy duration.
Patients infected with different HCV genotypes were divided into two groups: group 1 included 169 patients receiving genotypic specific regimens (GSR), while group 2 included 186 patients receiving pan-genotypic regimens (PGR). Patient's HCV RNA was quantified and sequenced.
Comparable sustained viral response (SVR) rates were observed in both GSR and PGR treated patients. Nevertheless, even if not significant, a greater proportion of non-detectable levels (NDL) of HCV RNA was observed in patients treated with PGR as compared with GSR. Overall, among patients in the GSR and PGR groups with residual viremia, 124/169 (73.4%) and 125/186 (67.2%) at four weeks, and 66/169 (39.1%) and 58/186 (31.2%) at eight weeks, achieved SVR. No difference was observed in the clinical outcome comparing patients in the GSR and PGR groups according to genotype. While, comparing patients between the two groups, the proportion of patients with NDL HCV RNA at four and eight weeks was higher in patients infected with genotype 1b treated with PGR (=0.0015). A significantly higher number of patients infected with 1b had RASs at baseline (=0.0001). In addition, the proportion of patients with treatment failure was higher in patients with RASs at baseline compared with those without (=0.012). Overall, 2.5% patients failed to achieve SVR after DAA treatment.
A sharp HCV RNA decrease was observed in patients treated with both GSR and PGR. However, even if comparable, a slightly greater number of patients treated with PGR achieved NDL HCV RNA as compared with GSR. A significant difference was observed in patients with baseline RASs, both in relation to treatment failure and genotype. In conclusion, the use of new DAA combinations helps patients achieve a more rapid virologic response.
新型丙型肝炎病毒（HCV）疗法提高了疗效，可用于泛基因型治疗，增加了耐药性障碍并缩短了治疗疗程。
将感染不同HCV基因型的患者分为两组：第1组包括169例接受基因型特异性治疗方案（GSR）的患者，而第2组包括186例接受泛基因型治疗方案（PGR）的患者。对患者的HCV RNA进行定量和测序。
在接受GSR和PGR治疗的患者中观察到了可比的持续病毒学应答（SVR）率。然而，尽管差异不显著，但与GSR相比，接受PGR治疗的患者中HCV RNA不可检测水平（NDL）的比例更高。总体而言，在GSR组和PGR组中有残余病毒血症的患者中，四周时分别为124/169（73.4%）和125/186（67.2%），八周时分别为66/169（39.1%）和58/186（31.2%）实现了SVR。根据基因型比较GSR组和PGR组患者的临床结局，未观察到差异。然而，比较两组患者时，接受PGR治疗的1b基因型感染患者在四周和八周时HCV RNA为NDL的比例更高（P=0.0015）。基线时携带耐药相关变异（RAS）的1b基因型感染患者数量显著更多（P=0.0001）。此外，基线时携带RAS的患者治疗失败的比例高于未携带RAS的患者（P=0.012）。总体而言，2.5%的患者在接受直接抗病毒药物（DAA）治疗后未实现SVR。
接受GSR和PGR治疗的患者均观察到HCV RNA急剧下降。然而，尽管结果可比，但与GSR相比，接受PGR治疗的患者中达到HCV RNA为NDL的人数略多。在基线携带RAS的患者中，在治疗失败和基因型方面均观察到显著差异。总之，使用新型DAA联合疗法有助于患者实现更快的病毒学应答。
