Observational Study
Copyright ©The Author(s) 2022.
World J Gastroenterol. Dec 7, 2022; 28(45): 6380-6396
Published online Dec 7, 2022. doi: 10.3748/wjg.v28.i45.6380
Table 7 Safety of antiviral therapy in genotype 1b-infected patients according to treatment regimens
Parameter
GT1b patients, n = 11385
ASV + DCV, n = 135
LDV/SOF ± RBV, n = 2652
OBV/PTV/r + DSV ± RBV, n = 3685
GZR/EBR ± RBV, n = 2270
GLE/PIB, n = 1684
GLE/PIB + SOF + RBV, n = 3
SOF/VEL ± RBV, n = 931
VOX/VEL/SOF, n = 9
Therapy course, n (%)
      According to schedule11031 (96.9)130 (96.3)2549 (96.1)3513 (95.3)2245 (98.9)1666 (98.9)3 (100)900 (96.7)9 (100)
      Discontinuation134 (1.2)5 (3.7)27 (1)60 (1.6)18 (0.8)8 (0.5)016 (1.7)0
      Modification151 (1.3)062 (2.4)76 (2.1)1 (< 0.1)3 (0.2)09 (1)0
      No data69 (0.6)014 (0.5)36 (1)6 (0.3)7 (0.4)06 (0.6)0
Patients with at least one AE, n (%) 2167 (19)49 (36.3)518 (19.5)911 (24.7)362 (15.9)184 (10.9)1 (33.3)133 (14.3)0
Serious adverse events, n (%)123 (1.1)7 (5.2)27 (1)59 (1.6)11 (0.5)5 (0.3)014 (1.5)0
AEs leading to treatment discontinuation, n (%)82 (0.7)2 (1.5)20 (0.8)47 (1.3)7 (0.3)4 (0.2)02 (0.2)0
Most common AEs (≥ 1%), n (%)
      Weakness/fatigue1073 (9.4)20 (14.8)409 (15.4)395 (10.7)141 (6.2)57 (3.4)046 (4.9)0
      Anemia142 (1.2)1 (0.7)65 (2.5)55 (1.5)9 (0.4)1 (0.1)1 (33.3)5 (0.5)0
      Sleep disorders214 (1.9)4 (3)49 (1.8)95 (2.6)29 (1.3)25 (1.5)012 (1.3)0
      Skin lesions106 (0.9)6 (4.4)24 (0.9)41 (1.1)10 (0.4)13 (0.8)012 (1.3)0
      Itchy skin205 (1.8)031 (1.2)135 (3.7)6 (0.3)27 (1.6)05 (0.5)0
      Diarrhea83 (0.7)4 (3)20 (0.8)32 (0.9)17 (0.7)4 (0.2)06 (0.6)0
      Nausea136 (1.2)4 (3)29 (1.1)50 (1.4)25 (1.1)20 (1.2)08 (0.9)0
      Headaches306 (2.7)5 (3.7)87 (3.3)95 (2.6)60 (2.6)45 (2.7)013 (1.4)0
      Myalgia/arthralgia166 (1.5)5 (3.7)27 (1)65 (1.8)45 (2)13 (0.8)011 (1.2)0
      Abdominal pain159 (1.4)10 (7.4)27 (1)45 (1.2)41 (1.8)22 (1.3)014 (1.5)0
      Loss of appetite52 (0.5)3 (2.2)6 (0.2)24 (0.7)9 (0.4)4 (0.2)06 (0.6)0
AEs of particular interest (cirrhotics), n (%)n = 2768n = 55n = 737n = 1019n = 380n = 278n = 1n = 290n = 3
      Ascites60 (2.2)031 (4.2)21 (2.1)2 (0.5)006 (2.1)0
      Encephalopathy44 (1.6)022 (3)16 (1.6)1 (0.3)2 (0.7)03 (1)0
      Gastrointestinal bleeding16 (0.6)010 (1.4)4 (0.4)0002 (0.7)0
Death, n (%)64 (0.6)019 (0.7)18 (0.5)9 (0.4)5 (0.3)013 (1.4)0