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©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
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 schedule | 11031 (96.9) | 130 (96.3) | 2549 (96.1) | 3513 (95.3) | 2245 (98.9) | 1666 (98.9) | 3 (100) | 900 (96.7) | 9 (100) |
Discontinuation | 134 (1.2) | 5 (3.7) | 27 (1) | 60 (1.6) | 18 (0.8) | 8 (0.5) | 0 | 16 (1.7) | 0 |
Modification | 151 (1.3) | 0 | 62 (2.4) | 76 (2.1) | 1 (< 0.1) | 3 (0.2) | 0 | 9 (1) | 0 |
No data | 69 (0.6) | 0 | 14 (0.5) | 36 (1) | 6 (0.3) | 7 (0.4) | 0 | 6 (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) | 0 | 14 (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) | 0 | 2 (0.2) | 0 |
Most common AEs (≥ 1%), n (%) | |||||||||
Weakness/fatigue | 1073 (9.4) | 20 (14.8) | 409 (15.4) | 395 (10.7) | 141 (6.2) | 57 (3.4) | 0 | 46 (4.9) | 0 |
Anemia | 142 (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 disorders | 214 (1.9) | 4 (3) | 49 (1.8) | 95 (2.6) | 29 (1.3) | 25 (1.5) | 0 | 12 (1.3) | 0 |
Skin lesions | 106 (0.9) | 6 (4.4) | 24 (0.9) | 41 (1.1) | 10 (0.4) | 13 (0.8) | 0 | 12 (1.3) | 0 |
Itchy skin | 205 (1.8) | 0 | 31 (1.2) | 135 (3.7) | 6 (0.3) | 27 (1.6) | 0 | 5 (0.5) | 0 |
Diarrhea | 83 (0.7) | 4 (3) | 20 (0.8) | 32 (0.9) | 17 (0.7) | 4 (0.2) | 0 | 6 (0.6) | 0 |
Nausea | 136 (1.2) | 4 (3) | 29 (1.1) | 50 (1.4) | 25 (1.1) | 20 (1.2) | 0 | 8 (0.9) | 0 |
Headaches | 306 (2.7) | 5 (3.7) | 87 (3.3) | 95 (2.6) | 60 (2.6) | 45 (2.7) | 0 | 13 (1.4) | 0 |
Myalgia/arthralgia | 166 (1.5) | 5 (3.7) | 27 (1) | 65 (1.8) | 45 (2) | 13 (0.8) | 0 | 11 (1.2) | 0 |
Abdominal pain | 159 (1.4) | 10 (7.4) | 27 (1) | 45 (1.2) | 41 (1.8) | 22 (1.3) | 0 | 14 (1.5) | 0 |
Loss of appetite | 52 (0.5) | 3 (2.2) | 6 (0.2) | 24 (0.7) | 9 (0.4) | 4 (0.2) | 0 | 6 (0.6) | 0 |
AEs of particular interest (cirrhotics), n (%) | n = 2768 | n = 55 | n = 737 | n = 1019 | n = 380 | n = 278 | n = 1 | n = 290 | n = 3 |
Ascites | 60 (2.2) | 0 | 31 (4.2) | 21 (2.1) | 2 (0.5) | 0 | 0 | 6 (2.1) | 0 |
Encephalopathy | 44 (1.6) | 0 | 22 (3) | 16 (1.6) | 1 (0.3) | 2 (0.7) | 0 | 3 (1) | 0 |
Gastrointestinal bleeding | 16 (0.6) | 0 | 10 (1.4) | 4 (0.4) | 0 | 0 | 0 | 2 (0.7) | 0 |
Death, n (%) | 64 (0.6) | 0 | 19 (0.7) | 18 (0.5) | 9 (0.4) | 5 (0.3) | 0 | 13 (1.4) | 0 |
- Citation: Zarębska-Michaluk D, Brzdęk M, Jaroszewicz J, Tudrujek-Zdunek M, Lorenc B, Klapaczyński J, Mazur W, Kazek A, Sitko M, Berak H, Janocha-Litwin J, Dybowska D, Supronowicz Ł, Krygier R, Citko J, Piekarska A, Flisiak R. Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients. World J Gastroenterol 2022; 28(45): 6380-6396
- URL: https://www.wjgnet.com/1007-9327/full/v28/i45/6380.htm
- DOI: https://dx.doi.org/10.3748/wjg.v28.i45.6380