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©The Author(s) 2022.
World J Gastroenterol. Jan 14, 2022; 28(2): 263-274
Published online Jan 14, 2022. doi: 10.3748/wjg.v28.i2.263
Published online Jan 14, 2022. doi: 10.3748/wjg.v28.i2.263
Table 1 Baseline characteristics of hepatitis C virus-infected patients receiving directly-acting antivirals therapy between sporadic hepatitis C virus therapy in outpatient clinics and campaign of hepatitis C virus micro-elimination in Penghu prison
Total | Sporadic HCV therapy in outpatient clinics (January 1, 2019 - December 31, 2019) | Campaign of HCV micro-elimination (January 1, 2020 - March 31, 2020) | P value | |
n | 303 | 91 | 212 | - |
Age (yr) | 48.4 ± 8.2 | 47.6 ± 8.7 | 48.7 ± 8.0 | 0.271 |
Male | 303 (99.7) | 90 (98.9) | 212 (100.0) | 0.126 |
1BMI, kg/m2 | 23.9 ± 3.2 | 23.9 ± 3.3 | 23.9 ± 3.2 | 0.986 |
> 27 kg/m2 | 34 (13.8) | 11 (13.9) | 23 (13.4) | 0.960 |
Diabetes | 10 (3.3) | 8 (8.8) | 2 (0.9) | 0.0005a |
Hypertension | 59 (19.5) | 25 (27.5) | 34 (16.0) | 0.021a |
Hyperlipidemia | 8 (2.6) | 7 (7.7) | 1 (0.5) | 0.0003a |
Cardiovascular disease | 2 (0.7) | 1 (1.1) | 1 (0.5) | 0.537 |
HBsAg (+) | 30 (9.9) | 9 (9.9) | 21 (9.9) | 0.997 |
AST, IU/L | 41.3 ± 35.5 | 45.9 ± 38.9 | 39.4 ± 33.8 | 0.168 |
ALT, IU/L | 65.4 ± 77.4 | 71.6 ± 69.8 | 62.7 ± 80.4 | 0.329 |
Abnormal AST or ALT | 159 (52.5) | 54 (59.3) | 105 (49.5) | 0.117 |
White cell count, × 103/ìL | 6.6 ± 1.9 | 6.4 ± 2.0 | 6.7 ± 1.8 | 0.188 |
Hemoglobin concentration, g/dL | 15.9 ± 1.3 | 16.0 ± 1.3 | 15.9 ± 1.3 | 0.762 |
Platelet count, × 103u/L | 227.6 ± 67.4 | 219.4 ± 72.1 | 231.2 ± 65.1 | 0.181 |
Albumin, g/dl | 4.5 ± 0.3 | 4.5 ± 0.4 | 4.5 ± 0.2 | 0.233 |
Total bilirubin, mg/dL | 0.8 ± 0.3 | 0.9 ± 0.4 | 0.8 ± 0.3 | 0.003a |
LC | 1 (0.3) | 1 (1.1) | 0 (0.0) | 0.300 |
FIB-4 | 1.3 ± 1.0 | 1.5 ± 1.4 | 1.2 ± 0.8 | 0.096 |
> 3.25 | 20 (6.6) | 10 (11.0) | 10 (4.7) | 0.044a |
eGFR, mL/min/1.73 m2 | 99.9 ± 17.7 | 99.1 ± 21.0 | 100.3 ± 16.4 | 0.624 |
< 60 | 4 (1.3) | 3 (3.3) | 1 (0.4) | 0.048a |
HCV RNA, log10 IU/mL | 6.5 ± 1.1 | 6.0 ± 1.0 | 6.7 ± 1.1 | < 0.001a |
HCV genotype, 1/2/1+2/3/6 | 128 (42.2)/32 (10.6)/1 (0.3)/35 (11.6)/107 (35.3) | 38 (41.8)/9 (9.9)/0/11 (12.1)/33 (36.2) | 90 (42.5)/23 (10.8)/1 (0.5)/24 (11.3)/74 (34.9) | 0.968 |
DAA regimen | ||||
SOF/VEL | 212 (70.0) | 0 (0.0) | 212 (100.0) | < 0.001a |
SOF/LDV | 78 (25.7) | 78 (85.7) | 0 (0.0) | |
GLE/PIB | 13 (4.3) | 13 (14.3) | 0 (0.0) | |
Prior treatment history | ||||
Naïve | 300 (99.0) | 89 (97.8) | 211 (99.5) | 0.216 |
Experienced-IFN | 3 (1.0) | 2 (2.2) | 1 (0.5) |
Table 2 Virological responses of hepatitis C virus-infected patients receiving directly-acting antivirals therapy before and during campaign of hepatitis C virus micro-elimination in Penghu prison in Penghu prison
Undetectable HCV RNA, n/N (%) | Total | Sporadic HCV therapy in outpatient clinics (January 1, 2019 - December 31, 2019) | Campaign of HCV micro-elimination with simplified pan-genotypic SOF/VEL regimen (January 1, 2020 - March 31, 2020) | P value |
Intention-to-treat population | ||||
Treatment 4 wk | 284/303 (93.7) | 85/91 (93.4) | 199/212 (93.9) | 0.879 |
End-of-treatment | 300/303 (99.0) | 91/91 (100.0) | 209/212 (98.6) | 0.557 |
End-of 12 wk follow-up | 289/303 (95.4) | 86/91 (94.5) | 203/212 (95.8) | 0.126 |
Per-protocol population | ||||
Treatment 4 wk | 284/301 (94.4) | 85/901 (94.4) | 199/2112 (94.3) | 0.964 |
End-of-treatment | 300/300 (100.0) | 91/91 (100.0) | 209/2093 (100.0) | - |
End-of 12 wk follow-up | 289/290 (99.7) | 86/874 (98.9)e5 | 203/2036 (100.0) | 0.126 |
Table 3 Safety profiles of hepatitis C virus-infected patients receiving direct-acting antivirals therapy in Penghu prison
n (%) | Total | Sporadic HCV therapy in outpatient clinics (January 1, 2019 - December 31, 2019) | Campaign of HCV micro-elimination with simplified pan-genotypic SOF/VEL regimen (January 1, 2020 - March 31, 2020) |
n | 303 | 91 | 212 |
Treatment discontinuation other than released or transferred | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Serious adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Adverse events | 7 (2.3) | 4 (4.3) | 3 (1.4) |
Fatigue | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pruritus | 2 (0.7) | 0 (0.0) | 2 (0.9) |
Rash | 3 (1.0) | 3 (3.2) | 0 (0.0) |
Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Anorexia | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Constipation | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dizziness | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Insomnia | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Headache | 1 (0.3) | 0 (0.0) | 1 (0.5) |
Others | 1 (0.3) | 1 (1.0) | 0 (0.0) |
Grade 3 or 4 laboratory abnormalities | |||
Total blood bilirubin | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Alanine aminotransferase | 0 (0.0) | 0 (0.0) | 0 (0.0) |
- Citation: Chen CT, Lu MY, Hsieh MH, Tsai PC, Hsieh TY, Yeh ML, Huang CI, Tsai YS, Ko YM, Lin CC, Chen KY, Wei YJ, Hsu PY, Hsu CT, Jang TY, Liu TW, Liang PC, Hsieh MY, Lin ZY, Huang CF, Huang JF, Dai CY, Chuang WL, Shih YL, Yu ML. Outreach onsite treatment with a simplified pangenotypic direct-acting anti-viral regimen for hepatitis C virus micro-elimination in a prison. World J Gastroenterol 2022; 28(2): 263-274
- URL: https://www.wjgnet.com/1007-9327/full/v28/i2/263.htm
- DOI: https://dx.doi.org/10.3748/wjg.v28.i2.263