Outreach onsite treatment with a simplified pangenotypic direct-acting anti-viral regimen for hepatitis C virus micro-elimination in a prison

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)

¹56 patients did not have body mass index information (12 patients before campaign of hepatitis C virus (HCV) micro-elimination; 44 patients in campaign of HCV micro-elimination).

^aP < 0.05. DAA: Directly-acting antivirals; HCV: Hepatitis C virus; BMI: Body mass index; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; LC: Liver cirrhosis; FIB-4: Fibrosis-4 index; HBsAg: Hepatitis B surface antigen; eGFR: Estimated glomerular filtration rate (mL/min/1.73 m²); SOF: Sofosbuvir; VEL: Velpatasvir; LDV: Ledipasvir; GLE: Glecaprevir; PIB: Pibrentasvir; IFN: Interferon.

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

¹One missing data.

²One transferred; One missing data.

³Two transferred; One released.

⁴Four released.

⁵One relapser.

⁶Four transferred; Five released. HCV: Hepatitis C virus; VEL: Velpatasvir; SOF: Sofosbuvir.

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)

DAA: Directly-acting antivirals; HCV: Hepatitis C virus; VEL: Velpatasvir; SOF: Sofosbuvir.