| Literature DB >> 32818142 |
Tsung-Hua Yang1,2, Yu-Jen Fang1,2, Shih-Jer Hsu1,2, Ji-Yuh Lee1,2, Min-Chin Chiu1,2, Jian-Jyun Yu1,2, Chia-Chi Kuo1,2, Chien-Hung Chen1,3.
Abstract
BACKGROUND: Incarcerated persons are a special population with higher hepatitis C virus (HCV) prevalence and should be prioritized for microelimination. In this study, we investigate the seroprevalence and evaluate the effectiveness and safety of direct-acting antiviral (DAA) therapy in custodial settings.Entities:
Keywords: Taiwan; chronic hepatitis C; direct-acting antiviral agent; hepatitis C virus; prison
Year: 2020 PMID: 32818142 PMCID: PMC7423289 DOI: 10.1093/ofid/ofaa301
Source DB: PubMed Journal: Open Forum Infect Dis ISSN: 2328-8957 Impact factor: 3.835
Descriptive Characteristics of the Incarcerated Persons With Positive Anti-HCVa
| Characteristics | All Patients | Positive | Negative |
|
|---|---|---|---|---|
| Age, years | 45.5 (30–73) | 45.6 (30–73) | 45.3 (30–64) | .5843 |
| IFN-experienced | 14 (5.1%) | 5 (2.6%) | 9 (10.6%) |
|
| DAA-experienced | 1 (0.4%) | 0 (0%) | 1 (1.2%) | .3080 |
| Hepatic Fibrosis on Fibrosis-4 Score | ||||
| F3 | 8 (2.9%) | 6 (3.1%) | 2 (2.4%) | 1 |
| F4 | 0 | 0 | 0 | |
| HBV | 35 (12.7%) | 9 (4.7%) | 26 (30.6%) | |
| HIV | 23 (8.3%) | 17 (8.9%) | 6 (7.1%) | .6093 |
| PWID | 233 (84.4%) | 166 (86.9%) | 67 (78.8%) | .0872 |
Abbreviations: DAA, direct acting antiviral; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IFN, interferon; PWID, people who inject drugs; RNA, ribonucleic acid.
aData are expressed as n (%) or median (range). Categorical variables were compared by the χ 2 test or the Fisher’s exact test; continuous variables were compared by the Student’s t test.
bComparison was made between positive HCV RNA and negative HCV RNA groups; significant P values are shown in bold text.
Descriptive Characteristics of the Incarcerated Persons With Positive HCV RNAa
| Characteristics | All Patients | Treated | Untreated |
|
|---|---|---|---|---|
| Age (years) | 45.6 (30–73) | 45.8 (30–73) | 44.3 (33–63) | .38219776 |
| IFN-experienced | 5 (2.6%) | 5 (3.0%) | 0 (0%) | 1 |
| Hepatic Fibrosis on Fibrosis-4 score | ||||
| F3 | 6 (3.1%) | 6 (3.6%) | 0 (0%) | 1 |
| F4 | 0 | 0 | 0 | |
| Liver cirrhosis with splenomegaly on ultrasonography | 6 (3.1%) | 6 (3.6%) | 0 | 1 |
| HCV Genotype | ||||
| 1a | 42 (22.0%) | 36 (21.8%) | 6 (23%) | .8855 |
| 1b | 27 (14.1%) | 24 (14.5%) | 3 (11.5%) | 1 |
| 2 | 20 (10.5%) | 17 (10.3%) | 3 (11.5%) | .7397 |
| 3 | 20 (10.5%) | 19 (11.5%) | 1 (3.8%) | .3203 |
| 6 | 75 (39.3%) | 64 (38.7%) | 11 (42.3%) | .7327 |
| 1a + 1b | 2 (1.0%) | 1 (0.6%) | 1 (3.8%) | .2543 |
| 1b + 2 | 2 (1.0%) | 1 (0.6%) | 1 (3.8%) | .2543 |
| 2 + 6 | 3 (1.6%) | 3 (1.8%) | 0 (0%) | 1 |
| HCV RNA (log10 IU/mL) | 6.235 | 6.246 | 6.165 | .67385888 |
| Platelet count (k/μL) | 218.1 (50–408) | 218.2 (50–408) | 216.9 (93–349) | .90530737 |
| ALT (U/L) | 49.2 (7–350) | 47.9 (7–350) | 58.0 (10–315) | .44189620 |
| AST (U/L) | 34.2 (9–175) | 34.0 (9–175) | 35.5 (14–115) | .78307864 |
| Total bilirubin (mg/dL) | 0.77 | 0.77 | 0.73 | .44094274 |
| Albumin (g/dL) | 4.47 (3.6–5.3) | 4.47 (3.6–5.1) | 4.45 (4.0–5.3) | .77880776 |
| INR | 0.97 (0.88–2.12) | 0.98 (0.88–2.12) | 0.96 (0.91–1.07) | .08209333 |
| Creatinine (mg/dL) | 0.92 (0.6–2.2) | 0.92 (0.6–2.2) | 0.89 (0.7–1.1) | .17604307 |
| CKD stage 4–5 | 0 | 0 | 0 | |
| HBV | 9 (4.7%) | 7 (4.2%) | 2 (7.6%) | .3528 |
| HIV | 17 (8.9%) | 16 (9.6%) | 1 (3.8%) | .4766 |
| PWID | 166 (86.9%) | 143 (86.6%) | 23 (88.4%) | 1 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CKD, chronic kidney disease; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IFN, interferon; INR, international normalized ratio; PWID, people who inject drugs; RNA, ribonucleic acid.
aData are presented as no. (%) or median (range). Categorical variables were compared using the χ 2 test or the Fisher’s exact test. Continuous variables were compared using the Student’s t test.
bComparison was made between treated and untreated patient groups. Significant P values are shown in bold text.
Figure 1.Chronic hepatitis C genotype distribution of treated patient group in Yunlin prison. PWID, people who inject drugs.
Figure 2.Selection protocol and outcome of patients treated for hepatitis C virus (HCV) infection in prison. RNA, ribonucleic acid; SVR12, sustained virologic response at week 12 off therapy.
Safety Summary of the 165 Patients Treated With GLE/PIBa
| Adverse Events | All Treated Patients |
|---|---|
| Pruritus | 16 (9.7) |
| Anorexia | 0 (0) |
| Fatigue | 0 (0) |
| Deaths | 0 (0) |
| Laboratory Abnormalitiesb | |
| ALTc >5 × ULN | 1 (0.6) |
| ASTc >5 × ULN | 1 (0.6) |
| Total Bilirubin | |
| >1.5–3 × ULN | 17 (10.3) |
| >3 × ULN | 2 (1.2) |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GLE/PIB, glecaprevir/pibrentasvir; ULN, upper limit of normal.
aData are presented as no. (%).
bPost-baseline laboratory abnormalities.
cPostnadir increase to >5 × ULN.