Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population and Design
2.2. PBMC Isolation from Whole Blood
2.3. Detection of HCV RNA in PBMCs
2.4. Liver Fibrosis Assessment
2.5. Statistical Analysis
2.6. Aim and Study Endpoints
3. Results
3.1. SVR
3.2. Kidney Function
3.3. Liver Function
3.4. CNI Dose Adjustments
3.5. Safety
3.6. OCI
3.7. Long-Term Outcomes of DAAs in Kidney Transplant Recipients
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | N = 59 | |
---|---|---|
Sex | ||
Male | N (%) | 37 (62.7) |
Female | N (%) | 22 (37.3) |
Age, years | Mean (SD) | 48.8 (13.1) |
Concomitant disease | ||
Hypertension | N (%) | 51 (86.4) |
Diabetes | N (%) | 21 (35.6) |
Dyslipidemia | N (%) | 32 (54.2) |
Number of Ktx | ||
1 | N (%) | 26 (44.1) |
2 | N (%) | 18 (30.5) |
3 | N (%) | 7 (11.9) |
Genotype | ||
1a | N (%) | 2 (3.4) |
1b | N (%) | 38 (64.4) |
3 | N (%) | 5 (8.5) |
4 | N (%) | 14 (23.7) |
HCV viral load | Median (IQR) | 1.97 × 106 (3.22 × 106) |
Treatment status | ||
Experienced | N (%) | 12 (20.3) |
Naive | N (%) | 47 (79.7) |
DAA therapy used | ||
Ombitasvir/parytaprevir/rytonavir | N (%) | 14 (23.7) |
Ledipasvir/sofosbuvir | N (%) | 31 (52.5) |
Glecaprevir/pibrentasvir | N (%) | 3 (5.1) |
Elbasvir/grazoprevir | N (%) | 11 (18.6) |
RBV | N (%) | 45 (76.2) |
Treatment duration | ||
8 weeks | N (%) | 2 (3.4) |
12 weeks | N (%) | 49 (83.0) |
16 weeks | N (%) | 2 (3.4) |
24 weeks | N (%) | 6 (10.2) |
Immunosuppression | ||
CNI | N (%) | 48 (81.4) |
MMF | N (%) | 45 (76.3) |
GKS | N (%) | 53 (89.9) |
Time since Ktx and DAAs, years | Mean (SD) | 11.18 (7.49) |
BMI, kg/m2 | Mean (SD) | 24.2 (4.3) |
Past HBV infection | ||
Yes | N (%) | 23 (39.0) |
No | N (%) | 36 (61.0) |
ESRD | ||
Glomerulonephritis | N (%) | 24 (40.7) |
Unknown etiology | N (%) | 7 (11.9) |
Hypertension | N (%) | 3 (5.1) |
Diabetes | N (%) | 8 (13.6) |
Vasculitis | N (%) | 1 (1.7) |
Congenital urinary tract defect | N (%) | 6 (10.2) |
Obstructive nephropathy | N (%) | 4 (6.8) |
Chronic interstitial nephritis | N (%) | 4 (6.8) |
HUS | N (%) | 2 (3.4) |
Fibrosis | ||
LS, kPa | Median (IQR) | 6.1 (3.75) |
F0–F1 | N (%) | 38 (64.4) |
F2 | N (%) | 10 (16.9) |
F3 | N (%) | 6 (10.2) |
F4 | N (%) | 5 (8.5) |
FIB-4 | Median (IQR) | 1.33 (1.3) |
APRI | Median (IQR) | 2.76 (5.36) |
CAP, dB/m | Mean (SD) | 231.19 (44.0) |
Variable | Before Treatment | After Treatment | 1 Year AT | 2 Years AT | 4 Years AT |
---|---|---|---|---|---|
ALT Mdn (IQR), U/I | 40.0 (40.0) | 20.0 (8.0) | 14.0 (9.0) | 15.0 (7.0) | 15 (9.0) |
AST Mdn (IQR), U/I | 33.0 (24.0) | 19.0 (11.0) | 20.0 (7.0) | 19.0 (6.0) | 18.0 (8.0) |
GGT Mdn (IQR), U/I | 61.0 (72.0) | 27.0 (27.0) | 24.0 (22.0) | 28.0 (23.0) | 26.0 (18.0) |
Adverse Event | N = 59 | |
---|---|---|
Anemia | N (%) | 15 (25.4%) |
Weakness | N (%) | 13 (22%) |
Urinary tract infection | N (%) | 13 (22%) |
Sterile leukocyturia | N (%) | 8 (13.6%) |
Upper respiratory tract infection | N (%) | 7 (11.9%) |
Headache | N (%) | 4 (6.8%) |
Diarrhea | N (%) | 3 (5.1%) |
Hypertransaminasemia | N (%) | 3 (5.1%) |
Pneumonia | N (%) | 3 (5.1%) |
Abdominal pain | N (%) | 2 (3.4%) |
Ankle edema | N (%) | 2 (3.4%) |
Worsening of blood pressure control | N (%) | 2 (3.4%) |
Herpes | N (%) | 2 (3.4%) |
Fatigue | N (%) | 2 (3.4%) |
Worsening of exercise tolerance | N (%) | 1 (1.7%) |
Bone pains | N (%) | 1 (1.7%) |
Distal deep vein thrombosis | N (%) | 1 (1.7%) |
Nausea | N (%) | 1 (1.7%) |
Sleep disturbance | N (%) | 1 (1.7%) |
Hematuria | N (%) | 1 (1.7%) |
Weight loss | N (%) | 1 (1.7%) |
Syncope | N (%) | 1 (1.7%) |
Hyperkalemia | N (%) | 1 (1.7%) |
Gout | N (%) | 1 (1.7%) |
Sinusitis | N (%) | 1 (1.7%) |
Hypotension | N (%) | 1 (1.7%) |
Fistulae | N (%) | 1 (1.7%) |
Atrial fibrillation | N (%) | 1 (1.7%) |
Inflammatory fistula tumor | N (%) | 1 (1.7%) |
Otitis | N (%) | 1 (1.7%) |
Pruritus | N (%) | 1 (1.7%) |
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Czarnecka, P.; Czarnecka, K.; Tronina, O.; Bączkowska, T.; Wyczałkowska-Tomasik, A.; Durlik, M.; Czerwinska, K. Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study. J. Clin. Med. 2023, 12, 3513. https://doi.org/10.3390/jcm12103513
Czarnecka P, Czarnecka K, Tronina O, Bączkowska T, Wyczałkowska-Tomasik A, Durlik M, Czerwinska K. Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study. Journal of Clinical Medicine. 2023; 12(10):3513. https://doi.org/10.3390/jcm12103513
Chicago/Turabian StyleCzarnecka, Paulina, Kinga Czarnecka, Olga Tronina, Teresa Bączkowska, Aleksandra Wyczałkowska-Tomasik, Magdalena Durlik, and Katarzyna Czerwinska. 2023. "Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study" Journal of Clinical Medicine 12, no. 10: 3513. https://doi.org/10.3390/jcm12103513