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Saudi Journal of Kidney Diseases and Transplantation
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RENAL DATA FROM THE ARAB WORLD  
Year : 2021  |  Volume : 32  |  Issue : 6  |  Page : 1715-1721
National Epidemiological Study about Hepatitis C Virus Infection among Dialysis Patients


1 Department of Medicine A; Laboratory of Renal Pathology LR00SP01, Charles Nicolle Hospital, Tunis, Tunisia
2 Department of Medicine A, Charles Nicolle Hospital, Tunis, Tunisia
3 Laboratory of Renal Pathology LR00SP01, Charles Nicolle Hospital, Tunis, Tunisia

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Date of Web Publication27-Jul-2022
 

   Abstract 


The World Health Organization estimates that 3% of the general population is infected with this virus. Hepatitis C remains the main viral infection in dialysis patients, and the severity of this infection is the risk of developing cirrhosis or hepatocarcinoma. We aim to determine the prevalence of hepatitis C in dialysis patients, to calculate the rate of hepatitis C virus (HCV) seroconversion, and to identify the risk factors for seroconversion. This is a nationwide multicenter observational study including all dialysis patients regardless of age and gender. Those with acute renal failure and vacationers were excluded from the study. We included 185 centers including 176 hemodialysis (HD) centers and nine peritoneal dialysis (PD) centers with a total number of patients at 11,238, a number of HCV-positive patients at 402, and a number of functional machines at 3139. The mean age of a patient was 55.6 years (range: 18-65), and sex ratio was 0.9. The prevalence of HCV-positive patients is 3.6%; it is higher in private centers with an average of 2.7 compared to 1.18 in public centers with a significant difference (P = 0.009). The prevalence of HCV-positive patients was significantly higher in HD centers compared to PD centers, in centers where the number of generators was >15 and when the number of patients per center is >70. One hundred and fifty-six patients seroconverted after dialysis, i.e., a prevalence of seroconversion at 1.3% with a mean delay of 6.052 ± 5.3 years. Our study shows a lower prevalence of HCV seroconversion than that reported in the literature; this requires a national survey to be carried out by homogenizing virological diagnostic kits and treating infected patients to eradicate this infection in dialysis patients.

How to cite this article:
Hajji M, Barbouch S, Manaa R, Ajimi K, Hamida FB, Goucha R, Gorsane I, Abdallah TB. National Epidemiological Study about Hepatitis C Virus Infection among Dialysis Patients. Saudi J Kidney Dis Transpl 2021;32:1715-21

How to cite this URL:
Hajji M, Barbouch S, Manaa R, Ajimi K, Hamida FB, Goucha R, Gorsane I, Abdallah TB. National Epidemiological Study about Hepatitis C Virus Infection among Dialysis Patients. Saudi J Kidney Dis Transpl [serial online] 2021 [cited 2022 Aug 14];32:1715-21. Available from: https://www.sjkdt.org/text.asp?2021/32/6/1715/352433



   Introduction Top


A major cause of morbidity and mortality in dialysis patients is hepatitis C virus (HCV) infection.[1] Dialysis patients are a particular group of patients in which prognosis and treatment options for HCV-related liver disease remain problematic. Some studies indicate a decrease in the incidence in parallel with the prevalence of dialysis centers over the last 10 years, while others maintain a high incidence.[2] In some countries, both prevalence and incidence remain high, with a major route of transmission being nosocomial, probably due to limited resources for a rapidly growing dialyzed population.[3] We aim to determine the national prevalence and epidemiologic profile of hepatitis C among dialysis patients in our country, as well as the rate of seroconversion, on the one hand, and to identify seroconversion factors, on the other hand.


   Patients and Methods Top


It is a national multicentric observational study including hemodialysis (HD) and peritoneal dialysis (PD) patients who are residents in Tunisia among private and public dialysis centers. We gathered data from dialysis centers such as the number of dialysis generators per center and the number of patients and physicians. Regarding dialysis patients, we have collected the following data: age, gender, residential status, the onset of renal failure and HD history, HCV serology at the beginning of dialysis and during the follow-up as well as the date of seroconversion.

Study population

This cohort has been conducted during a one-month period (March 2019), ensuring the most complete coverage for all HD and PD centers. Patient’s data were collected into a nationwide register using dialysis center telephone numbers or fax. Those with acute renal failure and transient patients were excluded from the study.

Serological testing

Patients were investigated for HCV antibodies (IgG)-specific immunoglobulin using an HCV enzyme-labeled antigen test. Screening for hepatitis C was performed in all patients who initiate the dialysis program or are transferred from other centers, initially with immunoassay, and if positive, confirmed by nucleic acid (NAT) assays, by the polymerase chain reaction (PCR) which can rapidly detect HCV infection, within approximately one week post exposure. All NAT-based tests approved for clinical use have specificity above 99% for the six genotypes and viral load detection levels from 12 IU/mL for PCR.[14]


   Statistical Analysis Top


Data were analyzed statistically using descriptive statistics: frequencies, mean, and standard deviation. Data handling was performed using Statview statistical software program 13.20. The factors associated with survival of patients with HCV infection on HD were analyzed using a univariate regression analysis and presented as odds ratios. A stepwise multivariate regression model was used to assess factors that were independently associated with survival. The survival hazard ratio for patients not receiving HCV treatment adjusted for the factors independently associated with survival was calculated using a Cox regression model. A Kaplan-Meier survival curve was performed to visualize survival over time and was analyzed using a log-rank test. Fisher’s exact test was used to test statistical significance of contingency tables. Mann-Whitney U-test was used to test the differences of medians. All reported P values are two-sided. P ≤0.05 was considered to be significant.


   Results Top


The participation rate of dialysis centers throughout the Tunisian territory was estimated to 100%. The total number of centers was 185, of which 176 were HD centers and 9 were PD centers. The total number of functional machines was 3139 versus 398 spare machines. We counted 474 doctors of which 389 were HD physicians and 85 were nephrologists (17.9%). We enrolled 11,238 patients, of whom 308 were PD patients (2.7%). We noted a total of 402 patients with HCV, which makes a prevalence of 3.6% of hepatitis C patients.

[Figure 1] illustrates the distribution by type of dialysis center of hepatitis C and [Figure 2] shows that the governorate of Tunis has the highest prevalence of dialysis patients, knowing that at the same time it has the largest concentration of dialysis centers; Sfax comes in the second position. At the same time, the number of dialysis patients carrying hepatitis C is greater in these two governorates. On the other hand, in other governorates such as Kasserine, Jendouba and Gafsa, there were a higher number of patients with hepatitis C compared to the total number of dialysis patients. In contrast, [Figure 3] shows the highest prevalence of hepatitis C in Tunisia, which is found in the governorate of Gafsa in southwestern Tunisia (13.7%), followed by Tunis (11.04%) then Jendouba (9.01%). The lowest HCV prevalence was found in Tozeur (0.26%). [Table 1] indicates that the nonstate dialysis centers are most concerned about the high prevalence of hepatitis C (P = 0.07), knowing that the predominant type of center in Tunisia is state centers (115 vs. 61), excluding PD centers. It has been noticed that the more dialysis machine number is >15 with a high number of patients, the higher the prevalence of hepatitis C (P = 0.01) [Table 2].
Figure 1. Distribution of hepatitis C by type of center.

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Figure 2. Distribution of hepatitis C virus patients by number by governorate.
HCV: Hepatitis C virus.


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Figure 3. Prevalence of hepatitis C virus by governorate.

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Table 1. Prevalence of hepatitis C virus-positive patients by type of center.

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Table 2. Prevalence of HCV by the number of dialysis machine in dialysis centers.
SD: Standard deviation.


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One hundred and fifty-six patients had sero-conversion in HD, i.e., 1.3% as seroconversion rate. The mean seroconversion time was 6.052 ± 5.3, with an average age of 52.17 ± 14.55. The mean age of patients according to HCV serology at the start of extrarenal purification was, respectively, 57.87 years old for HCV-positive patients versus 53.18 years old for HCV-negative patients (P = 0.0034). The most affected age group by seroconversion in HD was the one between 50 and 64 years old. Demographic and clinical characteristics of our study population as well as initial nephropathy type are represented in, respectively, [Tables 3 and 4].
Table 3. Characteristics of patients with hepatitis C virus.
HCV: Hepatitis C virus.


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Table 4. Distribution of hepatitis C virus by the nephropathy type.
HCV: Hepatitis C virus, CGN: Chronic glomerular nephropathy, ICN: Interstitial chronic nephropathy.


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In our study, we found, in univariate analysis, that the following factors were significantly associated with the risk of seroconversion: age >50 years old (P = 0.0034) and diabetic nephropathy (P = 0.002).


   Discussion Top


The prevalence of HCV infection is variable in dialysis patients from one center to another and from one country to another[4]. The prevalence of anti-HCV-positive patients on long-term dialysis has been reported to be below 5% in northern Europe, approximately 10% in most of Southern Europe and the United States, and between 10% and 70% in the developing world.[5] HD prevalence rates have declined in western Europe since the 1990s, along with an effective screening of blood products and implementation of universal precautions.[6] However, HCV infection remains prevalent across the globe in the dialysis population and continues to be an ongoing public health issue in many countries like ours. HCV is highly prevalent in dialysis patients as compared to the general population,[7] as it is often the consequence of a breakdown in universal precautions with an important issue of transmission of disease within dialysis units.[8] The HD setting has particular features that facilitate transmission of HCV, such as high risk of blood contamination of surfaces, objects, and devices and/or health-care worker hands as a result of poor infection control practices as well as a large number of patients treated simultaneously in a shared space.[9],[10]



In Tunisia, in the general population, the prevalence of HCV was 0.87% or 99,000 individuals versus 3.6% in this current study. Several Tunisian studies conducted in the 1990s[11],[12],[13],[14],[15] have looked at this subject and have made it possible to retain the following points: first, the prevalence of HCV infection in Tunisian HD patients varied between 20% and 46%, which nevertheless reveals a fairly significant drop in the prevalence of hepatitis C in the population on chronic dialysis. It is thus 60-100 times greater than in the general population. Second, there is a significant correlation between the duration of dialysis and the prevalence of HCV infection, which favors the nosocomial transmission of this infection. In fact, this finding was confirmed by Hmaïed et al, who carried out a phylogenetic analysis of circulating HCV strains in two Tunisian HD centers and who confirmed the nosocomial transmission of HCV infection in HD patients.[16] In our study, the prevalence of seroconversion of HCV was lower than that reported in previous Tunisian studies. Moreover, according to data from the national observatory of new and emerging diseases, HCV infection prevalence in dialysis patients has fallen over time from 18% in 2002 to 11% in 2008, and our national study has just shown that the prevalence is currently at 3.6%. This decrease in prevalence could be linked to the improvement of hygienic conditions within the dialysis centers and better compliance with the rules of isolation and handling through the continuous training of nurses and nursing assistants in this perspective.

These last years, the recommended treatment for HCV-infected patients on dialysis was a regimen of interferon (IFN) with or without ribavirin.[17] However, treatment in dialysis has been very rare due to the increased risk of side effects in this population and the complexity of this treatment that requires close monitoring. In fact, in a large international observational study: Dialysis Outcomes and Practice Patterns Study (DOPPS) (Phase I-IV), it was noted that only 1% of patients with HCV infection on HD had received antiviral treatment.[17] In 2014, sofosbuvir-based IFN-free, all-oral direct-acting antivirals (DAAs) were approved. Despite this, a larger observational study conducted in patients on HD between 2012 and 2015 DOPPS (Phase V), found that the antiviral treatment rate in HCV patients had only increased to 2.1% and only a limited number of patients were actually treated with DAAs.[18] The opportunity to cure HCV via DAA treatment has had an impact on all chapters of the 2018 KDIGO guideline on HCV in CKD including diagnosis, treatment, and prevention of transmission in HD units.[19]

Our current study will be completed with prospective data, as our dialysis patients will receive DAA treatment as things progress, and results regarding outcome measures will be published.


   Conclusion Top


The management of HCV in CKD populations has really changed over the past 10 years, primarily due to the development of DAA agents and proof of their efficacy in CKD patients. Our first step was to diagnose the current situation in our country in terms of frequency and prevalence of hepatitis C in chronic dialysis patients. The second step would be to follow the process of distributing the treatment in the various dialysis centers and to assess the therapeutic and prognostic aspects.

Conflict of interest: None declared.



 
   References Top

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Cacoub P, Desbois AC, Isnard-Bagnis C, Rocatello D, Ferri C. Hepatitis C virus infection and chronic kidney disease: Time for reappraisal. J Hepatol 2016;65:S82-94.  Back to cited text no. 1
    
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Caragea DC, Mihailovici AR, Streba CT, et al. Hepatitis C infection in hemodialysis patients. Curr Health Sci J 2018;44:107-12.  Back to cited text no. 2
    
3.
Bianco A, Bova F, Nobile CG, Pileggi C, Pavia M; Collaborative Working Group. Healthcare workers and prevention of hepatitis C virus transmission: Exploring knowledge, attitudes and evidence-based practices in hemodialysis units in Italy. BMC Infect Dis 2013;13:76.  Back to cited text no. 3
    
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Ohsawa M, Kato K, Itai K, et al. Standardized prevalence ratios for chronic hepatitis C virus infection among adult Japanese hemodialysis patients. J Epidemiol 2010;20:30-9.  Back to cited text no. 4
    
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Fabrizi F. Hepatitis C virus infection and dialysis: 2012 update. ISRN Nephrol 2013; 2013:159760.  Back to cited text no. 5
    
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Fabrizi F, Messa P. The epidemiology of HCV infection in patients with advanced CKD/ ESRD: A global perspective. Semin Dial 2019;32:93-8.  Back to cited text no. 6
    
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Ladino M, Pedraza F, Roth D. Hepatitis C virus infection in chronic kidney disease. J Am Soc Nephrol 2016;27:2238-46.  Back to cited text no. 7
    
8.
Nguyen DB, Bixler D, Patel PR. Transmission of hepatitis C virus in the dialysis setting and strategies for its prevention. Semin Dial 2019;32:127-34.  Back to cited text no. 8
    
9.
Shimokura G, Chai F, Weber DJ, et al. Patient-care practices associated with an increased prevalence of hepatitis C virus infection among chronic hemodialysis patients. Infect Control Hosp Epidemiol 2011;32:415-24.  Back to cited text no. 9
    
10.
Jadoul M, Horsmans Y. Towards eradication of hepatitis C virus from dialysis units. Lancet 2015;386:1514-5.  Back to cited text no. 10
    
11.
Jemni S, Ikbel K, Kortas M, et al. Seropositivity to hepatitis C virus in Tunisian haemodialysis patients. Nouv Rev Fr Hematol 1994;36:349-51.  Back to cited text no. 11
    
12.
Hachicha J, Hammami A, Masmoudi H, Ben, et al. Viral hepatitis C in chronic hemodialyzed patients in southern Tunisia. Prevalence and risk factors. Ann Med Interne (Paris) 1995; 146:295-8.  Back to cited text no. 12
    
13.
Sassi F, Gorgi Y, Ayed K, Abdallah TB, Lamouchi A, Maiz HB. Hepatitis C virus antibodies in dialysis patients in Tunisia: A single center study. Saudi J Kidney Dis Transpl 2000;11:218-22.  Back to cited text no. 13
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14.
Ayed K, Gorgi Y, Ben Abdallah T, et al. Hepatitis C virus infection in hemodialysis patients from Tunisia: National survey by serologic and molecular methods. Transplant Proc 2003;35:2573-5.  Back to cited text no. 14
    
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Ben Othman S, Bouzgarrou N, Achour A, Bourlet T, Pozzetto B, Trabelsi A. High prevalence and incidence of hepatitis C virus infections among dialysis patients in the East-Centre of Tunisia. Pathol Biol (Paris) 2004;52:323-7.  Back to cited text no. 15
    
16.
Hmaïed F, Ben Mamou M, Dubois M, et al. Determining the source of nosocomial transmission in hemodialysis units in Tunisia by sequencing NS5B and E2 sequences of HCV. J Med Virol 2007;79:1089-94.  Back to cited text no. 16
    
17.
Goodkin DA, Bieber B, Gillespie B, Robinson BM, Jadoul M. Hepatitis C infection is very rarely treated among hemodialysis patients. Am J Nephrol 2013;38:405-12.  Back to cited text no. 17
    
18.
Goodkin DA, Bieber B, Jadoul M, Martin P, Kanda E, Pisoni RL. Mortality, hospitalization, and quality of life among patients with hepatitis C infection on hemodialysis. Clin J Am Soc Nephrol 2017;12:287-97.  Back to cited text no. 18
    
19.
Gordon CE, Balk EM, Francis JM. Summary of the 2018 Kidney Disease Improving Global Outcomes (KDIGO) Guideline on hepatitis C in chronic kidney disease. Semin Dial 2019;32:187-95.  Back to cited text no. 19
    

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Correspondence Address:
Meriam Hajji
Department of Medicine A, Charles Nicolle Hospital, Tunis, Tunisia.
Tunisia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1319-2442.352433

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