|Year : 2020 | Volume
| Issue : 2 | Page : 48-53
Seroprevalence of hepatitis C infection in patients undergoing haemodialysis in a tertiary care centre
Anjali Nair Vinayakumar1, Reena John2
1 Department of Microbiology, Government Medical College, Kozhikode, Kerala, India
2 Consultant Microbiologist, DDRC SRL Diagnostics, Kollam, Kerala, India
|Date of Submission||13-Aug-2020|
|Date of Decision||21-Oct-2020|
|Date of Acceptance||14-Sep-2020|
|Date of Web Publication||21-Dec-2020|
Dr. Anjali Nair Vinayakumar
Flat B1, Twin Tower Castle, Bhavana Nagar, Kadappakkada, Kollam - 691 008, Kerala
Source of Support: None, Conflict of Interest: None
Introduction: Hepatitis C virus (HCV) infection is a major health problem among these patients in developing countries like India. This could be either due to a non-adherence to strict infection control measures or the unavailability of vaccine to prevent HCV infection.
Objectives of the Study: This study aims to estimate the prevalence of HCV infection in patients undergoing haemodialysis and assess the major risk factors, the efficacy of infection control measures in the dialysis unit by studying the seroconversion rates from HCV negative to HCV positive and also formulate ways to prevent the nosocomial spread of HCV infection in the dialysis unit.
Materials and Methods: This was a cross-sectional study carried out among 250 patients undergoing haemodialysis in the dialysis unit of a tertiary care centre. They were tested for the presence of anti-HCV antibody by enzyme linked immunosorbent assay.
Results: The seroprevalence of HCV infection among the patients undergoing haemodialysis as per this study is 4.8%. The risk factors identified were age >50, prolonged duration of dialysis and multiple blood transfusions. One significant observation was of the probability of lateral spread of HCV infection within the dialysis unit.
Conclusions: Although there is no consensus regarding machine dedication between HCV non-infected and HCV-infected patients, we found that using dedicated HD machines had an important role in reducing HCV transmission in our dialysis unit. However, risk prevails if any seronegative patient acts as HCV carrier.
Keywords: Haemodialysis, hepatitis C virus, seroprevalence
|How to cite this article:|
Vinayakumar AN, John R. Seroprevalence of hepatitis C infection in patients undergoing haemodialysis in a tertiary care centre. J Patient Saf Infect Control 2020;8:48-53
|How to cite this URL:|
Vinayakumar AN, John R. Seroprevalence of hepatitis C infection in patients undergoing haemodialysis in a tertiary care centre. J Patient Saf Infect Control [serial online] 2020 [cited 2021 Jan 21];8:48-53. Available from: https://www.jpsiconline.com/text.asp?2020/8/2/48/304216
| Introduction|| |
Hepatitis C virus (HCV) is a blood-borne virus and the most common modes of infection are through unsafe injection practices, inadequate sterilisation of medical equipments, and the transfusion of unscreened blood and blood products. More than 185 million persons are HCV antibody positive worldwide and around 3–4 million people are newly infected each year. HCV can cause both acute and chronic hepatitis infection; ranging in severity from a mild illness lasting a few weeks to a serious lifelong illness.
Hepatitis C is an emerging infection in India; the high risk of chronicity of this blood-borne infection and its association with hepatocellular carcinoma underscores its public health importance. It is one of the leading causes of liver transplantation.
Haemodialysis and hepatitis C virus infection
The hepatotropic viruses A through G remain the causative agents in 60%–80% of hepatitis. However, as far as haemodialysis is concerned, Hepatitis C and Hepatitis B viruses are the two most important organisms responsible for almost all the patients' morbidity and mortality. Despite improvements, transmission of HCV remains a substantial problem for dialysis centres throughout the world. HCV seroprevalence among dialysis patients is 2- to 10-fold higher than in the general population and is an important cause of liver disease in this population both during dialysis and after renal transplantation.
HCV infection is a major health problem among haemodialysis patients in developing countries. The nosocomial transmission of HCV within haemodialysis units is a particular concern related to contamination of surfaces and failure to adhere to hand hygiene and glove use in dialysis units.,, HCV prevalence was found to differ among haemodialysis units according to geographical location, health-care procedure and socio-economic factors. It depends on sterilisation of equipment, hygiene of the hospital and the patient, rotation of dialysis machine and the undertaking of rigorous universal precaution rules in the dialysis unit.
Various studies have shown that longer duration of dialysis, mode of dialysis, dialysis from multiple centres and those receiving multiple transfusion products are at increased risk.
Patient-to-patient transmission of HCV occurs in haemodialysis units by:
- Needle stick injury
- Breakdown in standard infection control practices
- Physical proximity to an infected patient
- From the dialysis machines
- The dialysis membrane
- The haemodialysis ultra-filtrate
- Re-processing of the dialyser.
Even with increase in safety of blood products and decrease in the need for transfusion in the population, HCV was proved to still circulate among patients. Although the dialyser is separate; machine and tubings are same, and hence some virus may be retained in the machine after cleaning. A potential risk despite isolation policies is that some HCV seronegative patients happen to be active carriers of the virus.
The morbidity and mortality of patients on haemodialysis by viral hepatitis is further promoted by the characteristic immunological dysfunction that develops in renal failure and interferes with the patient's ability to eliminate the virus. In addition, these patients are often anaemic and require multiple blood transfusions.
There is abundant information on prevalence and incidence rates of HCV infection among patients on long-term dialysis in developed countries. However, the data of prevalence of anti HCV in India in haemodialysis cases is scanty and mostly based on single-centre studies and hence, this study becomes significant.
| Materials and Methods|| |
This hospital-based cross-sectional study was conducted among 250 patients undergoing haemodialysis in the dialysis unit of a Government Medical College in Kerala, India for a period of 1 year. Those who were diagnosed to have chronic hepatitis due to other causes and patients with hepatocellular carcinoma were excluded from the study.
All applicable institutional guidelines for the participants were followed; confidentiality of the patients was ensured and maintained. The study was approved by the institutional ethical committee.
Subjects were informed about the study and a written consent was obtained for collection of their blood samples and participation in the study. Relevant history and other data were collected with the help of a data collection form. Intravenous blood sample (2–4 mL) was collected by direct venepuncture under aseptic precautions. Serum was separated and stored at-20°C until the test was performed.
Antibody to HCV in the sera was detected using an in vitro third generation enzyme linked immunosorbent assay (ELISA) kit– 'Erba LISA HCV Gen3(v2)'. This kit is designed for use in blood banks to screen infected units as well as for clinical diagnostic laboratories. In the biochemistry section, liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase and alkaline phosphatase levels were evaluated by standard procedures.
The data were analysed using Epi Info is statistical software for epidemiology developed by Centers for Disease Control and Prevention in Atlanta, Georgia. and Chi square test applied to find out the association between variables. P ≤ 0.05 was taken as significant.
| Results and Analysis|| |
A total of 250 patients undergoing haemodialysis were included in the study.
Of the 250 patients tested for anti-HCV antibody by ELISA, 238 (95.2%) were negative for the antibody while 12 (4.8%) tested positive [Figure 1].
|Figure 1: Total anti-hepatitis C virus enzyme linked immunosorbent assay positivity|
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Two-hundred and ten (84%) out of the 250 were male and they showed an increase in anti-HCV antibody positivity. [Figure 2]
|Figure 2: Gender and anti-hepatitis C virus enzyme linked immunosorbent assay result|
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Most of the patients (136, 54%) had been undergoing dialysis for a period ranging from 1 to 3 years.
Two-hundred and seventeen (86.8%) patients gave a positive history of transfusion of blood or blood products in the past. Among them, eight tested positive for anti-HCV antibody. The P value was calculated by Fischer's exact test and was 0.058, making it statistically almost significant. [Figure 3]
Out of the 250 patients studied, 48 (9.2%) gave a history of undergoing dialysis from outside at some point in the past while 202 (80.8%) gave no such history.
We observed that 212 (84.8%) of the 250 patients had serum ALT levels within the normal range, contrary to expectations. [Figure 4]
A comparison of the study population's HCV antibody status before the study and after completion of the study is given in [Figure 5]. Three patients who were previously anti-HCV antibody negative were tested and found to be newly positive.
| Discussion|| |
Chronic haemodialysis is a well-known risk factor for HCV transmission. Renal failure patients on haemodialysis are at high risk for blood borne infections because of prolonged vascular access and the potential for exposure to infected patients and contaminated equipment. HCV infection has a negative impact on the survival of haemodialysis patients, attributed mostly to HCV-related liver disease and its sequelae including hepatocellular carcinoma as well as complications in renal transplantation.
Out of the 250 patients, 84% were male and only 16% were female. This may be due to the fact that in our society, males seek health-care services earlier than females. In a study by Surendra et al., the preponderance of HCV infection was observed in males on hemodialysis. A study by Chen et al. also showed male gender as a risk factor for developing chronic HCV infection. Niu et al., on the other hand, found that the overall percentage was not significantly different between men and women over the past 5 years.
Among the 250 patients, 78 were in the 51–60 years age category [Table 1]. In a study to assess the demographic aspects of Hepatitis C in Northern Pakistan by Tariq et al., the majority of cases were males and in the age group of 30–60 years. These results were similar to a study conducted at Lahore by Khan.
Out of the 250 patients, 13% had been on dialysis for >3 years. The longer duration of dialysis was identified as a risk factor in many studies around the world. One such study was by Ozer et al., in which they mentioned long dialysis duration as one of the determinants of increased risk of HCV infection in the haemodialysis patient group. In a study, Fabrizio et al. stated that one of the most important risk factors for acquisition of HCV in dialysis patients include blood transfusions and total time spent on dialysis.
In the present study, 86.8% of the patients gave a history of blood or other blood products being transfused at least once at some point in the past. Haemodialysis patients are often anemic and require multiple blood transfusions. Eight out of them were found to be positive for anti-HCV antibody (3.7%). This association was found to be almost statistically significant (0.058). According to many studies, post-transfusion hepatitis (PTH) has been a major issue. Jasuja et al. observed that along with a longer duration of dialysis, mode of dialysis and dialysis from multiple centres, those receiving multiple transfusion products are at increased risk. Studies show that 80%–90% of all PTH cases are attributed to non-A, non-B hepatitis.
The patients were also screened for HIV or HBV infection by testing for anti-HIV antibody and HBsAg respectively, by ELISA. Three tested positive for HIV infection and 3 for HBV infection. Out of them, only 1 person who was a case of PLWHA was also anti-HCV antibody positive. He showed no clinical or serological evidence of chronic liver disease (CLD). In a study by Graham et al., it was shown that HCV replication is enhanced in the presence of HIV coinfection, resulting in higher serum and liver HCV RNA levels. The rate of progression of fibrosis in HIV/HCV coinfected patients was estimated to be three times higher than that in HCV-monoinfected patients.
Acute hepatitis C is followed by chronic HCV infection in at least 85% of cases. Bellentani et al., in a study conducted in Northern Italy, made a conclusion that only <50% of the anti-HCV-positive patients, particularly those infected with genotype 1b, are associated with more severe liver disease. In the present study, 215 out of 250 patients had no symptoms or signs of CLD. Thirty-five had features suggestive of CLD (14%). Four persons (11.4%) tested positive for the anti-HCV antibody. This association was statistically significant. Only 6 out of the 35 patients who had CLD were females, while the rest, i. e, 29 were male. They also gave a history of excessive alcohol consumption. Among HCV positive individuals, more advanced liver disease was found to be associated with male gender, advanced age at the time of infection, excessive alcohol use, co-infection with HBV or HIV, and concomitant other liver disease as elaborate by Thomas et al. in their study.
In our study, 212 (84.8%) out of 250 patients had serum ALT within normal range with 5 anti-HCV antibody-positive cases. 38 (15.2%) had ALT level elevated and out of this, 7 were tested and found to be positive. According to Santana et al., the most common laboratory abnormality seen in chronic hepatitis C infection is an isolated, elevated ALT, although as many as 60% of HCV-infected patients will have a normal ALT level. The level of serum ALT elevation does not correlate with histological disease and may be normal in any stage of chronic hepatitis C. On the other hand, a newly elevated serum ALT level corresponds more with acute HCV infection. A significant correlation was found between serum HCV RNA and ALT levels in the patients who received IFN therapy by Ghany et al. but no correlation was observed in untreated patients.
Only 9.1% of patients in the study group were unaware of their anti-HCV status, reiterating the fact that the majority of the patients were well informed of their disease. Out of the 229 cases which were previously negative, 3 were found to be newly positive. This underlines the significance of seroconversion phase and its potential role in the transmission of HCV infection in the haemodialysis unit. Another important point noted was that, out of the 10 known positive cases, 2 had reverted back to a negative antibody status.
The 'serologic window' between HCV infection and the detection of specific antibodies varies from patient to patient. With current assays, seroconversion occurs on an average at 6–8 weeks after the onset of infection. In patients with spontaneously resolving infection, anti-HCV may persist throughout life, or decrease slightly while remaining detectable, or gradually disappear after several years. In patients who develop chronic infection, anti-HCV persists indefinitely, although antibodies may become undetectable in haemodialysis patients or in cases of profound immunosuppression.
The seroprevalence of HCV infection among the 250 patients included in this study was found to be 4.8%. This was much less than the prevalence observed in studies elsewhere in India. Jasuja et al. in their study in Delhi obtained a seroprevalence of 27.7%. In a study among 102 chronic renal patients (CRF) on haemodialysis conducted in Andhra Pradesh, the overall prevalence of HCV infection was 23.5%. In one study in AIIMS Delhi by Agarwal et al., it was much less– 4.3%. In a multi-speciality hospital in Calicut, Kerala, 102 CRF patients who were on haemodialysis were screened for HCV infection and 8.3% were positive for anti-HCV.
Among all the other risk factors for HCV infection discussed here, the chances for procuring HCV from the dialysis unit needed to be carefully evaluated. Lateral spread of HCV can occur when some viral particles are retained even after cleaning and disinfection via contaminated machines, tubes or the dialysis membrane. Low prevalence of HCV infection in a haemodialysis unit (HD) in Istanbul (4.7%) showed that patient isolation and the use of dedicated dialysis machines for seropositive patients decreased the transmission of HCV infection in HD centres. Saxena et al. in their study, also arrived at a similar conclusion. Data from another study in Turkey demonstrated that nosocomial spread of HCV in HD units, in which both seropositive and seronegative patients were treated together were higher than that of units with dedicated machines. Another study from Portugal also demonstrated that the incidence of HCV infection was lowest in units that used dedicated machines or dedicated rooms for anti-HCV-positive patients. This study also re-emphasised that cross-infection through dialysis machines, rather than transfusion of blood products, was the primary mode of transmission of HCV among HD patients. The opinion regarding this is conflicting. Some authors recommended that it is sufficient to treat every dialysis patient as potentially infectious, strictly adhering to the universal precautions to prevent the spread of HCV in dialysis units.
Limitations of the study
- Nucleic acid amplification tests (NAATs) for detecting HCV RNA remain the mainstay for diagnosing HCV infection. However due to financial constraints, we could not do NAAT in these samples
- Detection of HCV infection during the seroconversion period remains a challenge
- Viral genotyping assays also were not feasible in the current set up.
| Conclusions|| |
The seroprevalence of HCV infection among the patients undergoing haemodialysis in our hospital as per this study was 4.8%. Maximum patients were in the 51–60 age group. History of multiple blood transfusions and years on dialysis were potential risk factors. One significant observation was the possibility of lateral spread of HCV infection within the HD unit. Using dedicated HD machines had an important role in reducing HCV transmission in our dialysis unit. However, risk prevails if any seronegative patient acts as HCV carrier.
Departments of Microbiology and Nephrology, Government Medical College, Thrissur, Kerala, India.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]