RENAL DATA FROM THE ARAB WORLD
|Year : 2017 | Volume
| Issue : 1 | Page : 107-114
|Incidence of hepatitis c virus seroconversion among hemodialysis patients in the Nile Delta of Egypt: A single-center study
Amany Talaat Kamal1, Mohamed Nazmy Farres1, Abeer Mohamed Eissa1, Naglaa Ahmed Arafa2, Raafat Saad Abdel-Reheem3
1 Department of Internal Medicine, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt
2 Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt
3 Damanhour Medical National Institute, Damanhour, Beheira Governorate, Egypt
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|Date of Web Publication||12-Jan-2017|
| Abstract|| |
Egypt has the highest worldwide prevalence of hepatitis C virus (HCV) infection, caused in part by nosocomial transmission. Patients on hemodialysis (HD) are at especially high risk of infection. We aimed to estimate the incidence of seroconversion among HCV-negative patients undergoing regular HD at a unit in a large public hospital in the Nile Delta of Egypt, which implements the Egyptian Ministry of Health guidelines for infection control, and an isolation policy for hepatitis-positive patients. We also assessed the adherence to infection control practices and evaluated nurses and physicians' knowledge and attitude toward infection control procedures. Records of HCV-negative patients undergoing regular HD at the unit from August 2008 to August 2010 were reviewed retrospectively for data on HCV status. Patients were then followed up until September 2011, when polymerase chain reaction was performed for all patients. Infection control practices were evaluated by four checklists applied monthly and analyzed by control charts. Nurses and physicians' knowledge and attitudes toward infection control were assessed by interview questionnaires. Of 60 patients followed up, there was one case of HCV seroconversion giving an incidence rate of 0.676/100 person-years of follow-up (95% confidence interval: 0.017-3.76). There were no cases of hepatitis B virus seroconversion. The mean scores of all the infection control practices' checklists were very high and generally remained above the lower control limit over the 12-month period. Physicians and nurses achieved very high scores on knowledge and attitude on infection control (mean score >95%). This public facility had a low seroconversion rate and high adherence to infection control guidelines.
|How to cite this article:|
Kamal AT, Farres MN, Eissa AM, Arafa NA, Abdel-Reheem RS. Incidence of hepatitis c virus seroconversion among hemodialysis patients in the Nile Delta of Egypt: A single-center study. Saudi J Kidney Dis Transpl 2017;28:107-14
|How to cite this URL:|
Kamal AT, Farres MN, Eissa AM, Arafa NA, Abdel-Reheem RS. Incidence of hepatitis c virus seroconversion among hemodialysis patients in the Nile Delta of Egypt: A single-center study. Saudi J Kidney Dis Transpl [serial online] 2017 [cited 2018 Jan 23];28:107-14. Available from: http://www.sjkdt.org/text.asp?2017/28/1/107/198162
| Introduction|| |
It is estimated that 2.8% of the world's population or about 185 million individuals are infected with hepatitis C virus (HCV). The prevalence of anti-HCV antibodies in serum among hemodialysis (HD) patients is consistently higher than in the general population, indicating an increased risk of acquiring HCV infection among HD patients.
Various observations support the theory of transmission of HCV among HD patients including increasing duration of HD, the higher incidence of HCV in units with a high prevalence of infection, and the relative homogeneity of HCV isolates in patients receiving treatment in the same HD unit. The prevalence of HCV among HD patients varies greatly by geographic area (between 4% and 59% in different countries), and in Egypt, may lie between 50% and 90%. HCV infection has been found to be associated with increased mortality in maintenance HD patients. , In the absence of a vaccine, routine screening for infection and strict adherence to standard infection control practices are vital for preventing HCV transmission in HD units. In response to the large proportion of HCV infections attributed to health-care interventions, the Egyptian Ministry of Health and Population (MoHP) developed national infection control guidelines in 2003, and infection control programs were established in MoHP facilities.
The present study aimed to estimate the incidence of seroconversion among HCV negative patients undergoing regular hemodialysis at a HD unit in a large MoHP hospital in the Nile Delta of Egypt. We further aimed to assess the adherence to infection control practices (as recommended by the Egyptian MoHP, 2005), and to evaluate nurses and physicians' knowledge and attitude toward infection control procedures.
| Subjects and Method|| |
The present study was conducted at a HD unit in a large MoHP hospital in the Nile Delta of Egypt. We used both retrospective data extracted from medical records (August 2008- August 2010) and prospective data collected from September 2010-August 2011. In this HD unit, all patients are routinely screened for anti-HCV antibodies and hepatitis B surface antigen (HBsAg) by enzyme-linked immunoassay (ELISA) every three months, according to the guidelines of the Egyptian MoHP, 2005. The unit has dedicated machines for the dialysis of hepatitis B virus (HBV) or HCV positive patients and HBV/HCV-negative patients. Each group of patients is separated in different rooms, with separate health-care workers assigned to them, as per the MoHP guidelines.
Inclusion criteria consisted of patients with chronic renal failure undergoing regular HD at the center, negative for HCV antibodies at the time of starting dialysis at the center. Twentyfour patients were already undergoing HD in August 2008, and the rest of the patients (36) began HD at varying times onward until August 2010. All patients were then followed up for a one-year period up to August 2011. The unit routinely investigates patients for anti-HCV antibodies and HBsAg by thirdgeneration ELISA every three months, to detect seroconversion. Real-time polymerase chain reaction (RT-PCR) to detect HCV-RNA is performed for patients with HCV antibody seroconversion. RT-PCR was also performed for all the remaining HCV-seronegative patients at the end of the one-year follow-up period to confirm the absence of HCV infection. A written informed consent was obtained from all patients, and the study was approved by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University.
Four checklists evaluating the adherence to infection control guidelines are implemented monthly at this HD unit. The first checklist assesses the general infection control activities including the presence of written infection control policies, layout of the HD unit, hand washing, use of personal protective devices, prevention of contamination, re-use of instruments, handling of laundry, waste disposal, and environmental sanitation, as recommended by the Egyptian MoHP. The other three checklists evaluate the safety of blood withdrawal procedures, deep invasive procedures (attachment of the HD machine to the patient), and changing of dressings.
Interview questionnaires were used to assess the knowledge of and attitude toward infection control guidelines of the staff members of the HD unit (physicians and nurses). The knowledge questionnaires consisted of closed-ended questions (17 for physicians and 18 for nurses). For both physicians and nurses, the knowledge questions included knowledge about hand hygiene, and questions specific to HCV and HBV transmission in a HD setting. The physicians' knowledge questionnaire also included knowledge about HBV vaccination procedures and regular screening tests for HD patients. Nurses' knowledge questions included classification of waste and correct nursing practices specific to a HD unit.
The attitude questions assessed attitudes toward routine infection control procedures, and the importance of infection control in preventing infection of patients and staff using a 5-point Likert scale. Scores for both knowledge and practice were converted to percentages. Vaccination status to HBV and previous attendance of infection control training were inquired about.
HCV surveillance activities were evaluated from the patients' records by checking on the timeliness and appropriateness of HCV screening at this unit.
| Statistical Analysis|| |
Data were analyzed using the Statistical Program for Social Sciences (SPSS) software version 11 for Windows (SPSS Inc., Chicago IL, USA) Quantitative data were summarized using mean ± standard deviation (SD), whereas qualitative data were summarized with percentages. To monitor the infection control processes at the HD unit over the period from September 2010 to August 2011, control charts for individual variable data were created for each of the four checklists. The upper control limit (UCL) and lower control limit (LCL) were set at the mean ± SD. The incidence rate of HCV infection was estimated by dividing the number of seroconverters by the total person-years of follow-up.
| Results|| |
This study was performed on all HCVnegative patients (n = 60) undergoing regular HD at a government hospital in the Nile Delta, using available retrospective data from August 2008 to August 2010, as well as prospective data collected over a one-year period from September 2010 to August 2011. Fifteen patients (25%) were HBV positive at the start of the study, whereas 45 patients (75%) were HBV negative. All HD patients in this unit are isolated according to hepatitis status by room, machine, medical and disposable equipment, and nursing and medical staff. Gender and age distribution of the study participants are shown in [Table 1].
The total period of follow-up among all study participants was 1773 months (147.7 person years). During this period, one case of HCV seroconversion was detected by ELISA and confirmed by RT-PCR. RT-PCR showed that there were no other cases of HCV positivity among this group. The incidence rate of HCV seroconversion was 0.676/100 person-years of follow-up (95% confidence interval: 0.017- 3.76/100 person-years follow-up). The incident case was a 45-year-old male who had been on regular HD since February 2007 and seroconverted in August 2011. He had no previous history of surgery. He had received blood transfusion for severe anemia on May 2010, November 2010, and April 2010. Among the 45 HBV-negative patients followed up, no incident case of HBV was recorded.
Evaluation of infection control measures Surveillance activities for viral hepatitis infection, in the form of regular three-monthly testing of all negative HD patients with ELISA, were correctly performed at the unit. The mean score for checklist 1 (evaluation of infection control measures) over the 12-month period was 91.75 ± 4.64, of a maximum score of 96 ([Figure 1]). The mean subscores of the various components of the checklist are shown in [Table 2]. The subscores of checklist 1 were very high for all its components. The lowest score, and the highest variation, was seen for hand washing and was mainly due to a lack of soap and disinfectant materials for hand washing over some months, and suboptimal compliance to hand washing by the staff.
|Figure 1. Checklist 1, control chart of evaluation of infection control measures, September 2010–August 2011.|
UCL: Upper control limit; LCL: Lower control limit.
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The mean score for checklist 2 (evaluation of blood withdrawal procedures) was 10.67 ± 0.49, of a maximum score of 12 ([Figure 2]), whereas the mean score for checklist 3 (evaluation of dialysis process) was 12.42 ± 0.96, of a maximum score of 13 ([Figure 3]). During the 12-month period, the maximum score of 4 was obtained each month for checklist 4 (evaluation of changing of ordinary dressing).
|Figure 2. Checklist 2, control chart of evaluation of blood withdrawal procedures, September 2010– August 2011.|
UCL: Upper control limit; LCL: Lower control limit.
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|Figure 3. Checklist 3, control chart of evaluation of dialysis process, September 2010–August 2011.|
UCL: Upper control limit; LCL: Lower control limit.
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Over the 12-month period, only once did the monthly score drop below the LCL of its control chart (of checklist 4) indicating good quality control during that period.
Nineteen nurses were included in the study. Their mean age was 31.89 ± 4.95 years, the mean duration since their graduation was 12.16 ± 6.40 years, and the mean duration spent working in the HD unit was 10.37 ± 6.60 years. Nine physicians were also included in the study. Their mean age was 40.0 ± 8.57 years, the mean duration since graduation was 15.89 ± 8.27 years, and the mean duration spent working in the HD unit was 7.89 ± 6.71 years. All nurses and physicians had received three doses of HBV vaccine, and all had received training on infection control.
All the nurses and physicians achieved very high knowledge scores for infection control in the HD unit. Among nurses, knowledge scores ranged from 92.59% to 100% with a mean of 98.44% ± 2.56%, whereas among physicians, knowledge scores ranged from 95.46% to 100% with a mean score of 99.49 ± 1.52.
The mean scores for attitude were similarly high but showed a wider range of results. The mean score for nurses was 95.49 ± 4.89 and ranged from 88.57-100. The mean score for physicians was 98.10 ± 4.04 and ranged from 88.57-100.
| Discussion|| |
Numerous studies were performed to estimate HCV prevalence and seroconversion rates in HD units. HD centers are high-risk facilities for hepatitis virus transmission because of the high prevalence of HCV in these facilities, the relatively large volume of patients sharing a small area, undergoing procedures that require frequent vascular access and repeated opportunities for blood contamination of the environment and equipment.
This study was performed in a HD unit which implements the Egyptian MoHP guidelines for infection control, which includes isolation of HCV and HBV-positive patients. The incidence rate of HCV seroconversion was 0.676/100 person-years of follow-up (95% confidence interval: 0.017-3.76/100 person-years follow-up). The incident case was a 45-yearold male who had received several blood transfusions over the study period. He had no other risk for HCV infection, and it is likely that this was the cause of infection. Among the 45 HBV-negative patients followed up, no incident cases of HBV were recorded.
The present study detected a low incidence rate of HCV seroconversion and is similar to rates reported in 308 representative HD units in developed countries such as France, Germany, Italy, Spain, Japan, the UK, and the US (1.2-3.9/100 patient-years). It was also similar to that recorded in Zhejiang province in China which decreased from 0.66 per 100 patients in 2007 to 0.26 per 100 patients in 2010, with the implementation of HD quality control measures. A large-scale study performed in 13 governmental HD centers in Khartoum, Sudan, revealed an incidence rate of 2.5 seroconversions per 100 patient-years, dropping to a rate of 0.6 per 100 patient-years in centers that catered only for HCV-negative patients, highlighting the importance of segregation of HCV-positive patients as an infection control measure.
The results of the present study highlight the importance of strict isolation of HCV-positive patients in HD units in Egypt, the country with the highest prevalence of HCV in the world.
While the Centers for Disease Control and Prevention (CDC) does not, at present, recommend isolation of patients with viral hepatitis, several studies performed in Egypt, reported reduced seroconversion rates among patients attending at HD units practicing strict isolation of hepatitis-positive patients, compared to those practicing infection control only. Yassin et al reported a seroconversion rate of 13% among patients attending at HD units applying isolation policies after one year of follow-up, compared to 23% among patients attending at units practicing infection control measures only, whereas other investigators reported that 42.9% of patients attending at HD units which followed standard infection control procedures only seroconverted to positive after three years, compared to 14.8% of patients attending in HD units also practicing isolation policies. A further study reported a seroconversion rate of 16% among patients attending at a HD unit implementing infection control procedures only, and no seroconversions among patients attending at a unit also implementing strict isolation procedures, after oneyear follow-up. These studies also highlight the imperfect adherence to infection control guidelines in Egyptian HD units since they record considerable HCV seroconversion even in units which implement infection control procedures, further emphasizing the importance of isolation of hepatitis-positive patients to reduce infection.
Routine serological testing for HCV infection among HD patients is recommended by the CDC (15), and the Egyptian MoHP guidelines for infection control advice serological testing for HCV and HBV every three months. However, one should bear in mind that the window period for HCV seroconversion may last up to six to 12 months among immunodeficient participants.
A study performed on 78 patients undergoing regular HD in three centers in Cairo compared the results obtained by serology using thirdgeneration ELISA with RT-PCR and found a false-negative rate of 17.9% among the ELISA tested patients. On repeating serology testing four months after PCR was performed, the authors found that anti-HCV seroconversion was detected in only 3 (21.4%) out of 14 false negative anti-HCV patients. Nasser et al reported a very similar false-negative rate (16%) among their studied patients, all of whom were among the units not practicing strict isolation of viral hepatitis patients. In the current study, PCR was performed only at the end of the study period and coincided with the time of appearance of antibodies in the seroconverted patient. It is possible that the patient was infected earlier but was not detected earlier by ELISA technique if he was still in the window period. However, the study confirmed the lack of infection among the other studied participants. The issue of false negativity by ELISA is of concern, especially in HD units which do not practice strict isolation of patients infected with viral hepatitis; further large-scale studies are required to investigate the sensitivity of the ELISA technique as compared to PCR in the HD setting, especially in HCV high-prevalence countries. We also investigated the adherence to infection control guidelines of the Egyptian MoHP in our HD unit prospectively over the course of 12 months, by implementing checklists provided by the MoHP. The performance of the different aspects of infection control measured by these checklists was assessed using control charts for individual variable data. Control charts are a graphical tool used to assess the variation in a routine procedure carried out over time. These charts have the ability to assess the presence of "special cause variation" which is an unnatural variation due to events, changes, or circumstances that have not previously been inherent or typical in the regular process. These variations can be detected when a data point lies above the UCL or below the LCL. The control chart is also able to detect trends of improvements or deterioration in the process, even when the data points do not cross the control limits. The results of the study show a very high level of infection control in this period. The control charts used in this study show that the infection control procedures were in "statistical control," i.e., that the procedures were stable and predictable during this period of time, and that there were no unexpected variations due to lack of quality control of the infection control procedures. Observation of the infection control measures over a 12-month period provided a better assessment of infection control procedures overall than simply taking a "snapshot" of the procedures at a single point in time. Several Egyptian studies performed in Cairo and Alexandria had assessed nurses' adherence to infection control guidelines and found suboptimal perfor-mance. , , , Hand hygiene, in particular appeared to be deficient in these studies. Ahmed and others had documented that only 13% of patients and 63.7% of health personnel in the units had been vaccinated against HBV. This is in contrast to the results of the present study, where all physicians and nurses, and HBV- negative patients were vaccinated. Previous studies had also recorded deficient knowledge of proper infection control procedures. Yassin et al had recorded improved infection control practices among nurses who had undergone training. The nurses and physicians in the present study had all undergone training in infection control, which may explain the good performance of this unit, and the subsequent low seroconversion rate, which is much lower than those recorded in the above studies.
In conclusion, this study demonstrated a low incidence rate of HCV seroconversion among HD patients at this public center in the Nile Delta of Egypt, where the Egyptian infection control guidelines are strictly enforced and monitored, and where patients are isolated according to their viral hepatitis status. The MoHP should enforce these guidelines in all HD units in Egypt, including the private sector.
Conflict of interest: None declared.
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Naglaa Ahmed Arafa
Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Cairo
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]
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