HEPATITIS C VIRUS INFECTION RATES AMONG EGYPTIAN BLOOD DONORS AFTER IMPLEMENTATION OF THE NATIONAL TREATMENT PROGRAM

HEPATITIS C VIRUS INFECTION RATES AMONG EGYPTIAN BLOOD DONORS AFTER IMPLEMENTATION OF THE NATIONAL TREATMENT PROGRAM

By

Ahmed Mohamed Abd El-Wahed, Helmy Ahmed Shalaby, Mohamed Saad El-Deen Radwan*, Ashraf Mohamed El-Bahrawy

Department of Internal Medicine and Clinical Pathology*, Faculty of Medicine, Al-Azhar University, Egypt

Corresponding author: Ahmed Mohamed Abd El-Wahed,

E-mail: docahmed907@gmail.com

ABSTRACT

Background: Hepatitis C virus (HCV) infection is a worldwide public health problem where its seroprevalence had an estimated 2.8% increase over the last decade.

Objective: To assess the changes in HCV infection rates among Egyptian blood donors, 12 years after implementation of anti-HCV treatment program.

Patients and methods: This was a prospective cross-sectional study conducted at Al-Azhar University Hospitals, and Mansoura New General Hospital. A total of 2000 consecutive blood donors were tested for anti-HCV antibodies. All donors filled blood donor questionnaire. Anti-hcv positive donors were subjected to hepatitis C ribonucleic acid (HCVRNA) testing by real-time polymerase chain reaction (PCR).

Results: The majority of donors (n=1992; 99.6%) were males. A total of 1515 (75.75%) donors were living in rural areas, while 485 (24.25%) were living in urban areas. In addition, 862 (43.1%), 620 (31%) and 466 (23.3%) graduated from secondary, high and primary schools, respectively. Blood donors whom graduated from higher education were less likely to be anti-HCV-positive (P ≤ 0.05). Among 35 anti-HCV positive blood donors, 6 (17.15%) were HCVRNA positive. Blood donors with positive viremia were older (34.0± 5.29 years) than those with negative (29.66± 6.75 years) viremia. Intravenous drug user, previous needle stick injury, previous surgery, family history of viral hepatitis, previous hospitalization and history of anti-HCV treatment were identified as risk factors for anti-HCV positivity (P < 0.01). Out of the 2000 blood donors, only 5 (0.25 %) males with mean age of 30.6± 3.29 years were positive for HBs Ag. Lower education levels (P ≤0.05), marriage (P ≤0.05) and previous surgery, (P ≤0.01) were identified as risk factors for HBV infection.

Conclusion: A significant reduction of HCV prevalence among Egyptian blood donors was detected in our survey. In addition, a lower rate of HBsAg among blood donors was also detected. Notably, the iatrogenic transmission of HBV and HCV still ongoing in Egypt.

Keywords: Hepatitis C virus, Hepatitis B, virus PCR, Blood donors.

INTRODUCTION

     Hepatitis C virus infection is a worldwide public health issue where its seroprevalence had an estimated 2.8% increases over the past 10 years, corresponding to more than 185 million infections (3% of the world’s population). Nearly 75% of infected persons are living in middle income countries (Mohd Hanafiah et al., 2013 and Petruzziello et al., 2016).

     China, Pakistan, Nigeria, Egypt, India, and Russia together accounted for more than 50% of total infections. A recent estimation demonstrated that 119 million adult individuals worldwide have chronic HCV infection, with 3-4 million new infections and 350000 - 500000 mortalities occurring yearly as a result of HCV-related adverse events (Petruzziello et al., 2016).

     Egypt had the largest iatrogenic transmission of blood-borne pathogens in the general population globally. The use of parenteral anti-schistosomiasis treatment in Egypt, extensively practiced with poor sterile techniques since the 1920s, is considered to be the main etiology of dramatic increase in the human HCV reservoir (Kandeel et al., 2017). In Egypt, HCV antibody (anti-) prevalence was estimated to be 15% in 2008 (El-Zanaty and Way, 2014). The prevalence of anti-HCV in Egyptian blood donors ranged from 1.7%-16.8% on the period between 2006 and 2009 (Kandeel et al., 2017).

     In 2008, the Egyptian national program of anti-HCV treatment was implemented, resulting in treatment of millions of HCV cases. This ongoing program is expected to reduce the burden of HCV infection in different Egyptian population groups (Aboushady et al., 2019). Accordingly, the current work aimed to assess the changes in HCV infection rates in Egyptian blood donors, 12 years after implementation of anti-HCV treatment program.

     The present work aimed to assess the changes in HCV infection rates among Egyptian blood donors, 12 years after implementation of anti-HCV treatment program.

PATIENTS AND METHODS

     This was a prospective cross-sectional study carried out at Al-Azhar University Hospitals and Mansoura New General hospital. A total of 2000 consecutive blood donors were tested for anti-HCV antibodies. All donors filled blood donor questionnaire. Anti-hcv positive donors were subjected to hepatitis C ribonucleic acid (HCVRNA) testing by PCR. This study was conducted after being approved of Al-Azhar University, Faculty of Medicine Research Ethics Committee.

     To be eligible to donate blood, an individual must have been in good health and must have been between 18–60 years of age. Generally, donors must have weighted at least 50 kg. All donors must pass general as well as medical examinations before donation. Exclusion criteria included: younger or older ages, past history of jaundice, HIV, hypotension, anaemia and severe chronic illnesses.

     An informed consent was obtained from every participant.

     All eligible donors fulfilled a blood donor questionnaire including age, sex, socioeconomic and educational standers. In addition, they were asked about jaundice, history of hepatitis, household contact with hepatic patient, previous hospitalization, previous surgery, and parenteral drug administration and previous anti HCV treatment. Moreover, all doners were asked for history for blood donation or blood transfusion. Sexual and occupational hazards of HCV infection, intravenous drug use, tattooing, and acupuncture were also documented.

     An enzyme linked immunoassay (4^th generation ELISA) was used to determine HCV antibodies in serum or plasma. Anti-HCV positive samples were then tested to HCV-RNA by real time PCR (Al-Tahish et al., 2013).

Statistical analysis:

     The data wereanalysed by Statistical Package for the Social Sciences software version 26.0. Descriptive statistics were performed for numerical parametric data as mean±SD, minimum and maximum of the range, while they were done for categorical data as numbers and %.

     Inferential analyses were performed for quantitative variables utilizing independent t-test in cases of two independent groups with parametric data. Inferential analyses were done for qualitative data using Chi square test for independent groups. The level of significance at P value <0.05 was considered significant.

RESULTS

     Among 2000 consecutive blood donors enrolled, the age ranged from 18 to 49 years with a mean age ± SD, 29.67± 6.75 years. The majority of donors (n=1992; 99.6%) were males. A number of 1515 (75.75%) donors were living in rural areas while 485 (24.25%) were living in urban areas.862 (43.1%), 620 (31%) and 466 (23.3%) graduated from secondary, high and primary schools, respectively. Indeed 52 (2.6%) blood donors were illiterate (Table 1).

Table (1):  Demographic characteristics of included blood donors

     Among 2000 blood donors, 12 (0.6%) had a history of curative anti-HCV treatment. Thirty-five (1.75%) donors tested positive for anti-HCV antibodies. In addition, 5 (0.25%), and one (0.05%) donor were positive for HBsAg and HIV antibodies, respectively. Among anti-HCV positive donors (n=35), 6 (17.15%) were positive for HCVRNA by PCR (Table 2).

Table (2):  Viral infection of blood donors

N=number; Anti-HCV= Antibody to hepatitis C virus; HCV=Hepatitis C virus; HCVRNA=Hepatitis C virus ribonucleic acid

     Among 35 blood donors positive for anti-HCV, their mean age was 30.23±6.65 years. All of them were males, and a small proportion of them graduated from higher education. Indeed, blood donors whom graduated from higher education were less likely to be anti-HCV-positive, (P ≤ 0.05) (Table 3).

Table (3):  Demographic characteristics of anti-HCV positive blood donors

     Intravenous drug user (P<0.01), previous needle stick injury (P<0.01), previous surgery (P<0.01), family history of viral hepatitis (P <0.01), previous hospitalization (P<0.01) and history of anti-HCV treatment (P< 0.01), were identified as risk factors for anti-HCV positivity. On the other hand, the history of blood donation, health care work, positive HBsAg and HIV positivity were not recognized as risk factors for anti-HCV positivity (Table 4).

Table (4):  Risk factors of anti-HCV positive serology

Anti-HCV=Antibody to hepatitis C virus, HBsAg=Hepatitis B surface antigen, Anti-HIV=Antibody to human immune deficiency virus

     Among 35 anti-HCV positive blood donors, 6 (17.15%) were HCVRNA positive. Blood donors with positive viremia were older (34.0± 5.29 years) than those with negative (29.66± 6.75 years) viremia, and all of them graduated from primary (n=2) and secondary education (n=4), (P≤0.05), (table 3). Among different risk factors only IV drug use, identified as risk factor for HCV viremia (P ≤ 0.05) (Table 5).

Table (5):  Characteristics of HCV infected blood donors

HCVRNA=Hepatitis C ribonucleic acid, SD=Standard deviation

     Among 2000 blood donors, 5 (0.25 %) were positive for HBsAg. Their mean age was 30.6± 3.29 years, and all were males. Lower education levels (P ≤0.05), marriage (P ≤0.05) and previous surgery, (P ≤0.01), (Table 6), identified as risk factors for HBV infection (Table 7).

Table (6):  Risk factors for HCV infection among blood donors

Anti-HCV=Antibody to hepatitis C virus, HBsAg=Hepatitis B surface antigen, Anti-HIV=Antibody to human immune deficiency virus, HCVRNA=Hepatitis C virus ribonucleic acid

Table (7):  Demographic characteristics hepatitis B infected blood donors

HBsAg=Hepatitis B surface antigen, SD=Standard deviation

DISCUSSION

     In this study, we found that the prevalence of anti-HCV among Egyptian blood donors after direct antiviral agent (DAA) treatment was 1.75 %. The frequency of HCV viremia among anti-HCV positive blood donors was 17.15 %. The prevalence of HBsAg among Egyptian blood donors was 0.25 %. Intravenous drug user, previous needle stick injury, previous surgery, and previous hospitalization, were identified as a significant risk factors for anti-HCV and HBsAg positivity in the current survey.

     HCV prevalence in Egyptian blood donors (1.6%–34%; median = 9.2%) was relatively high when compared with the corresponding global rates (Kouyoumjian et al., 2018). It ranged from 2.7% to 24.8% during 1992–2008 (Axley et al., 2018 and Ebeid et al. 2019). In addition, a rate of 3.18% (El-Adly et al., 2020) was reported by a study conducted during 2013–2014 in the Upper Egypt. 35 (1.75%) donors tested positive for anti-HCV in the current survey. Of them 12 donors received anti-HCV treatment and gained SVR, and only 6 (17.15%) donors had positive viremia. taken together these data infer a significant reduction of HCV prevalence among blood donors after the national intervention programs.

     In Egypt, only little is known regarding the clinical follow-up and outcomes of blood donors diagnosed with HCV-infection. Several studies have implicated that a significant percent of patients with confirmed HCV diagnosis do not receive adequate treatment or follow-up care. In US, the major barrier to care is the fact that majority of persons with HCV ignore the fact that they are infected. Conversely, in Europe, the lack of financial resources, illegal drug use, and alcohol abuse are the major barriers to patient’s self-care attitude. Moreover, the risk group most associated with the lack of loss to follow-up includes individuals who inject illegal drugs (Bruggmann, 2012, Treloar et al., 2013, Linas et al., 2014 and Papatheodoridis et al., 2014). The major reasons for the loss to follow-up among a Brazilian cohort were the lack of understanding of patients about the necessity for clinical care (71%) and healthcare access difficulties (14%) (Machado et al., 2017). These data highlight the necessity for strategies to improve the HCV cascade of care among blood donors diagnosed with HCV infection. Such strategies should include national registration, follow-up examinations, an understanding of the need for clinical care, designing of steps to overcome health-care difficulties, and ensuring steps toward infection eradication.

     The prevention and control of HCV in a community with a high burden of exposure is complex and challenging in terms of describing and detecting the driving factors and risk factors of HCV exposure. Before 2008, a commonly reported risk factor of HCV transmission in Egypt was related to the iatrogenic transmission at health care facilities. Indeed, factors such as old age, rural residence, unsafe injection practices, a history of operations, dental procedures, hospitalization, blood transfusion, and PAT were significantly associated with HCV transmission in several studies conducted since 2008 (Soliman et al., 2019, Elhendawy et al., 2020 and El-Adly et al., 2020). These observations supported the notion that healthcare exposures act as driving factors of HCV transmission in Egypt. Intravenous drug user, previous needle stick injury, previous surgery, and previous hospitalization, were recognized as risk factors for anti-HCV positivity in the current study. These data hints that the iatrogenic transmission of HCV is ongoing in Egypt. Data on continuous iatrogenic HCV exposure are fundamental for rational allocation of resources toward intervention through decrease of the exposure to HCV infection in health care facilities (Miller et al., 2015). Hence, successful intervention is expected to control the HCV exposure to reduce the incidence of infection in the future.

     Based on the last WHO estimates, the rate of incidence of HBV among the blood donors has been recorded as 0.02, 0.64, and 3.59% for high, middle, and low economic countries, respectively (Hennessey et al., 2013). In Egypt, HBsAg sero positivity among blood donors, was recently decreased from 1.1% in 2015 to reach 0.91% in 2018 (Nada and Atwa, 2013). Going with this decreasing trend, a lower HBsAg rate (0.25%) was detected in our study. Indeed, these improvements may be related to the national infantile immunization programs and blood donors screening programs.

HBV screening in most Egyptian blood banks relies only on HBsAg test. Nonetheless, depending on HBsAg as the sole screening test can increase the risk of transfusion -transmitted infection for several reasons: its limited sensitivity (sensitivity <0.1 to 0.62 ng/mL of HBsAg. Therefore, in the presence of extremely low viral load, this test can develop false-negative outcomes). The host serological response involves a phase (the window period) at which the HBsAg cannot be detected despite the presence of HBV infection) HBsAg is not detected in case of infection with a mutant strain. More importantly, this test cannot detect the occult hepatitis B infection (OBI) (Hollinger and Sood, 2010). Anti-HBc screening (Makroo et al., 2012 and Abdou et al., 2020) and nucleic acid test (NAT) are reliable tests to detect OBI in order to ensure safer blood transfusion (Nemr et al., 2018). However, these markers are not included in the Egyptian blood bank screening, which reflects that such screening system in Egypt miss OBI. Recent data collected from the blood bank of the Zagazig University hospital demonstrated that 34,671 blood donors were non-reactive to HBsAg, while 0.04% of the donors were tested positive for HBV DNA by NAT, confirming the presence of OBI among blood donors as well as the importance of using NAT as a screening tool (Ebeid et al., 2019). Recently, some blood centers in Egypt had already started to implement NAT, including the blood banks of National Cancer Institute, Nasser Institute, EL-Shabrwishy Hospital, and the Egyptian organization for biological products and vaccines (Madihi et al., 2020). However, the high cost of NAT limits its implementation in all blood banks (Ebeid et al., 2019).

CONCLUSION

     A significant reduction of HCV prevalence among Egyptian blood donors was detected in addition to a lower rated of HBsAg among blood donors. The iatrogenic transmission of HBV and HCV still ongoing in Egypt.

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