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Hepatitis C virus (HCV) infection remains a significant global health issue. WHO has set targets of diagnosing 90% of HCV patients and treating 80% of eligible patients to globally eliminate hepatitis C by 2030. However, China currently carries the highest burden of HCV infection worldwide. Alarmingly, estimates indicate that only 18% of the HCV-infected population in China had been diagnosed, and less than 1.3% received treatment in 2016 (1-2).
To investigate HCV-RNA testing, antiviral treatment (ART) uptake, and risk factors among HCV-infected individuals, a retrospective survey was conducted in Jiangsu Province from 2004 to 2020. Our findings revealed that the rates of HCV-RNA testing and ART were only 51.3% and 38.7%, respectively, falling short of the WHO's elimination targets. Several factors were associated with HCV-RNA testing and treatment uptake, including education level, awareness of HCV-related knowledge, exposure history, and residential location. Age, gender, presence of clinical symptoms, and previous HCV-RNA testing also impacted treatment uptake. These results highlight the need for improving HCV-related advocacy, innovating diagnostic strategies, and increasing access to ART.
A stratified and multi-stage cluster survey was performed among individuals with HCV infection aged 18 and above in four cities, including Xuzhou, Wuxi, Yancheng, and Zhenjiang. The semi-structured questionnaire covered the following areas: 1) Demographic characteristics, including gender, age, education level, marital status, occupation, monthly income, health insurance, and HCV-related knowledge; 2) HCV infection risk factors, such as blood transfusion, tattooing, drug abuse, needle sharing, dialysis, unprotected commercial sex, and living with hepatitis-infected individuals; and 3) HCV-RNA testing and ART regimens. All participants underwent HCV serological screening to confirm positive anti-HCV antibody status for eligibility. Demographic characteristics and HCV risk factors were sourced from the China Information System for Disease Prevention and Control (CISFDPC), while data on HCV-RNA testing and ART were obtained from medical records or participant recall. Participants provided written, fully informed consent. The study was approved by the institutional review boards at the National Center for AIDS/STD Control and Prevention, China CDC (Approval No. 210827664, 08/27/2021).
Statistical analysis was conducted using IBM SPSS Statistics software (version 26.0; IBM Corporation, Armonk, NY, USA). Statistical significance was defined as P<0.05. The univariable and multivariable logistic analyses were performed to examine factors associated with HCV-RNA testing and ART uptake.
Out of the total of 3,786 participants, 741 were excluded from the study, including inaccessibility due to Corona Virus Disease 2019 pandemic restrictions (n=32), death (n=164), refusal to participate (n=36), and negative serological antibody screening results (n=509). The baseline characteristics of remaining 3,045 participants are presented in
Supplementary Table S1 .Out of the total 3,045 participants, 1,908 participants (62.7%) were passively screened for HCV by targeting high-risk populations, while only 1,137 (37.3%) actively underwent anti-HCV testing when they exhibited clinical symptoms. A total of 2,417 (79.4%) participants reported engaging in HCV risk behaviors, including unsafe treatment or tattoo(s) (43.5%), blood transfusion or renal cell transplant (22.7%), commercial blood donation (6.8%), intravenous drug abuse or commercial sexual behavior or living with HCV infected person(s) (5.8%), and mother-to-child transmission (0.5%). About half of the participants (59.9%) participants demonstrated awareness of HCV-related knowledge, defined as correctly answering 6 out of 8 HCV-related knowledge questions. HCV-RNA testing was conducted on 1,563 (51.3%) participants, and 1,179 (38.7%) received ART. Factors contributing to not receiving ART included being asymptomatic (26.1%), unaffordable treatment costs (22.1%), failure to deliver ART (4.3%), and unknowing HCV infection status (6.6%).
Table 1 shows the multivariable analysis results of HCV-RNA testing. High school graduate or above [odds ratio (OR)=1.33, 95% confidence interval (CI): 1.10–1.61], better awareness of HCV-related knowledge (OR=1.41, 95% CI: 1.21–1.64), the history of blood transfusion or cell transplant (OR=1.21, 95% CI: 1.01–1.44), and the history of mother-to-child transmission (OR=4.34, 95% CI: 1.21–15.57) were associated with increased odds of undergoing HCV RNA testing. Additionally, residing in Yancheng (OR=1.24, 95% CI: 1.03–1.50) was significantly associated with receiving HCV-RNA testing, while residing in Zhenjiang (OR=0.76, 95% CI: 0.57–0.99) was significantly associated with not taking HCV-RNA testing.
Factor Univariable analysis Multivariable analysis OR 95% CI P value OR 95% CI P value Age group (years) 18–45 1.00 (Ref) 46–55 0.9 (0.72, 1.14) 0.381 56–65 0.95 (0.76, 1.18) 0.619 66–75 0.81 (0.65, 1.01) 0.065 ≥75 0.75 (0.55, 1.02) 0.070 Gender Male 1.00 (Ref) Female 0.87 (0.76, 1.01) 0.062 Employment Unemployed 1.00 (Ref) Employed 1.22 (0.99, 1.50) 0.064 Students and others 1.19 (0.86, 1.65) 0.287 Education level Under elementary graduate 1.00 (Ref) 1.00 (Ref) Secondary graduate 1.02 (0.86, 1.20) 0.860 1.04 (0.88, 1.23) 0.648 Above high school graduate 1.33 (1.11, 1.60) 0.002 1.33 (1.10, 1.61) 0.004 Marital status Single/separated/divorced/widowed 1.00 (Ref) Living together/married 0.95 (0.76, 1.18) 0.616 Residence Xuzhou City 1.00 (Ref) 1.00 (Ref) Wuxi City 0.79 (0.66, 0.94) 0.007 0.72 (0.60, 0.87) <0.001 Yancheng City 1.19 (0.99, 1.44) 0.067 1.24 (1.03, 1.50) 0.026 Zhenjiang City 0.76 (0.58, 0.99) 0.043 0.76 (0.57, 0.99) 0.046 Income level ≤3,000 CNY/month 1.00 (Ref) >3,000 CNY/month 1.17 (1.00, 1.36) 0.049 Health insurance No 1.00 (Ref) Yes 0.98 (0.64, 1.51) 0.935 Reasons for HCV antibody testing High-risk population passive screening & others 1.00 (Ref) Showed clinical symptoms of hepatitis C 1.03 (0.89, 1.19) 0.743 Awareness of HCV related knowledge No 1.00 (Ref) 1.00 (Ref) Yes 1.41 (1.22, 1.64) <0.001 1.41 (1.21, 1.64) <0.001 Having history of unsafe treatment (sharing needles, experience of dental clinic, endoscope examination) or tattoo (s) No 1.00 (Ref) Yes 1.08 (0.94, 1.25) 0.293 Having history of blood transfusion (organ, tissue) or cell transplant (renal) dialysis No 1.00 (Ref) 1.00 (Ref) Yes 1.196 (1.01, 1.42) 0.04 1.21 (1.01, 1.44) 0.035 Having history of commercial blood donation No 1.00 (Ref) Yes 0.906 (0.68, 1.20) 0.493 Having history of intravenous drug abuse, sexual intercourse with sex workers or living with person (s) infected with HBV/HCV No 1.00 (Ref) Yes 1.040 (0.77, 1.41) 0.801 Mother to child transmission No 1.00 (Ref) 1.00 (Ref) Yes 3.814 (1.07,13.54) 0.038 4.34 (1.21, 15.57) 0.024 Abbreviation: Ref=reference; OR=odds ratio; CI=confidence interval; CNY=Chinese Yuan; HCV=hepatitis C virus; HBV=hepatitis B virus; RNA=ribonucleic acid. Table 1. Univariable and multivariable analysis assessing characteristics associated with having conducted testing for HCV RNA.
Supplementary Table S2 . presents the results of the analysis result about factors related to receiving ART, which include having high school degree or above (OR=1.49, 95% CI: 1.17–1.89), experiencing clinical symptoms of hepatitis C (OR=1.50, 95% CI: 1.27–1.77), having better awareness of HCV-related knowledge (OR=1.64, 95% CI: 1.39–1.94), undergoing HCV RNA testing (OR=3.48, 95% CI: 2.96–4.10), having history of blood transfusion, cell transplant (renal), or dialysis (OR=1.52, 95% CI: 1.26–1.84), and having history of commercial blood donation (OR=1.51, 95% CI: 1.10–2.27). However, being 75 years or older (OR=0.60, 95% CI: 0.41–0.90) and being female (OR=0.79, 95% CI: 0.67–0.93) were factors that hindered HCV ART. -
China initiated the National Work Plan for Elimination of Hepatitis C as a Public Health Threat (2021–2030) in 2021 (3), which emphasizes the significance of HCV diagnosis and treatment.
In this study, we found that only 51.3% of participants with HCV antibody-positive underwent HCV-RNA testing. This rate was higher than the national average level (18%) (2) , similar to studies conducted in the USA (50%) (4), but lower than rates in Brazil (67.7%) (5), the Republic of Korea (70%) (6), and the global goal (90%). Participants with low educational levels and poor awareness of HCV-related knowledge had a lower testing rate. Previous studies have shown that some patients only seek testing when they experience clinical symptoms and seek medical advice (7). This pattern was also evident in this study, as the majority of participants with HCV antibody positive (62.7%) were screened through high-risk populations, while only 37.3% were tested due to clinical symptoms of HCV. The low awareness of HCV, combined with its asymptomatic nature, contributes to a reduced focus on the hidden hazards of HCV. Furthermore, our study revealed that individuals with a history of clinical blood transfusion, organ transplantation, or mother-to-child transmission were more likely to have detectable HCV-RNA. This could be attributed to the increased awareness of HCV among healthcare providers in China. Previous research has demonstrated that interventions aimed at healthcare practitioners are effective in increasing screening rates and identifying HCV-infected patients (7). Thus, enhanced public awareness and education, particularly among high-risk populations and general practitioners, should be focused.
Our study discovered that only 1,179 (38.7%) individuals had received ART prior to entering the study, which falls well below the global elimination target of 80% for eligible individuals with positive HCV RNA. Previous evidence has also indicated low rates of HCV treatment uptake worldwide, with average rates of 1.3% in China (2), 34.1% in Brazil (5), and 28% in the U.S. (8). This study indicates that a higher level of education and greater awareness of HCV-related knowledge can enhance the ART uptake among individuals with HCV infection. Furthermore, 26.1% of participants who did not undergo ART were asymptomatic and failed to undergo further HCV RNA testing. This finding is consistent with a prior study suggesting that asymptomatic HCV patients typically undergo anti-HCV testing and treatment only when they exhibit clinical symptoms (7).
In China, HCV-RNA testing is not widely available in primary healthcare institutions. The current two-step HCV diagnosis process in China is time-consuming and can result in patients being lost to follow-up after positive antibody testing. Moreover, the high cost of HCV-RNA detection makes it unaffordable for low-income patients. These factors hinder timely HCV diagnosis and delay early treatment. Recently, the WHO recommended performing HCV-RNA testing immediately after a positive HCV antibody test through a reflex test. This approach allows for a convenient and efficient single-visit HCV diagnosis. Therefore, it is crucial to develop innovative diagnostic strategies that ensure universal access and affordability of HCV-related testing.
Additionally, the study revealed a low prevalence of ART for hepatitis C among patients aged 75 years and older. Advanced age is a significant risk factor for liver fibrosis (9), and HCV-infected patients who are aged 50 years or older may develop cirrhosis within an average of 12 years if treatment is not initiated promptly (10). This finding highlights the need to enhance ART among the elderly population.
There are several limitations in this study. First, the retrospective design and use of a questionnaire survey may introduce information recall bias. Second, this study exclusively focused on the impact of individual patients on HCV RNA testing and ART uptake without considering the influence of healthcare providers or medical institutions.
In summary, there are significant deficiencies in the diagnosis and treatment of HCV compared to global targets. This entails increased advocacy and education to enhance public awareness of HCV for early antibody screening, diagnosis, and uptake of ART. Additionally, innovative diagnostic strategies are needed to identify more confirmed patients. Furthermore, we should enhance the coverage of ART for HCV-RNA-positive patients.
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No conflicts of interest.
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All the participants for their support and contributions to this study.
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