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Population Based Hospitalization Burden of Laboratory-Confirmed bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 1 Population based hospitalization burden of laboratory-confirmed 2 hand, foot and mouth disease caused by multiple enterovirus serotypes 3 in southern China 4 5 Shuanbao Yu1¶, Qiaohong Liao2,1¶, Yonghong Zhou2¶, Shixiong Hu3¶, Qi Chen4, Kaiwei 6 Luo3, Zhenhua Chen5, Li Luo1, Wei Huang3, Bingbing Dai6, Min He6, Fengfeng Liu1, 7 Qi Qiu2, Lingshuang Ren2, H. Rogier van Doorn7,8, Hongjie Yu1,2* 8 9 1 Division of Infectious Disease, Key Laboratory of Surveillance and Early-warning on 10 Infectious Disease, Chinese Center for Disease Control and Prevention, Beijing, China 11 2 School of Public Health, Fudan University, Key Laboratory of Public Health Safety, 12 Ministry of Education, Shanghai, China 13 3 Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan 14 Province, China. 15 4 Hubei Provincial Center for Disease Control and Prevention, Wuhan, Hubei Province, 16 China. 17 5 Chengdu Center for Disease Control and Prevention, Chengdu, Sichuan Province, 18 China. 19 6 Anhua County Center for Disease Control and Prevention, Anhua, Hunan Province, 20 China. 21 7 Nuffield Department of Medicine, University of Oxford, Oxford OX1 3SY, UK 22 8 Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi 1 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 23 Minh City, Vietnam. 24 25 * Corresponding author 26 E-mail: [email protected] (HY) 27 ¶ These authors contributed equally to this work. 28 29 Short title: Hospitalization rates of HFMD in Southern China 30 2 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 31 Abstract 32 Background. Hand, foot and mouth disease (HFMD) is spread widely across Asia, and 33 the hospitalization burden is as yet not well understood. Here, we estimated serotype- 34 specific and age-specific hospitalization rates of HFMD in Southern China. 35 Methods. We enrolled pediatric patients admitted to 3/3 county-level hospitals and 36 3/23 township level hospitals in Anhua county, Hunan (CN) with HFMD, and collected 37 samples to identify enterovirus serotypes by RT-PCRs between October 2013 and 38 September 2016. The information of other eligible but un-enrolled patients were 39 retrospectively collected from the same six hospitals. Monthly number of 40 hospitalizations for all causes was collected from each of 23 township level hospitals 41 to extrapolate hospitalizations associated with HFMD among these. 42 Results. During the three years, an estimated 3,236 pediatric patients were hospitalized 43 with lab-confirmed HFMD, and among these only one patient was severe. The mean 44 hospitalization rates were 660 (95% CI: 638-684) per 100,000 person-years for lab- 45 confirmed HFMD, with higher rates among CV-A16 and CV-A6 associated HFMD 46 (213 vs 209 per 100,000 person-years), and lower among EV-A71, CV-A10 and other 47 enteroviruses associated HFMD (134, 39 and 66 per 100,000 person-years, p<0.001). 48 Children aged 12-23 months had the highest hospitalization rates (3,594/100,000 49 person-years), followed by those aged 24-35 months (1,828/100,000 person-years) and 50 6-11 months (1,572/100,000 person-years). Compared with other serotypes, CV-A6- 51 associated hospitalizations were evident at younger ages. 52 Conclusions. Our study indicates a substantial hospitalization burden associated with 3 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 53 non-severe HFMD in a rural county in southern China. Future mitigation policies 54 should take into account the disease burden identified, and optimize interventions for 55 HFMD. 56 57 Key words: Hand, foot and mouth disease; enterovirus; hospitalization burden; 58 hospitalization rates. 59 4 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 60 Introduction 61 Hand, foot and mouth disease (HFMD) is a common infectious disease that mainly 62 affects children below 5 years of age [1]. HFMD is caused by multiple serotypes of 63 Enterovirus species A, among which enterovirus 71 (EV-A71) and coxsackievirus A16 64 (CV-A16) are the most frequently detected [2]. EV-A71 is of particular concern as it 65 can cause neurological and systematic complications, and even fatal outcomes [2-4]. 66 Coxsackie virus A6 (CV-A6) and Coxsackie virus A10 (CV-A10) have become more 67 prevalent among HFMD outbreaks. Their re-emergence was first identified in HFMD 68 cases in Europe and Singapore between 2008 and 2011 [5-8]. They are also responsible 69 for considerable cases of HFMD in China since 2013 [9, 10]. Severe complications 70 associated with CV-A6 and CV-A10 have also been reported [11, 12]. Currently, no 71 specific antiviral treatments are available for HFMD. Three inactivated monovalent 72 EV-A71 vaccines have been licensed in mainland China, with high efficacy (90.0%- 73 97.4%) against EV-A71-HFMD, but no cross-protection against other enterovirus 74 serotype-associated HFMD [13, 14]. Bivalent and multivalent enterovirus vaccines are 75 under development [15, 16]. 76 Since 1997, HFMD has widely spread across Asia, including Malaysia, Japan, 77 Singapore, Vietnam, Cambodia, and China [1]. Understanding the age and serotype- 78 specific burden of HFMD, including the hospitalization burden, is valuable in 79 informing healthcare systems, vaccine strategies and other intervention policies. 80 However, the hospitalization burden of HFMD has not been thoroughly studied in a 81 well-defined catchment population. Indirect estimates of hospitalization rates of HFMD 5 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 82 are hampered by limited availability of population level incidence and unknown 83 hospitalization rates among HFMD cases. Population level incidence of HFMD has 84 been estimated in Japan [17], Singapore [18], Malaysia [19], and China [2, 20]. These 85 estimates were based on notifiable surveillance data which may underestimate the true 86 prevalence. The risk of hospitalization for HFMD varied between 1.3% and 24.3% [21- 87 25], possibly due to patients with distinct severity and different causative serotypes of 88 enterovirus in different studies. The number of people that were included in these 89 studies ranged from 6,027 to 1,081,046 [21-25]. Additionally, there is an increasing 90 threat of enterovirus serotypes of non-EV-A71 among both mild and severe HFMD [7, 91 11, 20]. Therefore, the hospitalization burden of HFMD caused by CV-A6, CV-A10, 92 CV-A16 and other enterovirus serotypes requires further assessment. 93 We aim to estimate population level hospitalization rates of HFMD by age and 94 enterovirus serotype in a well-defined catchment population in China between October 95 2013 and September 2016. 96 97 Methods 98 Study setting 99 This study was conducted in Anhua County, Yiyang Prefecture, Hunan Province, China 100 [26]. The total population residing in Anhua County was 1,017,463 according to the 101 2015 census [27]. A total of 165,050 (16%) of the population were children aged <15 102 years, and of these 61,123 (6%) were aged <5 years [27]. There were three county-level 103 hospitals and 23 township level hospitals in Anhua County where HFMD patients were 6 bioRxiv preprint doi: https://doi.org/10.1101/403659; this version posted August 29, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. 104 admitted. According to vaccination records, the EV-A71 vaccine was initiated in Anhua 105 County on July 10, 2016. 106 Case definitions 107 A probable case of HFMD was defined as a patient with a rash on their hands, feet, 108 limbs or buttocks, ulcers or vesicles in the mouth, with or without fever. A lab- 109 confirmed case was defined as a probable case with laboratory evidence of enterovirus 110 infection detected by real-time RT-PCR (reverse transcription-polymerase chain 111 reaction) or nested RT-PCR. Hospitalized patients were defined as patients hospitalized 112 during at least 24 hours of admission.
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