Rotavirus is a major cause of severe diarrhea and hospitalization among children aged < 5 years worldwide. In 2008, globally rotavirus caused an estimated 453,000 deaths among children in this age group [1]; more than half of these deaths occurred in sub-Saharan Africa. In Libya, health service facilities in Libya are publicly owned and managed by the Ministry of Health. Public hospitals provide preventive and curative treatment to all citizens free of charge. While the Libyan government encourages the expansion of private health, private facilities have insufficient infrastructure to provide a full treatment service to severe diarrhea patients such as admission for intravenous fluid (IVF). Rotavirus disease accounted for 24 – 45% of diarrheal hospitalizations among children <5 during the period 1980-2009 [2,3]. The economic burden of rotavirus infections includes hospital costs, as well as indirect costs incurred by the society [4,5].

The World Health Organization (WHO) Strategic Advisory Committee on Immunization (SAGE) recommended adding rotavirus vaccine to all national immunization programmes, especially where the mortality rate of diarrhea affected up approximately 10% among children aged below 5 years [6-9]. Two live attenuated vaccines have been approved for global use: RotaTeq (RV5, Merck, Whitehouse Station, NJ, USA) is a pentavalent (G1, G2, G3, G4, P[8]) human-bovine reassortant vaccine and Rotarix (RV1, GlaxoSmithKline Biologicals, Rixensart, Belgium) is a monovalent (G1P[8]) vaccine derived from an attenuated human strain [10,11]. RotaTeq is administered at 2nd, 4th and 6th months of age, while Rotarix is administered at 2nd and 4th months of age. In 2009, the World Health Organization recommended the inclusion of rotavirus vaccine in the national immunization programs of all countries globally and particularly in those countries with high child mortality due to diarrhea [12]. In Libya, a live attenuated pentavalent vaccine based on a human rotavirus strain (RV5; RotaTeq™, Merck & Co. Inc., West Point, PA, USA) was introduced during October 1, 2013.

In February 2011, ongoing rotavirus surveillance activities in Libya were interrupted due to civil unrest. Our objective was to re-establish rotavirus surveillance to provide up-to-date estimates of the baseline pre-vaccine incidence of rotavirus hospitalizations among children aged < 5 years, and economic burden, in order to allow vaccine impact evaluations in the future.

A total of 410 children hospitalized due to diarrhea were enrolled, of whom 239 (58%) tested positive for rotavirus. Based on the catchment population in the studied hospitals (57,180 children aged < 5 years) in 2012, the unadjusted (conservative) incidence rate of rotavirus associated with hospitalization in the studied hospitals during the study period (9 months) was 418 per 100,000 (95% confidence interval, 405-431 per 100,000, Table 1). Applying the conservative estimate for incidence rate to whole population of Libya (705,190 children aged <5 years) was yielded an estimate of 2,948 (95% confidence interval, 2,845-3,048) national hospitalized rotavirus patients associated with hospitalization in 2012. Most (86%) patients with rotavirus diarrhea patients were under two years of age (Figure 1) and the disease showed a distinct winter seasonal peak during the months from December to March (Figure 2). Compared with rotavirus-negative patients, those who were rotavirus-positive were significantly more likely to suffer severe dehydration and vomiting (Table 2). Median duration of hospitalization of rotavirus patients was 3 days (range 1-15) as compared with 2 days (range 1-13) among rotavirus negative patients (p = 0.05), and nearly all patients receive intravenous fluids. No deaths were reported.Table 1

Conservative estimated number of rotavirus hospitalizations

Our prospective, active, hospital-based surveillance for rotavirus shows that, prior to rotavirus vaccine introduction, 58% of diarrheal hospitalizations among children < 5 years of age in Northwest Libya were caused by rotavirus. Each rotavirus hospitalization incurred a total cost of US$ 679, of which 72% were costs of hospital expenditures. By extrapolation, we estimated that nearly 3000 hospitalizations for rotavirus diarrhea occur each year in Libyan children 5 years of age or 1 in 50 children born each year is hospitalized for rotavirus by age 5, incurring total costs of US$ 2,001,662. This tremendous morbidity and economic burden highlights the potential value of vaccination of Libyan children against rotavirus.

Reports from Libya during the period 1980-2009 showed a rotavirus detection rate of 24% to 45% among children <5 years of age hospitalized with diarrhea [2,3,14-19], which were slightly lower compared with our data. This difference may have resulted from not including 3 months in our study during which rotavirus rates are usually lower, thereby increasing the proportion of rotavirus cases among the studied population; however, the detection rate of rotavirus in our study is also similar to other regional countries such as Oman (70%) and Iran (58%) [2]. Characteristics of rotavirus infection such as vulnerable ages to the disease, season of increased infection, difference in gender (male and female) and places of residence (urban and rural areas) were also comparable to previous reports of rotavirus disease in Libya [3,14,17-19].

Previous studies have not assessed the economic burden of rotavirus hospitalizations in Libya. Hospital costs in this study represented 72% of total costs of disease, which was higher than that reported in the U.S (66%) [20], but lower than in Brazil (86%) [21]. Lost income of caretaker in Hong Kong represented 10% of monthly income [22], while it was about 7% in Libya. These data illustrate the substantial economic burden of rotavirus on both the health care system and families.

Our study has some limitations. Notably, we had planned to continue surveillance for collection of data for at least one full calendar year; however, due to the political and security situation after the Libyan revolution, the study was interrupted in April 2013. Since the 3 months of data that we were not able to capture were late spring/summer months with lower rotavirus prevalence in previous years [23]. Also, since we conducted surveillance in only 2 cities in Libya, our findings may not be representative of the entire population. Nevertheless, these are among two of the large cities in Libya and their population structure and composition is similar to the rest of the country.

We documented pre-vaccine incidence of rotavirus hospitalization in Libyan children and their associated costs to provide baseline data for future vaccine impact evaluations. Further studies of rotavirus disease burden among hospitalized children, in the form of active hospital based surveillance in Libya, will be crucial to understand the effect of introducing the vaccine into national childhood immunization, to provide scientific evidence for continued immunization efforts and identification of barriers for vaccine impact and effectiveness [24,25].