Hepatitis prevention, control, and elimination program in Mongolia: national hepatitis elimination program in a country with the highest burden of viral hepatitis in the world

POSTER PRESENTATIONS FRI-472 Identification of the healthy ranges for enhanced liver fibrosis score M. Spreafico1, F.F. Maldini1, A. Berzuini1, L. Raffaele1, A. Colli2, D. Prati1. 1 Transfusion Medicine and Hematology; 2Internal Medicine, ASSTLECCO, Ospedale A. Manzoni, Lecco, Italy E-mail: [email protected] Background and Aims: Recent guidelines (NICE, BMJ 2016 and EASLEASD-EASO, J Hep 2016), recommended the use enhanced liver fibrosis (ELF) score, a non-invasive serum marker of liver fibrosis, in persons diagnosed with nonalcoholic fatty liver disease (NAFLD), to identify those at risk for progression. However, there is considerable debate on the optimal cutoff values. The manufacturer recommends different cutoffs according to clinical needs, i.e. 7.7. for moderate fibrosis, 9.8 for significant fibrosis, and 11.3 for cirrhosis; more recently, the NICE guidelines recommend a cutoff of 10.51 in subjects with NAFLD, to select individuals needing further clinical assessment, but doubts have been raised about its sensitivity. We aimed to define the healthy ranges of ELF score values in individuals at very low risk for liver disease. Methods: The ELF score was measured in apparently healthy blood donors attending our center using the ADVIA Centaur system (Siemens). Data about gender, age, blood pressure, serum biochemistries (including metabolic panel, liver enzymes, HOMA index), body fat indicators, Fatty Liver Index (FLI, according to Bedogni et al.), alcohol intake, and US abdominal scan, were collected. Statistical analysis were performed by the SPSS 19.0 software. Results: ELF scores were determined in 200 donors (120 males, 80 females), equally distributed into four age groups (years 18–30, 31– 40, 41–50, 51–60). The mean ELF score was 8.18 (range 6.78–9.81). Next, we calculated the healthy values in the subgroup of individuals (n = 95) without evidence and risk factors for conditions influencing liver fibrosis (FLI <30; absence of liver steatosis, metabolic syndrome, and insulin resistance). The mean ELF score was 8.05 (5th percentile: 7.06; 95th percentile: 9.10). No significant differences was observed between males and females, while a positive correlation with age ( p < 0.05) was found. Conclusions: A healthy cutoff for ELF score can be safely set at 9.1, indicating that lowering the NICE cutoff (10.51) would improve diagnostic yield, without impairing specificity. In addition, our data challenge the validity of the cutoff proposed by the manufacturer for the identification moderate fibrosis, as approximately 75% of healthy individuals without any evidence or risk factors for liver disease have ELF scores higher than 7.7. FRI-473 Non-steroid anti-inflammatory drugs for biliary colic M. Fraquelli1, G. Casazza2, D. Conte3, A. Colli4. 1UO Gastroenterology and Endoscopy, IRCCS Fondazione Ca Granda Ospedale Maggiore Policlinico Milano, Milan; 2Department of Biomedical and Clinical Sciences, University of Milan, Milano; 3UO Gastroenterology and Endoscopy, Fondazione IRCCS CÀ granda ospedale maggiore policlinico, Milan; 4Internal Medicine, Ospedale A Manzoni Lecco, Lecco, Italy E-mail: [email protected] Background and Aims: Biliary colic is the most common manifestation of cholelithiasis. Non-steroid anti-inflammatory drugs (NSAIDs) have been widely used to relieve biliary colic pain, but their role needs further elucidation. Methods: We searched for Randomised clinical trials (RCT) recruiting participants with biliary colic and comparing NSAIDs versus no intervention, placebo, or other drugs. Data were analyzed as fixedeffect and random-effects model meta-analyses, depending on the amount of heterogeneity. We controlled random errors with Trial Sequential Analysis (TSA). GRADE criteria were used to assess evidence. Results: Twelve RCTs (828 r participants: 416 received NSAIDs and 412 received placebo, spasmolytic drugs, or opioids) were included. S412

All participants were admitted to emergency departments for acute biliary pain. Only one trial was considered at low risk of bias. None study reported mortality and quality of life. For pain control the comparison NSAID s vs. placebo showed a significant lower proportion of participants without complete pain relief (RR 0.27, 95% CI 0.19–0.40; I2 = 0%; 5 trials; moderate-quality evidence confirmed by TSA), but for complications no difference was found (RR 0.66, 95% CI 0.38–1.15; I2 = 26%). NSAIDs showed more pain control than spasmolytic drugs (RR 0.51, 95% CI 0.37–0.71; 4 trials; low-quality evidence), not confirmed by TSA and a significantly lower proportion of participants with complications (RR 0.27, 95% CI 0.12– 0.57; 2 trials; low-quality evidence), not confirmed by TSA. We found no difference for complete pain relief comparing NSAIDs versus opioids (RR 0.98, 95% CI 0.47–2.07; I2 = 52%; 4 trials) (very low-quality evidence). Conclusions: NSAIDs have been assessed in few trials with few participants considering the common occurrence of biliary colic. There was no mortality and none RCT reported on the quality of life. The only strong conclusion is that NSAIDs are more effective than placebo on pain relief; the evidence of superiority respect to spasmolytic drugs such for the prevention of complications is poor. The comparison with opioid is not adequately assessed. FRI-474 Hepatitis prevention, control, and elimination program in Mongolia: national hepatitis elimination program in a country with the highest burden of viral hepatitis in the world N. Dashdorj1,2, N. Dashdorj1,2,3, A.S. Bungert1,2, Z. Genden1,2,3, B. Dendev1,2,3,4, D. Duger5,6, A. Dagvadorj1,2, D. Yagaanbuyant2,3,4,5. 1 ONOM Foundation; 2Mongolian Society of Hepatology; 3Liver Center; 4 National Center for Communicable Diseases; 5Mongolian National University of Medical Sciences; 6Mongolian Gastroenterology Association, Ulaanbaatar, Mongolia E-mail: [email protected] Background and Aims: Mongolia has the world’s highest rate of liver cancer mortality—nearly eight times the global average. Prevalences of chronic viral hepatitis B, C, and D in Mongolia are at an endemic level and constitute the main cause for Mongolia’s world-leading liver cancer mortality rate, which has been steadily increasing over the last decade. At the moment, liver cirrhosis and hepatocellular carcinoma (HCC) mortalities account for 15% of total annual mortalities in Mongolia. In short, the viral hepatitis endemic is wreaking a havoc in Mongolian society. Methods: To tackle this overwhelming burden of viral hepatitis, Onom Foundation, Mongolian Gastroenterology Association, and Mongolian Society of Hepatology initiated the Hepatitis Prevention, Control, and Elimination (HPCE) Program on September 8, 2014. Thanks to the persistent and unwavering effort of these organizations, the Government of Mongolia officially adopted the HPCE Program into the 2016–2020 Action Plan on September 9, 2016. The MISSION 2020 of the HPCE Program to eliminate HCV in Mongolia by 2020 and to significantly reduce viral hepatitis induced liver cirrhosis and HCC was explicitly stated in the 2016–2020 Action Plan of the Government of Mongolia. As of November 22, 2016, branded Sofosbuvir/Ledipasvir (Harvoni) and 4 kinds of generic Sofosbuvir/ Ledipasvir are available in Mongolia at prices of US$300 and US$150 respectively. In addition, both branded and generic Tenofovir and 2 kinds of generic Entecavir are available in Mongolia. Both branded and generic Tenofovir are subsidized by the Health Insurance Fund, resulting in costs of approximately US$15 (Viread) and US$3 (generic Tenofovir) per month. Both branded and generic Sofosbuvir/ Ledipasvir will be subsidized by the Health Insurance Fund in the near future. Results: Within the Screening Campaign, 72,000 Mongolians were screened for hepatitis B, C infections by Onom Foundation alone as of November 22, 2016. Under the Treatment Campaign, over 7,000 people with chronic HCV are at different stages of treatment.

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POSTER PRESENTATIONS According to analysis of several hundred randomly selected people with chronic HCV infection, SVR is around 98%.

Conclusions: The Government of Mongolia officially adopted the HPCE Program into the 2016–2020 Action Plan with explicit declaration of HCV elimination by 2020 and significant reduction of hepatitis related liver cirrhosis and HCC mortalities. The HPCE Program in Mongolia will serve as a model for other countries in their fight against viral hepatitis. FRI-475 Reaching hepatitis C virus elimination targets in Australia requires use of complementary cost-effective interventions along the care cascade N. Scott1, J. Doyle1, A. Wade1, D.P. Wilson1, J. Howell1, A. Pedrana1, A. Thompson2, M. Hellard1. 1Centre for Population Health, Burnet Institute; 2Department of Gastroenterology, St Vincent’s Hospital Melbourne, Melbourne, Australia E-mail: [email protected] Background and Aims: Modelling suggests that achieving hepatitis C virus (HCV) elimination targets is possible by scaling up use of directacting antiviral (DAA) therapy. However, poor linkage and retention to care and low treatment uptake, in particular among people who inject drugs (PWID), presents a major barrier. We identify, and assess the cost-effectiveness of, further interventions required to achieve HCV elimination targets in Australia, a setting with virtually unlimited and unrestricted access to DAA therapy. Methods: A dynamic HCV transmission and liver-disease progression mathematical model, capturing testing, treatment and other features of the care cascade was used to test scenarios of: scaling up primary care treatment delivery; using APRI scores <1 to bypass hepatic fibrosis assessment; point-of-care RNA testing; and increased testing of PWID. Results: Despite treatment scale-up substantially reducing the number of people with HCV, the model estimated that by 2030 most remaining infections would be undiagnosed and among PWID. Delivering services through primary care settings and using APRI scores to bypass hepatic fibrosis assessment was estimated to produce only modest impacts but could save AU$30 million by 2030, with no decrease in health outcomes. Adding to this pointof-care RNA testing increased the healthcare cost savings to AU$60 million and further reduced the number of HCV infections; however additional testing of PWID, such as annual RNA testing as part of OST, were required to achieve HCV elimination targets. Conclusions: Even with unlimited and unrestricted access to treatments, interventions to improve the HCV cascade of care will be required to achieve global elimination targets.

FRI-476 Eliminating hepatitis C virus from HIV-positive men who have sex with men: a multi-modelling approach to understand differences in sexual risk behaviour N. Scott1, M. Stoove1, D.P. Wilson1, O. Keiser2, C. El-Hayek1, J. Doyle1, M. Hellard1. 1Centre for Population Health, Burnet Institute, Melbourne, Australia; 2Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland E-mail: [email protected] Background and Aims: Outbreaks of hepatitis C virus (HCV) infections among HIV-positive men who have sex with men (MSM) have been observed globally. We use a multi-modelling approach to estimate the time and number of direct-acting antiviral treatment courses required to achieve an 80% reduction in HCV prevalence among HIV-positive MSM in the state of Victoria, Australia. Methods: Three models of HCV transmission, testing and treatment among MSM were compared: a dynamic compartmental model; an agent-based model (ABM) parametrized to local surveillance and behavioural data (“ABM1”); and an ABM with a more heterogeneous population (“ABM2”) to determine the influence of extreme variations in sexual risk behaviour. Results: Among approximately 5,000 diagnosed HIV-positive MSM in Victoria, 10% are co-infected with HCV. ABM1 estimated that an 80% reduction in HCV prevalence could be achieved in 115 (interquartile range (IQR) 108–130) weeks with 515 (IQR 483–565) treatments if the average time from HCV diagnosis to treatment was six months. This could be achieved in only 79 (IQR 74–83) weeks if the average time between HCV diagnosis and treatment commencement was reduced to 16 weeks. Estimates were consistent across modelling approaches; however ABM2 produced fewer incident HCV cases, suggesting that treatment-as-prevention may be more effective in behaviourally heterogeneous MSM populations. Conclusions: Major reductions in HCV prevalence can be achieved among HIV-positive MSM within two years through routine HCV monitoring and prompt treatment as a part of HIV care. Compartmental modelling approaches produce reliable estimates for settings where detailed behavioural data are unavailable. FRI-477 Implementing the WHO Global Health Sector Strategy on Viral Hepatitis in Denmark – modeling the effects of community-based care on the elimination of HCV by 2030 O. Henriksen1, P.B. Christensen2, J.V. Lazarus3, T. Awad4, A.L.H. Øvrehus2. 1Market Access, ABBVIE, Copenhagen; 2Department of infectious diseases, Odense University Hospital, Odense; 3Centre for Health and Infectious Disease Research, Rigshospitalet, University of Copenhagen; 4Medical, Abbvie A/S, Copenhagen, Denmark E-mail: [email protected] Background and Aims: The WHO Global Health Sector Strategy on Viral Hepatitis sets out a central goal to eliminate HCV by 2030, where prevalence should be reduced by 90%. As HCV particularly affects subpopulations, who are difficult to reach through the current healthcare set-up in Denmark, the effects and costs of implementing community-based care facilities in terms of eliminating HCV by 2030 were analyzed. Methods: A population-based model was developed to project HCV prevalence and direct medical costs from 2005 to 2030. The model was divided into three different populations: the general population, a high-risk population of people who inject drugs (PWID) and a population of former PWID. Model inputs relied on published literature and national registries for both epidemiologic and cost inputs. The model examined the effects of providing communitybased diagnostics and care on prevalence and cumulative costs between 2017 and 2030. Results: Continuing the current number of treatments per year (550) led to a 71% decline in prevalence from 2017 to 2030. Implementing community-based care facilities would lead to decreases of 73%, 79%

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