Abstract #38 Eligibility for and initiation of antiviral therapy in chronic hepatitis B virus infection in Zambia: a prospective cohort study Michael J. Vinikoor, Edford Sinkala, Bright Nsokolo, Annie Kanunga, Mutinta Muchimba, and Paul Kelly Tropical Gastroenterology and Nutrition Group, University of Zambia, Lusaka, Zambia; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, USA; University Teaching Hospital, Lusaka, Zambia; Levy Mwanawasa Medical University, Lusaka, Zambia; Queen Mary University of London, London, UK; *Presenting author: [email protected], +260974662483 Background Results: Baseline characteristics • After diagnosis, hepatitis B surface antigen (HBsAg)- Factor Median (IQR) or n (%) positive individuals must enroll in appropriate Median age (IQR) 33 (26-40) clinical care, be assessed for the need of antiviral Female sex 36 (27.7) therapy (AVT), and possible be re-assessed during longitudinal follow-up in order to access AVT Median ALT (IQR) 24 (17-35) • We characterized AVT eligibility at enrollment and ALT elevation 53 (41.7) during follow-up in a prospective cohort based at a APRI >2.0 6 (6.7) hospital in Zambia. Decompensated cirrhosis 9 (6.8) • We also described the percentage of those eligible HBV DNA >2,000 IU/ml 35 (31.8) who initiated AVT and some of the reasons for delays in initiation. Antiviral therapy criteria BL FU EASL Cirrhosis and detectable 15 4 Materials & Methods 2017 HBV DNA • At University Teaching Hospital in Lusaka, a cohort ALT elevation and HBV 3 8 was established for adults (18+ years) who were DNA >2,000 HBsAg-positive and HIV-negative. HBV DNA <2,000 and 11 8 • At baseline, 3, 6, 12, 18, and 24 months, we assessed normal ALT and age >30 ALT and AST. At baseline, 1, and 2 years we Subtotal (% of assessed) 29 (21.8) 20 (19.2) measured platelet count, HBV DNA and liver stiffness (LSM; Fibroscan 402, Echosens, France). HIV WHO Cirrhosis 18 6 testing was repeated yearly. Bus fare was provided. 2015 Persistently elevated ALT 0 25 • Acute HBV infection was suspected on the basis of Subtotal (% of assessed) 18 (13.5) 31 (31.3) symptoms and/or ALT >10 times the ULN. BL = at baseline, defined as enrollment in cohort • Normal ALT was <30 U/L for men <20 for women. FU = at follow-up among patients not eligible at baseline • Cirrhosis was defined as: decompensated cirrhosis, Note: we excluded from analysis patients with suspected acute AST-to-platelet ratio index >2.0, or LSM ³9.5 kPa. HBV and those who were AVT-experienced at enrollment. At baseline, 133 were assessed; Of these 104 EASL-ineligible and • AVT eligibility was assessed in AVT naïve patients 99 WHO-ineligible patients were re-assessed during follow-up. using EASL 2017 and WHO 2015 (see below) Results: Main reasons for delayed AVT Results Uncertainty or challenges in applying 9 • We enrolled 174 HBV patients. Of them, we criteria to start therapy excluded from further analysis 37 who were already Lost to follow-up 6 taking AVT and 4 with acute infection. Schistosomiasis coinfection with high 3 • We described baseline characteristics of the elastography remaining 133 (see adjacent table). • During 185.3 person-years of follow-up, we retained Patient declined AVT 1 104 patients (1.78 years per person on average). • The adjacent table shows the # and % who met EASL and WHO criteria at baseline and follow-up. Conclusions • So far, among the 32 who met baseline criteria • Longitudinal follow-up will be essential as HBV (either EASL or WHO), only 13 started AVT (40.6%). patients who are ineligible at diagnosis may later Delays in starting therapy are reported to the right. need therapy • Significant training and capacity building will be needed to correctly apply treatment criteria 2nd Conference on Liver Disease in Africa; September 6-8, 2019; Cairo, Egypt.