Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Patients Treated for Hepatitis B in the National University Hospital of Cotonou

Abstract

Introduction: Viral hepatitis B (VHB) is a serious a nd global p ublic health issue, particularly in sub-Saharan Africa where it is endemic. The objective of this work w as to evaluate the e ffectiveness and sa fety o f tenofovir d isoproxil fumarate (TDF) in the treatment of chronic VHB in Cotonou. Methods: This was a descriptive cross-sectional study with a retrospective collection of data from January 1st, 2015 to December 31st, 2016 (24 months) and prospective from M ay to August 2 017 ( 4 m onths). C hronic V HB p atients tr eated wi th TDF for at least 6 months were included. The non-detectability of HBV DNA and the normalization of aminotransferases defined the virological and bio- chemical responses, respectively. The evaluation of the treatment response on liver fibrosis w as done by u sing APRI score. Renal impairment was ass essed by a r eduction i n g lomerular filtration r ate according t o MDRD (Modifica- tions of the D iet in Renal D isease) formula b elow 90 mL/min/1.73 m2. Re- sults: In all, 42 patients treated with TDF were included. The average age was 46.7 ± 13.8 y ears. The s tudy population wa s p redominantly m ale wi th a sex ratio o f 2 .5. A mong t he 42 patients t reated w ith TDF f or an ave rage o f 6 0 weeks (24 to 96 weeks), 36 patients (85.7%) had a virological response; 21 pa- tients (50%) had a biochemical response. Virologic response was 70% at week 24 (W24), 92.6% at W48, 87.5% atW72 and 100% atW96 without significant difference between W24 and W48; betweenW48 andW72 then betweenW72 andW 96. There w as a r egression o f fibrosis and c irrhosis b ut not si gnifi- cantly. R enal involvement occurred in 3 out o f 19 c ases (15.8%) including a case o f chronic end stage renal fai lure and 2 cases of mi ld chronic renal failure. Conclusion: The treatment with TDF is effective and globally safe in our patients with chronic viral hepatitis B in Cotonou.