Factors associated with HBV Virological Breakthrough

Abstract

BREAKTHROUGHBackground: Little is known about non-adherence to Hepatitis B virus (HBV) therapy.This study aimed to investigate the relationship between self-reported missed days of anti-viral therapy and HBV virological breakthrough and factors associated with virological breakthrough.Methods: A cross-sectional survey of 211 HBV patients receiving oral anti-viral therapies was undertaken at three tertiary hospitals in Sydney, Australia. Associations between 0 to > 6 missed days in the last 30 days and virological breakthrough (defined as > 10-fold rise in serum HBV DNA above nadir or after achieving virological response in the last 12 months) were examined. Logistic regression analyses determined the number of missed days most strongly associated with virological breakthrough and the associated factors. We report odds ratios and relative risks.Results: Of the 204, 32 participants (15.6%) had quantifiable HBV DNA levels (> 20 IU/mL); 15 (46.8%) of them experienced virological breakthrough. Participants reported never missing medication (n=130, 63.7%) or missing one day (n=23, 11.3%), >one day (n=23, 11.3%), 2-6 days (n=15, 7.3%) and >6 days (n=13, 6.4%). The most discriminating definition of non-adherence was missing > one day of medication

Adherence to Nucleos(t)ide Analogue Therapies for Chronic Hepatitis B Infection: A Systematic Review and Meta‐Analysis

“…From an initial screen of 878 titles, 30 studies providing data for 23,823 patients met our eligibility criteria and were taken through for review (Fig. ) . The majority (23 studies, 17,057 patients) were from high‐income settings, mainly the United States (seven studies), Australia (four studies), and France (three studies).…”

Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance

“…(17,18,220,221) Virological breakthroughs, defined as a >1 log 10 (10-fold) increase in serum HBV DNA from nadir after initial virological response, may be related to medication nonadherence, so adherence should be ascertained before testing for genotypic resistance. (222) Virological breakthrough is usually followed by biochemical breakthrough, defined as ALT elevation during treatment in a patient who had achieved an initial biochemical response. Emergence of antiviral resistance mutations can lead to negation of the initial response and, in some cases, hepatitis flares and hepatic decompensation.…”

Factors Associated with Non-Adherence to HBV Antiviral Therapy

“…To the best of our knowledge, this is the first study to comprehensively assess the associations between risk factors and non-adherence to HBV anti-viral therapy using an evidence based definition [18]. Previous studies have investigated limited demographic, treatment and diseaserelated factors.…”

“…Using an established evidence base definition for non-adherence [18] this study aimed to 1) measure the frequency of self-reported non-adherence to HBV anti-viral medications in the last 30 days and 2) identify predictors of self-reported non-adherence.…”