Assessment and Simplification of Treatment Eligibility Among Patients With Chronic Hepatitis B Infection in Vietnam

Abstract

Background Treatment eligibility and the accuracy of its simplified criteria have been poorly documented in patients with chronic HBV infection worldwide, especially in low-and-middle-income countries. Methods From a cohort of HBV-infected patients in Vietnam, we assessed the proportion of patients eligible for treatment using the national guidelines based on reference tests (HBV DNA quantification and FibroScan); and the accuracy of simplified treatment criteria free from HBV DNA and FibroScan (TREAT-B score and simplified WHO criteria) to select patients for antiviral therapy using the national guidelines as a reference. Results We analysed 400 consecutive treatment-naïve HBV-monoinfected patients: 49% males, median age 38 years (range: 18-86), 32% HBeAg-positive, median HBV DNA 4.8 log10 IU/ml (undetectable-8.4), median FibroScan 5.3kPa (3.0-67.8), 25% having significant liver fibrosis including 12% with cirrhosis. Of them 167 (42%) fulfilled treatment criteria according to the national guidelines. Using the national criteria as a reference, the performance of TREAT-B to select patients for treatment was high (AUROC: 0.89 (95%CI: 0.87-0.92)) with a sensitivity of 74.3% and a specificity of 88.4%. In a subset of patients with two ALT measurements over a 6-month period (n=89), the AUROC of TREAT-B was significantly higher than that of the simplified WHO criteria (p<0.001). Conclusion Our study suggests that a large proportion of patients with chronic HBV infection require antiviral therapy in Vietnam. Compared to the simplified WHO criteria free from HBV DNA quantification, TREAT-B is a better alternative to easily indicate treatment eligibility and might help scale-up treatment intervention in Vietnam.

Assessment and validation of the TREAT-B score to assess the treatment eligibility of patients with chronic hepatitis B virus infection

“…A multicenter study in Australia revealed that TREAT-B had greater sensitivity (91%) but lesser specificity (63%) in the hospital than in the community cohort (sensitivity, 70%; specificity, 88%) ( 18 ). TREAT-B of ≥2 demonstrated a sensitivity of 94.6% and specificity of 46.7% in a cohort of Vietnamese patients with chronic HBV ( 14 ), a finding consistent with this current study showing that using a cut-off of TREAT-B of ≥2 had excellent sensitivity (96.3%) but low specificity (41.4%) and fair accuracy (AUROC, 0.69; 95% CI, 0.58–0.66). Therefore, using the cut-off of ≥2, 59.6% of patients receiving antiviral would have been unnecessary.…”

“…Previous studies found inconsistent results about the influence of using point-of-care HBeAg testing on the performance of TREAT-B for determining HBV treatment eligibility. A Vietnamese cohort showed that TREAT-B was accurate when a rapid HBeAg test (SD Bioline, South Korea) was used ( 14 ). In contrast, a Malawian cohort found that three commercial HBeAg rapid diagnostic tests, including SD Bioline (Gauteng, South Africa), Creative Diagnostics (Shirley, NY, USA), and Biopanda Reagents (Belfast, UK) had insufficient sensitivity, potentially rejecting patients access to treatment based on TREAT-B score ( 15 ).…”

“…TREAT-B score of ≥2 had an accuracy with an area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of 0.85, 85%, and 77%, respectively, for selecting treatment-eligible patients with chronic HBV in African cohorts (13). The performance of TREAT-B for identification of HBV treatment eligibility has been evaluated in several subsequent studies in East and West Africa, Australia, Europe, and Vietnam (14)(15)(16)(17)(18). Several factors might affect the performance of TREAT-B, such as age (18), type of HBeAg assay (15), and the presence of HBeAg (19).…”

A Novel and Simplified Score for Determining Treatment Eligibility for Patients with Chronic Hepatitis B

“…Racial differences were also apparent in performance studies of the WHO simplified criteria and the TREAT-B scoring system conducted among African, European, Australian, and Vietnamese populations. The sensitivities of the WHO criteria and the TREAT-B scoring system for chronic hepatitis B treatment eligibility ranged between 53.0% and 100.0% and from 73.9% to 98.8% [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ], respectively. Similarly, the specificity ranges of the WHO criteria and TREAT-B system for chronic hepatitis B treatment eligibility were from 40% to 77.4% and 57.5% to 88.0 [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ], respectively.…”

“…The WHO’s simplified criteria and the TREAT-B scoring system were validated in African, European, Australian, and Vietnamese populations. They showed variations in performance across geographic areas [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. The variations were explained by differences in viral genotype, modes of HBV transmission, and rates of spontaneous loss of HBeAg [ 18 , 19 ].…”