Reply to: "Prior surveillance can bias cross-sectional validation of novel HCC biomarkers: Incumbent test bias".
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Letter↗
Biomedical subjects
Mindie H Nguyen
Publications and source records attributed to Mindie H Nguyen.
A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma.
BACKGROUND & AIMS: Patients at high risk for hepatocellular carcinoma (HCC) are recommended to undergo biannual abdominal ultrasound surveillance; however, ultrasound has low sensitivity for small HCC nodules and is associated with poor adherence. To address these limitations, the multianalyte HelioLiver Dx blood test was developed to aid in the detection of HCC in patients with cirrhosis who are at high risk for HCC. METHODS: The performance of the HelioLiver Dx test and ultrasound for the detection of HCC in adults with cirrhosis was evaluated in a cross-sectional, prospective, blinded, multicenter validation study. All participants provided blood specimens for the HelioLiver Dx test and underwent ultrasound. All participants also underwent multiphasic MRI, which served as the reference standard for determining HCC status. RESULTS: Of 1,268 evaluable participants, 46 (3.6%) were considered to have HCC as determined by MRI, with many (46%) having small HCC lesions ≤2 cm in diameter. The HelioLiver Dx test had a sensitivity of 47.8% (95% CI 32.9-63.1) for all HCC lesions and 28.6% (95% CI 11.3-52.2) for HCC lesions ≤2 cm. In contrast, ultrasound demonstrated a lower sensitivity of 28.3% (95% CI 16.0-43.5) for all HCC lesions and failed to detect any (0%; 95% CI 0.0-16.1) HCC lesions ≤2 cm. The specificity of HelioLiver Dx and ultrasound were 87.6% (95% CI 85.6-89.4) and 93.9% (95% CI 92.5-95.2), respectively. The HelioLiver Dx test met prespecified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound. CONCLUSION: Compared with ultrasound and alpha-fetoprotein, the HelioLiver Dx test identified more HCC lesions overall, including more small lesions. A convenient and accurate blood-based test may improve HCC surveillance by facilitating earlier detection and reducing patient barriers to testing. GOV IDENTIFIER: NCT03694600 IMPACT AND IMPLICATIONS: There is a significant, unmet clinical need for more sensitive and accessible methods for the early detection of hepatocellular carcinoma (HCC) in high-risk patient populations. The current study is the first blinded, multicenter, prospective study to evaluate the performance of a multianalyte blood test compared to abdominal ultrasound for the detection of HCC among patients with cirrhosis. The multianalyte HelioLiver Dx test met prespecified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound for detection of HCC lesions. The availability of a more accessible, convenient and sensitive blood test to aid in the detection of HCC may improve utilization and consequently clinical outcomes for high-risk patients via reduction of care barriers and improved early HCC detection. CLINICALTRIALS: gov identifier: NCT03694600.
Humans↗
Long-Term Effectiveness of Tenofovir Alafenamide Versus Entecavir in Treatment-Naive Chronic Hepatitis B: A Real-World Evidence from the Global Alliance for the Study of Hepatitis B Virus.
INTRODUCTION: Although both tenofovir alafenamide (TAF) and entecavir (ETV) are recommended first-line treatments for chronic hepatitis B, comparative data on their effectiveness remain limited. We aim to compare their virologic (VR), biochemical (BR), and complete (CR) response rates. METHODS: This retrospective study enrolled treatment-naive chronic hepatitis B patients who initiated either TAF or ETV in 2016 or after across 22 international centers and evaluated their treatment response after balancing their characteristics using inverse probability treatment weighting and through Fine-Gray competing-risks analysis of the balanced cohort. RESULTS: The study included 1,605 patients (784 TAF and 821 ETV patients with significant background differences) of whom 1,553 (96.8%) were from Asia. Inverse probability treatment-weighting analysis yielded a total weighted cohort of 1,660 (822 TAF and 838 ETV patients with balanced characteristics). The 5-year cumulative VRs were high in both groups with a slightly higher rate in TAF patients (98.0% vs 93.9%, P < 0.001), and similar findings were found in a subgroup analysis by median hepatitis B virus (HBV) DNA (5.5 log IU/mL). However, there was no significant difference in the 5-year BR rates overall (93.7 vs 92.8%, P = 0.484) or by alanine aminotransferase (ALT) cutoff of 2× upper limit of normal. TAF patients had a slightly higher 5-year cumulative CR overall (94.9% vs 89.4%, P = 0.001) and in high HBV DNA (96.9% vs 87.9%, P < 0.001) or ALT ≥2× upper limit of normal patients (97.3% vs 90.6%, P < 0.001), but not in those with lower HBV DNA or ALT. DISCUSSION: BR rates were similar with ETV and TAF, while VR and CR were higher with TAF, although the difference was modest (<5% overall, 7%-9% in high HBV DNA or ALT groups). Antiviral selection between TAF vs ETV should be based mainly on cost, side effect profile, and patient preference.
Adult↗