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Patients with ‘double negative’ HBV at treatment end less likely to relapse

Results from two independent cohorts revealed that patients who had negative test results for both hepatitis B DNA and hepatitis B RNA at the end of nucelos(t)ide analogue therapy were more likely to have continued response for 4 years or more.

Rong Fan, MD, from the Southern Medical University in Guangzhou, China, and colleagues wrote that while off-treatment response was suboptimal in patients with HBV e-antigen positive chronic HBV, “double negative HBV nucleic acid” status at treatment end could provide a potent biomarker for guiding nucleos(t)ide (NA) discontinuation.

The evaluation cohort comprised 130 patients who met the stopping criteria. After 4 years, patients with HBV DNA of “target not detected” at treatment end had lower incidence of clinical relapse compared with those with either HBV DNA less than 20 IU/mL (20% vs. 39.8%; P = .036) or higher than 20 IU/mL (40%; P = .036).

Similarly, patients with negative HBV RNA levels at treatment end had a lower risk for clinical relapse (15.3% vs. 37%; P = .029).

However, the lowest incidence of clinical relapse occurred in patients with double negative status compared with patients positive for either HBV DNA or RNA (8% vs. 31.4%; P = .018), with a negative predictive value of 92%.

Multivariate analysis confirmed that HBV DNA and RNA level at treatment end was the strongest independent predictor of clinical relapse (HR = 4.54; 95% CI, 1.08-19) and virologic relapse (HR = 11.1; 95% CI, 2.69-45.8).

While not statistically significant, analysis of a smaller validation cohort showed that patients with a double negative status had numerically lower relapse rates compared with patients positive for either HBV DNA or RNA (15.4% vs. 33.3%).

“Based on these findings, we propose that the overall HBV nucleic acid level (that is HBV DNA and RNA) could be used as a reliable biomarker for guiding NA discontinuation decisions,” Fan and colleagues wrote. “Meanwhile, there is a need to develop a new kit that can directly detect overall HBV nucleic acid levels for better, simpler monitoring of treatment response and guidance for withdrawal.” – by Talitha Bennett

Disclosures: Fan reports no relevant financial disclosures. Please see the full study for all other author’s relevant financial disclosures.