In the Journals

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.

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.