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‘Double negative’ HBV levels at end of treatment mark lower relapse risk

Patients who demonstrated negative results from tests for both hepatitis B DNA and RNA at the cessation of nucleos(t)ide treatment were less likely to experience clinical or virological relapse years later compared with those with only one negative test result.

In the study published in Clinical Gastroenterology and Liver Disease, researchers explained that although patients positive for HBV e-antigen patients may discontinue NA if they achieve therapeutic endpoints, the risk of off-treatment relapse remains still high. “Double negative” tests results may therefore provide a potent biomarker to guide treatment discontinuation.

Rong Fan, MD, from the Southern Medical University in China, and colleagues enrolled 130 patients in an evaluation cohort who had ceased treatment for chronic HBV.

After 4 years, patients who had HBV DNA results of “target not detected” at end of treatment 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 more than 20 IU/mL (40%; P = .036). Similarly, those with negative HBV RNA results had a lower risk for clinical relapse (15.3% vs. 37%; P = 0.029).

However, patients with both negative DNA and RNA status at end of treatment had the lowest risk for clinical relapse compared with those with either positive HBV DNA or RNA (8% vs. 31.4%; P = .018) with a predictive value of 92%.

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

Additionally, in a validation cohort comprising 40 patients with HBeAg-positive infection, the researchers found that those with double negative status had numerically lower clinical relapse rates than those who were 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 ... 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

Disclosure: The study was funded by National Science and Technology Major Project, the National Natural Science Foundation of China, the Local Innovative and Research Teams Project of Guangdong Pearl River Talents Program and Novartis. Fan reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.