Clinical and virological evaluation of the detection of pre-S1 and pre-S2 antigens in serum from patients with chronic hepatitis B

OBJECTIVES AND METHODS: We performed a prospective study to determine the clinical and virological significance of pre-S antigen detection in serum samples from patients with chronic hepatitis B virus infection. Four hundred thirty seven consecutive serum samples from 116 patients were tested for the presence of both pre-S1 and pre-S2 antigens by radioimmunoassay using specific monoclonal antibodies. RESULTS: The pre-S1 antigen/HBs antigen ratio, gave an estimation of the number of pre-S1 epitopes expressed on the surface of circulating viral particles, and was positively correlated with the intensity of viral replication intensity (P < 0.05). Moreover, the pre-S1 antigen/HBs antigen ratio was significantly higher in patients suffering from chronic hepatitis associated with viral replication (24% +/- 13); in anti-HBe positive patients, the pre-S1 antigen/HBs antigen ratio was higher in patients replicating a HBe antigen minus variant of the hepatitis B virus and suffering from chronic hepatitis (17% +/- 9) than in asymptomatic HBs antigen carriers (5% +/- 6) (P < 0.05). The pre-S2 antigen/HBs antigen ratio was not correlated with the level of viral replication or with the patient's clinical status. CONCLUSION: This study confirms that pre-S1 antigen detection is a reliable marker of hepatitis B virus replication which can be easily performed in chronically infected patients. This assay is especially useful in identifying anti-HBe positive carriers who replicate a minus pre-core mutant and could benefit from antiviral therapy.