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Prolonged viral suppression with oral antiviral drugs allows partial immune reconstitution. Controlled therapy interruption (CTI), by leveraging secondary immune response, proposes further augmentation in chronic hepatitis B virus (HBV) infection. Transient treatment interruptions (TIs) at months 0, 1, and 3 during otherwise continuous oral antiviral therapy allow viremic bursts, simulating autovaccination. Four weekly injections of Hepatitis B Immunoglobulin are given before the second and third TI to simulate prime boosting, which specifically amplifies the immune response. Fourteen patients (10 males; four controls, four HBeAg positive, and six anti-HBe positive) aged 28-46 years were studied. The period between TI and reappearance of viremia, time to relapse (TTR) (weeks) estimated immune control. The other endpoints included reduction in serum HBsAg IU/mL and loss of HBeAg. TTR after the first TI was significantly shorter in HBeAg-positive patients, indicating low baseline immunity. TTR increased significantly after the second and subsequent TI in all four HBeAg-positive patients. One patient persistently lost HBeAg. Mean HBsAg levels fell significantly in three of four patients after the second TI. In contrast, in the anti-HBe-positive group, TTR was unchanged after all three TI. Furthermore, no significant changes in HBsAg levels were detected after the second or subsequent TIs. No significant differences in adverse events were noted between groups. HBeAg-positive patients have low baseline levels of host immune control against HBV. CTI consistently boosts this immunity. CTI did not influence immunity in anti-HBe-positive patients.
This article was published in the following journal.
Name: Viral immunology
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Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
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