Abstract:

After achieving a durable on-treatment virological response with NUC (nucleos(t)ide analogues), adding an immunomodulating agent seems to have beneficial effect on the course of chronic HBV disease. Methods: Nine patients were investigated (5 – HBeAg(-) and 4 – HBeAg(+). All patients achieved durable on-treatment virological response with NA and then Isoprinosine was added for a period of 21 to 27 months. Serum HBsAg and HBV DNA levels were evaluated at a 3-month interval. Aim: The aim of the present study was to evaluate the effect of adjuvant immunomodulation with Isoprinosine in patients with chronic HBV infection who achieved durable suppression of HBV DNA on-treatment with NUC. Results: In HBeAg-negative patients an initial increase of qHBsAg was observed in 4/5 of patients after the adding of Isoprinosine. On month 15 of combined therapy a reduction of more than 50% from the baseline HBsAg level was found in 4/5 of patients (P=0.043). In HBeAg-positive patients there was no significant reduction of HBsAg during the follow-up. A reduction of HBsAg levels (about 30%) from the baseline was established in 3/4 patients at month 18. In the remaining one patient a reduction of 70% was established at month 27. There was an initial increase of HBsAg in 3/4 patients. In 3/4 of the patients there was a negativation of HBeAg. Conclusion: After adding Isoprinosine to NA, HBeAg-loss was achieved in 3/4 of HBeAg positive patients. HBsAg decline was more pronounced in HBeAg-negative subjects, which was not observed in NUC monotherapy. Isoprinosine in combination with NUC is safe and well tolerated.