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In order to determine the safety and efficacy of the formulation HD-03/ES in the management of patients with chronic hepatitis B infection, Rajkumar and colleagues enrolled 25 patients with chronic hepatitis B in the present study who were administered HD-03/ES as two capsules twice a day over a period of 6 months.
Investigators conducted a clinical assessment of symptoms and signs making use of the “clinical observation table” once a month prior to and after the treatment. Biochemical investigations for total bilirubin, ALT, AST, serum protein for liver function tests took place every month after treatment initiation. Serum analysis was done for HBsAg, HBeAg and HBV DNA at baseline, 4 months and 6 months after therapy.
Six months of treatment with the formulation relieved chief clinical symptoms such as abdominal pain and poor appetite in majority of the patients. Following treatment with HD-03/ES, there was a significant reduction in ALT levels from 66.5 ± 11.1 to 39.1 ± 5.2 (P < 0.01), with a significant HBsAg loss (52%), HBeAg loss (60%) and HBV DNA loss (60%). There were mild adverse effects that never caused drug withdrawal.
The present pilot study thus suggests that HD-03/ES appears to be a safe and effective treatment option for chronic hepatitis B infection.
Source: Rajkumar JS, Sekar MG, Mitra SK. Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection. World J Gastroenterol 2007; 13(30): 4103-4107.