6 | Himalaya Livline | Vol 6 | No. 4 | May–Aug 2023 HD-03/ES* in the Management of Chronic Hepatitis B Infection An excerpt of a study conducted by Rajkumar JS et al published in the World Journal of Gastroenterology is featured here. Aim To study the safety and efficacy of Liv.52 HB capsules in patients with chronic hepatitis B (CHB) infection Materials and Methods This was an open, prospective, controlled clinical trial. A total of 25 patients aged 18 to 60 years, with serum alanine transaminase (ALT) level of 41 to 200 IU/L and who were positive for serum hepatitis B surface antigen (HBsAg) were included in the study. The patients were administered 2 capsules of Liv.52 HB, BID, for 6 months. The signs and symptoms were clinically assessed on a regular basis. Serum assay was done for HBsAg, hepatitis B e-antigen (HBeAg), and hepatitis B virus (HBV) DNA at baseline and 4 and 6 months after therapy. The patients underwent liver function tests every month during the treatment. HBsAg clearance was considered as the primary end point. HBV DNA level and ALT level normalization to 40 IU/L were considered as the secondary end points. Results After 6 months of treatment with Liv.52 HB, there was a remarkable alleviation in the chief clinical symptoms such as abdominal pain and poor appetite in most of the patients. There was a trend toward normalization of liver function parameters in all patients (Table 1). A significant decrease in the HBeAg, HBsAg, and HBV DNA levels was observed in 60%, 52%, and 60% of the patients, respectively (Table 2). Liv.52 HB was well tolerated by the patients. Most of the observed side effects were mild (fatigue, headache, and insomnia). No serious biochemical abnormalities were noted in any patient. Conclusion Thus, Liv.52 HB is safe and effective in the treatment of CHB infection. Table 1. Effect of 6 Months of Treatment With Liv.52 HB on Liver Function Parameters Parameter Day 0 Month 4 Month 6 Alanine Aminotransferase, IU/L 66.5 ± 11.1 41.6 ± 05.1 39.1 ± 05.2 Aspartate Aminotransferase, IU/L 47.5 ± 9.5 42.4 ± 10.7 40.2 ± 10.1 Serum Albumin, g% 3.5 ± 0.8 3.5 ± 0.7 3.6 ± 0.7 Serum Globulin, g% 2.9 ± 0.3 3.1 ± 0.2 3.2 ± 0.2 Total Protein, g% 6.2 ± 0.7 6.5 ± 0.7 6.5 ± 0.7 Serum Bilirubin, mg% 1.3 ± 0.6 1.2 ± 0.5 1.1 ± 0.5 Alkaline Phosphatase, IU/L 155.5 ± 9.8 140.2 ± 9.0 127.0 ± 7.5 Values are expressed as mean ± SD. Table 2. Effect of 6 Months of Treatment With Liv.52 HB on Biochemical and Serological Parameters Parameter No. of Patients Alanine Aminotransferase Normalization, % Month 4 32 Month 6 56 Positive Negative HBsAg Day 0 25 0 Month 4 19 6 Month 6 12 13a HBeAg Day 0 16 9 Month 4 11 14 Month 6 10 15b HBV DNA Day 0 16 9 Month 4 11 14 Month 6 10 15b aP < .001 and bP < .05 vs day 0 value. HBeAg, hepatitis B e-antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus. Liv.52 HB in Chronic Hepatitis B Infection *HD-03/ES is marketed as Liv.52 HB.
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