Rapid Communication
Copyright ©2007 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Aug 14, 2007; 13(30): 4103-4107
Published online Aug 14, 2007. doi: 10.3748/wjg.v13.i30.4103
Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection
JS Rajkumar, MG Sekar, SK Mitra
JS Rajkumar, MG Sekar, Lifeline Rigid Hospitals, Kilpauk, Chennai, Tamilnadu 600010, India
SK Mitra, The Himalaya Drug Company, Bangalore 562123, Karnataka, India
Author contributions: All authors contributed equally to the work.
Correspondence to: Dr. SK Mitra, MD, Executive Director, R&D Center, The Himalaya Drug Company, Bangalore-562 123, Karnataka, India. dr.s.k.mitra@himalayahealthcare.com
Telephone: +91-80-23714444 Fax: +91-80-23714471
Received: October 13, 2006
Revised: November 3, 2006
Accepted: November 14, 2006
Published online: August 14, 2007
Abstract

AIM: To investigate the safety and efficacy of the formulation HD-03/ES capsules in the management of patients with chronic hepatitis B infection.

METHODS: A total of 25 patients were recruited to the study and were given HD-03/ES, two capsules twice daily for six months. Clinical assessment of symptoms and signs were done using the “clinical observation table” once a month before and after the treatment. Biochemical investigations of total bilirubin, ALT, AST, serum protein for liver function tests were done every month after initiating treatment. Serum was analyzed for HBV markers for HBsAg, HBeAg and HBV DNA at baseline, 4 and 6 mo after therapy using ELISA kits from Roche.

RESULTS: After 6 mo of therapy with HD-03/ES, a significant reduction of ALT values from 66.5 ± 11.1 to 39.1 ± 5.2 (P < 0.01) and a significant HBsAg loss (52%, P < 0.001), HBeAg loss (60%, P < 0.05) and HBV DNA loss (60%, P < 0.05) was observed. Adverse effects were mild and never warranted withdrawal of the drug.

CONCLUSION: The results of this pilot study indicate that HD-03/ES might be a safe and effective treatment for chronic hepatitis B infection and a long-term multicentric comparator trial is warranted and under way.

Keywords: HD-03/ES; Chronic hepatitis B; Liver function tests; Hepatitis B Virus markers; Clinical trial; HBsAg; HBeAg