Manu Tandon,1 Anuradha,1 Pralhad S. Patki, MD2

1Department of Gastroenterology, C. Dayakar Reddy Hospital, Narayanguda, Hyderabad, India

2Medical Services and Clinical Trials, Research and Development Center, Himalaya Drug Company, Makali, Bangalore, India

CORRESPONDENCE TO:

Pralhad S. Patki, MD

Medical Services and Clinical Trials

Research and Development Center

Himalaya Drug Company

Makali, Bangalore 562 123, India

email: dr.patki@himalayahealthcare.com

Running title:

HD-03/ES IN HBeAg-negative chronic hepatitis B

Abstract

Background: Hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB) refers to an atypical presentation characterized by the absence of HBeAg but with clinical and histologic evidence of chronic hepatitis and the presence of ongoing viral replication. Individuals with this condition are at higher risk for progression to end-stage liver disease and for development of hepatocellular carcinoma.

Aims of the Study: To study the safety and efficacy of polyherbal extract HD-03/ES in the treatment of HBeAg-negative CHB.

Materials and Methods: This study was a phase 2 prospective open-label clinical trial among 42 patients attending the outpatient department of C. Dayakar Reddy Hospital, Narayanguda, Hyderabad, India. Patients with HBeAg-negative CHB who fulfilled the inclusion criteria comprised the study cohort. Clearance of hepatitis B surface antigen (HBsAg) and HBeAg and normalization of alanine aminotransferase (ALT) level were assessed after administration of HD-03/ES (1 capsule twice daily for 24 weeks). Biochemical variables (serum ALT and total bilirubin levels) were statistically analyzed using paired t-test. Variables such as symptomatic relief, hepatitis B virus (HBV) DNA loss, and HBsAg and HBeAg clearance were assessed using the exact binomial test. Missing values for 5 patients who were lost to follow-up were evaluated using the last-observation-carry-forward method.

Results: Statistically significant effects were observed with HD-03/ES treatment based on symptomatic improvement in appetite, jaundice, nausea, vomiting, fatigue, and normalization or reduction of ALT and bilirubin levels. Significant clearance was found in HBsAg; however, HBeAg clearance and HBV DNA loss were not significant. Improved rates of HBV infection were also observed. HD-03/ES was well tolerated in this study.

Conclusions: Clearance of HBsAg may be achieved in HBeAg-negative patients, supporting the use of HD-03/ES for the treatment of HBeAg-negative CHB. Although the initial results of this study are promising, large head-to-head randomized comparative studies with conventional drugs are needed to determine whether virological response can be sustained during chronic dosing and whether relapse occurs after stopping HD-03/ES.

Keywords:

HD-03/ES, chronic hepatitis B, HBsAg, HBeAg

 

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