Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection.
OBJECTIVE
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.


CONCLUSIONS
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.
Rajkumar
J S
JS
Lifeline Rigid Hospitals, Kilpauk, Chennai, India.
Sekar
M G
MG
Mitra
S K
SK
D000284:Administration, Oral; D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology / Q000821:virology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
D000998:Antiviral Agents; D004279:DNA, Viral; C119007:HD 03 polyherbal; D006513:Hepatitis B e Antigens; D010936:Plant Extracts; D000410:Alanine Transaminase
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