"This treatment results in significantly faster clearing of antigens and normalization of liver enzymes than placebo in acute hepatitis B," said principal investigator Sarabjeet Singh, MD, Consultant Hepatologist, L.L.R.M. Medical College, Meerut, Uttar Pradesh, India, in a presentation on November 2^nd.

The researchers were interested in the potential of P. amarus for the treatment of hepatitis B because of the cost of ongoing treatment with chronic disease, a particular concern with patients who are immune compromised and those who acquire the disease perinatally.

Dr. Singh and colleagues assessed the natural course of the disease in the initial 4 weeks and assessed the impact of P. amarus on the infection and on hepatic functions up to 24 weeks.

The 200 study subjects had serologically proven acute hepatitis B. They were randomized equally to receive either treatment or placebo. The researchers obtained the patients' medical histories, conducted physical examinations, and laboratory assessments, including hemoglobin, serum lipids, erythrosedimentation rate, and platelet counts.

Laboratory tests also focused on several hepatitis-specific laboratory values, such as serum bilirubin, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum proteins, as well as hepatitis B-specific values such as hepatitis B surface antigen (HBSAg), hepatitis B e-antigen (HBeAg), and immunoglobulin M anti-hepatitis B core antibodies.

Subjects received one 500-mg tablet of P. amarus or placebo three times daily. The treatment period was 4 weeks; the investigators recorded the patients' laboratory values and clinical findings at baseline and at 16 and 24 weeks.

By the end of the follow-up period, 82% of patients in the treatment group and 80% in the placebo group remained in the trial.

Patients on the study drug experienced a more rapid improvement of symptoms and normalization of ALT and AST values than did those on placebo, according to Dr. Singh.

In addition, 96.3% of patients on P. amarus showed a clearing of HBsAg, compared to 81.2% of patients on placebo (P < .001). HBeAg clearing occurred in 96.3% of the patients on the study drug compared to 88.7% of the patients on placebo (P < .001).

Eight patients in the placebo group had elevated liver enzymes, compared to none on the study drug.


[Presentation title: A Placebo-controlled Double-blind Clinical Trial of the Efficacy of Hepavirin in Viral Hepatitis B. Abstract 658]

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