A Randomised Double Blind Placebo Controlled Study to Assess the Efficacy, Safety and Antiviral Activity of Phyllanthus niruri (HEPAR-P) in patients with Chronic Hepatitis B. (N. S. Khairullah, I. Merican, R. Yusup)

The study Hepar-P was conducted in collaboration with Nova Laboratories, Malaysian Liver Foundation and CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Australia. Phyllanthus niruri (HEPAR-P) had been used traditionally in treatment of jaundice, diarrhea, kidney trouble, etc. Animal studies had showed that Hepar-P is non toxic and does not cause adverse effect of its consumptions.

In collaboration with MLF, clinical trial of Hepar-P was conducted to assess Hepar-P efficacy, safety and antiviral activity in treatment for Hepatitis B disease among 12 adult patients with chronic Hepatitis B in Selayang Hospital. The trial was conducted from August 2005 until July 2008 for 52 weeks for Hepar-P and placebo administration followed by 1st month, 3rd month and 6th month follow up after the administration of the Hepar-P and placebo.

All the results of the Hepar-P clinical trial was collected by Malaysian Liver Foundation and faxed to CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University Australia for data keeping and report.

Twelve patients comprised of six males and six females participated in the study. The patients were consistently monitored for 52 weeks. HBV genotype B and C were detected among the patients. Only 10 out of 12 patients completed the treatment.

We observed that 1 patient of HBV genotype C had achieved HBeAg clearance after 40th week treatment though viral load and ALT level was still high. However, in the 52nd week of treatment, viral load was decrease while ALT level was in the normal range. The HBeAg was persistently negative at 1st-, 3rd- and 6th-month follow-up after the treatment complete. There were no significance changes of viral load and ALT level among 9 patients from week 1 to week 52. For the past 52 weeks treatment, we observed that 9 patients persistently sero-positive HBeAg. Therefore, no seroconversion was seen in each patient.

The unblind report of the study is still in progress. The complete report will be reported after the CCRE Therapeutics finalized the data.