Normalization of elevated liver enzymes due to V-1 Immunitor therapy

* Corresponding author

Financial support: All work was supported by the Immunitor Corporation. Dr. Orapun Metadilogkul's salary is paid by the Thai Ministry of Public Health, she did not receive any compensation for participating in this study.

Keywords: AIDS, hepatitis, oral, therapeutic, transaminase, vaccine.

Abbreviations: AST/SGOT: aspartate aminotransferase; ALT/SGPT: alanine aminotransferases; V1: V-1 Immunitor; HIV: human immunodeficiency virus; AIDS: acquired immune deficiency syndrome; CBC: complete blood count; FDA: Food and Dug Administration.

V-1 Immunitor (V1) is an oral AIDS vaccine currently being used as a therapeutic modality by HIV-positive patients. Upon interim analysis of phase I safety trial it has been discovered that patients who had elevated liver enzymes aspartate (AST/SGOT) and alanine (ALT/SGPT) aminotransferases have experienced the reduction of enzyme levels back to normal. Two other hepatitis markers alkaline phosphatase and bilirubin have also decreased. V1’s effect may be hepatitis-specific since liver enzymes in normal patients treated with V1 have not changed and three patients who were Hepatitis B antigen positive at baseline became negative after therapy. The results suggest that V1 supplementation reduces hepatic damage caused by hepatitis viral infection.