Ibogaine in the treatment ofchronic hepatitis C

Howard S. Lotsof.President

Dora Weiner FoundationStaten Island, NY

http://www.doraweiner.org

6th National Conference on Harm Reduction

Oakland, California, November 2006

Forms of ibogaine in current use

• Botanical - root bark

• Total alkaloid extract

• purified ibogaine

Tabernanthe iboga shrub

Roots contain ibogaine

Total Alkaloid Extract

Large piece 2cm x 2cm, approx 4 grams

Estimate 15% ibogaineCourtesy Sara Glatt

Ibogaine HCl

99.4% purity

1973: Non A, Non B hepatitis is described

1989: HCV RNA virus identified

1990: Anti HCV effects of ibogaine

reported

2005: Patent application for ibogaine to

treat chronic HCV

Hepatitis C (HCV)timeline

Most common viral infection in the

United States

New infections per year 1990 - 242,000New infections per year 2001 - 25,000New infections per year 2004 - 25,000Greater than 75% of IVDUs test

positive

HCV infection

1. The discovery of ibogaine’s use in treating both chemical dependence and HCV was by ibogaine activist advocates who were themselves treated or self-treated with ibogaine.

2. Scientific research followed patent development in the treatment of chemical dependence and it is hoped the same will be true for ibogaine related HCV research.

Science follows patent development

1. Rapid method for interrupting the narcotic addiction syndrome, US 4,499,096 (1985)

2. Rapid method for interrupting the cocaine and amphetamine abuse syndrome US 4,587,243 (1986)

3. Rapid method for attenuating the alcohol dependency syndrome, US 4,957,523 (1989)

4. Rapid method for interrupting or attenuating the nicotine/tobacco dependency syndrome, US 5,026,697 (1991)

5. Rapid method for interrupting or attenuating poly-drug dependency syndromes, US 5, 124,994 (1992)

Ibogaine Patents

1. Broad ranging claims of ibogaine to treat multiple forms of chemical dependence doubted

2. Over time, all claims for treating chemical dependence have been confirmed by research

a) Opioids,

b) stimulants,

c) Alcohol

d) nicotine

Research follows skepticism

Opioids

Cocaine

Alcohol

Nicotine

• International Coalition for Addict Self-Help (ICASH) 1989

• Dutch Addict Self-Help (DASH) 1990

• Ibogaine Underground 2004

Ibogaine activist organizations play

role in ibogaine HCV research

HCV patent application

Example 1 Report

A thirty-three year old male diagnosed with HCV and using 1/4 gram of heroin a day was administered 25 mg/kg ibogaine HCl. Following administration of ibogaine heroin use ceased along with swelling of the liver and pain in the area of the liver.

Example 2 Liver enzyme values reduced

by 14 mg/kg ibogaine

Enzyme Pre Post

ALT 410 50

AST 201 25

GGT 155 33

Example 3

Example. 4 A forty-two year old female testing positive for HCV RNA type 3. RNA IU/ml was 12,600,000. Subject was administered a total of 27 mg/kg ibogaine HCl in the following regimen:

6 x 2 mg/kg1 x 12 mg/kg1 x 3 mg/kg

HCV RNA IU/ml was reduced to 50,100. Prior to ibogaine treatment patient’s urine was dark and stool light. Post treatment color of urine and stool returned to normal.

Encouraging results

1. Repetitive low dosing with ibogaine provided continuous depression of viral load.

2. Genotype 3 appears highly responsive in keeping with results of interferon riboviron therapy.

3. Continued reduction in viral load after stopping of ibogaine therapy observed.

4. Less toxic than current HCV therapies.

Future development

1. Interest of pharmaceutical companies with experience in development of HCV drugs.

2. Preclinical confirmation of efficacy if possible.

3. Phase I/II clinical studies to confirm findings and establish preferred dose regimen.