Ibogaine in the treatment of chronic hepatitis C Howard S. Lotsof. President Dora Weiner Foundation Staten 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

• 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% ibogaine Courtesy Sara Glatt

Ibogaine HCl 99.4% purity

Hepatitis C (HCV) timeline 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

HCV infection Most common viral infection in the United States New infections per year 1990 - 242,000 New infections per year 2001 - 25,000 New infections per year 2004 - 25,000 Greater than 75% of IVDUs test positive

Science follows patent development 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. 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.

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.

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.

Ibogaine Patents Rapid method for interrupting the narcotic addiction syndrome, US 4,499,096 (1985) Rapid method for interrupting the cocaine and amphetamine abuse syndrome US 4,587,243 (1986) Rapid method for attenuating the alcohol dependency syndrome, US 4,957,523 (1989) Rapid method for interrupting or attenuating the nicotine/tobacco dependency syndrome, US 5,026,697 (1991) Rapid method for interrupting or attenuating poly-drug dependency syndromes, US 5, 124,994 (1992)

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

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

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

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

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

Research follows skepticism Broad ranging claims of ibogaine to treat multiple forms of chemical dependence doubted Over time, all claims for treating chemical dependence have been confirmed by research Opioids, stimulants, Alcohol nicotine

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

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

Opioids,

stimulants,

Alcohol

nicotine

Opioids

Cocaine

Alcohol

Nicotine

Ibogaine activist organizations play role in ibogaine HCV research International Coalition for Addict Self-Help (ICASH) 1989 Dutch Addict Self-Help (DASH) 1990 Ibogaine Underground 2004

International Coalition for Addict Self-Help (ICASH) 1989

Dutch Addict Self-Help (DASH) 1990

Ibogaine Underground 2004

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/kg 1 x 12 mg/kg 1 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 Repetitive low dosing with ibogaine provided continuous depression of viral load. Genotype 3 appears highly responsive in keeping with results of interferon riboviron therapy. Continued reduction in viral load after stopping of ibogaine therapy observed. Less toxic than current HCV therapies.

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

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

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

Less toxic than current HCV therapies.

Future development Interest of pharmaceutical companies with experience in development of HCV drugs. Preclinical confirmation of efficacy if possible. Phase I/II clinical studies to confirm findings and establish preferred dose regimen.

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

Preclinical confirmation of efficacy if possible.

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