A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C

• number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  clinical and/or laboratory adverse events
  
  

• anti-viral efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  measured by reduction of circulating hepatitis C viral levels
  
  
• aspartate aminotransferase (AST or SGOT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  reduced circulating levels of AST (or SGOT), as a measure of liver inflammation
  
  
• alanine aminotransferase (ALT or SGPT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation
  
  

Hepatitis C virus (HCV) chronically infects 1% to 3% of the world's population, including about 3.9 million infected patients in the United States, with an estimated 36,000 new cases in the US each year. 70-85% of infected individuals develop a chronic infection complicated by chronic liver disease during the next 20 to 30 years, which is the tenth leading cause of death in the US. HCV is implicated in the development of hepato-cellular carcinoma. Chronic HCV hepatitis is the most frequent reason for liver transplantation. HCV genotype 1 is the most common genetic variant of HCV causing HCV hepatitis in the US. It responds less well to conventional anti-HCV treatment than the other HCV genotypes, so that 60% of genotype 1 patients fail conventional therapy due to the virus's resistance to treatment and/or due to toxic side effects of the therapy.

Extracellular levels of ascorbic acid (vitamin c) attainable only by high-dose, intravenous administration, are reported to have in vitro and in vivo anti-cancer and anti-viral effects in humans and animals. Ascorbic acid briefly generates extracellular hydrogen peroxide, an oxidative stress specifically toxic to cancer cells and cells infected with viruses, including HCV, but not to normal cells. High-dose, intravenous ascorbic acid has been given to large numbers of patients, particularly cancer patients, with anecdotal reports of good safety and occasional benefit. Given the foregoing, the investigators propose that there is sufficient rationale for a careful pilot study of the safety and anti-viral efficacy of infused ascorbic acid in HCV genotype 1 hepatitis.