Effect of Ozone gas with and without Anti-oxidants on Viral Kinetics , and Liver Histopathology, in Hepatitis C patients :A Phase II Clinical Study. Hope for an Effective and Safe Anti-Fibrotic agent

Author Sadek A
Author Lotfy H
Author Elbasha H
Author Hamed S
Author Abd El Hady A
Author Ibrahim O
Author Almesery A
Author Rakha M
Author Aql S
Author Alashry M
Author Sadek H.
Author Sadek H. **
Publication Al Haram Hospital –TBRI- Guiza –Egypt
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The aim of this work is to study the effect of oxidative stress induced by ozone gas with and without anti-oxidants on hepatitis C patients. One hundred patients with positive HCV Ab. and evidence of hepatitis in different stages of the disease were subjected to ozone treatment using both the major auto-hemotherapy and rectal insufflation for 12 weeks. A group of patients(A) was given ozone alone and the other was given ozone plus anti-oxidants(B). Patients were subjected to routine laboratory tests including ALT, quantitative PCR estimation, and liver biopsy before and after treatment.

The Histological grading and staging was done according to Ishak Modified HAI and evaluated by two accredited pathologists. 85% of the patients have shown a significant decline (more than 2 log decline or not detected ) in quantitative PCR on day 10 . 70% of the patients have shown a resurgence of the HCV RNA readings to day 0 readings or higher at 12 weeks , 65% have again shown significant decline (more than 2 log decline or not detected) 3-6 Months after cessation of Therapy. 75.5 % of the patients have shown improvement in liver biopsy in terms of the the Grade (necro-inflammation scores) from 2-8 points and 56.6 % in the Stage of fibrosis by 1 or 2 points after a 12 weeks therapy course. As regards group A patients given ozone alone the response in necroinflammatory changes was 65 % compared to 82.5 % response in group B given both ozone and antioxidants. As regards stage of fibrosis the response was also better in group B (54.5 %) compared to group A (50 %).

We conclude that ozone therapy has a positive effect on viral kinetics in hepatitis C patients. It improves ALT of patients, affects viral kinetics as seen by PCR and induces downgrading in necro-inflammatory changes in liver biopsy by 2-8 points and downstaging in fibrosis by 1-2 points in 12 weeks therapy period. This may raise hope for a possible safe and effective anti-fibrotic therapy.