CLINICAL EXPERIENCE WITH TABLETED V5 THERAPEUTIC VACCINE DERIVED FROM HYDROLYZED BLOOD OF DONORS WITH HEPATITIS B AND C / Шинэ санаа Шинэ нээлт

ABSTRACT

V5 is derived from pooled blood of donors with hepatitis B and C, which was hydrolyzed, autoclaved and foFWHlrtted into ordinary tablets. The principle of V5 action is similar to the first generation hepatitis B vaccine derived from plasma of hepatitis carriers. Preclinical studies have shown that V5 is safe - no acute or chronic toxicity in vitro or animals was seen at 1,882-fold higher doses than recommended once-per-day pill regimen. Safety Phase 1 two-month study has not demonstrated any adverse effects. Several clinical Phase II trials of V5 were conducted in past 5 years since its approval as a biologically active immunomodulator. Post-marketing survey in Mongolia assessed in 240 individuals with hepatitis B and C revealed that levels of liver damage biomarkcrs ALT; bilirubin and alkaline phosphatase decreased from mean 104.9192 to 63.2 • 51 (P« 0.0001); 14. I±12 to 9.9±7 (P=0.0001); 319±190 to 242±145 (P=0.049), respectively. The efficacy ofV5 based on ALT decrease in each individual was observed in 84.1% of patients. During trial in Ukraine on hepatitis C patients who also had tuberculosis it was accidentally discovered that V5 can clear Mycobacterium tuberculosis. Subsequent trials, including randomized placebo controlled phase II Mai, conducted in over 300 patients with TB has demonstrated that V5 has potent anti-TB activity r4iardless whether patients had drug sensitive TB, MDR-TB or TB with HIV. On average the c'crrance rate was observed in over 85% of TB patients after just one month. Recently wc have slJHed seeing patients with hepatocellular carcinoma who seemed to benefit from V5. The case rcR)rt from one patient will be presented to illustrate this effect. In conclusion. V5 appears to have kfSad spectrum activity against unrelated diseases. This needs to be verified in further clinical studies