Phase 2 Trial of V-5 Immunitor (V5) in Patients with Chronic Hepatitis C Co-infected with HIV and Mycobacterium Tuberculosis

Olga V. Arjanova, Nathalia D. Prihoda, Larisa V. Yurchenko, Nina I. Sokolenko, Valery M. Frolov, Marina G Tarakanovskaya, Vichai Jirathitikal and Aldar S. Bourinbaiar

V-5 Immunitor (V5) has been evaluated in patients with chronic hepatitis C with concomitant HIV and Mycobacterium tuberculosis infections. Once-daily tablet of V5 was administered per os to 20 patients for one month. Every patient who entered the study had enlarged liver, elevated hepatic damage markers, which at the end of study have improved in 19 out 20 (95%) patients. The reduction was highly significant, from 1.72±0.34 to 0.18±0.28 µmol/ml•h (P=5.0 E-012) and 22.1±3.4 to 10.9±2.5 µM/L (P=5.7 E-009) for ALT and total bilirubin respectively. Enlarged liver reduced from 3.5±1.4 to 0.95±1.1 cm above normal size (P=2.9 E-009). As patients were hospitalized in TB hospital they were treated with standard anti-TB therapy (ATT) in addition to V5. Surprisingly, V5 appeared to contribute to higher and faster than expected sputum conversion rate; 94.4% of smear-positive patients became negative within one month. TB-associated fever subsided within mean/median 4.1/3 days; indicators of infl ammation such as elevated erythrocyte sedimentation rate and high leukocyte counts returned back to normal from 32.3±11.4 to 9.9±6.4mm/h (P=3.7 E-008) and 14.3±3.9 to 4.7±1.4x109L (P=7.1 E-010) respectively. Average body weight gain was 7.7 kg (P=4.6 E-007) and hemoglobin levels increased from 114±7.1 to 123.4±6.6 g/L (P=1.4 E-007). No adverse events were observed at any time. After one month 17 out of 20 patients were deemed cured from TB and discharged from the dispensary. Further studies are needed to confi rm this preliminary observation suggesting that in addition to the benefi cial effect in managing chronic hepatitis, V5 might also be useful as a safe and effective means for immunotherapy of tuberculosis.