No abstract

This Phase IIb, placebo-controlled study involved 55 TB patients treated with anti-TB therapy. They were divided into two groups, matched by age, gender, baseline bodyweight and clinical manifestations: one group (n = 27) received a once-daily V-5 Immunitor (V5) immunotherapy pill and the other (n = 28) received placebo. Only one (3.7%) and three (10.7%) subjects in V5 and placebo arms, respectively had first-diagnosed, drug-sensitive TB; the remaining patients had re-treated TB, multidrug-resistant TB or HIV-TB coinfection. After 1 month, 26 out of 27 patients (96.3%) became sputum smear negative in the V5 group (p < 0.0000001), whereas seven out of 28 (25%) in the placebo group had converted (p = 0.005). V5 contributed to the downregulation of TB-associated inflammation, as shown by normalization of high leukocyte counts, erythrocyte sedimentation rate and faster defervescence than controls. Patients in both arms experienced an increase in the levels of hemoglobin corresponding to 128.9 ± 17.6 versus 133.1 ± 14.7 g/l (p = 0.03) and 112.6 ± 14 versus 117 ± 11.7 g/l (p = 0.03) in V5 and placebo arms, respectively. In total, 19 out of 28 placebo patients (67.9%) gained, on average, 1.07 kg (59.1 ± 10 vs 60.1 ± 10.4 kg; p = 0.003). By contrast, all patients in the V5 group gained weight with mean 3.4 kg (59.7 ± 8 vs 63.1 ± 9 kg; p = 5.7E-007). Clinical symptoms improved among all patients in V5 arm, while 28.6% of patients on placebo reported satisfactory results (p = 0.007). No adverse or side effects attributable to V5 were seen at any time. Further studies are needed to gauge the extent of the benefits of V5 as safe and effective adjunct immunotherapy for TB.

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 signifi cant, 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.

No abstract

Prognosis for TB/HIV co-infection is very unfavourable. In terminally-ill patients treatment options are often limited to palliative care. In our salvage, 2-month therapy of 40 late-stage TB/HIV patients we administered to half of the patients TB drugs along with over-the-counter botanical immunomodulator Dzherelo (Immunoxel). Despite best possible care 6 patients had died. Remaining 14 patients experienced marked clinical improvements and one patient was discharged due to full recovery. Among 20 matched subjects on conventional TB regimen, 12 died and only one was slightly better-off. These results indicate that Dzherelo might reduce mortality (P=0.055) and improve significantly the quality of life (P=0.00002). Improvement in quality of life is also supported by substantial weight gain (mean/median 3.3/4 kg) in much higher proportion of patients than among those who received TB drugs only, i.e., 16 vs. 1 (P=0.000001). At the end of two months 13 (65%) patients became sputum smear negative versus only one individual (5%) in ATT group (P=0.00007). These results suggest that adjuvant immunotherapy improves significantly therapy outcome and reduces mortality. Larger study is warranted to confirm the benefit of Dzherelo.