Research Article
Arjanova OV, Butov DA, Prihoda
Abstract
Open label phase 2b retrospectively controlled trial was conducted in 72 treatment-failed TB patients on socalled palliative support consisting of isoniazid (H) and rifampicin (R) with or without adjunct immunotherapy. The intervention group (N=36) received once-daily pill of V-5 Immunitor (V5) and comparison control (N=36) received HR only. The subjects in V5 and control groups had miliary: cavitary: MDR-TB: DR-TB: TB/HIV at 10: 26: 5: 4: 1 and 14: 22: 6: 6: 2 ratios, respectively. After 3 months 69.4% of V5-treated patients experienced negative sputum smear conversion (P<0.0001) vs. 16.7% (P=0.02) in comparison group who were treated for 3.5 months on average. 9 out of 10 V5 recipients with drug-resistant TB and TB/HIV became sputum negative, whereas none of 14 patients with same diagnosis converted (P<0.0001; OR 1732; 100-30008 at 95% CI). TB-associated inflammation was downregulated by V5 as shown by normalization of leukocytosis 7.9 vs. 6.2 x109/L (P=0.005) and decreased erythrocyte sedimentation rate 22.7 vs. 13.3 mm/h (P<0.0001), whereas among HR recipients changes were smaller, i.e., 7.2 vs. 7.5 x109/L (P=0.49) and 26.4 vs. 22.5 mm/h (P<0.0001). The body °C temperature was reduced from 37.4 ± 0.5 to 37.1 ± 0.3 (P=0.001) and from 37.7 ± 0.5 to 37.2 ± 0.5 (P=0.0002) in V5 and control respectively. In V5 arm average body weight accrual 2.2 ± 1.7 kg (P<0.0001) was higher than 0.08 ± 1.1 kg in control. No adverse effects or reactivation of disease were seen at any time. V5 is safe and in combination with simple two-drug regimen was highly effective as an immune adjunct for management of treatment-failed and/or drug-resistant TB.