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నైరూప్య

Therapeutic Vaccination of Treatment-Failed TB Patients on “Palliative&trdquo; Support Consisting of Isoniazid and Rifampicin

Arjanova OV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Stepanenko AL, Butova TS, Jirathitikal V, Bourinbaiar AS and Kutsyna GA

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.