One-month immunotherapy trial in treatment-failed TB patients

Olga V. Arjanova, Dmitry A. Butov, Natalia D. Prihoda, Svetlana I. Zaitzeva, Larisa V. Yurchenko, Nina I. Sokolenko, Anna L. Stepanenko, Tatyana S. Butova, Elena A. Grinishina, Olga A. Maksimenko, Vichai Jirathitikal, Aldar S. Bourinbaiar, Valery M. Frolov, Galyna A. Kutsyna
DOI: 10.4236/oji.2011.12006                

Abstract

reatment failed TB patients have very limited chances of survival. Open label trial of daily oral pill of V-5 Immunitor (V5) was conducted in 48 treatment-failed TB patients on palliative support consisting of isoniazid (H) and rifampicin (R). The subjects had the following forms of TB; cavitary: disseminated: MDR-TB: DR-TB: TB/HIV at 35:13:7:4:1 ratio. After 1 month 62.5% of V5-treated patients experienced negative sputum smear conversion (P < 0.0001), comprising 11 out of 12 (91.7%) converted among those who had drug-resistant TB and TB/HIV. TB-associated inflammation was downregulated as evidenced by normalization of leukocytosis 7.4 vs. 6.7 x 109 L (P = 0.01) and decreased erythrocyte sedimentation rate 20.5 vs. 14.9 mm/h (P < 0.0001). The mean body temperature normalized from 37.25° ± 0.6° to 36.98° ± 0.4° (P = 0.0002). The average body weight gain and body mass index (BMI) increased by 0.8 ± 0.7 kg and from 18.9 to 19.6 kg/m² respectively (P < 0.0001). Two patients (4.2%) died from illicit drug- and alcohol-abuse related causes. No adverse effects or reactivation of disease due to immune intervention were seen at any time. V5 is safe and in combination with a simple two-drug regimen was highly effective as an immune adjunct to produce favorable outcome among treatment-failed and/ or drug-resistant TB patients.

Keywords

Biomarker; HIV; Inflammation; MDR-TB; Mycobacterium; Survival; Treatment Failure; Vaccine

Conflicts of Interest

The authors declare no conflicts of interest.

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