Treatment of cognitive impairment in HIV-infected patients receiving tuberculosis therapy: results of an observational program

Objective. To obtain data on the efficacy and safety of Prospekta in the therapy of cognitive impairment (CI) in HIV-infected patients with chemotherapy for tuberculosis. Patients and methods. A total of 120 patients older than 18 years (mean age 43.9 years) who met the inclusion criteria were included in the observational program. All participants were assessed initially, after 4, 8, 12, 24 weeks using the Montreal Cognitive Assessment Scale (MoCA), and quality of life using the European Quality of Life Questionnaire. Patients were randomized into two groups: the group of starting administration of Prospekta (n = 60) – patients received Prospect for 12 weeks against the background of tuberculosis chemotherapy, the group of delayed administration of Prospekta (n = 60) – patients received tuberculosis chemotherapy for 12 weeks without Prospekta. After 12 weeks, the therapy was changed: patients in the initial prescription group continued TB chemotherapy for another 12 weeks without Prospecta. Patients in the delayed prescription group were treated with Prospecta for 12 weeks against the background of chemotherapy. Patients were ranked into three subgroups depending on the severity of CI: subjective CI (SubCI; n = 8), moderate CI (MCI; n = 59), severe CI (SCI; n = 53). Patients' demographic characteristics were comparable across groups/subgroups. Results. Patients with SubCI in the Prospekta starter group showed an increase in mean MoCA score from 27.1 ± 1.3 to 29.1 ± 0.9 by 12 weeks of therapy (vs. 26.0 to 27.0 in the delayed group, p = 1.0000); after changing therapy with Prospekta exclusion at visit 4, there was a change in mean MoCA score of -0.1 by 24 weeks of therapy (vs. 2.0 on Prospekta addition, p = 1.0000). Patients with MCI in the Prospekta starter group showed an increase in mean MoCA score by 12 weeks of therapy from 22.2 ± 2.0 to 25.7 ± 2.3 (vs. 20.0 ± 1.2 to 20.9 ± 2.6 points in the delayed prescription group, p ≤ 0.0001), after changing the therapy with Prospekta exclusion at visit 4, there was a 0.1 change in the mean MoCA score by 24 weeks of treatment (vs. 3.4 points on Prospekta addition, p ≤ 0.0001). Patients with SCI in the Prospekta starter group showed an increase in mean MoCA score by 12 weeks of therapy from 15.8 ± 2.5 to 22.3 ± 3.8 (vs. 16.3 ± 1.7 to 18.7 ± 2.5 points in the delayed prescription group, p = 0.0063), after the change of therapy with Prospekta exclusion at visit 4, there was a 0.8 change in the mean MoCA score by 24 weeks of treatment (vs. 4.0 points on Prospekta addition, p ≤ 0.0001). Patients in the Prospekta starter group showed a 10-fold advantage in quality of life after 4 weeks compared to respondents in the delayed prescription group. A total of 9 AEs were recorded in 4 patients, among which 8 AEs were mild and 1 AE was severe. All of them were unrelated to the drug. Conclusion. The efficacy and safety of Prospekta in the treatment of SubCI, MCI and SCI in HIV-associated patients receiving tuberculosis chemotherapy have been demonstrated. Key words: cognitive disorders of varying severity, pulmonary tuberculosis, HIV infection, Prospekta, chemotherapy