Feasibility and acceptability of asynchronous VOT among patients with MDR-TB.

BACKGROUND: We conducted a feasibility and acceptability study of video-observed therapy (VOT) among patients with multidrug-resistant TB (MDR-TB) and other types of drug-resistant TB (DR-TB) in the Philippines.METHODS: Patients aged ≥13 years were approached to use VOT. A smartphone with VOT mobile application to video-record medication intake was provided. Healthcare workers (HCWs) monitored adherence by watching videos via a web-based dashboard. Good adherence was defined as intake of >90% of expected doses. Feasibility and acceptability were assessed using a semi-structured questionnaire on a Likert scale.RESULTS: Of 308 patients, 110 (36%) patients chose VOT; 67 completed treatment using VOT and 43 stopped VOT prior to treatment outcome; 74/110 (67%) had good adherence. The treatment success rate was 88% and the loss to follow-up rate was 8.1%. Among HCWs, 90% (9/10) had a positive perception of VOT. All HCWs agreed that VOT data accurately reflect medication intake of the patients; 88/89 (99%) mentioned benefits of VOT, notably convenience, sense of comfort, privacy and security.CONCLUSIONS: VOT is feasible and acceptable for both patients and HCWs. This study could provide guidance to the country programme to launch VOT for treatment of patients with MDR-TB and other DR-TB.

Bedaquiline for multidrug-resistant TB in paediatric patients.

BACKGROUND: TMC207-C211 (NCT02354014) is a Phase 2, open-label, multicentre, single-arm study to evaluate pharmacokinetics, safety/tolerability, antimycobacterial activity and dose selection of bedaquiline (BDQ) in children (birth to <18 years) with multidrug-resistant-TB (MDR-TB).METHODS: Patients received 24 weeks' BDQ with an anti-MDR-TB background regimen (BR), followed by 96 weeks of safety follow-up. Results of the primary analysis are presented based on data up to 24 weeks for Cohort 1 (≥12-<18 years; approved adult tablet at the adult dosage) and Cohort 2 (≥5-<12 years; age-appropriate 20 mg tablet at half the adult dosage).RESULTS: Both cohorts had 15 patients, of whom respectively 53% and 40% of Cohort 1 and Cohort 2 children had confirmed/probable pulmonary MDR-TB. Most patients completed 24 weeks´ BDQ/BR treatment (Cohort 1: 93%; Cohort 2: 67%). Geometric mean BDQ area under the curve 168h values of 119,000 ng.h/mL (Cohort 1) and 118,000 ng.h/mL (Cohort 2) at Week 12 were within 60-140% (86,200-201,000 ng.h/mL) of adult target values. Few adverse event (AE) related discontinuations or serious AEs, and no QTcF >460 ms during BDQ/BR treatment or deaths occurred. Of MGIT-evaluable patients, 6/8 (75%) Cohort 1 and 3/3 (100%) Cohort 2 culture converted.CONCLUSION: In children and adolescents aged ≥5-<18 years with MDR-TB, including pre-extensively drug-resistant-TB (pre-XDR-TB) or XDR-TB, 24 weeks of BDQ provided a comparable pharmacokinetic and safety profile to adults.