Ferlazzo G, et al. - In this study, early safety and efficacy of regimens containing the bedaquiline and delamanid combination were described in patients with drug-resistant tuberculosis in Yerevan, Armenia; Mumbai, India; and Khayelitsha, South Africa. Researchers noted no additive or synergistic QTcF (QTc corrected using the Fridericia formula)-prolonging effects via using bedaquiline and delamanid combination. For people with few treatment options, access to bedaquiline and delamanid in combination should be expanded while awaiting the results of formal clinical trials.

Methods

• A retrospective analysis was performed of a cohort of all patients who received 6–12 months of oral bedaquiline and delamanid in combination (400 mg bedaquiline once per day for 2 weeks, then 200 mg bedaquiline three times per week and 100 mg delamanid twice per day) in MSF-supported projects.
• Serious adverse events, QTcF interval data, and culture conversion data during the first 6 months of treatment were reported.

Results

• This analysis included 28 patients (median age 32·5 years [IQR 28·5–40·5], 17 men) from Jan 1, 2016, to Aug 31, 2016.
• Among these, 11 (39%) were reported to be HIV-positive.
• Isolates resistant to fluoroquinolones were noted in 24 patients (86%); 14 patients (50%) showed extensively drug-resistant tuberculosis.
• They identified no patient with an increase of more than 500 ms in their QTcF interval.
• In this study, 4 patients (14%) showed six instances of QTcF increase of more than 60 ms from baseline but none permanently discontinued the drugs.
• Seven patients experienced 16 serious adverse events.
• Seventeen (74%) of 23 individuals with positive baseline cultures converted to negative by month 6 of treatment.