Successful implementation of bedaquiline for multidrug-resistant TB treatment in remote Papua New Guinea

Abstract

Setting: Bedaquiline (BDQ) was introduced in the multidrug-resistant tuberculosis (MDR-TB) programme in Daru in remote Papua New Guinea in 2015, along with a core package of active drug-safety monitoring (aDSM). Objective: To assess interim results and safety of BDQ for the treatment of MDR-TB from 1 July 2015 to 31 December 2017. Design: A retrospective cohort analysis of routine programme data. Results: Of 277 MDR-TB patients, 77 (39%) received BDQ with a total of 8 serious adverse events including 5 (6.5%) deaths, of which 1 (1.3% QTcF prolongation, grade 3) was attributable to BDQ. Of 200 (61%) patients who did not receive BDQ, there were 17 (9%) deaths. Completeness of monitoring for the BDQ group was 90% for 5 electrocardiograms and 79% for 2 cultures. In the interim result indicator analysis at month 6 in the BDQ and non-BDQ groups, there were respectively 0% and 1% lost to follow-up; 6.5% and 8.5% who died; 94% and 91% in care; and 92% and 96% with negative culture among those monitored. Conclusion:Early experience in Daru shows BDQ is safe and feasible to implement with aDSM with good interim effectiveness supporting the rapid adoption and scale-up of the 2019 WHO MDR-TB treatment guidelines in the programme and in similar remote settings. * Among eligible patients who had 2 valid culture tests sent 30 days apart (see Figure 2 for full definitions). MDR-TB = multidrug-resistant tuberculosis; BDQ = bedaquiline.

Efficacy of Bedaquiline in the Treatment of Drug-resistant Tuberculosis: A Systematic Review and Meta-analysis

“…Taune, M., et al conducted a retrospective cohort to describe the implementation of bedaquiline and assess the safety and interim effectiveness for MDR-TB patients commenced on bedaquiline, their results found that bedaquiline is a safe and feasible drug with good interim effectiveness [20]. Studies based on children and adolescents with DR-TB also show that bedaquiline containing regimens are effective and well tolerated in children and adolescents, which may provide new ideas for tuberculosis treatment in this group and contribute to the global strategy to end tuberculosis [20][21][22]. However, we did not evaluate the e cacy of bedaquiline in the treatment of children and adolescent patients with DR-TB, further studies are needed.…”

“…There are many adverse reactions in the use of bedaquiline, such as hyperuricaemia, nausea, arthralgia, liver injury and QT prolongation and so on [18][19][20][21][22][23][24]. Guglielmetti, L., et al found nearly 20% patients experienced a > = 60-ms increase in QT interval, and leading to bedaquiline discontinuation in 6% patients [19].…”

Telemedicine in Resource-Limited Settings to Optimize Care for Multidrug-Resistant Tuberculosis

“…Although there were a number of concurrent interventions across this time period, we believe that this service has contributed, in part, to the very good outcomes now seen for MDR-TB patients in Daru (20, 21). Treatment success rates for the 2015 MDR TB enrolment cohort were 81%, with only 4% of patients being lost to follow up and 4% failing treatment (20).…”

“…This led to the establishment of the emergency response task force for MDR-TB in 2014, led by the National Department of Health in PNG with support from the Australian Government, across three identified “hotspot” provinces, including Daru, Western Province. The programmatic interventions during the response in Daru 2014-17 and clinical care model have been described elsewhere (20, 21).…”

“…The telemedicine service facilitated the uptake of innovations where technical support was required. The programmatic use of the TB drug Bedaquiline was scaled up in PNG in 2016, procured by the National TB Program, and supported by the global donation program (21). In this context, the consilium proved useful in supporting local clinical decision making in the scale up of this drug where there was little previous in-country experience and a limitation on its supply.…”