In April 2015, USAID and Janssen Therapeutics officially launched the bedaquiline (BDQ) donation initiative, under which Janssen committed to providing free BDQ to 30,000 patients with multidrug-resistant tuberculosis (MDR-TB) over a four-year period. Along with delamanid, BDQ is one of only two new TB medicines released to the market in over 40 years. These medicines are being used for the treatment of MDR-TB patients, as well as TB patients who have experienced life-altering side effects or developed intolerance or resistance to some second-line TB drugs.
To learn about implementing new TB medicines in the Ugandan context, we talked to Hawa Nakato, who works with SIAPS partner the Uganda Health Supply Chain (UHSC) as a Senior Technical Officer for the National TB and Leprosy Program.
Approximately how many MDR-TB patients are in need of treatment in Uganda? How many are expected to receive treatment through the BDQ donation program?
240 patients were enrolled in treatment during the course of 2015, and more than 700 have been treated since the MDR-TB program began in 2012.At present, two patients are awaiting bedaquiline treatment at the National Referral Hospital, and an estimated five patients per quarter are expected to enroll in BDQ treatment.
In your experience, what problems commonly arise over the course of treatment? (i.e. emergence of resistance to medicines, lack of patient adherence to treatment, lack of supplies, etc.)
Often, there is poor patient adherence to treatment. Additionally, important monitoring tests and chest X-rays are not freely available for all patients. We have also run into a lack of supplies, including medicines like clofazimine, capreomycin, linezolid, and amoxicillin/clavulanic acid that are needed to treat patients with extended drug resistance.
Patient errors and lack of adherence to treatment regimens can increase drug resistance and render effective treatments ineffective. What steps can be taken in Uganda to ensure that new TB medicines are used properly by patients?
Strategies for management include directly observed therapy administered by health workers and support of treatment by family members to ensure patients are adhering to treatment instructions. Patients should also be counselled by health workers, both at the initiation and during the course of treatment, and should be given socioeconomic support when necessary to ensure they are able to reach the health facilities and maintain a proper diet.
What steps are being taken to access the BDQ donation program? How is SIAPS Program facilitating access to the new TB medications?
The National TB Program first reviewed WHO policy guidelines on the use of BDQ, and then placed a request for a donation through the GDF in October 2015. A stakeholders meeting was held on the 14th Jan 2016 with support from SIAPS Program. SIAPS Program is now providing technical assistance in developing an implementation plan for the BDQ program, and will facilitate a training of trainers for health workers of the MDR TB treatment sites scheduled to take place in April 2016. SIAPS Program is also working to secure supplies of companion medicines like linezolid and clofazimine, which are not currently stocked in the country. We expect a donation of linezolid, moxifloxacin, and amoxicillin/clavulanic acid from Pakistan.
What challenges have you faced in getting the country ready for BDQ?
We lack procurement and supply management costs for BDQ and the donation of linezolid, amoxicillin/clavulanate, and moxifloxacin. Additionally, MDR-TB patients cannot freely access tests like the ECG due to the fear of transmission of the infection to non MDR-TB patients.
What partners have you worked with to implement the BDQ donation program in Uganda?
Currently there are a number of partners involved in the preparations, including the Ministry of Health, TRACK TB and UHSC (implemented by Management Sciences for Health), the WHO, the Clinton Health Access Initiative, the National Drug Authority, and the Mulago Hospital pilot site. We plan to bring on board other partners, including implementing partners who can support MDR-TB treatment sites, national medical stores, and health workers at the MDR-TB treatment sites.