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My patient’s choice – the Jolene Samuels MDR-TB Pledge

A carer’s pledge to offer patients an informed choice between a novel drug or an injectable drug for the treatment of MDR-TB

~ In loving memory of nurse Jolene Samuels, MDR-TB Champion & Cochlear Implant recipient ~

Jolene Samuels #TBunmasked from Visual Epidemiology on Vimeo.

 

I, the undersigned, am involved in the direct and/or indirect care of people with MDR-TB (multidrug-resistant tuberculosis). I hereby pledge to empower the people I care for to choose between the use of a novel drug (currently bedaquiline or delamanid) or an injectable aminoglycoside drug as part of their MDR-TB regimen, based on all relevant information about known benefits and risks shared with them.

I acknowledge that there are current data limitations, but in my opinion there is enough information to reasonably assume that MDR-TB regimens with a novel drug are at least equally effective compared to the old MDR-TB regimen containing an injectable during the intensive phase of treatment. Based on all available information, as summarised in a recent review by Reuter et al, both current novel drugs likely result in fewer serious adverse events than the injectables, particularly debilitating irreversible ones such as hearing loss, which may occur in as many as half of people treated with injectables for MDR-TB. I am also aware that an individual patient data meta-analysis of 9153 patients from 32 observational studies with MDR-TB in 2012 by Ahuja et al found no association between the use of any injectable agent and the probability of treatment success. Furthermore, in the new shorter MDR-TB treatment course of nine months the injectable agent has been replaced by bedaquiline for all pregnant patients in the Western Cape Province of South Africa, and injectable-free regimens have been recommended by the WHO for some children who are living with MDR-TB.

There are a number of clinical trials currently being done to formally assess the efficacy and safety of injectable free regimens, but the results of these studies are likely to take several years to become available. Given the limited evidence to support the efficacy of injectable agents and the clearly documented safety risks they pose, I believe that persons living with MDR-TB should be offered treatment options that would allow them to avoid the use of injectable agents in their treatment plan, while simultaneously according them the right to enjoy the benefits of scientific progress. (London et al, 2016)

I therefore commit to giving every person diagnosed with MDR-TB under my care the opportunity to choose whether they would prefer to be treated with an MDR-TB regimen that contains a novel agent (either bedaquiline or delamanid) or one that contains an injectable agent. In settings where novel drugs are not yet available, I will ensure my patients can take part in shared decision making about their care and I will support their calls for access to safer and more effective alternatives.

 

Signed:

Anybody involved in the direct or indirect care of people with TB is most welcome to sign on. For more information or if you would like to get more involved, please email vuzumsi@gmail.com.

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