Roughly four years after the World Health Organization recommended that the newest drugs against tuberculosis be made available to patients for whom they represented a last resort, fewer than a fifth of patients needing them have received them, according to a report in the International Journal of Tuberculosis and Lung Disease.
The approvals of bedaquiline in 2013 and delamanid in 2014 represented long awaited advances in the field of tuberculosis treatment, which hadn’t seen a new drug in half a century, and a reprieve for patients whose disease didn’t respond to older drugs, or who could not tolerate sometimes permanently debilitating side effects from those drugs.
While the new drugs came with caveats of their own, including a potential effect on heart rhythm during use, they had been demonstrated to be effective in clearing and curing the tuberculosis disease where other medicines hadn’t worked.
With added concerns about the pricing of the drugs, and the imperative to protect the effectiveness of the new treatments, national TB program uptake of medicines was slow. While a 2017 WHO report estimating 89 countries were making bedaquiline available, and 54 countries were including delamanid, that does not necessarily reflect broad access to the drugs in many countries providing the medicines as exceptions, rather than the rule for patients in need, under compassionate use programs, authors of the report note.
To assess the gap between need for the medicines and access, researchers led by Dr. Vivian Cox of the Stop TB Partnership’s Drug-Resistant TB Scale-UP Treatment Action Team, collected monthly data from 36 countries on numbers of patients treated with the medicines between 2015 and 2017, data from the partnership’s Global Drug Facility on orders placed for the drugs, and estimates from 2015 and 2016 WHO TB reports on the numbers of patients started on any treatment for multidrug-resistant tuberuclosis who would qualify for the new drugs. While an estimated 29,900 people were estimated to be eligible for the new medicines in 2015, and 39,313 in 2016, by July 2017 just 10,852 patients had received either of the two drugs. The difference in access between the drugs was stark as well and reflected continuing issues with the costs of the drugs — with 10,164 people receiving bedaquiline, which a USAID-sponsored partnership with the drug manufacturer was supplying without cost in some countries, and 688 receiving delamanid. Of the 688 who received delamanid, more than 78 percent — all but 142 of them — had received the drug through a UNITAID project making the drug available at lower cost.
Significantly, South Africa, where the burden of multidrug-resistant tuberculosis is severe, but which also has embarked on a multifaceted effort to tackle the disease, accounted for 60 percent of bedaquiline use worldwide (Russia accounted for another 20 percent). Along with pointing to a need across the globe to scale up access to the drugs, the authors note, the data indicates a potential for other nations to glean lessons from South Africa’s comparably accelerated scale-up.