by Mel Spigelman, President and CEO, TB Alliance – World Tuberculosis Day, 24 March 2018.
Phumeza Tisile is a young South African woman, one of the too few people fully cured of extensively drug-resistant tuberculosis (XDR-TB), a strain of TB that is resistant to at least four commonly used anti-TB drugs. Her path to surviving XDR-TB was long and arduous. The University of Cape Town student endured three and a half years of treatment, hundreds of painful drug injections and about 30,000 pills. She initially lost her hearing, a side effect of one of the standard drugs still used to treat drug-resistant TB.
Phumeza is, however, a TB success story. XDR-TB kills about two-thirds of those diagnosed. There is no approved, highly effective and safe treatment. Instead, healthcare providers are forced to use an assortment of often poorly active and highly toxic antibiotics which can wreak havoc on the body if used for the length of time treatment requires.
Drug-resistant TB is on the rise. The World Health Organization (WHO) estimates that in 2016 there were 600,000 new cases with resistance to rifampicin – the most effective first-line drug, of which 490,000 had multidrug-resistant TB.
The dearth of new treatments for drug-resistant as well as drug-susceptible TB is holding back progress to meet international goals for ending the pandemic by 2030. Except for two new drugs coming to market in recent years (bedaquiline and delamanid), most TB therapies on the shelf are old, too frequently ineffective and often toxic.
Until recently, paediatric tuberculosis patients have had even fewer treatment options. Children with TB are often given drugs made for adults. These tablets are large, unpalatable and come in the wrong doses. Parents and caregivers have had to break or crush pills or mix them with food to mask their taste. This inadequate approach has led to negative treatment outcomes for the world’s youngest victims of TB, with nearly 600 children dying every day. In response to this growing need, TB Alliance in partnership with our donors such as Unitaid has brought to market new formulations for children that are specifically adapted for their needs. These quality-assured, affordable treatments are markedly improved versions of the existing first-line medicines, dissolvable in water, flavored and easy to administer to kids. Since the 2016 launch of these improved medicines, close to 80 countries have ordered more than 700,000 treatment courses.
TB Alliance continues to advance drug regimens that could significantly impact the tuberculosis pandemic. Results from late-stage clinical trials point to the possibility of a new treatment paradigm consisting of two short, simple regimens to treat all people with TB, including the most difficult cases. The Nix-TB trial, for example, is testing a three-drug regimen that includes the novel drugs bedaquiline and pretomanid as well as linezolid in XDR-TB patients who, like Phumeza, have few if any treatment alternatives. We are working closely with the Medicines Patent Pool to ensure that if successfully developed, new treatments will be widely available in low- and middle-income countries where 95% of deaths from TB occur.
The science is slowly advancing, but not nearly rapidly enough to improve the treatment paradigm for millions of people living with the infection. The lack of sufficient research and development (R&D) funding is stalling progress. The WHO reports that despite accounting for about two percent of deaths globally, TB receives only 0.25 percent of the estimated USD265 billion spent worldwide on medical research each year. The WHO also estimates that R&D budgets must amount to more than USD1 billion annually to meet the challenges of addressing the TB pandemic. We are losing years of patients’ lives to inadequate and harmful treatment, while missing thousands in need of care through the lack of proper and effective diagnostics and therapeutics.
At last November’s WHO Ministerial Conference on Ending TB in Moscow, governments around the world acknowledged the need to invest in TB R&D to push new compounds through the pipeline as quickly as possible. We need a redoubling of this commitment at the global level. Today’s treatments take six to thirty months or longer and are at best 50% effective for people with drug-resistant TB. Long treatment times and debilitating side effects result in poor adherence, which drives the development of even more resistant forms of the infection. Tuberculosis can be eradicated, but only with a markedly enhanced commitment from governments, non-governmental organisations and private sector constituencies.
For patients like Phumeza, we must do better.