The GeneXpert diagnostic testing technology from the US corporation Cepheid, and its parent company Danaher, has revolutionised rapid, accurate diagnosis of tuberculosis (TB) and other diseases, since entering the market in 2010. Yet, due to the high cost of the GeneXpert test cartridges, many countries are not able to scale up testing for all people who need lifesaving diagnosis and subsequent treatment.
At the September TB summit, world leaders must commit to ambitious action to defeat TB
TB is the world’s leading infectious disease killer. Poor political commitment and underfunding of TB research and development (R&D) are fuelling this global health emergency.
World leaders will meet in New York on 26 September 2018 for the first ever UN High-Level Meeting (HLM) on TB. Ahead of the summit, Médecins Sans Frontières (MSF) joins others in calling on governments to make firm commitments to close the deadly gaps in TB testing, treatment and prevention. To save lives, governments must pledge to scale up use of the tools we have to tackle TB today – and commit to developing and delivering faster, safer and simpler tools for tomorrow.
An ancient and deadly disease
Kyaw Thu, 26, is receiving treatment for multidrug-resistant TB at an MSF clinic in Yangon, Myanmar. His treatment will take two years to complete and consist of 12,000 pills and 168 painful injections. Photograph by Alessandro Penso/MAPS
People continue to lose their lives to TB because they can’t access treatment, or because the treatment they need simply doesn’t exist at all.
An estimated 1.6 million people died from TB in 2017. TB is also the leading cause of death among people living with HIV – an estimated 300,000 of whom died due to TB the same year.
Of the estimated 10 million people who fell ill with TB in 2017, only 6.4 million were diagnosed1, leaving more than 3.5 million people with TB undiagnosed and untreated. Late diagnosis can lead to delayed treatment initiation, poorer treatment outcomes and greater risk of transmitting TB to others.
Drug-resistant TB (DR-TB) is a growing threat. By 2050, DR-TB could cause up to one-quarter of an estimated 10 million deaths every year due to antimicrobial resistance (AMR).
Diagnosing DR-TB is difficult. In 2017, only 29% of people with DR-TB are diagnosed; just 25% were started on treatment.
Standard treatments for DR-TB can take up to two years and can have severe side effects, including deafness and psychosis; they also have low cure rates: 55% for multidrug-resistant (MDR) and 34% for extensively drug-resistant (XDR) TB.
Saving lives today
Governments have a responsibility to rapidly scale up the use of improved TB diagnostic, treatment and prevention tools that are already available. A growing body of evidence shows that treatment regimens containing the newer DR-TB drugs bedaquiline and/or delamanid are more beneficial to patients than standard regimens.4,5,6 However, these medicines remained inaccessible to almost 90% of people who were eligible to receive them in 2017. New World Health Organisation (WHO) recommendations released in August 2018 prioritise the use of oral drugs, including bedaquiline.6 Expanding access to safer, more effective, injection-free treatment regimens will improve treatment outcomes and prevent the needless suffering that often results from older treatments.
Research and development for tomorrow
The 2015 “End TB” goals endorsed by WHO Member States to reduce TB deaths and new infections cannot be met unless improved treatment regimens, fast and simple diagnostics and effective vaccines are developed. Although governments also committed to support and intensify TB R&D, current funding is extremely insufficient. There is an estimated $1.3 billion per year funding gap8.
Governments have a collective responsibility to mobilize the TB research community and to immediately and significantly increase TB R&D funding for affordable new treatments, diagnostics and vaccines. Action is needed to expedite the development and delivery of:
Faster, safer and simpler all-oral treatment regimens that are effective to treat children and adults and all forms of TB, and adapted for use in low-resource settings. This requires a healthier drug pipeline that continues to deliver multiple improved treatment regimens.
TB diagnostic tools suited for use in low-resource settings, including rapid drug resistance tests for all TB drugs to guide individualised, appropriate and effective treatment for people with DR-TB.
Governments have a collective responsibility to create an enabling environment and support novel collaborative research models that guarantee a better public return on public investment. Action is needed to ensure researchers and developers:
Follow agreed-upon target product and treatment regimen profiles that address priority health needs and deliver tools adapted for use in low-resource settings;
Share research results, including pre-clinical and clinical trial data, as well as molecules, in order to accelerate research and facilitate the development of regimens comprising novel classes of drugs; and
Commit to equitable access and fair pricing of end products, including by ‘de-linking’ investments in R&D from the expectation of high profits through high prices and sales.