Global TB Caucus event updates on the future of the TB response with the roll out of a promising new treatment regimen for highly drug-resistant TB
(September 1, 2021, Manila) A panel event held today by the Global TB Caucus highlighted recent progress in the response to tuberculosis (TB), including drug-resistant forms of the disease, in the Asia Pacific and around the world. Chaired by Dr. Angelina “Helen” D.L. Tan, M.D, Chairperson, Committee on Health, House of Representatives, Philippines and Asia Pacific Co-Chair of Global TB Caucus, the event reported on the adoption of new therapies to treat highly drug-resistant forms of TB, the need to expand access to new TB technologies, as well as the importance of continued investment in the development and delivery of improved technologies to prevent, diagnose and treat TB in all its forms.
In her opening remarks, Cong. Tan highlighted the significance of the event by calling for urgency. "Unless broad immediate action is taken, [we] will not meet the targets agreed in the Political Declaration from the UN HLM on Tuberculosis. We hope these stories will not only educate you, but further galvanise each of us to work much harder to ensure that the TB response and people with TB get the resources and care they deserve, as well as supporting those in the fight against it. But more importantly, to make sure that the world remains committed to investing in TB research and development."
Each year, there are approximately ten million cases of active TB. In 2020, an estimated 1.5 million people died of TB, according to the World Health Organization (WHO), although the precise numbers are not known and recent research suggests that TB could have killed as much as half a million more people in that same year (1). The Asia Pacific region, covering three of the six (WHO) Regional Offices (WPRO, SEARO and EMRO), represents more than 60 percent of the world’s population and more than 68 percent of the global TB burden.
The event focused on the burden of multidrug-resistant (MDR) TB and extensively drug-resistant (XDR) TB, forms of the disease which have traditionally been especially deadly and difficult to treat, but for which a new therapy has recently been developed and introduced. The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa) and linezolid (L)—received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB (2) and has shown efficacy rates between 84 percent and 93 percent in the recently completed ZeNix trial. Developed by the non-profit TB Alliance, the all-oral, six-month, three-drug regimen has now been procured by more than 30 countries, including several in Asia.
Following this, Eloisa "Louie" Zepeda-Teng, President of TBPeople Philippines and a survivor of MDR-TB recounted her battle with TB. When Ms. Zepeda-Teng fought MDR-TB in 2007, there were no reliable diagnostic tests and treatments were woefully inadequate. Ms. Zepeda shared that it took months to identify her condition and was subsequently put on 24 months of treatment. During her treatment, she suffered permanent vision loss and severe depression.
Historically, treatment for highly drug-resistant TB would consist of thousands of pills and injections administered over 18 months or longer, with reported global success rates averaging 43 percent (3,4). Subsequent advances shortened the duration of treatment and eliminated the need of injections, though pill burden remained extremely high. The approval of the BPaL regimen offers a path to further shorten and simplify therapy for highly drug-resistant TB.
Dr. Pauline Howell, a TB doctor and researcher based in Johannesburg recounted her experiences treating people who suffered from MDR-TB and XDR-TB with traditional therapies, contrasting them with her experiences as an investigator on TB Alliance’s Nix-TB and ZeNix clinical trials of the BPaL regimen. Dr. Howell recalled, “how encouraging it was when patients who have been [at the hospital] for several years ended up getting culture converted quickly and discharged”.
Sandeep Juneja, Senior Vice President, Market Access at TB Alliance, gave an update on TB Alliance’s efforts to ensure global access to the regimen. Mr. Juneja highlighted a number of important milestones achieved in the global roll out of BPaL, including Leveraging Innovation for Faster Treatment of Tuberculosis (LIFT-TB), an initiative to broaden adoption of BPaL targeting seven countries across Southeast and Central Asia, including Indonesia, Myanmar, The Philippines, and Vietnam. Mr. Juneja emphasized the need to continue to secure donor investments and commitments to support the widespread and rapid adoption of new technologies to advance the global battle against the disease.
Dr. Anna Marie Celina G. Garfin, National Tuberculosis Program Manager, Department of Health, Philippines provided an overview of the country’s recent progress in more proactively and effectively combating TB, including MDR-TB and XDR-TB. The Philippines was one of the early adopters of a WHO recommendation to implement a shortened MDR-TB therapy, which enabled the country to improve the efficacy and reach of its MDR-TB treatment programs. Iterating the importance of remaining on the forefront of new tools to combat TB, Dr. Garfin noted that the Philippines is participating in the LIFT-TB initiative, with a goal of enrolling 100 patients in the program by the end of this year.
The final speaker, Dr. Stephanie Williams, an Ambassador for Regional Health Security at Australia’s Department of Foreign Affairs and Trade (DFAT) offered perspective from a donor country that helped fund the development and roll-out of pretomanid and the BPaL regimen, improved TB diagnostics, and strengthening of health systems. Dr. Williams noted, “Australia sees a clear role for funders to support across the spectrum—TB R&D through product development partnerships, operational research funding in our region, supporting national TB programs, strengthening regulatory authorities, and underneath all of that, continued health system strengthening.”
On a global level, many of these activities are not sufficiently funded. For example, despite significant progress in the development of new technologies to address TB, there remains a near USD1.5 billion funding gap in TB research. The Stop TB Partnership estimates USD2.16 billion is needed annually to develop and deliver new drugs, vaccines, and diagnostics required to end the TB pandemic, but recent data indicates that slightly less than USD700M was invested in 2019. As many bilateral funders of TB research base their funding levels on GDP, the economic impact of the COVID-19 pandemic is expected to exact a significant toll on these already insufficient funding levels.
The event was attended by Parliamentarians and other government representatives from around the world, as well as TB and global health advocates, product developers, and other global health stakeholders. The Global TB Caucus will continue to engage with its network of parliamentarians to share information and seek guidance on the latest developments in the fight to end TB.
About the Global TB Caucus
The Global TB Caucus is a unique international network of more than 2500 parliamentarians that has presence in more than 150 countries. We work collectively and individually towards ending the TB epidemic.
We are a non-political and non-partisan global network of parliamentarians who share a commitment to end the tuberculosis (TB) epidemic. Led by its members for its members, the Caucus aims to transform the response to TB through targeted interventions at national, regional, and global levels.
About Tuberculosis
TB, in all forms, must be treated with a combination of drugs; the most drug-sensitive forms of TB are typically treated for six months using four anti-TB drugs. An estimated 1.5 million people died of TB in 2020, according to the World Health Organization (WHO), although the precise numbers are not known and recent research suggests that TB could have killed as much as half a million more people in that same year.
Drug-resistant forms of TB develop when the long, complex, decades-old TB drug regimen is improperly administered, or when people with TB stop taking their medicines before the disease has been fully eradicated from their body—highlighting the urgent need to develop better and shorter treatment regimens. Once a drug-resistant strain has developed, it can be transmitted directly to others through the air, just like drug-sensitive TB. There are over half a million cases of drug-resistant TB each year and its spread undermines efforts to control the TB pandemic. Drug-resistant TB accounts for close to one-third of all deaths caused by antimicrobial resistant pathogens around the world.
About the BPaL Regimen
The six-month, all-oral, three-drug regimen was studied in TB Alliance’s pivotal Nix-TB trial, which demonstrated a favorable outcome in 90 percent of patients, as published in the 5 March 2020 issue of the New England Journal of Medicine. It includes a new chemical entity developed by TB Alliance and commercialized by their global partner Viatris as part of the regimen, which has been approved as an oral tablet formulation for the treatment of adult patients with highly drug-resistant TB strains.
Treatment of highly drug-resistant TB strains has historically been lengthy and complex; most patients are treated with a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer.
If you have any questions, please email:
Kaye Yuvallos
Communications and Partner Engagement Manager
Global TB Caucus
Sources:
WHO (2021). Impact of the COVID-19 pandemic on TB detection and mortality in 2020. Available at: https://www.who.int/publications/m/item/impact-of-the-covid-19-pandemic-on-tb-detection-and-mortality-in-2020
Pretomanid and BPaL. Full Prescribing Information. August 2019.
The Review on Antimicrobial Resistance. Tackling Drug-Resistant Infections Globally. Available at: www.amr-review.org
WHO (2020). Global TB Report 2020.