19 March 2024 | Stories

Overlooked No More: Access to TB Innovations for Children and Pregnant Women is a Must

Photo credit: Aurum Institute/Unitaid.

Geneva – Ahead of World TB Day, 24 March, Unitaid reaffirms its commitment to accelerate efforts to end tuberculosis (TB) by 2030 by addressing health inequities, making new health products for TB rapidly available to everyone, everywhere, including to neglected populations.

While TB can be prevented and cured, more than 10 million people a year continue to fall ill with this airborne disease, making it one of the world’s deadliest infectious killers. And the drug-resistant forms of the disease remain a challenging growing public health threat.

Like COVID-19, TB has no boundaries, nor does it discriminate. However, a lack of basic health services, poor nutrition and inadequate living conditions exacerbate the spread of TB, leaving poor and vulnerable populations most affected. 80% of cases and deaths of TB occur in low- and middle-income countries.

Children, people living with HIV, and pregnant and post-partum women have a much greater risk of falling ill from TB. In 2022 alone, TB in children and young adolescents accounted for 12% of the global TB burden, with children under the age of five suffering some of the worst outcomes. TB also stands as the leading cause of death among people with HIV and a major driver of maternal mortality worldwide.

Yet for far too long, these vulnerable populations have been neglected, with longstanding gaps in maternal and child TB prevention, diagnosis, treatment and care. Because their specific needs differ from the general adult population, they require tailored approaches in terms of TB care services.

Vulnerable populations have always been at the heart of Unitaid’s response. Our investments have significantly contributed to progress over the last decade in the development, wide-scale introduction and rapid uptake of life-saving TB innovations for children, adolescents and pregnant women, while also furthering broader public health efforts to improve TB care.

As the leading multilateral funder of pediatric TB research for years, Unitaid’s work has generated important evidence to improve the prevention and quality care of TB in children and adolescents. This includes innovative solutions for integrated TB screening, driving TB detection to primary and community levels, enhanced diagnosis and access to treatment, as well as child-friendly medicines, including optimized drug-resistant and preventive treatments.

The challenges of drug-resistant TB in pregnancy and young children

Busisiwe Beko is a drug-resistant (DR) TB survivor and mother of two kids. She lives in Khayelitsha, a township in Western Cape in South Africa, a country where TB mortality remains high, mainly due to HIV co-infections.

Photo caption: Busi was pregnant when she was diagnosed HIV-positive and with DR-TB. Much suffering could have been avoided if she’d had access to appropriate TB preventive therapy. Photo credit: Aurum Institute/Unitaid.

Busi intimately understands the challenges faced by pregnant women living with HIV and dealing with TB. She experienced those challenges back in 2005, at a time when improved diagnosis and treatment were still in their infancy.

“When I found out that I was pregnant, it was really a struggle for me in that period because I was also diagnosed HIV-positive and with TB. I was in a kind of denial, but I was really losing appetite, feeling persistent fatigue and weakness, and had a funny dry cough,” she said.

Maternal TB presents a significant risk to both the mother and the newborn. Failure to diagnose and treat TB promptly can result in heightened neonatal morbidity, premature birth, and other obstetric complications. Because of her HIV status, and without effective and appropriate TB preventive treatment, Busi was more than 15 times more likely to develop active TB than a woman without HIV, putting her and her baby’s health at risk. Also, HIV and TB coinfection can each speed the other’s progress.

Today, although sputum smear microscopy remains common for TB diagnosis in low and middle-income countries, molecular diagnostic tests, some capable of detecting drug resistance simultaneously, are gradually replacing it, bringing early detection and treatment initiation for everyone with signs and symptoms of TB. However, this was not the case for Busi.

Despite taking the antibiotics that she was prescribed at the local clinic, she was not feeling any better. Understandably so, as she had a drug-resistant form of TB. Her dry cough made it impossible to produce the sputum required for testing and, in the absence of confirmatory sputum tests, drug-resistant TB is frequently misdiagnosed and treated with first-line medicines as though it was susceptible to drugs, fueling continued drug resistance.

Busi’s health deteriorated further, and she became very sick.

“I was losing hope to be honest,” she said. “I thought it was because of the pregnancy or the side effects of the treatment. And I didn’t realize that TB was a danger for my baby, I was more worried about HIV. I would have needed human support and counseling to help me going through this.”

Eventually, she was diagnosed with DR-TB. But by the time she received the results, she had safely delivered a baby girl, Othandwayo, who was exposed to and contracted the same drug-resistant strain of TB. Othandwayo was diagnosed with DR-TB at five months of age and remained in the hospital for seven months.

The downward spiral continued.

Busi experienced severe side effects from the second-line treatment that she had to take for 10 months, and which required at that time a combination of extensive toxic medicines including painful injections – medicines that have since been replaced by shorter, more effective drug regimens in most high burden countries.

“This treatment is harsh. I had to take 21 pills a day plus the injections. It made me vomit, feel nauseous and diseased. The injection was torture; it’s so painful when it goes inside your muscles,” Busi said.

Othandwayo had the same treatment as her mother. The healthcare givers had to crush and dissolve the oral tablets, potentially leading to inaccurate dosages.

Busi faced many more challenges beyond the physical vulnerability posed by pregnancy and DR-TB. These included stigma, income loss, separation from children, and suffering due to a lack of empathetic counseling.

Fortunately, Busi and Othandwayo survived DR-TB, but in 2022, still only about two in five people with DR-TB accessed treatment. An estimated 2 million children and adolescents lack preventive treatment, a critical therapy recommended for those living with HIV or exposed to TB at home. Yet TB prevention is considered one of the most critical public health measures in the TB response.

Ensuring no one is left behind

Unitaid and the IMPAACT4TB consortium are expanding access to safer, shorter and more affordable TB preventive treatments, with a special focus on reaching people living with HIV, children under five years old, pregnant women and household contacts of TB patients. Coverage has skyrocketed since this program began, helping drive prices down by more than 85%, increasing manufacturing to more than 4.5 million doses and supporting uptake in 78 countries. To date, this intervention has helped to reach the World Health Organization’s (WHO) endTB targets for coverage of TB prevention in people living with HIV and has paved the way for wide scale-up of TB prevention treatment by key funders, including the Global Fund, PEPFAR and Stop TB Partnership. Moreover, a new child-friendly formulation for short-course TB prevention, which is water-dispersible and fruit-flavored, is reaching the market at an affordable price, improving access for millions of children and adolescents.

The Benefit Kids project introduced the first DR-TB preventive regimen for children which underpinned a WHO rapid communication last month. The development of pediatric treatment and further adaptation of formulations for children typically lags years after an adult treatment is approved, but in this case, pediatric treatments and child formulations were announced at the same time as the first-ever DR-TB prevention for adults.

And the Unitaid-funded EndTB program has led vital research into better, shorter and less toxic treatment options for all people with drug-resistant TB, including children, pregnant women and people with common co-morbidities. If recommended by WHO, four new all-oral regimens for multidrug-resistant (MDR) TB could soon swiftly expand coverage as they are composed of drugs already available in most high-burden countries.

Photo caption: Chad, 5 years old, living with HIV and diagnosed with MDR-TB, is receiving the new child-friendly formulation treatment for DR-TB, as part of the CATALYST study. Photo credit: Stellenbosch University/Unitaid.

Photo caption: Chad, 5 years old, living with HIV and diagnosed with MDR-TB, is receiving the new child-friendly formulation treatment for DR-TB, as part of the CATALYST study. Photo credit: Stellenbosch University/Unitaid.

Bringing better tasting formulations to children with drug-resistant TB

Chad is a 5-year-old boy from an urban community in Cape Town. He is living with HIV and was diagnosed with DR-TB in December 2021. He is enrolled in the CATALYST study, part of the Unitaid’s Benefit Kids project, working on making TB treatment experience more bearable for children in the context of their families and communities.

With the new formulations of critical drugs clofazimine and moxifloxacin which are in tablet form and taste better, it is much easier to administer the treatment compared to the previous formulations.

Unitaid is also investing in long-acting formulations of key medicines that could revolutionize TB prevention and treatment, helping patients to succeed in their treatment and stop spreading the disease.

Unitaid and its partners have joined forces to bridge the gaps in TB care, with an emphasis on pediatric TB, so that stories like Busi’s and her daughter’s become a thing of the past.

“Over the last decade, a lot of improvements in TB have been driven by Unitaid. We have built so much, especially in pediatric and drug resistant TB. You wouldn’t have the same impact in the next ten years if you didn’t have Unitaid. I feel very proud,” said Dessie Tarlton, Programme Manager leading the TB portfolio at Unitaid. “But it’s not solved yet, we need more innovations. I am excited about the new upcoming TB investments that will allow for more patient-centered care.”

In line with the political declaration of the 2023 UN High Level Meeting to accelerate progress to end TB, Unitaid launched a call for proposals aimed at reducing drug-resistant TB cases and deaths by supporting introduction and scale-up of new treatment regimens. The new investments will have a strong focus on people-centered approaches, community-driven demand creation and innovative case-finding.

As the TB community puts out a call of ‘Yes! We can end TB!’ this World TB Day, Unitaid stands in support. But it will require more investments in research and innovation focused on children and pregnant women and all neglected populations to close the gaps and ensure equitable access to TB prevention and care, leaving no one behind.

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