Wwhen she was pregnant with her second child, Busisiwe Beko was living with HIV, but it didn’t worry her. She has been taking antiretroviral drugs for years and as an experienced AIDS activist in South Africa she knew that as long as she continued to take her pills every day, her second baby would be born free of infectionjust like his first.
But another disease lurked in Beko’s lungs: tuberculosis (TB). hiding behind the common signs of pregnancy. The disease turned her pregnancy into a nightmare.
At the clinic she attended in the Western Cape township of Khayelitsha, she was given drugs as soon as nurses realized she had TB, but they didn’t work. When she was five months pregnant, she was diagnosed with drug-resistant TB (DR-TB).
Beko became sicker. “I wasn’t sure I was going to make it,” she says.
After seven months of pregnancy, she was finally admitted to hospital, but because there are few treatments known to be safe for pregnant women, she didn’t start medication – a brutal 24-month drug regimen – until after he was born. Her son was born with DR-TB.
Worldwide, approx 500,000 people a year are diagnosed with DR-TBwhich is already difficult to treat without the added complication of pregnancy. In fact, there is still no recommended treatment regimen for DR-TB in pregnant women.
Pregnant women are excluded from drug trials, meaning doctors don’t have high-quality clinical trial data to work with. Instead, they must rely on shaky forms of evidence, such as individual case reports, analyses of patient records and data from animal studies or trials in which people were allowed to continue to participate after an unexpected pregnancy.
The result is that pregnant women do not benefit from the shorter, softer and more efficient TB treatments that have emerged over the years.
Women are also likely to face discrimination and substandard care from wary health professionals in some countries. Some have been called “fools” for getting pregnant or even being forced into an abortion because “we don’t know what you will give birth to”, according to a 2019 study in South Africa’s KwaZulu-Natal province.
This is not unique to TB drugs. Less than 1.5% of drug trials conducted between 1960 and 2013 included pregnant women. A key reason is fears about potential risks to the fetus. The 1960s thalidomide scandal – in which a drug intended to treat morning sickness resulted in more than 10,000 children being born with severe birth defects – added to researchers’ hesitation.
Since her experience, Beko (49) has been fighting for change and there are signs that it is working.
In May, the World Health Organization’s first working group on TB in pregnancy held its first meeting. The group is made up of scientists, researchers and activists, including Beko – whose son, Onahoyo, is now a healthy 18-year-old.
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“Being pregnant does not mean that people cannot make good decisions for themselves,” says Beko, who works for the South African organization. TB proof. “Pregnant and lactating women deserve good quality healthcare just like anyone else.”
Meanwhile, the results of the first TB trials to include pregnant women from the start – the Beat TB trial conducted in South Africa, which the WHO list as one of 30 countries with the highest burdens of the disease – is assessed.
Pregnant women will also be included in two trials conducted by the Smart4TB Consortiumwhich will determine the effectiveness of shorter treatment regimens. Smart4TB is a USAid-funded project led by Johns Hopkins University’s TB Research Center with groups including the Elizabeth Glaser Pediatric Aids Foundation, and Treatment Action Group.
The Prisma TB trial will begin in December or January, and the Violation TB trials will begin later in 2025.
“It is time for researchers to stop saying ‘we don’t have data’. The data is there in the communities, they have to start collecting it,” says Beko.
“Pregnant and breastfeeding women have clear options for HIV, a disease that only emerged in the 1980s,” she says. “Why is this not the case for TB, which has been around for so much longer?”
Nicole Salazar-Austin, an assistant professor of pediatrics at Johns Hopkins University, says the world of TB has not yet caught up with the progress made with HIV. Earlier in the HIV epidemic, it was clear that doctors had to start giving pregnant women drugs because more than half of babies born with the virus would die by the age of two.
“Babies are affected by TB, but this is not always the case infected,” she says. “The outcomes are not great; they can be born early or small, and TB can also increase the risk of miscarriage.”
Including pregnant women in trials will require some adjustments, Salazar-Austin says. They will need extra monitoring for any changes in the mother’s or baby’s health, and doses will need to be carefully determined.
Clinical trials are never completely free of dangers, but Salazar-Austin believes that highly controlled trials are the right place for the risks to be explored.
“These risks exist in any case. But without good information, it falls squarely on the shoulders of the pregnant women and their doctors.”
