November 21, 2023
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Key takeaways:
- Two phase 3 trials showed levofloxacin reduces the risk for multidrug-resistant TB after household exposure.
- There was a 60% reduction in risk, according to a novel analysis that combined data from both trials.
Levofloxacin was safe and reduced the risk for multidrug-resistant tuberculosis among children, adolescents and adults by 60% in two phase 3 trials, according to results presented at the Union World Conference on Lung Health.
The studies, conducted separately among children in South Africa and adults and adolescents in Vietnam, confirmed the safety and efficacy of levofloxacin and identified a method to prevent the spread of multidrug-resistant TB (MDR-TB) among family and household members, researchers said.
Globally, there were 7.5 million people diagnosed with TB in 2022, the highest number of cases since 1995, according to WHO, which noted that the increase can at least partially be attributed to public health system improvements in many nations.
There were more than 410,000 cases of MDR-TB or rifampin-resistant TB reported worldwide in 2022, with roughly two in five patients receiving treatment, according to WHO. Of these, roughly 115,000 infections occurred in children, with fewer than four in five able to receive treatment.
“There have been many advancements in the science around preventing drug-susceptible TB but very little rigorous data on preventing drug-resistant TB,” Anneke Hesseling, MBchB, MSc, PhD, director of the Desmond Tutu TB Centre at Stellenbosch University in Cape Town, South Africa, said in a press release. “We have now found a way to safely protect children when an adult in the household has MDR-TB. The importance of safeguarding our children from drug-resistant disease cannot be underestimated.”
The first study, TB-CHAMP, was a community-based, cluster-randomized, placebo-controlled phase 3 trial conducted in South Africa by Hesseling and colleagues at six research sites in five South African provinces among 922 children exposed to an MDR-TB-positive adult in their household.
Participants received oral levofloxacin once a day for 6 months or placebo. Five children (1.1%) in the levofloxacin group and 12 (2.6%) in the placebo group developed TB, resulting in a 56% reduction in TB risk.
The second study, V-QUIN, conducted by Fox and colleagues, was a double-blind randomized controlled trial conducted in 10 Vietnamese provinces between March 2016 and August 2019 among 2,041 adults and adolescents with a median age of 40.
Participants received levofloxacin or placebo for 30 months, with six participants (0.6%) in the levofloxacin group diagnosed with TB compared with 11 (1.1%) in the placebo group, for a roughly 45% reduction in TB risk, according to the researchers.
Researchers analyzed the data from both studies jointly using a novel Bayesian approach developed at the University College London, which showed a 60% reduction in MDR-TB risk among participants treated with levofloxacin.
“We now have evidence that people with early infection can be protected from becoming sick due to drug-resistant TB,” Greg Fox, PhD, MIPH, FRACP, MBBS, BSc, GAICD, professor at the Woolcott Institute of Medical Research and the University of Sydney, said in a press release. “This 6-month, once-daily treatment can protect adults, children and adolescents and young kids from the physical, social and financial consequences of drug-resistant TB.”
References:
- First effective treatment to prevent multidrug-resistant TB. https://www.ucl.ac.uk/news/2023/nov/first-effective-treatment-prevent-multidrug-resistant-tb. Published Nov. 16, 2023. Accessed Nov. 21, 2023.
- Fox GJ, et al. Abstract LB02-106-16. Presented at: World Conference on Lung Health; Nov. 15-18, 2023; Paris.
- Hesseling AC, et al. Abstract LB02-107-16. Presented at: World Conference on Lung Health; Nov. 15-18, 2023; Paris.
- New preventive treatment for children cuts the risk of drug-resistant tuberculosis by more than half, in first-ever study of its kind. https://unitaid.org/news-blog/new-preventive-treatment-for-children-cuts-the-risk-of-drug-resistant-tuberculosis-by-more-than-half-in-first-ever-study-of-its-kind/#en. Published Nov. 16, 2023. Accessed Nov. 21, 2023.
- Tuberculosis response recovering from pandemic but accelerated efforts needed to meet new targets. https://www.who.int/news/item/14-11-2023-who-launches-new-5-year-roadmap-to-prevent-and-treat-tb-in-children-and-adolescents. Published Nov. 7, 2023. Accessed Nov. 21, 2023.
- Two new clinical trials find first-ever safe and effective treatment to prevent multidrug-resistant TB in both children and adults: Results presented at Union Conference in Paris. https://blogs.sun.ac.za/dttc/benefit-kids-breaking-news/. Published Nov. 16, 2023. Accessed Nov. 21, 2023.
- WHO launches new 5-year roadmap to prevent and treat TB in children and adolescents. https://www.who.int/news/item/14-11-2023-who-launches-new-5-year-roadmap-to-prevent-and-treat-tb-in-children-and-adolescents. Published Nov. 14, 2023. Accessed Nov. 21, 2023.
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