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Tuberculosis: New Treatment Approved For Deadly Infection - CNN
CNN —
The US Food and Drug Administration approved a new treatment for highly drug-resistant tuberculosis, offering new hope in the fight against the world's most deadly infectious disease.
TB most affects the lungs and can be particularly difficult to treat. Drug-resistant strains are on the increase due to incomplete and challenging courses of treatment that last for more than 18 months.
Pretomanid, a compound developed by the nonprofit TB Alliance and approved by the FDA on Wednesday, forms part of a three-drug regimen that people can take orally over six months. It treats two drug-resistant strains of the disease, XDR-TB and MDR-TB.
"Until very recently, people infected with highly drug-resistant TB had poor treatment options and a poor prognosis," said Dr. Francesca Conradie, principal investigator of the trial. "This new regimen provides hope with nine out of 10 patients achieving culture negative status at six months post-treatment with this short, all-oral regimen."
Tuberculosis claims 4,400 lives a day worldwide. According to the World Health Organization, highly drug-resistant strains account for more than 500,000 of the 10 million new cases of the disease each year and are found in 127 countries around the world.
Scientists tested safety and effectiveness of Pretomanid, which is taken together with bedaquiline – approved as a TB treatment in 2012 – and linezolid, an antibiotic, in patients in South Africa.
Of the 107 patients who were evaluated six months after the end of therapy, 95 (89%) had a successful outcome.
South Africa's burden of the airborne disease is particularly high, as a high incidence of HIV works with drug-resistant TB, weakening immune systems to make people more susceptible.
"The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options," FDA Principal Deputy Commissioner Amy Abernethy said in a statement.
Pretomanid is expected to be available in the United States by the end of this year, with the European Medicines Agency and the World Health Organization highly likely to follow suit and approve the treatment.
Pretomanid is only the third new anti-TB drug approved for use by the FDA in more than 40 years.
Treatment of highly drug-resistant TB has traditionally been complex and lengthy, with patients taking a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer. Some older regimens can cause patients to lose their hearing.
Dr. Mel Spigelman, president and CEO of TB Alliance, said the new "regimen will hopefully provide a shorter, more easily manageable and highly efficacious treatment for those in need."
"FDA approval of this treatment represents a victory for the people suffering from these highly drug-resistant forms of the world's deadliest infectious disease."
Millions Of People Could Live Thanks To New Access To Tuberculosis ...
Patrick Pleul/AP
Get your news from a source that's not owned and controlled by oligarchs. Sign up for the free Mother Jones Daily.Johnson & Johnson announced on Friday that the company will not enforce patents for the lifesaving tuberculosis treatment bedaquiline in 134 low- and middle-income countries globally. Bedaquiline, which was approved in 2012, is an essential part of treatment for multidrug-resistant tuberculosis, also known as MDR-TB. MDR-TB impacts half a million people annually, and 200,000 of those infected will die.
Bedaquiline was the first new tuberculosis drug to become available in around forty years, and its development was a major step forward in treating the deadly illness. But for millions of patients globally, the drug has been out of reach. Johnson & Johnson's patent prevented cost-effective generic versions of the drug from being available to many in lower-income countries where tuberculosis is most prevalent and most deadly.
The announcement from Johnson & Johnson has the potential to reduce the price of bedaquiline by at least 50 percent, greatly increasing the availability of the drug globally. Johnson & Johnson has faced immense pressure to give up control of its patent from organizations like Doctors Without Borders and Partners in Health. Doctors Without Borders began a public campaign against the company in 2019, arguing that because taxpayers had invested five times more in the development of bedaquiline than Johnson & Johnson, it was wrong for the corporation to control the price of the drug.
Those advocates are now celebrating a major step towards treating tuberculosis globally. "Johnson & Johnson's announcement is a heartening example of solidarity, and one that will make a real difference in the lives of the half-million people who newly fall sick with MDR-TB each year," said Partners In Health CEO Dr. Sheila Davis in a statement.
The hugely popular author and YouTuber John Green has also been extremely vocal about pressuring Johnson & Johnson to drop enforcement of their patent, recently penning a piece for the Washington Post about his experience visiting a tuberculosis treatment center in Sierra Leone in 2019. On Saturday, he celebrated the enormous victory on YouTube. "This is the announcement that we have been waiting for and that I have to confess, despite my ridiculous over-the-top optimism about all this stiff never thought was possible."
Bedaquiline-based Treatment Associated With Favorable Outcomes In ...
December 09, 2019
2 min read
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Russell Kempker
Bedaquiline-based regimens for treating patients with multidrug-resistant tuberculosis, MDR-TB, were associated with favorable outcomes and a lower rate of acquired drug resistance compared with delamanid-based regimens, according to a study conducted in the country of Georgia.
"At the time of this study, bedaquiline was approved by the FDA and delamanid by the [European Medicines Agency] for use among certain patients with multidrug-resistant tuberculosis and these medications were eagerly received by the TB community and being implemented into national TB programs, including in the country of Georgia. However, there [were] relatively scarce data on their use and performance in programmatic settings," Russell Kempker, MD, MSc, assistant professor of medicine in the division of infectious diseases at Emory University School of Medicine, told Infectious Disease News.
"Additionally," Kempker said, "there [were] no available data comparing outcomes among patients receiving a bedaquiline- vs. Delamanid-based regimen, and at the time of this study, it was recommended not to combine these drugs and there was no clear preference for prioritizing either drug. The implementation of bedaquiline and delamanid into MDR-TB treatment regimens in the country of Georgia provided us with a unique opportunity to carry out a comparison of outcomes."
Kempker and colleagues conducted a prospective, observational study among patients with MDR-TB Georgia at the Georgian National Center for Tuberculosis and Lung Diseases. According to the study, they performed monthly sputum cultures, minimum inhibitory concentration testing and monitored participants for adverse events.
In total, 100 participants with MDR-TB were enrolled, including 64 receiving bedaquiline-based treatment and 31 receiving delamanid-based treatment. Results of the study showed that median effective dose was four in each group, but rates of acquired drug resistance were significantly higher among patients receiving delamanid (36%) compared with those receiving bedaquiline (10%). Additionally, adjusted rates of sputum culture conversion at 2 months (67 vs. 47%) and 6 months (95 vs. 74%) and favorable clinical outcomes (96 vs. 72%) were higher among patients receiving bedaquiline compared with those receiving delamanid.
Kempker said they were "pleasantly surprised to find such a high rate of favorable outcomes among patients with MDR-TB receiving a bedaquiline- or delamanid-based regimen as compared with those seen in prior studies with traditional second-line regimens."
"The use of new antituberculosis drugs offers excellent new options in the treatment of MDR-TB, and based on our data, bedaquiline-based regimens are especially promising and can achieve extremely high cure rates," Kempker said. – by Caitlyn Stulpin
Disclosures: The authors report no relevant financial disclosures.
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