A new TB regimen reduces the course of treatment for patients

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Dr. Susan Dorman, represented here in her lab at the Medical University of South Carolina, led the trial of the new treatment for tuberculosis. Credit: Sarah Pack, Medical University of South Carolina.

Tuberculosis (TB) is a deadly infection that occurs in all parts of the world. Standard treatment for tuberculosis, a six-month multidrug regimen, has not changed in more than 40 years. Patients may have difficulty completing the long regimen, making resistance to treatment more likely to develop.

A research team led by a researcher at the Medical University of South Carolina (MUSC) reports in the May 6 issue of the New England Journal of Medicine that a four-month treatment regimen with rifapentin is effective for the treatment of tuberculosis. Shortening the duration of treatment is an important step towards increasing .

In 2019 alone, 1.4 million people died from tuberculosis worldwide. Tuberculosis is caused by a bacterial infection that attacks the lungs of those infected. The World Health Organization estimates that a quarter of the world’s population has a tuberculosis infection and that these people will have a 5% to 10% risk of developing all of TB disease. People with compromised immune systems, such as people with HIV, have a much higher risk of developing TB.

“Tuberculosis often affects adults in the early hours of their lives,” said Susan Dorman, MD, a professor at the MUSC College of Medicine and lead author of the study. “This disease and treatment can alter lives and push families into poverty.”

Although tuberculosis can be cured and prevented, multidrug-resistant tuberculosis remains a threat to public health. Resistance occurs when bacteria develop the ability to defeat drugs designed to kill them. When a colony bacterium finds out how to defeat a certain one , can quickly communicate these instructions to neighboring bacteria, similar to sending a group text message.

The current treatment for those with an active TB infection is a multidrug regimen over six to nine months. Because different antibiotics use different mechanisms to defeat bacteria, TB is treated with several antibiotics at once to decrease the chances of the bacteria becoming drug resistant.

“Patients’ adherence to the prescription drug regimen has been a huge problem worldwide and is the main factor that has led to highly drug-resistant forms of tuberculosis, which are much more toxic, expensive and require a lot of time to deal, ”he said. Sleep.

Reducing the time needed to treat tuberculosis has long been a major public health goal. The more patients complete their tuberculosis treatments, the less likely the bacteria are to escape knowingly to defeat a particular drug and continue the group message thread toward other bacteria.

“Shortening treatment time improves adherence, decreases program costs, and decreases patient loads themselves,” Dorman explained.

Dorman and his MUSC team worked with both a Centers for Disease Control and Prevention (CDC) and a trial group at the National Institutes of Health to find a way to shorten the overall duration of treatment needed to completely cure the disease.

The team focused on a drug called rifapentin. This drug is similar to the antibiotic used in the current TB treatment protocol, but remains effective in the body for longer periods of time. Over the course of 15 years, Dorman and his team performed a preclinical and initial phase to determine the best way to use this medicine. They determined what dose should be given, how often the drug can be administered, and what other antibiotics should be combined. They then launched a Phase III global study with the TB Trials Consortium and the AIDS clinical trials group.

Patients with active tuberculosis infections were treated with one of two four-month rifapentin-based regimens or the standard six-month regimen. They followed them for 12 months. The results of the trial revealed that the four-month regimen containing rifapentin and another antibiotic, moxifloxacin, worked as well as the six-month regimen. It was also safe and well tolerated by patients.

Dorman and his team hope these results will change the way tuberculosis is currently treated. In the United States, the results of their trials will be presented to the Food and Drug Administration (FDA). After the FDA reviews the data, the CDC will get involved and issue guidelines to change the treatment regimen. This process can take another twelve months to complete. Meanwhile, Dorman and his team have met with WHO representatives to develop guidelines for the new treatment.

“We hope the WHO will adopt this regime and recommend it to everyone,” Dorman said.

The results of this great Phase III trial emphasize the importance of global participation and collaboration.

“Our intention was to enroll participants who reflected the global global population of people with TB so that our results could be generalized,” Dorman said.

They also made sure to include those under the age of 18, along with people who have HIV. People living with HIV are 18 times more likely to develop active TB compared to people without HIV. The combination of HIV and tuberculosis is particularly lethal because the HIV virus attacks the major immune cells that help coordinate a defense against TB bacteria. It is important to note that HIV patients eliminated tuberculosis as well as those who did not have HIV in this phase III study.

“This work really represents a milestone in the care of tuberculosis and some of the scientific work included in this trial will help us and others understand how to further improve the treatment of tuberculosis,” Dorman said. “Four months is still too long.”


Four-month rifapentin regimen with moxifloxacin not inferior to tuberculosis


More information:
Susan E. Dorman et al, Four-month diets of rifapentin with or without moxifloxacin for tuberculosis, New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2033400

Citation: A new tuberculosis regimen reduces the course of treatment for patients (2021, June 4) recovered on June 4, 2021 at https://medicalxpress.com/news/2021-06-tuberculosis-regimen-shortens-treatment -patients.html

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