NEJM: Treatment for tuberculosis shortened by 30% to only four months
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NEJM: Breakthrough! The treatment period for tuberculosis has been shortened by 30% to only four months.
A 4-month phase III clinical trial of tuberculosis treatment proved to be as effective as the 6-month standard treatment.
Pulmonary tuberculosis (TB), also known as the “white plague”, is a disease caused by tuberculosis bacillus infection. It usually causes lung infections and also infects other systems of the body. According to statistics from the World Health Organization, a quarter of the world’s population suffers from latent tuberculosis.
Currently, the standard treatment for tuberculosis consists of four drugs, rifampicin, isoniazid, pyrazinamide and ethambutol. With this treatment, approximately 95% of patients can be cured of tuberculosis.
Recently, researchers from the University of Texas Health Science Center published a research paper entitled “Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis” in the top international medical journal “NEJM”.
The study showed that a 4-month phase III clinical trial of tuberculosis treatment proved to be as effective as the 6-month standard treatment.
The researchers said that the treatment time of the treatment plan was significantly shortened, not inferior to standard treatments, and it was safe and well tolerated.
The study recruited more than 2500 participants in 13 countries/regions, distributed in 34 test sites including Brazil, China (Hong Kong), India, South Africa, Thailand, the United States, Vietnam and Zimbabwe.
The study population was randomly divided into three groups, one group received standard treatment; two experimental multi-drug groups, one with rifapentine and the other with rifapentine and moxifloxacin.
Participants were followed up for 18 months, and the main result of the study was TB-free survival within one year after the study was randomized.
In this phase 3 trial, the non-inferiority of the rifapentin, moxifloxacin regimen and the control regimen was confirmed in the analysis of the population and sensitivity and pre-specified subgroup analysis. The efficacy of the 4-month regimen containing rifapentin but not moxifloxacin did not meet the non-inferiority criteria.
The study found that in the moxifloxacin group, the efficacy of the rifapentine-based 4-month regimen in the treatment of tuberculosis was not inferior to the current standard 6-month regimen.
The researchers said that with the development of the generic drug rifapentin, the medical expenses of tuberculosis will be saved. The research provides a new feasible method for the treatment of the global tuberculosis pandemic.
(source:internet, reference only)
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