EndtB-Q study illuminates the importance of individual regimes

Some patients with strongly medication -resistant tuberculosis could benefit from shorter treatment with fewer medication, while others can justify more aggressive therapy. This is possible from the results of a new study, which is led by an international group of researchers, including Harvard Medical School scientists, and may be carried out in six countries in Asia, Africa and South America.

The study, some of which is financed by the National Institutes of Health, is known as the EndTB-Q, is the first clinical study that focuses exclusively on people with pre-extemsive drug-resistant tuberculosis (pre-XDB), which drug-resistant TB. Pre-XDR-TB is resistant to the most effective first medication against TB and fluorchinolone, which has so far been the most effective TB medication in the second line.

The results, published on July 14th in The Lancet Respiratory MedicineSelect the importance of individualizing therapy for differences to patients to patients and give each infected person a treatment scheme that is most effective and least toxic for you, according to the researchers.

“This shorter regime is not a deadly remedy for everyone. The great thing is that we may need a tailor -made approach for the treatment of this type of resistant TB,” said the TB Expert Carole Mitnick, professor of global health and social medicine at Blavatnik Institute at HMS. MITNICK was the co-senior author of the study and member of the THETB project, which was cited by partners for health, Médecins Sans Frontières and interactive research and development and was carried out in collaboration with researchers and clinicians worldwide.

In recent years, researchers have increasingly found that shorter, less hard drug regimes benefit certain patients, added.

More than 80 years after the first patients were healed using TB antibiotics, tuberculosis worldwide remains the leading cause of infection and kills almost 1.5 million people a year. The disease has a global range, also in the United States, where more than 500 people have died from TB per year in the past ten years and the cases increase.

One reason for this is drug -resistant tribes of the disease. Another is that many common therapies for patients are difficult for patients due to the number of pills required, the duration of treatment and the serious side effects of many established therapies. This means that the treatment is canceled in some patients so that the infection is flooded back.

The aim of the EndtB-Q study was to test whether a shorter, probably better tolerated treatment against pre-XDR-TB would be effective. The study compared an experimental regime, in which a combination of four medication (Bedaquilin, Delamanide, ClofaziMin and Linezolid) took part in the basis of the standards recommended by the World Health Organization, which included four to six medicines, which was taken for 18 to 24 months for six or nine months.

The results of the study showed that the shorter regime could be a promising alternative for many patients with pre-XDR TB. A favorable result was determined by two consecutive cultures that are negative for the TB bug late in the 17-month period of the follow-up period after the randomization or by favorable bacteriological, radiological and clinical evolution in this follow-up examination. According to this standard, the shorter regime was 87 percent effective, while the longer therapy was 89 percent effective. Both groups of patients received social support, including access to nutritious foods and means of transport that help patients complete the TB treatment.

Research was developed to measure the “non-inferment”, a technical term that describes when experimental treatment is good enough to replace an existing supply standard. In this study, the shorter regime did not meet this standard in the entire study population.

But not all patients reacted to the shorter regime in the same way. For example, those with more advanced lung damage did not occur as well as with less advanced diseases. For these people, the shorter regime – delivered for nine months – was not always sufficient to prevent relapse. These patients benefited more from the longer regime. This could mean that treatment in this group must be longer or that treatment with more medication needs to be reinforced, according to the researchers.

Mitnick found that other studies of shortened regime that included people with this type of drug-resistant TB in their study population did not have enough statistical power to distinguish the effectiveness of regime in people with pre-XDR TB or to distinguish between those with different degrees of symptoms.

The researchers find that the latest guidelines from WHO and North American and European experts who emerged after the end of the EndTB-Q-Studius recommend six-month regime regardless of the severity of the disease. In view of the results of the EndTB-Q study and similar results from other studies, the guidelines should be updated according to the researchers in order to take into account the consideration of layered care approaches on the basis of the resistance pattern and the extent of the disease.

After millennia of the struggle against these complex, constantly developing disease, we know that we have to tackle them with great caution and attention to detail. “

Carole Mitnick, Professor, Blavatnik Institute, Harvard Medical School

“Instead of concentrating on the 'price' of the shortened treatment, we have to keep an eye on the help of the helper as many people as possible.”