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One small medicine, one giant leap to treat tuberculosis



The infectious disease that once kills most people annually today, in 2019, is tuberculosis (tuberculosis). This fact may be surprising to many who think of tuberculosis only in connection with well-known consumables from works of art such as Mimi La Boem, Violetta La Traviata or Hans Castrop of the Magic Mountain.

Fortunately, the US is at an ever-lower rate with tuberculosis rates – less than 10,000 cases per year. Approximately one-third of the world's population is infected with tuberculosis bacteria, and in 2017, approximately 1.6 million people died of tuberculosis.

Existing cases of tuberculosis are sometimes very difficult to treat. This challenge, which is synergistic with all other difficulties in the treatment of tuberculosis (such as multidrug regimens, social circumstances, co-infection with HIV), is antibiotic resistance. Tuberculosis is a bacterial infection, and like any other bacterial infection, the threat of antimicrobial resistance is emerging.

Tuberculosis resistance can be to a single drug or to multiple drugs. The latter, when administered to two spinal tuberculosis drugs, is called multidrug-resistant tuberculosis (MDR-TB) and represents about 3.7 percent of new cases.

Within the MDR-TB class is a lethal subset of extremely drug-resistant tuberculosis (XDR-TB). There are no good drug regimens to treat this infection and those that do exist are toxic, extremely cumbersome in terms of the severity of the pills and the need for intravenous therapy. And prolonged XDR-TB is often a death sentence. The Revolution in Treatment with XDR-TB Food and Drug Administration (FDA). The drug is called pretomanide and will be used in combination with two other pre-approved drugs (Bedaquilin and Linezolid in the so-called BPaL regimen) in the treatment of drug-resistant tuberculosis.

The Nix-TB clinical trial that led to its approval included 1

09 patients with XDR or MDR TB and included a 6-month course of treatment. Although there was no control group in this trial – an important limitation to keep in mind – a breakthrough cure rate of 89 percent was achieved. This percentage of 89 percent was achieved with 3 medications in 6 months compared to the poor 34 percent cure rates resulting from the historical medication regimen of 18 to 24 months 6-8. This type of result is exceptional. New ways and incentives for anti-infective agents the most difficult infectious disease to treat. It is also important because its approval uses some of the important new pathways and incentives that have been created, some as part of the 21st Century Treatment Act, in recognition of the fact that antimicrobial resistance and infectious diseases are generally unique in biotechnology, ie pharmaceutical and healthcare.

Antibiotics should be used judiciously through proactive guidance in order to maintain their maximum efficacy against resistance. Because they are relatively inexpensive and are accepted for a certain period of time, they are not big profits.

The return on investment, after the cost of developing billion-dollar drugs, is not attractive, so the move of antibiotic pharmaceutical companies and the threat of bankruptcy remain among those who remain. Reflecting this reality, pretomanide has been uniquely developed by the non-profit organization, the Tuberculosis Alliance.

The approval of Pretomanid is an important step as it illustrates the additive impact of many systems designed to stimulate the development of infectious disease control. Pretomanid was the subject of an accelerated review of the priority and approved using a modified criterion known as restricted population (LPAD).

This time, because it targets a small population of patients with few options, it allows for smaller and shorter clinical trials than would otherwise be the case. Qualified Infectious Disease Product (QIDP) has also been identified, which increases the time to market exclusivity before generic versions can be licensed. Pretomanid also deserves a tropical medicines priority voucher that can be sold very favorably to another pharmaceutical company allowing a quick review of a different FDA product. Hopefully, other infectious diseases can successfully navigate these myriad programs.

As with any new test for the diagnosis of antimicrobials, vaccines or infectious diseases, I note the development of preomanid as a major technological advance that increases the resilience of humanity to the existing threats of infection. The emergence of a true treatment option for one of the deadliest forms of top killer infectious disease is a great example of the power of the human mind. What used to be a problem is an elegant and relatively simple solution.

Dr. Adalja Board Certified for Infectious Diseases, Critical Care Medicine, Emergency Medicine and Internal Medicine. He is a senior scientist at the Jones Hopkins Health Center. Follow him on Twitter: @AmeshAA .


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