TB Clip 2023년 2월호 본문 이미지

편집자 한마디!

국내외 결핵(TB)뉴스

학술연구자료

STOP-TB한국사무국 소식

23년 새해 벽두부터 항결핵 신약의 국내 출시와 국내발 신약의 연구개발 및 상용화가 결핵퇴치의 시기를 앞당기고 있습니다. 지난50년 베다퀼린, 델라마니드에 이어 세번째 승인된 결핵약 프레토마니드가 1월부터 광범위 약제내성 및 치료내성 또는 비반응성 다제내성 폐결핵에 대하여 건강보험급여가 적용되어, regimen의 선택지가 하나 더 늘어났습니다. 또한 국내 바이오벤쳐인 큐리언트는 결핵치료제 개발 전문 국제기구인 TB얼라이언스와 기술이전 계약을 체결하여, 경구용 cytochrome bc1 억제제인 텔라세벡의 개발 및 상용화에 박차를 가하고 있습니다. 현재 Cycloserine을 WHO에 납품하고 있는 동아ST도 신규 결핵치료 후보물질을 발굴한 후 다제내성균에서 약효 평가 등을 진행할 예정이라고 합니다. 큐리언트와 동아ST의 항결핵 신약들이 전세계의 결핵퇴치에 한 획을 긋는 날이 빨리 오기를 기대해 봅니다.

The World Health Organization (WHO) invites all stakeholders to comment by 9 March 2023 on the latest drafts of the target regimen profiles for TB treatment and the target product profiles for tests for TB treatment monitoring and optimization, by means of online feedback forms. Full details about the invitation are available here.

The Stop TB Partnership announced the theme for this year’s World TB Day: Yes! We Can End TB. The theme brings attention to TB and that it is in our collective power to end TB by 2030 and therefore reach the Sustainable Development Goals. The campaign will contribute to boosting global TB awareness and ensure the endorsement of a strong political declaration and maximum participation by the Heads of State and Heads of Government at the upcoming UN High-Level Meeting on TB in September 2023. World TB Day is observed every year on 24 March to build public awareness about the global TB epidemic and efforts to eliminate the disease.

The World Health Organization announced the publicly accessible global individual patient data (IPD) platform for TB treatment (TB-IPD) , an initiative that will increase the knowledge base for normative guidance on optimal treatment modalities for TB and stimulate TB research. Requests for access to data from, or to contribute more data to the TB-IPD platform can be made by following the processes described on the TB-IPD platform website.

The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the latest practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms.

WHO announces plans to establish a TB Vaccine Accelerator Council. The Council will facilitate the licensing and use of effective novel TB vaccines catalysing high-level alignment between funders, global agencies, governments and end users in identifying and overcoming barriers to TB vaccine development.

On Valentine’s Day 2023, the Stop TB Partnership was invoking the feeling of togetherness and the collective will to fight against all odds and support all the people who are suffering and those in need, and save lives. Its social media toolkit with images and messages to share has been uploaded to the official website.

Treatment Action Group (TAG) released the 2022 Tuberculosis Treatment Pipeline , putting results from phase III drug trials in context, sheding light on the next generation of TB treatment shortening research, and providing an update on the status of nineteen new or repurposed drugs in clinical development for TB. The report is the final installment in TAG’s series of TB Pipeline Reports covering 2022, following previous reports on TB vaccines and diagnostics.

Policy Cures Research released the G-FINDER 2022 report analyzing research and development (R&D) funding trends for neglected diseases. The report revealed that global investments in TB R&D totaled $723 million in 2021, comparable to last year’s total and far short of the $2.16 billion estimated by the Stop TB Partnership as needed annually to develop and deliver the suite of drug regimens, vaccines, and diagnostics that can end the TB pandemic. The press release announcing the report can be accessed here . TB Alliance's statement on the report is available here

Qurient Co. Ltd. and TB Alliance announced that they have entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for the treatment of tuberculosis and other non-tuberculosis mycobacterium infections. Source: TB Alliance

On 17 January 2023, the Indian Patent Office held its final hearing on a patent challenge filed by two TB survivors to prevent Johnson & Johnson from extending its monopoly on bedaquiline beyond the primary patent expiry in July 2023. The verdict is expected in about four weeks. If the Indian Patent Office decides in favour of the petitioners to the challenge, it will pave the way for generic versions of bedaquiline to enter into the global market and into countries. Advocates urged Johnson & Johnson to correct its course and stop blocking entry of generic versions of the drug (see here and here )

According to the World Health Organization, of the roughly 10 million people who fall ill with TB annually, over 80% survive, in most cases due to a six-month treatment course. Unfortunately, as with long COVID, being cured is not always the last hurdle and many people go on to struggle with post-TB lung disease. Post-TB lung disease refers to any chronic lung or respiratory abnormality after the successful completion of TB treatment. Source: Spotlight

The State of California Department of Public Health, Tuberculosis Control Branch (CDPH), the Rutgers Ernest Mario School of Pharmacy (EMSOP), the Rutgers Global Tuberculosis Institute (GTBI), and the Curry International Tuberculosis Center (CITC) released a guide, Rifamycin Drug-Drug Interactions: A Guide for Primary Care Providers Treating Latent Tuberculosis Infection , summarizing drug-drug interactions between drugs commonly used in primary care and rifamycins, in the context of treatment of latent TB infection.

The bacillus Calmette-Guérin vaccine against tuberculosis—or simply BCG—is the oldest vaccine in the world that is still currently in use. Millions of infants in Africa and Asia receive the inoculation each year. Source: Scientific American

Pulmonary hypertension (PH) is estimated to be highly prevalent among people with a history of tuberculosis (TB) who successfully completed treatment, a study in South Africa reports. Source: Pulmonary Hypertension News

TB researchers find link between vaccine efficacy, environmental pathogens. Tuberculosis is an infectious disease of the lungs that’s been with humanity for centuries and affects a quarter of the world’s population. The stubborn disease killed over a million and a half people in 2021 , mostly in lower- and middle- income countries where access to basic resources is scarce.

Urgent action necessary to improve equitable access to bedaquiline-based regiments and achieve 1/4/6×24. Advocates urge Johnson & Johnson to correct its course and stop blocking entry of generic versions of bedaquiline into the global market and into countries. To read the full letter, click here.

Médecins Sans Frontières urges the Indian Patent Office to reject the secondary patent application filed by Johnson & Johnson to prevent the company from extending its monopoly on bedaquiline beyond the primary patent’s expiry in July 2023.

In January, Viatris Korea launched Dovprela (ingredient: pretomanit), a drug-resistant tuberculosis (TB) treatment, which reduced the treatment period from 18-20 months to 5-6 months thanks to its rapid anti-tuberculosis effect.

Skin tuberculosis (TB) is a bacterial infection that can manifest differently depending on the individual, leading to a range of symptoms, including rashes, bumps (lesions), and ulcers on various part of the body. If left untreated, it can lead to serious complications or spread to other parts of body. To read the full article, click here.

The Bacillus Calmette-Guerin vaccine (BCG) was the first effective vaccine to protect the lungs from TB and became the standard vaccine from then on. However, as tuberculosis continues to be a top killer across the world, a new vaccine a new vaccine is urgently in need.

A study , published in Proceedings of the National Academy of Sciences, discovered that over-the-counter drugs commonly used to treat heartburn could shorten the TB treatment, and could also reduce the chances of the TB bacteria becoming drug-resistant.

Mycobacterium tuberculosis has a particularly complex cell envelope, which acts as a physical barrier to antibiotics, making it extremely difficult to treat. Using a computer model, researchers showed how bedaquiline interacted with it on a molecular level. This revealed a level of detail that previously could not be observed and could be critical in developing new and improved TB drugs.

Gaucher disease is a rare disease that is frequent in Ashkenazi Jews. A study , published in Proceedings of the National Academy of Sciences, showed the genes carried by many Ashkenazi Jews that put them at a higher risk of Gaucher disease also help protect them against TB. The fatty chemical that accumulates in the macrophages in Gaucher disease was found to act as a solvent that can kill TB bacteria within minutes by disrupting their cell walls.

Ferredoxins are small proteins that play a pivotal role in the main metabolic pathways, the series of chemical reactions occurring within a cell. Researchers studied the structures of ferredoxins from the tubercle bacillus and their complexes with partner proteins. Their findings would help find targets for new TB drugs.

The TB vaccine (or the Bacillus Calmette-Guérin (BCG) vaccine) does not protect the elderly with co-morbidities against disease symptoms caused by a coronavirus infection. This was reported in the BCG-PRIME study which was initiated during the early days of the COVID-19 pandemic when no vaccines against the virus were available. The study was conducted in 20 Dutch hospitals.

Findings from a study in animal models showed that a U.S. Food and Drug Administration (FDA)-approved antibiotic regimen for multidrug-resistant TB (MDR-TB) -- bedaquiline, pretomanid and linezolid (BPaL) -- may not work for TB meningitis. Studies in a small number of people also provided evidence that a new combination of drugs is needed to develop effective treatments for TB meningitis due to MDR-TB strains.

The International Union Against Tuberculosis and Lung Disease released the February 2023 issue of the International Journal of Tuberculosis and Lung Disease (IJTLD). It includes TB-related research publications.

Researchers conducted a modeling study that showed TB vaccination could be cost-effective in 73 of 105 (70%) low- and middle-income countries. The results, published in PLOS Medicine , also predicted $474 billion in vaccine-related benefits by 2050.

RESIST-TB released its December 2022 newsletter with the latest updates and research publications on drug-resistant TB, including the publication of the TB-PRACTECAL trial results reporting on the efficacy and safety of a six-month, all-oral drug regimen for the treatment of multidrug-resistant TB, and the announcement of a new agreement to reduce the price of pretomanid.

The 1/4/6x24 (one, four, six by 2024) Campaign calls for TB patients to have access to evidence-based, long-awaited, shorter, less toxic treatment. But without mass availability of drugs, can India afford to adopt the protocol. Experts worldwide have argued for swifter implementation of short-course regimens as a human right in Nature Medicine.

A case report published in Frontiers in Immunology concluded that vitamin D can help the immune system fight TB. Researchers have long suspected that vitamin D can help fight the disease, but they did not have direct proof, until now.

Researchers found high rates of TB among high-risk patients who sought care at primary health care clinics in South Africa, many of whom had no preceding symptoms suggesting a high rate of subclinical TB.

Study published in Open Forum Infectious Diseases found that people with latent TB infection have more inflammation and could be at a higher risk for cardiovascular disease.

According to a systematic review and meta-analysis published in the International Journal of Infectious Diseases , increased mortality and longer time to sputum culture conversion among individuals with multidrug-resistant TB is significantly associated with undernutrition.

Researchers published results from a study using cutting edge-technology to identify new targets for novel TB vaccine candidates, exploring the role of T cells - immune cells critical to control the Mycobacterium tuberculosis.

A study published in The Lancet Global Health reported on the cost and cost-effectiveness analysis of decentralised molecular testing for TB in Uganda.

The International Union Against Tuberculosis and Lung Disease released the January 2023 issue of the International Journal of Tuberculosis and Lung Disease (IJTLD). It includes TB-related research publications.