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국내외 결핵(TB)뉴스

학술연구자료

STOP-TB 한국사무국 소식

2023 Union World Conference on Lung Health 가 2023년 11월 15~18일 프랑스 파리에서 3년만에 직접 개최되었습니다. 신약의 개발과 함께 진행되었던 연구성과들이 컨퍼런스에서 발표되었으며, 중요한 결핵 연구의 개요를 아래의 공식 보도 자료에서 확인할 수 있습니다.

• New global research: Four new, improved drug regimens could cut treatment time for drug-resistant TB by up to two-thirds
  (15 November 2023)
• New research: Safer, shorter, and more effective treatment discovered for TB
  (16 November 2023)
• ‘The time for the global TB community to act is now’ - new research shows failure of current policies to eradicate TB
  (17 November 2023)
• New research: How drones are tackling TB in the Himalayas
  (18 November 2023)

Тhe World Health Organization and the Stop TB Partnership with support from the U.S. Agency for International Development and the Global Fund to Fight AIDS, Tuberculosis and Malaria convened a global meeting of the Working Group on Public-Private Mix for TB Prevention and Care in Paris, France on 12 November 2023 on the sidelines of the 2023 Union World Conference on Lung Health. Detailed overview of the meeting is available here.

The World Health Organization (WHO) is seeking experts to serve as members of the Civil Society Task Force on TB (CSTF-TB). The WHO CSTF-TB provides a platform for discussion and exchange with WHO on leveraging engagement with civil society and affected communities at all levels to accelerate progress towards ending TB in line with WHO End TB Strategy. Full details about the call are available here. The deadline to apply has been extended until 7 December 2023.

After three years being held virtually due to the COVID-19 pandemic, the 2023 Union World Conference on Lung Health took place in-person on 15-18 November 2023 in Paris, France under the theme 'Transforming evidence into practice'. The official press releases, giving an overview of a number of important TB studies presented at the Conference, can be accessed here. The Union World Conference on Lung Health, convened annually by the International Union Against Tuberculosis and Lung Disease (The Union), is the world’s largest gathering of clinicians and public health workers, health program managers, policymakers, researchers, affected communities and advocates working to end the suffering caused by lung disease, with a focus specifically on the challenges faced by low- and lower-middle income populations.

To mark World Diabetes Day, 14 November, the World Health Organization highlighted the need for equitable access to essential care for people affected by diabetes and TB. 'Equitable access to essential care for people with TB and diabetes is something that we must strive for. Optimal management of both conditions has the potential to improve health outcomes, including TB treatment outcomes and health related quality of life. The Political Declaration of the UN High-Level Meeting on TB recognizes the fundamental importance of addressing the drivers of the TB epidemic, including diabetes, underlining that equitable access to screening, prevention, treatment and co-management is essential.' (Dr Tereza Kasaeva, Director of the World Health Organization Global TB Program)

The World Health Organization (WHO) released the third edition of the Roadmap towards ending TB in children and adolescents. The Roadmap outlines an ambitious five-year plan with 10 key actions to improve the prevention, treatment, and care of TB in children and adolescents.The full press release on the Roadmap launch event with the accompanying materials can be accessed here. Médecins Sans Frontières issued a statement welcoming the release of the Roadmap and urging all countries with high TB burden to prioritize adoption, implementation and scale-up of the WHO’s consolidated guidelines on management of TB to reduce the number of children killed by TB. TB remains a major killer in children, causing the death of a child every 3 minutes.

The Stop TB Partnership launched a call for nominations for the Community Award 2023 under the theme Serving the most vulnerable: Increasing access to TB services for key and vulnerable populations. Each year, the Stop TB Partnership recognizes significant contributions from TB-affected communities and civil society to the TB response in high TB burden settings with the Stop TB Partnership Community Award. Full details about the nomination process are available here. The deadline for nominations is 1 December 2023.

TB Alliance launched a new Pan-Phase 2 clinical trial incorporating elements of Phase 2a, b and c, identified as NC-009, to evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of TB Alliance’s BPaL regimen (comprised of bedaquiline, pretomanid, and linezolid). This new regimen has the potential to become a 'universal TB regimen', shortening and improving treatment for both drug-sensitive and drug-resistant TB. Results from preclinical and Phase 1 studies presented at the 2023 Union World Conference on Lung Health showed that the new compound, when compared with bedaquiline (a TB medicine in the same drug class), eliminated TB bacteria faster and had a potentially safer profile.

The interim results of the LIFT-TB operational research from five Central and Southeast Asian countries (Indonesia, Kyrgyzstan, the Philippines, Uzbekistan, and Vietnam) showed that the new, shorter drug-resistant TB (DR-TB) treatment regimen – BPaL (comprised of bedaquiline, pretomanid, and linezolid) – had a 94.5% cure rate in countries with a high DR-TB burden. Interim results of this research, along with results from the Ukraine program, were presented at the 2023 Union World Conference on Lung Health, in addition to four abstracts from the Philippines on additional advantages of the BPaL regimen. LIFT-TB program provides funding, resources, technical assistance, and wide-ranging expertise from multiple partners for seven countries (Indonesia, Kyrgyzstan, Myanmar, the Philippines, Ukraine, Uzbekistan, and Vietnam) to advance the implementation and rollout of the BPaL regimen. BPaL and BPaLM (comprised of bedaquiline, pretomanid, linezolid, and moxifloxacin) were officially recommended by the World Health Organization for all patients with multidrug- or rifampicin-resistant TB in 2022

The endTB clinical trial results presented at the 2023 Union World Conference on Lung Health revealed evidence to support the use of four new, improved, all-oral regimens to treat multidrug- or rifampicin-resistant TB (MDR/RR-TB). Three of the regimens have shown similar efficacy and safety to conventional MDR-TB treatment while reducing treatment time to 9 months. The fourth regimen could be used effectively as an alternative for people who cannot tolerate bedaquiline or linezolid. If recommended by the World Health Organization, these new treatment regimens would empower clinicians to offer shortened MDR-TB treatment regardless of age, pregnancy, and comorbidities. For further details about the endTB clinical trial results, download a leaflet here, watch a short video here, visit endTB.org.

Two clinical trials results presented at the 2023 Union World Conference on Lung Health showed that an oral antibiotic taken for six months once-daily substantially reduced the risk of developing multidrug-resistant TB (MDR-TB). The TB-CHAMP Phase 3 clinical trial tested levofloxacin in children as part of the BENEFIT Kids project and showed it safely reduced the risk of developing MDR-TB disease in children by 56%. The V-QUIN Phase 3 clinical trial tested levofloxacin in adults and adolescents and found it reduced the risk of developing MDR-TB disease in adults and adolescents by 45%. Both pieces of research are expected to guide World Health Organization recommendations for preventing MDR-TB in children and adults anticipated in the coming months. In addition, results of PERFORM, CATALYST, and ChilPref studies were presented, exploring the pharmacokinetics, safety, tolerability and acceptability of child-friendly formulations of key drugs used in treating MDR-TB (levofloxacin, clofazimine, moxifloxacin and linezolid).

Treatment Action Group (TAG) released the latest addition to its series of Activist Guides, In 2022, the World Health Organization updated its guidelines for treating drug-resistant TB (DR-TB), recommending a six-month cure. This guide lays out what activists need to know about the new DR-TB treatment regimens, andequips them with actions they can take and arguments they can use to advocate for access to those regimens.

The UNITE4TB Consortium announced the start of its Phase 2B/C clinical trial program which will test 14 combinations of nine existing TB drugs, as well as two newly developed candidates (GSK656 and BTZ-043). The ultimate aim is to create regimens that can further improve multidrug-resistant TB treatment, and also be effective for drug-sensitive TB. Full details about the program are available here. Watch a short video here.

STREAM Stage 2 study data submitted. as part of Type II Variation to European Medicines Agency (EMA) and supplemental New Drug Application to U.S. Food and Drug Administration (FDA) aim to support the full and traditional approval of SIRTURO® (bedaquiline) in the European Union and U.S., respectively.

Indian pharmaceutical company Macleods has become the second manufacturer to launch pretomanid, a new medicine and essential component of shortened, World Health Organization (WHO)-recommended treatment regimens for drug-resistant TB. Under license from TB Alliance, Macleods will be able to supply to 135 low- and middle-income countries. Macleods has recently commenced supplying pretomanid to the Stop TB Partnership's Global Drug Facility for distribution of the medicine to those countries. Source : TB Alliance

The Association for Social Development (ASD) has registered 206 participants with drug-resistant TB (DR-TB) in Pakistan through a pilot program for treatment with new regimens recently recommended by the World Health Organization (WHO), known as BPaL/M – combinations of bedaquiline, pretomanid, and linezolid, with or without moxifloxacin. ASD reported that out of 113 treatment outcomes declared, so far 105 (95%) have been successful. As an outcome of these positive results, Pakistan has updated its treatment guidelines for DR-TB to enable the use of these six-month, all-oral regimens. Source: TB Alliance

In a recent study, published in The Lancet Respiratory Medicine, researchers reported the final TB-PRACTECAL clinical trial outcomes, evaluating the efficacy and safety of oral bedaquiline, pretomanid, and linezolid (BPaL)-based regimens for pulmonary TB resistant to rifampicin.

With one of the highest TB incidences (368/100,000) in the African region, Mozambique is particularly affected by the TB epidemic. Drug-resistant TB is also a major problem, with 4,800 new cases of multidrug- (MDR)/rifampicin-resistant TB in the country estimated in 2021. Even more worrisome, researchers found a high proportion of fluoroquinolone resistance and increasing resistance to bedaquiline among MDR-TB strains.

Researchers have developed a new and rapid test that can detect both HIV and TB at the same time with just a small amount of blood. In a new paper published in Clinical Chemistry, researchers described the new blood-based test that can not only detect the two diseases but also measure their viral and bacterial loads in patients.