In my meeting with Prof. @NNdjeka, 🇿🇦National TB Programme Manager, I highlighted South Africa’s leadership in TB research – including the TB PRACTECAL trial that led to @WHO’s 6-month all-oral drug-resistant TB (DR-TB) regimen – now saving lives worldwide. South Africa’s experience with DR-TB and TB/HIV co-infection is highly relevant for the European Region as we face rising DR-TB linked to conflict & migration. We also explored stronger interregional cooperation through TB-Free Central Asia, BRICS health work, and joint research on vaccines & diagnostics. #EndTB #HealthForAll

“New drugs for the management of tuberculosis” (Sept 25, 2025): 🧪 New Drugs for Tuberculosis – Clinical Pearls (2025 Update) 🔹 Key Advances Bedaquiline, delamanid, pretomanid → transformed MDR/XDR-TB therapy; now part of all-oral BPaL / BPaLM regimens. Study 31, TRUNCATE-TB, SHINE → validated treatment shortening (4–6 months) in selected patients. TB-PRACTECAL, ZeNix, endTB, BEAT-TB → confirmed safety & efficacy of newer regimens. Repurposed old drugs (linezolid, clofazimine, fluoroquinolones) remain crucial. 🔹 Pipeline Drugs Next-gen diarylquinolines (TBAJ-876, WX-081/Sudapyridine) → improved potency, less QT toxicity. DprE1 inhibitors (Quabodepistat, BTZ-043, TBA-7371) → novel class, strong lesion penetration. Gabfeborole (GSK-656) → first-in-class benzaxaborole, PET-CT biomarkers show promise. Telacebec (Q203) → targets mycobacterial respiration, role in M. leprae & M. ulcerans. New oxazolidinones (Delpazolid, Sutezolid, Contezolid) → aim to reduce linezolid toxicity. Alpibectir Ethionamide → enhances activity & reduces GI side effects. Sanfetrinem (oral carbapenem) → synergy with rifampicin, phase II EBA ongoing. 🔹 High-Dose Rifamycins Rifampicin 20–35 mg/kg → ↑ CSF penetration in CNS-TB, but hepatotoxicity risk noted. Rifapentine (1200 mg) → validated 4-month DS-TB regimen (WHO adopted). 🔹 Practice-Changing Evidence Shorter regimens (4–6 months) → feasible for low-burden, non-cavitary TB. Children (SHINE trial) → 4 months RHZE = 6 months in non-severe TB. BPaLM regimen → safer & more effective than conventional MDR-TB therapy. Risk-stratified approaches → PET-CT, Xpert Ct, cavity status guide duration. 🔹 Challenges Ahead Drug toxicity: QT prolongation (Bedaquiline/Delamanid), Linezolid neuropathy/myelosuppression. Resistance: Rv0678 mutations → cross-resistance between Bedaquiline & DprE1 inhibitors. Implementation gaps: Access, affordability, scaling in high-burden countries. Need for biomarkers, precision medicine, host-directed therapy. 🔹 CME INDIA Pearls 🧬 TB therapy is no longer one-size-fits-all → shorter, safer regimens are now evidence-based. 💊 Bedaquiline remains cornerstone but resistance & stewardship are urgent concerns. ⚡ Pipeline is rich: diarylquinolines, DprE1 inhibitors, gabfeborole, oxazolidinones. 🧒 Children benefit most from shorter regimens → adherence improves drastically. 🩺 Future = precision TB medicine using biomarkers, PET-CT, and endotype-driven therapies. journals.lww.com/co-infectio…

肺癌だと思ったら肺結核だった症例をしっかりと診断できてホッとしました。今回はMDRではないと思いますが、最新治療薬はどうなっているか？ 【肺結核治療2025アップデート】 6か月・全経口が標準に接近。 1）BPaLM（Bedaquiline＋Pretomanid＋Linezolid＋Moxifloxacin） 　対象：Rifampicin-resistant TB (RR-TB) かつ Fluoroquinolone-susceptible、年齢14歳以上。 　FDA承認状況：Bedaquiline（2012年承認）、Pretomanid（2019年BPaLで承認）ともに単剤承認あり。ただしBPaLM全体としての承認はなし。 　RCT（TB-PRACTECAL）で**治療成功率89％**を示し、従来を大きく上回る。 2）BPaL（Bedaquiline＋Pretomanid＋Linezolid） 　対象：RR-TBでFQ耐性または不耐、年齢14歳以上。 　FDA承認状況：Pretomanidは2019年にBPaLレジメンとして承認済み（特定条件下）。 3）BDLLfxC（Bedaquiline＋Delamanid＋Linezolid＋Levofloxacin＋Clofazimine） 　対象：Multidrug-resistant / Rifampicin-resistant TB（±FQ耐性） に対し、6か月・全経口の新規推奨（条件付き）。 　FDA承認状況：Bedaquiline・Linezolid・Levofloxacin・Clofazimineは既承認薬だが、Delamanidは米国未承認、レジメン全体も未承認。 ＜適応上の注意＞ CNS tuberculosis・osteoarticular TB・disseminated TBなどではBPaLM/BPaLは原則対象外。長期レジメンや個別化が必要。 ＜臨床Tips＞ Linezolidは骨髄抑制・末梢神経障害、Bedaquiline/Delamanid/ClofazimineはQT延長リスクあり。定期モニタリング必須。レジメン選択は**Drug Susceptibility Testing（DST）**と禁忌を考慮。 #肺結核 #ホスピタリスト

Old MDR-TB regimens had 7 drugs & high toxicity. Nix-TB trial introduced BPaL (Bedaquiline, Pretomanid, Linezolid) – 90% efficacy but 80% neuropathy, 37% anemia. ZeNix & TB-PRACTECAL trials showed Linezolid dose ↓ = fewer side effects.

📣New thesis now live in Research Online! Short, effective and safe all-oral treatment for rifampicin resistant tuberculosis. The TB-PRACTECAL trial and its drugs pharmacokinetics by @docwak77 doi.org/10.17037/PUBS.046758… #thesis #tuberculosis #OpenAccessNew #PhD

We published the costs of TB-PRACTECAL, a clinical trial conducted to identify a shorter, all-oral treatment for drug-resistant tuberculosis (DR-TB): journals.plos.org/globalpubl…

Cost analysis of the TB-PRACTECAL clinical trial on novel tuberculosis treatment regimens journals.plos.org/globalpubl…

24-week, all-oral regimens for pulmonary rifampicin-resistant tuberculosis in TB-PRACTECAL trial sites: an economic evaluation - The Lancet Global Health thelancet.com/journals/langl…

🩺👨‍⚕️ Glad to know that city is going to roll out the game changing TB regimen. The evidence comes from PRACTECAL study. The study included 301 patients:15 years or more of age with rifampicin resistant pulmonary TB in Uzbekistan, South Africa, and Belarus. Patients were randomly assigned to treatment with BPaLM ( 6 month regimen) or a standard care regimen (9 to 20 months regimen). The linezolid dose consisted of 600 mg once daily for 16 weeks, followed by 300 mg once daily for 8 weeks. The bedaquiline dose consisted of 400 mg once daily for two weeks, followed by 200 mg thrice weekly for 22 weeks. The primary outcome of unfavorable status at 72 weeks post randomization occurred less frequently among those with BPaLM than those with the standard regimen. Hepatotoxicity & peripheral neuropathy were less in BPaLM group. The BPaLM regimen compared favorably to standard regimen among HIV patients also. 🩺😃🥼🔬🦠🧫 #MedTwitter #IDTwitter #BPaLM #Tuberculosis #TB #DrugResistantTB #infectiousdiseases #DrSwapnilGautam

🩺🥼The approval of the shortened 6-month treatment regimen (BPaL) for drug resistant TB, can now may make the treatment a more manageable one. This will improve compliance and reduce pill burden. Three studies, I will strongly recommend to read for medicos :- NiX - TB, ZeNiX & PRACTECAL, to understand the evidence behind this regimen. #MedTwitter #IDTwitter #Tuberculosis #MedicalResearch #HealthcareForAll #HealthAndWellness #DrSwapnilGautam

🆕️⚡️⚡️#AAC @mckiremba @catherineeberry How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL RCT #IDXposts journals.asm.org/doi/10.1128…

Dzintars Gothams expertly breaks down the cost analysis for TB clinical trial: TB-PRACTECAL. Helping make drug development process more transparent💊 #clinicaltransparency #MSFSci @MSF_access

Amazing to see the brilliant @dizgotham presenting the results of our study on the costs of the pivotal MSF TB-PRACTECAL clinical trial at #MSFSci msfaccess.org/precedent-sett…

Dzintars Gothams expertly breaks down the cost analysis for TB clinical trial: TB-PRACTECAL. Helping make drug development process more transparent💊 #clinicaltransparency #MSFSci @MSF_access

#MSFsci #TB #PRACTECAL trial cost breakdown. Main divers were staff costs, external diagnostic services, medicines costs. This sharing of costs reported recently in #TheGuardian theguardian.com/global-devel…

#MSFSci #TB#PRACTECAL clinical trial showed that #BPaLM regimen was superior to the standard of care and influenced #WHO #TB treatment recommendations. Detailed costs of clinical trials are rarely shared publicly. Enter #MSF clinical trial transparency policy.

🗣️Listen to Dzintars Gotham present for the first-time on the spending for TB-PRACTECAL clinical trial, showing the true cost of developing a medicine ➡️msf.org.uk/msf-scientific-da… #MSFSci #ClinicalTrial #DRTB @msf_tb

MSF published costs of its TB PRACTECAL trial (EUR 34 million) -a sum that hints drug companies may be exaggerating about R&D costs. We're not surprised: @theguardian cites TAG analysis that public investment in TB drug bedaquiline exceeded private by ~5x: theguardian.com/global-devel…

#BreakingNews: Seit gestern findet in Wien die 5. #PPRIconference2024 der @WHO statt. Gestern präsentierten unsere Kolleg:innen detaillierte Kosten der PRACTECAL Studie & dekonstruierten mehrere Pharmamythen: volle Kostentransparenz ist möglich! 👇

BIG NEWS! @MSF presented the costs of its landmark TB-PRACTECAL clinical trial that helped identify a shorter, all-oral treatment regimen for drug-resistant tuberculosis (DR-TB). This is the first time the detailed costs of an individual clinical trial will have ever been shared publicly. msfsouthasia.org/msf-reveals… #TB #DRTB