BDQ/DLM COMBINATION: FRENCH-LATVIAN EXPERIENCE AND FUTURE PERSPECTIVES LORENZO GUGLIELMETTI RESIST-TB WEBINAR, 5 APRIL 2018
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1 BDQ/DLM COMBINATION: FRENCH-LATVIAN EXPERIENCE AND FUTURE PERSPECTIVES LORENZO GUGLIELMETTI RESIST-TB WEBINAR, 5 APRIL 2018
2 OUTLINE New TB drugs in France and Latvia Bdq/Dlm: the French-Latvian experience Future perspectives
3 New drugs in France Supervised by the national MDR-TB Consilium Bdq available since 2011, Dlm since 2014 Bdq DST available routinely since 2014 MDR-TB Consilium ( ): 337 MDR-TB patients treated 142/337 with new drugs (42%): 129 Bdq, 4 Dlm, 9 both 92/142 with prolonged treatment (65%)
4 Bdq MDR-TB cohort: efficacy and safety C1 C2 C3 45 MDR-TB patients Sputum culture conversion and safety centres Retrospective cohort 6 months endpoint: 96% culture conversion Good safety Guglielmetti et al. Clin Inf Dis 2015.
5 Bdq MDR-TB cohort: efficacy and safety C1 C2 C3 45 MDR-TB patients Sputum culture conversion and safety Treatment outcome and safety Guglielmetti et al. Eur Resp J, centres Retrospective cohort 6 months endpoint: 96% culture conversion Good safety End of treatment: 80% favourable outcomes No additional toxicity of prolonged Bdq
6 Bdq resistance surveillance ( ) 209 MDR-TB strains Systematic analysis of all strains in France 4 resistant strains (2%) Primary 2 patients never treated before 2 patients exposed to Bdq Secondary Conclusion: rapid resistance selection! Veziris N, et al. Eur Resp J, 2017.
7 New drugs in Latvia MDR-TB treatment prescribed by national Consilium Dlm available since 2014 Cohort of 19 MDR-TB patients treated with regimens containing Dlm, 10 for prolonged duration: 84% cure, good tolerability Kuksa L, et al. Eur Resp J, 2017.
8 OUTLINE New TB drugs in France and Latvia Bdq/Dlm: the French-Latvian experience Future perspectives
9 BDQ+DLM Retrospective cohort study Multicentric, international (Latvia and France) MDR-TB patients exposed to 30 days of Dlm-Bdq combination, treatment started up to 31/10/2015
10 Characteristics of the cohort (1) (N=10) Variable % Sex, male 100 Age (median, range) 32 (20-55) HIV infection 0 HCV infection 40 HBV infection 10 Concomitant Bdq/Dlm 60 Sequential Bdq/Dlm (no washout) 40
11 Characteristics of the cohort (2) (N=10) Variable % Pulmonary TB 100 Bilateral involvement 80 Lung cavity 100 Smear + at treatment start 90 Simple MDR-TB 0 Pre-XDR TB (Fq) 40 XDR-TB 60 Bdq resistance 40
12 Exposure to Bdq and Dlm
13 Concomitant treatment 80% 70% 60% 50% 40% 30% 20% 10% 0% Cfz PAS Lzd Am Mfx Ipm
14 Safety 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Any AE SAE Increased liver enzymes >60 ms QTcF increase 500 ms QTcF Cardiac event
15 Treatment outcomes 10% Favourable outcomes LTFU 90% Time to sputum culture conversion (median, IQR) 77 (43-88)
16 For further information
17 OUTLINE New TB drugs in France and Latvia Bdq/Dlm: the French-Latvian experience Future perspectives
18
19 DELIBERATE (ACTG 5343) Sponsor National Institute of Allergy and Infectious Diseases (NIAID) PI Kelly Dooley Gary Maartens Characteristics Phase II, Parallel Population R-R, FQ-S, Ag-S Target 84 patients Estimated results July 2020 Bdq Dlm Bdq + Dlm Plus optimized background regimen, for 24 weeks HIV patients: treated with Dolutegravir plus 2 NRTIs
20 endtb Sponsor Médecins Sans Frontières PI Carole Mitnick Lorenzo Guglielmetti Characteristics Phase III, Adaptive Population R-R, FQ-S Target 750 patients Estimated results April 2021 Bdq + Lzd + Mfx + Z Bdq + Cfz + Lzd + Lfx + Z Bdq+Dlm+Lzd +Lfx + Z Dlm + Cfz + Lzd + Lfx + Z Dlm + Cfz + Mfx + Z for 39 weeks Vs. Standard of care Randomization adapted to efficacy at W8 and W39
21 NiX-TB Sponsor TB Alliance PI Francesca Conradie Dan Everitt Bdq + Pa + Lzd for 26 to 39 weeks Characteristics Phase III, Uncontrolled Population XDR, MDR-TB failures Target 200 patients Estimated results October 2021 Linezolid: 1200 mg qd Pa: 200 mg qd Bdq: 400 mg daily for 2 weeks, then 200 mg thrice a week
22 ZeNiX Sponsor TB Alliance PI Dan Everitt Characteristics Phase III, Uncontrolled Population XDR Target 180 patients Estimated results January 2022 Bdq + Pa + Lzd 1200 mg qd for 26 wks Bdq + Pa + Lzd 1200 mg qd for 9 wks Bdq + Pa + Lzd 600 mg qd for 26 wks Bdq + Pa + Lzd 600 mg qd for 9 wks Total treatment: 26 to 39 weeks Bdq: 200 mg qd for 8 weeks, then100 mg qd
23 TB-PRACTECAL Sponsor Médecins Sans Frontières PI Bern Nyang wa Characteristics Phase II/III, MAMS Population R-R (MDR+XDR) Target 630 patients Estimated results June 2020 Bdq + Pa + Lzd + Mfx Bdq + Pa + Lzd + Cfz Bdq + Pa + Lzd for 24 weeks Vs. Standard of care Experimental arm/s will be dropped based on culture conversion at 8 weeks
24 Conclusions Few clinical trials testing Bdq/Dlm (or Pa) Results are years away from now Observational studies can offer precious evidence Use Bdq/Dlm when needed Collect and share your data and results
25 Thank you very much!
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