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The results are in: now what?

The results are in: now what?. Exploring implications for the field of the delamanid phase III and STREAM stage 1 trial results December 11, 2017. To view a live transcript of this webinar: http://www.streamtext.net/player?event=TAG. Webinar agenda.

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The results are in: now what?

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  1. The results are in:now what? Exploring implications for the field of the delamanidphase III and STREAM stage 1 trial results December 11, 2017 To view a live transcript of this webinar: http://www.streamtext.net/player?event=TAG

  2. Webinar agenda • Introduction– Erica Lessem, Treatment Action Group • Dr. Francesca Conradie, Wits University • Dr. Carole Diane Mitnick, Harvard Medical School • Marcus Low, Spotlight • Mandy Slutsker, ACTION • Q&A – please write in your questions in the “chat” feature

  3. THE TB NEWS THE WORLD’S OLDEST INFECTIOUS DISEASE October 2017 www.TBOnline.info FIRST EVER MDR-TB CLINICAL TRIALS SUCCESSULLY CONDUCTED MDR-TB on the rise! For decades, standards of care not based on RCT data Two trials successfully built site and lab capacity, enrolled hundreds of patients, followed them up, did dozens of analyses… and now we have the results!

  4. What was the STREAM Stage 1 trial? • Randomized, controlled, open-label, non-inferiority trial • Evaluate the shorter regimen (also called “modified Bangladesh regimen,” recommended by WHO in advance of RCT data in 2016)vs the previous WHO standard of care (18-24 months) • Started July 2012, sponsored by the Union (USAID funding) http://www.treatmentactiongroup.org/tb/drug-guide-2016

  5. What was the DELAMANID C213 trial? • Randomized, placebo-controlled, double-masked, superiority trial • Primary endpoint = time to sputum culture conversion over 6 months • Evaluate adding delamanid vs placebo to the previous WHO standard of care (18-24 months) • Started September 2011, sponsored by Otsuka

  6. efficacy results

  7. Spoiler alert • Neither trial demonstrated its primary hypothesis BUT many “buts” –each intervention may still have utility What does this mean for the field?

  8. WHO policy plans: DELAMANID • WHO has concluded a rapid review of the delamanid phase III trial data • WHO is working on a formal Position Statement to be released in early January 2018 • based on the Otsuka trial data (204 and 213) only • WHO has not received any observational data yet from implementers

  9. WHO policy plans: SHORTER REGIMEN • Same process as for delamanid will be followed in January for the STREAM Stage 1 interim results • challenge: the trial follow-up has not concluded yet

  10. WHO policy plans: Consolidated guidance • WHO will not attempt to consolidate October 2016 MDR-TB guidelines • Current data gaps • Burden on human/financial resources due to compliance with Guidelines Review Committee rules • Extensive review of WHO MDR-TB guidelines planned for Q3, 2018, once all necessary data are available, including: • final results for STREAM Stage 1, • observational data for delamanid, • observational data for bedaquiline, • systematic reviews on the use of the injectable drugs, and • detailed individual patent data (IPD) analyses to inform the possible regrouping of the second-line medicines used to treat MDR- and XDR-TB.

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