#ManuscriptMonday: Fostemsavir is a first-in-class investigational HIV-1 attachment inhibitor being studied in treatment-experienced PLWH with multiple mutations and limited ART options
Fostemsavir:
🔸oral, +/- food
🔸prodrug of temsavir, which binds directly to gp120
2/BRIGHTE trial @NEJM :
Phase 3 trial in 23 countries
Enrolled 371 pts with MDR HIV into 2 cohorts
🔸Cohort 1 (N=272): patients w/ 1-2 active drug options left
🔸Cohort 2 (N=99): no remaining ART options
DOI: 10.1056/NEJMoa1902493
3/Study design:
🔸Cohort 1➡️randomized 3:1
Day 1-8: add on fostemsavir (600mg BID) or placebo to failing regimen (blinded)
Day 8 onward: open-label fostemsavir + optimized background therapy (OBT)
🔸Cohort 2➡️non-randomized
Day 1 onward: open-label fostemsavir + OBT
4/1⃣endpoint: mean⬇️from baseline in HIV-1 RNA level at day 8 in Cohort 1
Results:
🔸Fostemsavir: ⬇️0.79 log10 copies/mL
🔸Placebo: ⬇️0.17
🔸Diff: -0.63 (95 %CI -0.81 to -0.44; P<0.001)
5/Other findings:
🔸Cohort 1: 54% undetectable at 48w
🔸Cohort 2: 38% UD at 48w
🔸Cohort 1: 18% virologic failure at 48w
🔸92% reported adverse event at 48w
🔸Most common: diarrhea, nausea, headache, URI
🔸Adverse events➡️treatment discontinuation in 7% at 96w
6/Thanks to Dr. Udit Dhal for discussing this paper at our virtual journal club and @MannyGuajardoMD for the #tweetorial highlights.
So tell us #IDTwitter, are you excited about this drug’s potential? What are your reservations?
@ShitalPatelMD @MelanieGoebelMD @MariaCRodrigu20
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