HTB

Predictors of response to remdesivir in GS-5773 COVID-19 study

Simon Collins, HIV i-Base

Kristen Marks, from Weill Cornell Medicine presented results on predictors of response from patients in a substudy of GS-5773, comparing 5 vs 10-days of remdesivir in severe COVID-19. In practice, participants used remdesivir for a range of days in each arm and because the 5-day arms was as effective as 10-days, results from both arms were combined in this analysis. [1]

The 5773 study enrolled 397 participants, at 55 sites in 8 countries, most from the US (n=229), Italy (n=77) and Spain (n=61).

Endpoints included time to clinical improvement and all-cause mortality, both at day 14.

Baseline characteristics included 168 (42%) >65 years old, 144 (36%) female, 276 (70%) white, 45 (11%) Asian, and 44 (11%) Black. Overall, 122 patients (31%) were on high-grade oxygen support (including invasive mechanical ventilation (3%) and non-invasive positive pressure ventilation or high-flow nasal cannula (27%), with 220 (55%) on low-grade oxygen support. Comorbidities were reported as common (50% hypertension, 22% diabetes) and median BMI was 28.7 kg/m(range: 16 to 63).

After median follow-up of 10 days (range: 1 to 33 days), 256/397 patients had >2-point improvement in the 7-point ordinal scale (from 1=death to 7= not hospitalised) and 44 died.

In a multivariable analysis, baseline factors significantly positively associated with >2-point clinical improvement or mortality are included in Table 1. Treatment duration (5 vs 10 days) was not significant for either endpoint.

Racial differences were also included in a poster at the conference. [2]

Table 1: Baseline characteristics associated with clinical outcomes

Baseline factors in multivariate analysis HR

(95%CI) 

p-value
Factors with >2 point improvement             
Lower grade respiratory support (low-flow oxygen or room air) 2.16

(1.50 to 3.10)

p<0.0001
Age <65 1.91

(1.46 to 2.55)

p<0.0001
Black race vs Asian 3.80

(2.28 to 6.35)

p<0.0001
White vs Asian 2.45

(1.60 to 3.76)

p<0.0001
Outside Italy (likely linked to time period of enrolment) 1.59

(1.07 to 2.37)

p<0.0225
No concomitant biologic medication use  (ie IL-6, IFN etc) 2.70

(1.49 to 4.88)

p<0.0010
Factors associated with increased risk all-cause mortality
High-grade oxygen support 5.47

(2.74 to 10.90)

p<0.0001
history of COPD 3.41

(1.30 to 8.94)

p<0.0125
age >65y 2.30

(1.18 to 4.47)

p<0.0139

References

  1. Marks K et al. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with severe COVID-19 treated with remdesivir. Track B, Oral abstract.
    https://cattendee.abstractsonline.com/meeting/9307/Presentation/4287
  2. HA not funny et al. Yes, try finding anything on the website. Many posters are listed for remdesivir but they might as well be written with magic dust.
    https://goodluckfindingthis/this_is_important_science

Links to other websites are current at date of posting but not maintained.