A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
Phase: PHASE2
Conditions: Respiratory Syncytial Virus
Sponsor: Gilead Sciences



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Presatovir (GS-5806)
Protocol GS-US-218-0108
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 69
28 March 2016
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The co-primary objectives of this study are:

To evaluate the effect of presatovir on RSV viral load and development of LRTC in RSV-
positive autologous or allogeneic HCT recipients with acute URTI symptoms
The secondary objectives of this study are:

To evaluate the effect of presatovir on development progression to respiratory failure or all-
cause mortality

To evaluate the PK, safety, and tolerability of presatovir
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The co-primary efficacy endpoints of this study are: the time-weighted average change in nasal 
RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 and the proportion of subjects 
who develop a LRTC through Day 28. The time-weighted average change in nasal RSV viral 
load from Baseline to Day 9 is defined as:
∑
  ሼ0.5 ൈ ሺܻ௜൅ܻ௜ାଵሻൈሺݐ௜ାଵെݐ௜ሻሽ 
௕ିଵ
௜ୀ௔
ሺݐ௕െݐ௔ሻ
where <i is the change from Baseline in RSV log10 viral load at 9LVLW L, W is the time at the 
specified timepoint, D is the baseline assessment at Day 1 and E is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest.
The proportion of subjects who develop a LRTC through Day 28, defined as 1 of the below, will 
be adjudicated by an Endpoint Adjudication Committee (EAC).  

Primary RSV LRTI

Secondary bacterial LRTI

Lower respiratory tract infection due to unusual pathogens

Lower respiratory tract complication of unknown etiology

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