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 Lower Respiratory Tract
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infection
Sponsor: Gilead Sciences



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Presatovir (GS-5806)
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 67
28 March 2016
8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objective of this study is as follows:

To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI
The secondary objectives of this study are as follows: 

To evaluate the effect of presatovir on being free of any supplemental oxygen, and rates of 
respiratory failure and all-cause mortality

To evaluate the PK, safety and tolerability of presatovir
8.1.2.
Primary Endpoint
The primary endpoint is the time-weighted average change in nasal RSV viral load 
(log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR. 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.
8.1.3.
Secondary Endpoint
Secondary endpoints are:

Number of supplemental O2 free days through Day 28

Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28

Proportion of all-cause mortality among subjects through Day 28

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