TABLE 1.

Study populations, key inclusion criteria, presatovir treatment regimens, nasal swab sampling schedules, and primary endpoints in the 4 phase 2b trials^a

Parameter	GS-US-218-0108	GS-US-218-1502	GS-US-218-1797	GS-US-218-1227
Population	HCT recipients	HCT recipients	Lung transplant recipients	Hospitalized patients
RSV infection site	Isolated URTI	LRTI	URTI or LRTI	URTI or LRTI
Randomization	1:1	1:1	2:1	1:1
Efficacy population (n)	176	57	54	154
Presatovir dosing	200 mg on days 1, 5, 9, 13, and 17	200 mg on days 1, 5, 9, 13, and 17	200 mg on day 1 followed by 100 mg daily on days 2–14	Single 200-mg dose on day 1
Nasal swab days for genotypic analysisb	1, 9, 28, or last detectable	1, 9, 28, or last detectable	1, 7, 28, or last detectable	1, 5, 14, or last detectable
Primary endpoint	Time-weighted avg change in nasal RSV viral load from day 1–9 and proportion of subjects developing lower respiratory tract complications through day 28 (coprimary)	Time-weighted avg change in nasal RSV viral load from day 1–9	Time-weighted avg change in nasal RSV viral load from day 1–7 in the entire efficacy population and in subjects with shorter-than-median symptom duration before start of study treatment (coprimary)	Time-weighted avg change in nasal RSV viral load from day 1–5

^aHCT, hematopoietic cell transplant; LRTI, lower respiratory tract infection; RSV, respiratory syncytial virus; URTI, upper respiratory tract infection.

^bOnly samples with RSV RNA levels of >1,000 copies/ml were analyzed.