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Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating <t>remdesivir.</t> The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.
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Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating <t>remdesivir.</t> The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.
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Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating <t>remdesivir.</t> The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.
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Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating <t>remdesivir.</t> The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.
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Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating remdesivir. The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.

Journal: The Journal of infectious diseases

Article Title: Pharmacokinetics and Safety of Remdesivir in Pregnant and Non-Pregnant Women with COVID-19: Results from IMPAACT 2032.

doi: 10.1093/infdis/jiae298

Figure Lengend Snippet: Figure 1. Study design. The preinfusion period provided baseline data collection for 48 hours prior to initiating remdesivir. The infusion period included the initiation of RDV (200 mg on day 1 and 100 mg every 24 hours thereafter) for up to 5 or 10 days as clinically indicated. The safety follow-up period was inclusive of the time from discontinuing or completing remdesivir through 4 weeks after the last infusion. Among pregnant women (Arm 1), safety and birth outcomes were collected from the onset of labor or start of the cesarean delivery through 24 hours after delivery. The delivery visit could occur during remdesivir treatment, safety follow-up, or afterward. Except for PK sampling, study procedures and data collections were largely performed by medical chart abstraction or remote contact. Abbreviations: EOI, end of infusion; IV, intravenous; PBMC, peripheral blood mononuclear cell; PK, pharmacokinetics; RDV, remdesivir.

Article Snippet: Plasma Pharmacokinetic Parameters for Remdesivir, GS-704277, and GS-441524 and Protein Binding by Study Arm PK Parameters Pregnant (n = 21) Nonpregnant (n = 22) GMR (90% CI) Infusion duration, ha 1.0 (0.5–1.28) 1.0 (0.5–2.0) ... Remdesivir AUClast, ng · h/mL 1132 (85.7) 1190 (82.7) 0.95 (0.65–1.38) AUC0-24h, ng · h/mL 1247 (87.2) 1303 (49.2) 0.96 (0.67–1.37) Cmax, ng/mL 1360 (108) 1237 (111) 1.10 (0.70–1.73) Tmax, h 1.17 (0.60–1.31) 1.08 (0.66–1.53) 0.86 (0.64–1.15) t1/2, h 1.01 (36.0) 1.09 (36.4) 0.92 (0.75–1.13) CL, L/h 80.2 (87.2) 79.6 (47.4) 1.01 (0.70–1.45) Vd, L 118 (89.8) 125 (57.4) 0.94 (0.63–1.39) GS-704277 AUClast, ng · h/mL 408 (47.8) 424 (35.5) 0.96 (0.78–1.18) AUC0-24h, ng · h/mL 454 (29.8) 437 (36.2) 1.04 (0.88–1.23) Cmax, ng/mL 217 (41.4) 213 (34.1) 1.02 (0.85–1.23) Tmax, h 1.18 (0.62–1.36) 1.08 (0.66–1.46) 0.99 (0.79–1.24) t1/2, h 1.33 (19.9) 1.23 (30.0) 1.08 (0.95–1.23) GS-441524 AUClast, ng · h/mL 1842 (31.9) 2065 (36.0) 0.89 (0.75–1.06) AUC0-24h, ng · h/mL 1836 (32.2) 2046 (37.7) 0.90 (0.75–1.07) Cmax, ng/mL 113 (27.8) 121 (32.0) 0.93 (0.80–1.09) Tmax, h 2.1 (2.0–3.4) 2.9 (2.0–4.7) 0.77 (0.61–.97) t1/2, h 20.0 (28.6) 20.3 (30.3) 0.96 (0.82–1.18) C24h, ng/mL 51.6 (38.5) 57.1 (44.1) 0.90 (0.73–1.12) Protein binding Remdesivir free fraction, % 3.43 (22.8) 3.22 (26.2) 1.06 (0.95–1.19) Albumin, g/L 28.0 (26.0–30.0) 36.0 (33.5–38.0) 0.70 (0.56–.86) AAG, mg/dL 94.6 (77.2–144.3) 124.4 (98.9–172.4) 0.73 (0.60–.88) Data presented as geometric mean (CV%), except infusion duration which is reported as median (range), and Tmax, albumin, and AAG which are reported as median (IQR).

Techniques: Sampling, Drug discovery

Figure 2. Concentration-time profiles for total remdesivir (A), free remdesivir (B) GS-704277 (C), and GS-441524 (D). Data presented as median concentrations for each nominal time point by arm assuming a 1-hour infusion duration. Total remdesivir plot overlaid with half maximal effective concentration (EC50) in human airway epithelial (HAE) cells [15].

Journal: The Journal of infectious diseases

Article Title: Pharmacokinetics and Safety of Remdesivir in Pregnant and Non-Pregnant Women with COVID-19: Results from IMPAACT 2032.

doi: 10.1093/infdis/jiae298

Figure Lengend Snippet: Figure 2. Concentration-time profiles for total remdesivir (A), free remdesivir (B) GS-704277 (C), and GS-441524 (D). Data presented as median concentrations for each nominal time point by arm assuming a 1-hour infusion duration. Total remdesivir plot overlaid with half maximal effective concentration (EC50) in human airway epithelial (HAE) cells [15].

Article Snippet: Plasma Pharmacokinetic Parameters for Remdesivir, GS-704277, and GS-441524 and Protein Binding by Study Arm PK Parameters Pregnant (n = 21) Nonpregnant (n = 22) GMR (90% CI) Infusion duration, ha 1.0 (0.5–1.28) 1.0 (0.5–2.0) ... Remdesivir AUClast, ng · h/mL 1132 (85.7) 1190 (82.7) 0.95 (0.65–1.38) AUC0-24h, ng · h/mL 1247 (87.2) 1303 (49.2) 0.96 (0.67–1.37) Cmax, ng/mL 1360 (108) 1237 (111) 1.10 (0.70–1.73) Tmax, h 1.17 (0.60–1.31) 1.08 (0.66–1.53) 0.86 (0.64–1.15) t1/2, h 1.01 (36.0) 1.09 (36.4) 0.92 (0.75–1.13) CL, L/h 80.2 (87.2) 79.6 (47.4) 1.01 (0.70–1.45) Vd, L 118 (89.8) 125 (57.4) 0.94 (0.63–1.39) GS-704277 AUClast, ng · h/mL 408 (47.8) 424 (35.5) 0.96 (0.78–1.18) AUC0-24h, ng · h/mL 454 (29.8) 437 (36.2) 1.04 (0.88–1.23) Cmax, ng/mL 217 (41.4) 213 (34.1) 1.02 (0.85–1.23) Tmax, h 1.18 (0.62–1.36) 1.08 (0.66–1.46) 0.99 (0.79–1.24) t1/2, h 1.33 (19.9) 1.23 (30.0) 1.08 (0.95–1.23) GS-441524 AUClast, ng · h/mL 1842 (31.9) 2065 (36.0) 0.89 (0.75–1.06) AUC0-24h, ng · h/mL 1836 (32.2) 2046 (37.7) 0.90 (0.75–1.07) Cmax, ng/mL 113 (27.8) 121 (32.0) 0.93 (0.80–1.09) Tmax, h 2.1 (2.0–3.4) 2.9 (2.0–4.7) 0.77 (0.61–.97) t1/2, h 20.0 (28.6) 20.3 (30.3) 0.96 (0.82–1.18) C24h, ng/mL 51.6 (38.5) 57.1 (44.1) 0.90 (0.73–1.12) Protein binding Remdesivir free fraction, % 3.43 (22.8) 3.22 (26.2) 1.06 (0.95–1.19) Albumin, g/L 28.0 (26.0–30.0) 36.0 (33.5–38.0) 0.70 (0.56–.86) AAG, mg/dL 94.6 (77.2–144.3) 124.4 (98.9–172.4) 0.73 (0.60–.88) Data presented as geometric mean (CV%), except infusion duration which is reported as median (range), and Tmax, albumin, and AAG which are reported as median (IQR).

Techniques: Concentration Assay