Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-5806
Presatovir · 6 trials · 5 indications
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: * Primary RSV lower respiratory tract infection (LRTI) * Secondary bacterial LRTI * LRTI due to unusual pathogens * Lower respiratory tract complication of unknown etiology
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.
The primary outcome measure of this study is the urine and fecal recovery of total \[14C\]-radioactivity.
| Arm | Type | Description |
|---|---|---|
| Presatovir | EXPERIMENTAL | Presatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14 |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets for a total of 14 days |
| Presatovir placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of presatovir placebo. |
| GS-5806 | EXPERIMENTAL | GS-5806, powder for oral solution |
| Sugar powder for oral solution in juice | PLACEBO_COMPARATOR | Sugar powder for oral solution |
| Intervention Arm | EXPERIMENTAL | One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning. |
| Name | Type | Description |
|---|---|---|
| Presatovir | DRUG | Tablets administered orally or via nasogastric (NG) tube once daily |
| Placebo | DRUG | Tablets administered orally or via NG tube once daily |
| Presatovir placebo | DRUG | Presatovir placebo tablets administered orally |
| GS-5806 | DRUG | GS-5806, powder for oral solution |
Key Inclusion Criteria: * Males and females ≥18 years of age who have received a LT (single or double) or heart/lung transplant \> 90 days prior to Screening * Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract samp...
Presatovir is an investigational small molecule antiviral developed by Gilead Sciences for the treatment of respiratory syncytial virus (RSV) infection. It has been studied in adults, including lung transplant recipients and hematopoietic cell transplant recipients, as well as hospitalized adults with RSV infection. It remains in clinical development and is not an approved therapy.
Presatovir is being studied for the treatment of respiratory syncytial virus infection in adults. Clinical trials have enrolled lung transplant recipients with RSV, hematopoietic cell transplant recipients with upper or lower respiratory tract RSV infection, and hospitalized adults with RSV infection. It is investigational and has not been approved for any use.
Presatovir is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the Phase 2 clinical program evaluating the drug in patients with respiratory syncytial virus infection, including transplant recipients and hospitalized adults.
Presatovir is in Phase 2 clinical development. All four of its recorded trials are Phase 2 studies, and all have been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of respiratory syncytial virus infection.
Presatovir has been evaluated in four completed Phase 2 trials: NCT02534350 in lung transplant recipients with RSV, NCT02254421 in hematopoietic cell transplant recipients with lower respiratory tract RSV, NCT02254408 in hematopoietic cell transplant recipients with upper respiratory tract RSV, and NCT02135614 in hospitalized adults with RSV infection. All were randomized, double-blind, and placebo-controlled.
The Presatovir Phase 2 program enrolled approximately 250 patients across its studies. Individual trial enrollments were 61 participants in NCT02534350, 60 in NCT02254421, and 189 each in NCT02254408 and NCT02135614. All trials enrolled adults aged 18 years and older and were conducted across multiple countries.