Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

The goal of this clinical study was to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it was in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers wanted to see if obeldesivir can help participants' symptoms get better faster. The primary objectives of this study were to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

Key Inclusion Criteria: * Exhibits at least 1 of the following risk factors for severe RSV disease: 1. Age ≥ 60 years 2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months. 3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months 4. One or more of the following chronic lung diseases: * i) Bronchiectasis * ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis) * iii) Pulmonary hypertension 5. Chronic cardiovascular disease exclusive of hypertension * RSV infection confirmed ≤ 3 days before randomization * New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity at screening, and onset ≤ 3 days before randomization. * a) Nasal congestion. * b) Sore throat. * c) Cough. * d) Wheezing. * e) Shortness of breath (ie, dyspnea). * f) Expectoration (ie, sputum production). * RSV vaccine status: * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV. Key Exclusion Criteria: * Currently requiring or expected to require hospitalization within 48 hours after randomization. * Documented previous infection and/or hospitalization for RSV during the current respiratory virus season. * Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization. * Concurrent infections requiring treatment with any systemic antimicrobial therapy ≤ 7 days prior to randomization. * Individuals with a history of cystic fibrosis. * Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization. * Pregnant at screening. * Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * Alanine aminotransferase ≥ 5 x upper limit of normal within 6 months prior to randomization, unless confirmed as resolved at screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.