Results
cardiovascular comorbidity, COPD
VIRUS, SUPPRESSION, LUNG, EVENT, COPD, ADVERSE EVENT, REGRESSION, EVENTS
Between October 2018 and March 2020, 171 patients underwent trial screening. In total, 84 patients were assigned randomly to receive either valaciclovir (n = 43) or placebo (n = 41) (Consolidated Standards of Reporting Trials flow diagram showing the Epstein-Barr Virus Suppression in COPD Study: a randomized double-blind placebo-controlled trial. Baseline Patient Demographic and Clinical CharacteristicsData are presented as No. (%), mean ± SD, or median (IQR). EBV = Epstein-Barr virus; ICS = inhaled corticosteroid; IQR = interquartile range; LABA = long-acting β-agonist; LAMA = long-acting muscarinic antagonist; qPCR = quantitative polymerase chain reaction.Includes patients with at least one cardiovascular comorbidity.Primary Efficacy Outcome: Sputum EBV Suppression in the Intention-to-Treat Population (n = 81)Data are presented as No. (%), unless otherwise indicated. EBV = Epstein-Barr virus.Primary analysis.χLogistic regression.Adjusted analysis for FEVInteraction term.Boxplot showing baseline sputum EBV viral load and change from baseline to week 8. Error bars show the interquartile range. EBV = Epstein-Barr virus.Because of the initial COVID-19 national lockdown restrictions in the United Kingdom, the final 12 enrolled patients were unable to undergo lung function measurements at the end of treatment. Seventy patients had lung function measured at baseline and week 8 (Change in Lung Function From Baseline to Week 8 in Patients With Measurements at Both Time PointsData are presented as mean ± SD, unless otherwise indicated. Changes are calculated on the basis of available measurements for both time points. PEF = peak expiratory flow; TLCO = transfer factor for carbon monoxide.Independent samples Quality-of-life data were available for all 81 patients in the intention-to-treat population (A, B, Graphs showing effect of intervention on symptom scores and quality of life quantified at baseline, week 4, and week 8 using CAT (A) and EQ-5D-5L (B), respectively. CAT = COPD Assessment Test; VAS = visual analogue scale.The sputum total cell count was reduced significantly at week 8 in the valaciclovir group (difference, 2.9 × 10A-C, Boxplots showing baseline sputum biomarkers and mean change from baseline to week 8: sputum total cell count (A), IP-10 (B), and MCP-1 (C) quantified at baseline and at week 8 using trypan blue exclusion method and enzyme-linked immunosorbent assay, respectively. No safety concerns were identified during the conduct of the study, and the incidence of treatment-emergent AEs was comparable in both groups (Treatment-Emergent AEs in the Safety Population (n = 84)Data are presented as No. (%), unless otherwise indicated. A patient reporting more than one event in a category is counted only once. AE = adverse event; RR = relative risk.Those events with an incidence of ≥ 10% in either group.We conducted a post hoc analysis to examine the effect of sputum EBV suppression, regardless of treatment allocation, on change in FEV