Outcomes of Influenza with Treatment in Patients with Diabetes: Subgroup Analysis of the Phase 3 CAPSTONE-2 Trial

Abstract

Background: Patients with diabetes are at increased risk of developing complications from influenza infections, suggesting prompt antiviral treatment could be beneficial. Objective: This analysis explored the potential benefits of antiviral treatment of influenza in patients with diabetes. Methods: Patients with influenza at high risk of complications received single-dose baloxavir versus five days of oseltamivir versus placebo. A subgroup analysis was performed in patients with diabetes. Results: Overall, 329 of 1163 patients (28.3%) in the ITTI population (oseltamivir n=111, baloxavir n=103, placebo n=115) had diabetes. Baseline characteristics in patients with diabetes were balanced. Overall, the frequency of AEs was low and similar between arms; no safety signals were unique to patients with diabetes. Of patients with diabetes, median TTIIS was shorter for patients treated with baloxavir (73.2 h) than those treated with oseltamivir (95.7 h, p=0.572) or placebo (100.6 h; p=0.048). For influenza A infections, median TTIIS (baloxavir vs oseltamivir vs placebo) was 75.4 h vs 76.5 h vs 125.0 h, respectively and for influenza B infections, 70.7 h vs 109.9 h vs 82.6 h, respectively. Baloxavir- treated patients had significantly shorter median time-to-viral-clearance compared with oseltamivir- and placebo-treated patients (p<0.001) (48 h vs 96 h vs 96 h; both groups). Systemic antibiotic use for secondary infections was low across all arms (baloxavir 3.9% vs oseltamivir 4.5% vs placebo 7.0%). Conclusions: Clinical and virological efficacy was observed in baloxavir-treated diabetic outpatients with influenza in CAPSTONE-2 and no unique safety signals were identified.