DISCUSSION
infection, pneumonia, ill
RSV INFECTION, PNEUMONIA, DISEASE, INFECTION, INFECTION TOE
The current Phase 2 study supports a favorable safety profile of the The results may appear moderate but need to be viewed in context. In a Phase II study with JNJ‐8678 in infants hospitalized with RSV, a greater reduction in RSV viral load than with placebo did not translate into observed clinical benefit, with no improvements in length of hospital stay or time to clinical stability.The safety profile of AK0529 was favorable, an important consideration given the age of the studied population. The two cases of pneumonia were deemed unrelated to the treatment. Increased transaminase level is associated with the disease severity of RSV infection,A problem with some candidate molecules has been the resistance mutations in RSV strains.Although of limited size, this Phase 2 study enrolled patients from five countries/regions on three continents during RSV seasons in four calendar years, suggesting that the results are representative of global patients and treatment conditions. A disadvantage is that the time from infection to first dose could not be captured. It is difficult to determine the time of infection in infants who are not able to communicate. Moreover, some of the participating centers were central hospitals treating severely ill patients transferred from local clinics with possibly limited initial records. On the upside, the results support the efficacy of AK0529 under conditions closely related to those of actual clinical practice and regardless of time from infection to treatment.Among other shortcomings, the limited follow‐up time meant that the question of rebound could not be addressed. The 96 h timepoint was not the pre‐defined primary timepoint for the analysis, and significance tests were not adjusted for multiple analyses. Differences in national healthcare and insurance policy prevented analysis of the potential impact of the therapy on the length of hospital stay. There was a limited information about the need for respiratory support (e.g., ventilation or nasal oxygen) at baseline, which may have affected the assessment of disease severity. There is an ongoing discussion around the relative performance of different sampling methods for respiratory viruses.In conclusion, this proof‐of‐concept study supported a relevant effect on viral load and clinical signs and symptoms with 2 mg/kg bid AK0529 in infants hospitalized with RSV infection. Further study on AK0529 is warranted.