Single Intravenous Dose of Oritavancin for the Treatment of Gram-positive Acute Bacterial Skin and Skin Structure Infections: Summary of Safety from the Phase 3 SOLO studies [PublishAheadOfPrint]

Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow for single dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating efficacy and safety of a single 1200 mg IV dose of oritavancin versus twice-daily IV vancomycin for 7 to 10 days in ABSSSI patients. Safety data were pooled across both studies for safety analysis. The pooled safety database comprised 976 oritavancin patients and 983 vancomycin patients. The incidence of adverse events, serious adverse events, and discontinuations due to adverse events were similar for oritavancin (55.3, 5.8 and 3.7%, respectively) and vancomycin (56.9, 5.9 and 4.2%, respectively). The median time to onset (3.8 days vs. 3.1 days, respectively) and duration (3.0 days for both groups) of adverse events were also similar between the two groups. The most frequently reported events were nausea, headache, and vomiting. Greater than 90% of all events were mild or moderate in severity. There were slightly more infections and infestation, abscesses or cellulitis, hepatic and cardiac adverse events in the oritavancin group; however, more than 80% of these events were mild or moderate. Subgroup analyses did not identify clinically meaningful differences in the incidence of adverse events attributed to oritavancin. A single 1200 mg dose of oritavancin was well tolerated and had a similar safety profile to twice-daily vancomycin. The long elimination half-life of oritavancin compared to vancomycin did not result in clinically meaningful delay to onset or prolongation of adverse events.

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