EFFICACY AND HOSPITALIZATION LENGTH OF STAY OF SINGLE DOSE ORITAVANCIN COMPARED TO 7-10 DAYS OF VANCOMYCIN IN PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS IN THE US AND EASTERN EUROPE
Author(s)
LaPensee K1, Fan W1, Fiset C1, Jiang H1, Lodise TP2
1The Medicines Company, Parsippany, NJ, USA, 2Albany College of Pharmacy and Health Sciences, Albany, NY, USA
OBJECTIVES Oritavancin (ORI) is a lipoglycopeptide with bactericidal activity against Gram-positive bacteria including MRSA. This analysis evaluated efficacy and hospital length of stay of ORI for patients with acute bacterial skin and skin structure infections (ABSSSI) who received care in the SOLO program in the US and Eastern Europe. METHODS SOLO I and II were identically-designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and healthcare resource utilization (HRU) of single 1200 mg dose IV ORI versus 7-10 days of twice-daily intravenous (IV) vancomycin (VAN) for the treatment of ABSSSI. SOLO protocols were amended (Amendment 2) to allow outpatient treatment at the investigator's discretion. Efficacy and HRU of treatment were assessed in inpatient and outpatient settings. Efficacy for the European Medicines Agency (EMA) was investigator-assessed clinical cure 7-14 days after end of treatment. HRU endpoints were hospitalization rate and length of stay (LOS) in days if the patient was hospitalized. RESULTS In the combined studies, 1959 patients were in the modified intent-to-treat (mITT) population; 1,172 patients (60%) received a portion of their care in as inpatients; 202 patients were treated in Eastern European countries (EUC: Russian Federation, Romania and Ukraine) and 1,165 were treated in the US. Clinical cure rates were similar for ORI and VAN in both regions (86.1% and 84.2% in EUC, 80.6% and 77.9% in the US. The average LOS (ALOS) in the EUC was longer than in the US (14.9 and 14.7 vs. 6.0 and 6.4 days). CONCLUSIONS Clinical cure rates at PTE were similar between ABSSSI patients who received a single dose of ORI or 7-10 days of VAN in SOLO, but the ALOS in the US was considerably shorter than in Eastern Europe. Using oral or long-acting antibiotic treatments may reduce the numbers of inpatient IV antibiotic administrations, which has been associated with reduced LOS in other studies.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PIN4
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Infectious Disease (non-vaccine)