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)

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