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Single IV Dose of Dalvance Treats ABSSSI in IDUs Equally Well
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BOSTON — A single IV dose of Dalvance appears to be comparable to two-dose regimens for the treatment of acute bacterial skin and skin structure infection, and remains so when treating patients with a history of injection drug use, according to data presented at ASM Microbe 2016.
Pedro Gonzalez
“[Dalvance (dalbavancin; Allergan)] is a single-dose treatment for skin and skin structure infection,” Pedro L. Gonzalez, MD, MT, medical director for infectious diseases at Allergan, told Infectious Disease News. “In our commitment to look for a place where we can actually offer the best value for the drug, we look for unmet needs, and one of the areas of unmet need that we identified was the IV drug user population.”
In their double blind, phase 3 trial, Gonzalez and colleagues enrolled adult acute bacterial skin and skin structure infection (ABSSSI) patients with (n = 212) and without a history of injection drug use (n = 486) to receive either a single-dose (1,500 mg) or two-dose (1,000 mg, 500 mg) IV infusion of dalbavancin. The researchers reported the proportion of patients demonstrating 20% or greater reductions in erythema within 48 to 72 hours of treatment initiation, as well as the percentage achieving clinical success on days 14 and 28.
When comparing the baseline characteristics of each study population, injection drug users (IDUs) were more often younger, male, and Hispanic or Latino. In addition, IDUs had lower BMIs, systemic inflammatory response syndrome rates, cellulitis rates and less often demonstrated bandemia of at least 10%.
There were no significant differences in 48- to 72-hour treatment response rates between dosage groups, and between IDUs and non-IDUs. The proportion of patients with clinical success at 14 and 28 days also was similar between the different study groups, and there was no difference in the incidence of adverse events.
In light of these favorable results and the convenience of a single-dose ABSSSI treatment, David Melnick, MD, vice president of clinical development for anti-infectives at Allergan, said dalbavancin could become a key tool for health providers treating IDUs.
“You can think of this as an almost ‘fire-and-forget’ intervention — you give the dose, the patient no longer needs to take daily medication, you don’t need an indwelling line,” Melnick told Infectious Disease News. “Therefore, we think it’s an important therapeutic advancement for that population of patients.” – by Dave Muoio and John Schoen
Reference:
Gonzalez PL, et al. Treatment of acute bacterial skin and skin structure infection with single dose dalbavancin in the intravenous drug user population. Presented at: ASM Microbe; June 16-20, 2016; Boston.
Disclosure: Gonzalez and Melnick are employees of Allergan.