Dalbavancin: A Review in Acute Bacterial Skin and Skin Structure Infections

Abstract

Intravenous dalbavancin (Dalvance™; Xydalba™) is approved for use in adult patients with acute bacterial skin and skin structure infections (ABSSSI), with the recommended regimen being a 1000 mg dose followed 1 week later by a 500 mg dose. In the multinational DISCOVER 1 and 2 trials in adult patients with ABSSSI, dalbavancin treatment was noninferior to vancomycin (for ≥ 3 days with an option to switch to oral linezolid to complete a 10- to 14-day course) in terms of early clinical success rates (assessed 48-72 h after initiation of treatment; primary endpoint required by the FDA to assess noninferiority in registration trials of ABSSSI). Clinical response rates were also similar in both treatment groups at the end of treatment (day 14-15), irrespective of geographic region or baseline characteristics, including by infection type, diabetes mellitus status, systemic inflammatory response syndrome status, causative pathogen and renal function. Dalbavancin was generally well tolerated, with adverse events generally being of mild to moderate intensity and transient. With its broad spectrum of activity against clinically relevant Gram-positive pathogens and its favourable pharmacokinetic profile that permits a convenient two-dose, once-weekly regimen with no requirement for therapeutic drug monitoring, dalbavancin is a promising emerging option for the treatment of ABSSSI in adult patients.

New developments in the treatment of acute bacterial skin and skin structure infections: considerations for the effective use of dalbavancin

“…IV dalbavancin was recently approved by the US Food and Drug Administration (FDA) and represents a convenient treatment option for adult patients with ABSSSIs. 2 , 3 , 11 …”

Lipoglycopeptide Antibacterial Agents in Gram-Positive Infections: A Comparative Review

“…Likewise, additional studies in more severe infections as well as clinical experience in real-life situations will possibly help to document these advantages and position these drugs in our current arsenal. At this stage, one can already point out the possibility of using oritavancin or dalbavancin for outpatient therapy, which could contribute to containing costs, improving quality of life, and adherence to the treatment, as well as to reducing adverse reactions related to prolonged intravenous therapy such as thrombophlebitis or catheterrelated bloodstream infections [32,130,134]. On the other hand, their long half-life asks the question of how to manage adverse effects [133], oritavancin being not extracted by dialysis [171] and dalbavancin only by high-flux dialysers [172].…”

“…Thus, among these three drugs, and based on current knowledge of their respective safety profile, the clinician's choice should take into account specific safety concerns, such as a possibly increased risk of osteomyelitis with oritavancin, of nephrotoxicity and QTc interval prolongation with telavancin, and of increased hepatic enzymes with dalbavancin. Also, in this context, dalbavancin may show an advantage by presenting a lower potential for drug interactions or interference in laboratory testing than the other two drugs [134]. As a result, further clinical experience is warranted to better position each of these molecules in our current arsenal and to define their potential in difficult-totreat infections in which they could reveal all of their advantages.…”

“…Table 4 shows the main clinical trials that led to the registration of lipoglycopeptides for the treatment of acute bacterial skin and skin structure infections and for hospitalacquired pneumonia (telavancin only). The reader is referred to recent reviews that have examined these studies in details (oritavancin [32,130], telavancin [131,132], and dalbavancin [133,134]). …”

Dalbavancin Alone and in Combination with Ceftaroline against Four Different Phenotypes of Staphylococcus aureus in a Simulated Pharmacodynamic/Pharmacokinetic Model

“…The half-life of DAL is 147 to 258 h, which facilitates a single-dose or two-dose administration for the treatment of acute bacterial skin and skin structure infections. This simple dosing strategy is an alternative to more resource demanding intravenously administered antibiotics used to treat serious infections in the hospital and community setting (3,9,14,15).…”