Work

Generic versus branded tigecycline for multidrug-resistant gram-negative bacilli and nontuberculous mycobacterial infections

Year: 2026

Type: article

Abstract: The increasing prevalence of multidrug-resistant gram-negative bacilli (MDR-GNB) and non-tuberculous mycobacteria (NTM) necessitates effective salvage therapies like tigecycline. While generic formulations offer significant cost savings, clinical data comparing their real-world efficacy against original branded formulations remain limited. This study evaluated the therapeutic efficacy and safety of generic versus branded tigecycline in a resource-limited setting. We conducted a retrospective cohort study at Siriraj Hospital, Bangkok, Thailand, involving adults treated with tigecycline for MDR-GNB or NTM infections. Patients were divided into generic (Tygin®) and branded (Tygacil®) groups. The primary endpoint was 30-day all-cause mortality, with secondary endpoints including microbiological response and safety profiles. Penalized logistic regression and sensitivity analysis were performed to adjust for baseline confounders and identify independent predictors of mortality. A total of 135 patients were analyzed (27 generic, 108 branded). Acinetobacter baumannii was the most common pathogen in this cohort. Thirty-day mortality did not differ significantly between the generic and branded groups (51.9% vs 63.9%). Among non-NTM infections, mortality rates were 59.1% and 66.3%, respectively (P = .366). The branded tigecycline group demonstrated a higher frequency of concomitant antibiotic use (P = .018). The generic tigecycline group exhibited a significantly lower incidence of adverse events (48.1% vs 70.4%; P = .018). In multivariate and sensitivity analyses, tigecycline formulation was not associated with mortality. Higher APACHE II scores and Charlson Comorbidity Index were independent predictors of mortality. In this retrospective cohort, clinical and safety outcomes were exploratory and did not demonstrate significant differences between formulations. However, given the wide confidence intervals, clinically meaningful differences cannot be definitively excluded, and these findings warrant validation in adequately powered prospective studies.

Source: Medicine

DOI: 10.1097/md.0000000000050510

Authors: Rujipas Sirijatuphat, Subhara Sathienluckana, Yupin Suputtamongkol

Institutions: Siriraj Hospital, Mahidol University

Language: English

Topic: Antibiotics Pharmacokinetics and Efficacy

Subfield: Pharmacology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,950