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. 2024 Sep 3;2(1):58.
doi: 10.1186/s44263-024-00087-w.

Recommendations for the optimal introduction of novel antibiotics to treat uncomplicated gonorrhoea in the face of increasing antimicrobial resistance: a case study with zoliflodacin

Fernando Pascual  1 , Carmen Au  2 , Chido Dziva Chikwari  3   4 , Pierre Daram  2 , Carolyn Deal  5 , Angelica Espinosa Miranda  6 , Yonatan H Grad  7 , Edward Wiii Hook  8 , Rossaphorn Kittiyaowamarn  9 , Alison Luckey  2 , Nicola Low  10 , Venessa Maseko  11 , Remco P H Peters  12   13   14 , Teri Roberts  2 , Magnus Unemo  15   16 , Subasree Srinivasan  2
Affiliations

Recommendations for the optimal introduction of novel antibiotics to treat uncomplicated gonorrhoea in the face of increasing antimicrobial resistance: a case study with zoliflodacin

Fernando Pascual et al. BMC Glob Public Health. .

Abstract

New, first-in-class oral antibiotics like zoliflodacin, developed in a public-private partnership, require an optimal introduction strategy while ensuring antibiotic stewardship. Zoliflodacin, given as a single dose for uncomplicated urogenital gonorrhoea, recently demonstrated non-inferiority to ceftriaxone plus azithromycin and safety in a phase 3 randomised controlled trial. Following regulatory approval, zoliflodacin could improve sexually transmitted infection (STI) management and help address the threat of untreatable gonorrhoea, as levels of resistance to current first-line treatments increase. The Global Antibiotic Research & Development Partnership (GARDP) convened an expert meeting during the 2023 STI and HIV World Congress to discuss key questions about the introduction of zoliflodacin in low- and middle-income countries (LMICs). The questions included: which patients to treat in which situations, the timing of introduction, and what additional evidence is needed to change policy for the use of new antibiotics for gonorrhoea. Recommendations from the expert group included: the generation of evidence for the role of a drug like zoliflodacin in clinical treatment failures; the need for additional antimicrobial resistance surveillance; investigation of the role of novel diagnostic approaches, such as point-of-care tests, to improve stewardship; study of preferences and values among the population in need; and modelling of the emergence of N. gonorrhoeae resistance and transmission in different scenarios. Forthcoming World Health Organization (WHO) global guidelines could outline recommendations for a new oral antibiotic like zoliflodacin based on existing evidence, and rational approaches for certain populations or use cases, while the evidence base is further strengthened.

Keywords: Neisseria gonorrhoeae; Antimicrobial resistance; Gonorrhoea; Health policy; Public health; Sexually transmitted infections; Treatment guidelines.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: Zoliflodacin is co-developed by the Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA). CA, AL, PD, SS, TR and FP are employees of GARDP. GARDP covered the expenses for RK. CD, HE, RK and MU have participated in zoliflodacin development. The remaining authors declare that they have no competing interests.

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