P-1210. Real-World Efficacy and Safety of Meropenem-Vaborbactam in Patients with Moderate to Severe Renal Impairment

TL;DR

This study shows that Meropenem-Vaborbactam is effective and safe for patients with moderate to severe kidney impairment, similar to those with normal kidney function.

Contribution

The study provides real-world evidence on the efficacy and safety of MEV in patients with significant renal impairment.

Findings

Clinical success rates were 76% in the renal impairment group and 79% in the non-impaired group.

Adverse events were rare and similar in both groups.

Thirty-day mortality and microbiological recurrence rates were comparable between the groups.

Abstract

Meropenem-vaborbactam (MEV) is a novel β-lactam β-lactamase inhibitor combination approved in the United States for the treatment of complicated urinary tract infections caused by resistant organisms. Its spectrum includes carbapenem-resistant Enterobacterales and Pseudomonas aeruginosa. Limited data exist on the use of MEV in patients with reduced renal function. This study compared clinical characteristics and outcomes between patients with moderate to severe renal impairment and those with mild or no impairment.Table 1.Baseline, infection, and treatment characteristics.Table 2.Clinical outcomes.

Baseline, infection, and treatment characteristics.

Clinical outcomes.

This was a real-world, multicenter, retrospective cohort study conducted between 2017 and 2025 in adult patients who received MEV for ≥72 hours. Patients with KDOQI CKD stages 3-5 or GFR < 60 mL/min/1.73m2 or on chronic dialysis were assigned to the renal impairment (RI) group. All other patients were assigned to the non-impaired (NI) group. The primary outcome was clinical success, defined as resolution or improvement in signs of infection without recurrence. Secondary outcomes included 30-day all-cause mortality, 30-day microbiologic recurrence, 30-day hospital readmission, and occurrence of treatment-emergent adverse events.

Seventy-two patients were included in the RI group and 151 patients were included in the NI group. The median baseline eGFR was 52.3 vs. 91.3 mL/min/1.73m2 in the RI and NI groups, respectively. Nearly half (47%) of patients in the RI group were receiving chronic dialysis. Clinical success was achieved in 76% of patients in the RI group compared to 79% in the NI group (p=0.60). Thirty-day all-cause mortality was 20.8% in the RI group vs. 23.8% the in the NI group (p=0.62). Thirty-day microbiological recurrence and hospital readmission rates were similar between the two groups. Adverse events were rare in both groups and similar in incidence (2.8% vs. 2.6% in the RI and NI groups, respectively [p=0.96]).

This study demonstrated the clinical outcomes of MEV when used in patients with moderate to severe renal impairment. Prospective randomized trials in this patient population are needed to validate these findings.

Kevin W. Garey, PharmD, MS, FIDSA, FASHP, Acurx: Grant/Research Support|Merck & Co.: Grant/Research Support|Paratek Pharmaceuticals: Grant/Research Support Wesley D. Kufel, Pharm.D., BCPS, BCIDP, Merck & Co.: Grant/Research Support|Shionogi, Inc: Grant/Research Support|Shionogi, Inc: Honoraria Tamara Krekel, PharmD, BCPS, BCIDP, AbbVie: Advisor/Consultant|AbbVie: Honoraria|Shionogi: Advisor/Consultant|Shionogi: Honoraria Taylor Morrisette, PharmD, MPH, AbbVie Inc: Advisor/Consultant|AbbVie Inc.: Grant/Research Support|Copeland, Stair Valz & Lovell: Expert Testimony|Infectious Diseases Special Edition: Honoraria|Stellus Rx: Grant/Research Support Travis J. Carlson, PharmD, BCIDP, Aimmune Therapeutics, Inc.: Speaker bureau Venugopalan Veena, PharmD, Merck: Grant/Research Support Vasilios Athans, PharmD, BCIDP, Astellas Pharma: Advisor/Consultant Kimberly C. Claeys, PharmD, PhD, bioMérieux: Advisor/Consultant|bioMérieux: Honoraria Michael J. Rybak, PharmD, PhD, MPH, Abbvie: Grant/Research Support|Innoviva: Grant/Research Support|Melina: Grant/Research Support|Merck: Grant/Research Support|Shionogi: Grant/Research Support

Figures