SYSTEMATIC LITERATURE REVIEW OF ADVERSE EVENTS OBSERVED IN THE REAL WORLD WITH ISAVUCONAZOLE, VORICONAZOLE AND LIPOSOMAL AMPHOTERICIN B IN INVASIVE MOLD INFECTION TREATMENTAND LIPOSOMAL AMPHOTERICIN B IN INVASIVE MOLD INFECTION TREATMENT
Author(s)
MARIA CARLOTA MOYA, MSc1, Manuel Galvez, MD2, José Ramón Azanza, MD3, Isabel Izquierdo, MD4, Vicente Merino-Bohórquez, PhD5, José Tiago Silva, MD6, Carlos Rubio Terrés, BSc7, Edward Ivor Broughton, BSc, MPH, PhD8.
1Pfizer SLU, ALCOBENDAS, Spain, 2PFIZER SLU, Madrid, Spain, 3Universidad de Navarra, Pamplona, Spain, 4Hospital Universitario Miguel Servet, Zaragoza, Spain, 5Hospital Universitario Virgen Macarena, Seville, Spain, 6Hospital Universitario 12 de Octubre, Madrid, Spain, 7Director, HEALTH VALUE, Madrid, Spain, 8Pfizer, Muenchen, Germany.
1Pfizer SLU, ALCOBENDAS, Spain, 2PFIZER SLU, Madrid, Spain, 3Universidad de Navarra, Pamplona, Spain, 4Hospital Universitario Miguel Servet, Zaragoza, Spain, 5Hospital Universitario Virgen Macarena, Seville, Spain, 6Hospital Universitario 12 de Octubre, Madrid, Spain, 7Director, HEALTH VALUE, Madrid, Spain, 8Pfizer, Muenchen, Germany.
OBJECTIVES: To determine the occurrence of adverse events (AEs) associated with isavuconazole (ISAV), voriconazole (VORI) and liposomal amphotericin B (L-AMB) for treatment of invasive mold infections (IMI) reported in real-world evidence (RWE), pharmacovigilance studies and meta-analyses.
METHODS: A systematic literature review (SLR) was conducted following PRISMA guidelines and PICOS system. The risk of bias was assessed using the MINORS index. RWE, pharmacovigilance studies (using FAERS, FPVD and VigiBase databases) and safety meta-analyses were analyzed separately. The frequency of AEs, reported in the source publication, was recalculated according to patient-weeks criteria.
RESULTS: The SLR identified 18 RWE studies, 9 pharmacovigilance analyses, and 16 meta-analyses that examined AEs with ISAV, VORI, and L-AMB. Analysis of RWE studies indicated that the mean rates of AEs per patient-week observed were 0.97% (0.2-14.3%) for ISAV, 2.83% (2.2-31.0%) for VORI, and 14.8% (1.9-17.8%) for L-AMB. ROB was high in the 18 RWE studies. Reported Odds Ratios (ROR) calculated from pharmacovigilance data confirmed better tolerability of ISAV compared to VORI. One study reported an ROR of drug-induced liver injury of 4.58 (95% CI 4.29-4.90) with VORI and 1.22 (95% CI 0.92-1.63) with ISAV. In the two meta-analyses identified, ISAV was associated with a significantly lower incidence of drug-related AEs compared with VORI. ISAV was associated with a significantly lower incidence of drug-related AEs compared with VORI (RR = 0.70, 95% CI: 0.61 to 0.81, p < 0.001) as well as significantly lower discontinuation rate due to drug-related AE (RR = 0.56, 95% CI: 0.39 to 0.82, p = 0.003).
CONCLUSIONS: The rate of AEs observed in clinical practice with ISAV was lower than that described with VORI and L-AMB for treatment of IMI according to the available studies.
METHODS: A systematic literature review (SLR) was conducted following PRISMA guidelines and PICOS system. The risk of bias was assessed using the MINORS index. RWE, pharmacovigilance studies (using FAERS, FPVD and VigiBase databases) and safety meta-analyses were analyzed separately. The frequency of AEs, reported in the source publication, was recalculated according to patient-weeks criteria.
RESULTS: The SLR identified 18 RWE studies, 9 pharmacovigilance analyses, and 16 meta-analyses that examined AEs with ISAV, VORI, and L-AMB. Analysis of RWE studies indicated that the mean rates of AEs per patient-week observed were 0.97% (0.2-14.3%) for ISAV, 2.83% (2.2-31.0%) for VORI, and 14.8% (1.9-17.8%) for L-AMB. ROB was high in the 18 RWE studies. Reported Odds Ratios (ROR) calculated from pharmacovigilance data confirmed better tolerability of ISAV compared to VORI. One study reported an ROR of drug-induced liver injury of 4.58 (95% CI 4.29-4.90) with VORI and 1.22 (95% CI 0.92-1.63) with ISAV. In the two meta-analyses identified, ISAV was associated with a significantly lower incidence of drug-related AEs compared with VORI. ISAV was associated with a significantly lower incidence of drug-related AEs compared with VORI (RR = 0.70, 95% CI: 0.61 to 0.81, p < 0.001) as well as significantly lower discontinuation rate due to drug-related AE (RR = 0.56, 95% CI: 0.39 to 0.82, p = 0.003).
CONCLUSIONS: The rate of AEs observed in clinical practice with ISAV was lower than that described with VORI and L-AMB for treatment of IMI according to the available studies.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE339
Topic
Clinical Outcomes, Economic Evaluation
Disease
Infectious Disease (non-vaccine)