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Durand reports to be a shareholder in Pfizer, a manufacturer of voriconazole. Please refer to the study for all relevant financial information from the other authors.
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Patients treated with isavuconazole as primary or salvage therapy for invasive fungal sinusitis achieved overall survival rates of 82% after 42 days and 70% after 84 days, according to study results published in Clinical Infectious Diseases.
The results come from a post hoc analysis of two Phase 3 studies of isavuconazole that identified 50 patients in the studies with invasive fungal sinusitis.
“I suggested the study because I was caring for patients with invasive fungal sinusitis (IFS).” Marlene L. Durand, MD, an infectious disease doctor at Harvard Medical School and Massachusetts General Hospital, said Healio. “This is a very rare but terrible infection and information about possible therapeutic options is helpful.”
Durand and colleagues performed the post-hoc analysis of the international phase 3 studies of the SECURE and VITAL studies, in which patients participated from 2007 to 2013 (SECURE) and 2008 to 2013 (VITAL). According to the researchers, SECURE compared isavuconazole and voriconazole as the primary treatment for invasive fungal disease (IFD) in adults due to Aspergillus and other filamentous fungi, while VITAL examined the primary or saving isavuconazole treatment in adults with invasive aspergillosis with renal dysfunction or adults with IFD for rare mold .
Durand and colleagues reviewed the data of all patients in both studies who were treated with isavuconazole and who had at least one sinus site from IFD. The main study results were overall survival and clinical and overall responses to isavuconazole.
Of the 50 patients enrolled in the study, 44 were diagnosed with IFS by sinonasal (43) or brain biopsy (one), and six had probable IFD in a remote location but met criteria for probable IFS. According to the study, 34% of patients received isavuconazole as salvage therapy, 34% had disseminated IFD, and 90% were immunocompromised or had diabetes. Mucormycetes were the causative agent in 17 patients, while Mucormycetes plus Aspergillus infections were mixed in a further four.
According to the study, the primary therapy group of 33 patients received isavuconazole for a median of 78 days and 24 for a month or longer, while the salvage treatment group of 17 patients received isavuconazole for a median of 141 days and 12 received it for 1 month or longer.
Overall survival was 82% on day 42 and 70% on day 84. The researchers found that of the 15 deaths by day 84, 11 were attributed to IFD by the data review committee, one died with residual or persistent IFD, two were suspected, and one was unrelated.
The researchers said that day 84 survival rates were higher in primary therapy groups than salvage therapy groups, higher in men than women, higher in immunocompetent than immunocompromised patients, higher in those without central nervous system involvement, higher in those with diabetes alone compared to hematological malignancies, higher in patients with localized vs. disseminated IFD and higher in patients with Aspergillus vs. Mucormycetes infections.
“I believe there are many factors to consider in treating a patient with invasive fungal sinusitis and treatment should be tailored to the individual,” said Durand. “However, this study found that a number of patients with invasive fungal sinusitis were successfully treated with isavuconazole, including some patients with infections that do not respond to other antifungal therapies.”
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