This article is more than 5 years old. Information may no longer be current.
Isavuconazole effective against mucormycosis
Click Here to Manage Email Alerts
Isavuconazole treatment showed similar efficacy to amphotericin B against mucormycosis, according to data recently published in The Lancet Infectious Diseases.
Previously presented at IDWeek 2014, these findings were among those cited by the FDA’s Anti-Infective Drug Advisory committee when it recommended Cresemba (isavuconazonium sulfate, Astellas Pharma) for the rare infection in an 8-2 vote.
“Mucormycosis, an opportunistic invasive fungal disease which is classically associated with diabetic ketoacidosis and iron overload, is increasingly encountered in immunocompromised individuals, especially those receiving treatment for hematological malignancies or undergoing transplantation,” the researchers wrote. “Present guidelines recommend antifungal treatment, surgical debridement and correction of underlying predisposing disorders. Although amphotericin B and posaconazole show in-vitro activity against Mucorales molds, their clinical use is often restricted.”
In the single-arm, open-label global trial, researchers enrolled 37 patients with mucormycosis to receive a treatment regimen containing isavuconazole. Twenty-one of these patients received isavuconazole as their primary treatment, and were matched with controls from another global trial receiving amphotericin B-based treatment. The primary endpoint was overall response to the treatment as per criteria specified by an independent data review committee, with 42-day all-cause mortality outcomes compared between the case-matched participants.
Enrolled patients received isavuconazole for a median 84 days, with 24 patients discontinuing treatment. Leading reasons for discontinuation were death (30%), adverse events (16%) and noncompliance (11%). By day 42, 43% of patients had stable invasive fungal disease, 11% had a partial response, 3% has disease progression, and 35% died. Mortality between participants primarily taking isavuconazole and matched controls was similar at 42 days (33% vs. 39%).
The researchers wrote that the observed response rate among patients taking isavuconazole was similar to that reported among studies of liposomal amphotericin B, and represent a “welcome addition to the complex management of mucormycosis.”
Emmanuel Roilides, MD, PhD, and Charalampos Antachopoulos, MD, PhD, both of the Aristotle University School of Health Sciences, Thessaloniki, Greece, came to a similar conclusion. In a related editorial, they wrote that despite the study’s unavoidable small sample and reliance on external control matching, these findings are a welcome addition to the limited data currently available.
“Bringing active and safe treatments for rare fungal diseases, such as mucormycosis, to clinical practice is difficult, but the present report definitely opened a new path to achievement of this goal,” – by Dave Muoio
Reference:
Marty FM, et al. Lancet Infect Dis. 2016; doi:10.1016/S1473-3099(16)00071-2.
Marty FM, et al. Abstract 824. Presented at: IDWeek; Oct. 8-12, 2014; Philadelphia.
Roilides E, et al. Lancet Infect Dis. 2016; doi:10.1016/S1473-3099(16)00127-4.
Disclosures: Marty reports grants and personal fees from Astellas, Merck and WHISCON, nonfinancial support from Astellas and Merck, and holds a related patent. Roilides reports grants, personal fees and nonfinancial support from Astellas, Gilead Sciences, Merck and Pfizer. Antachopoulos reports nonfinancial support from Gilead Sciences and Pfizer, along with personal fees from Gilead Sciences. Please see the full study for a list of all other authors’ relevant financial disclosures.