New Drug Fights Deadly Fungal Infections

Noxafil recently gained FDA approval and is already in widespread use

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By
HealthDay Reporter

WEDNESDAY, Jan. 24, 2007 (HealthDay News) -- Two studies have found that a new drug, Noxafil, prevents fungal infections better than existing medications among high-risk patients and also seems to have fewer side effects.

Invasive fungal infections are a leading cause of death among people undergoing chemotherapy for blood cancers, bone marrow transplants or organ transplants and who have low white blood cell counts as a result.

Data from both studies contributed to the recent U.S. Food and Drug Administration (FDA) approval of Noxafil (posaconazole) for preventing fungal infections. The studies, which appear in the Jan. 25 issue of the New England Journal of Medicine, were funded by the Schering-Plough Research Institute, which makes the drug.

"Noxafil seems to have a better side effect profile and less drug interaction problems than other antifungal agents," said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City. "There certainly seems to be a place for this."

But expense will come into the equation, another expert said.

"The question is, how many people do you need to treat with drugs that are not cheap to prevent one infection?" said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "For most patients -- who you anticipate having low blood counts for a relatively short time -- this probably will not alter practice tremendously. But in patients who have prolonged episodes of low blood counts, this will give you an opportunity to change the way you plan to treat patients."

There's no doubt that fungal infections can be a big threat. "Fungal disease is very, very serious, and it kills people," Brooks said. "It's unusual, but it does occur."

A drug called Diflucan (fluconazole) is standard treatment but does not affect aspergillus species and other molds. Another drug, Sporanox (itraconazole), affects aspergillus, but is not well utilized by the body.

Noxafil is a newer agent that does affect aspergillus and other species.

The first trial compared Noxafil with Diflucan in preventing invasive fungal infections in 600 patients with graft-versus-host-disease (GVHD) who were receiving immunosuppressive therapy. GVHD can be a serious complication of bone marrow transplantation.

Noxafil was as effective as Diflucan in preventing all invasive fungal infections and was better in preventing invasive aspergillosis, the researchers report. Overall death rates were similar in the two groups, but the number of deaths from invasive fungal infections was lower in the Noxafil group. The proportion of patients experiencing side effects was similar in both groups.

"The study proved that targeted prophylaxis of a high-risk population prevents invasive fungal disease, especially invasive aspergillosis, and reduces the fungal disease-related mortality," said study author Dr. Andrew J. Ullmann, attending physician for hematology/oncology and infectious diseases at Klinikum Johannes Gutenberg University in Mainz, Germany. "Physicians should consider using the drug in these high-risk situations for prophylaxis. In Mainz, patients at high risk for invasive fungal disease receive posaconazole prophylaxis."

Researchers for the second study compared Noxafil with Diflucan or Sporanox for preventing invasive fungal infections in more than 600 patients undergoing chemotherapy for acute myelogenous leukemia (AML) or the myelodysplastic syndrome, which can be a precursor to AML.

Only 2 percent of patients in the Noxafil group developed invasive fungal infections vs. 8 percent in the Diflucan or Sporanox group. One percent of patients taking Noxafil had invasive aspergillosis compared with 7 percent in the competing group. Noxafil also improved survival.

"We introduced Noxafil for prophylaxis almost exactly a year ago and, during the year, it has really transformed what we are doing here," said study author Dr. Oliver A. Cornely, an assistant professor of internal medicine at University Hospital of Cologne in Germany. "Before posaconazole, we saw one case of aspergillosis every week and now we see one case in a year. It really changed things. It will become the standard."

More information

There's more on aspergillosis at the Mayo Clinic.

SOURCES: Andrew J. Ullmann, M.D., attending physician, hematology/oncology and infectious diseases, Klinikum Johannes Gutenberg University, Mainz, Germany; Oliver A. Cornely, M.D., assistant professor, internal medicine, University Hospital of Cologne, Germany; Jay Brooks, M.D., chairman, hematology/oncology, Ochsner Health System, Baton Rouge, La.; Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; Jan. 25, 2007, New England Journal of Medicine

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