First-line use of voriconazole yields better outcomes for life-threatening fungal infection

September 16, 2003

San Antonio (Sept. 16, 2003) Data presented at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) showed that the antifungal treatment voriconazole, a second-generation triazole, is more effective and less costly than the standard of care for invasive aspergillosis when used as first-line therapy (Posters M-964 and A-1359). Results from global studies were presented by The University of Texas Health Science Center at San Antonio (UTHSCSA) researchers, Thomas F. Patterson, M.D., professor of medicine, and James Lewis, Pharm.D., infectious diseases pharmacy specialist.

"For patients whose immune systems are compromised by cancer chemotherapy or organ and bone marrow transplants, invasive aspergillosis can be fatal," said Dr. Patterson. "Physicians need to understand that the type of therapy selected for first line impacts the patient's chance of survival. These studies showed that patients initially treated with voriconazole had better outcomes and incurred fewer antifungal drug costs than patients treated initially with the prior 'gold standard therapy' amphotericin B."

Enhancing Patient Outcome

Dr. Patterson and other investigators assessed how initial therapy with voriconazole impacts ultimate outcomes compared to amphotericin B. This analysis was done with data from a previously published clinical trial (Herbrecht, NEJM, 2002) that compared voriconazole to standard therapy with amphotericin B. The study (Poster M-964) assessed 277 patients who were randomized to either voriconazole or amphotericin B and treated for up to 12 weeks.

The results showed that initial treatment with voriconazole led to significantly better outcomes for patients compared to those treated initially with amphotericin B. Overall, voriconazole patients had a 53 percent success rate as compared to success in 32 percent of patients on amphotericin B. Notably success occurred in only 23 percent who were switched from amphotericin B for intolerance or progressive infection, suggesting the importance of effective initial antifungal therapy. In addition, significantly fewer voriconazole patients required other licensed antifungal therapy (OLAT). Thirty-six percent of voriconazole patients received OLAT following initial treatment compared to 80 percent taking amphotericin B. Seventy percent of amphotericin B patients switched therapies due to intolerance or insufficient response while only 24 percent of patients on voriconazole switched therapies.

Healthcare Cost Savings

As the treatment of invasive aspergillosis requires prolonged therapy and can be expensive, Dr. Lewis and other investigators analyzed data from the Herbrecht trial to evaluate "real-life" antifungal costs for aspergillosis therapy. The study (Poster A-1359) accounted for current drug acquisition costs of primary therapy, intravenous to oral switch in primary therapy, and the types and duration of OLAT.

The data showed that initial therapy with voriconazole resulted in significantly reduced drug costs when compared to the treatment with conventional amphotericin B. Overall per patient cost was $722 less for patients receiving voriconazole than those randomized to initial therapy with amphotericin B due to the fact that patients initially receiving amphotericin B required other licensed antifungal therapy. At the end of 12 weeks, total drug costs for patients randomized to voriconazole were $783,184 compared to $826,005 for patients initially treated with amphotericin B. Total drug cost per positive outcome (treatment success) was $10,305 for voriconazole and $19,667 for amphotericin B.

"The cost of antifungal therapy must include both the total drug costs as well as the potential for a positive outcome," said Dr. Lewis. "The reduced drug cost seen in the study is influenced by the improved efficacy and tolerability of voriconazole when compared to other therapies."

About Invasive Aspergillosis

Invasive aspergillosis is a severe pulmonary infection usually accompanied by chest pain, fever and coughing. The infection can spread throughout the body and can settle in numerous organs, including the brain. If left untreated, invasive aspergillosis can kill within a matter of days.

Invasive aspergillosis is caused by the fungus Aspergillus fumigatus, a ubiquitous fungus found in everything from water to dust to dirt. For healthy patients, aspergillosis has little effect, but for those whose immune system is compromised, the fungus could be deadly. The overall mortality rate for invasive aspergillosis in immunocompromised patients is estimated to be 58 percent, but approaches 90-100 percent in patients with disseminated infection.

About Voriconazole

Voriconazole is a treatment for progressive, potentially life-threatening and serious fungal infections marketed by Pfizer Inc. Vfend is indicated for the primary treatment of invasive aspergillosis and for infections caused by Fusarium and Scedosporium apiospermum in patients who are intolerant of or don't respond to other therapy. Voriconazole is available in both IV and oral formulations.

The University of Texas Health Science Center at San Antonio (UTHSCSA) is a leading research institution with broad expertise in both basic science and clinical aspects of fungal disease. UTHSCSA is the primary catalyst of San Antonio's $11.5 billion-a-year biomedical industry and a significant contributor to the international scientific and medical communities. The UTHSCSA is home to the nation's top aging research team and is the site of a premier diabetes research team and one of the largest U.S. transplant programs. Health Science Center faculty have patented the world's first balloon expandable cardiac stent, contributed to the international Human Genome Project and published landmark alcohol addiction discoveries. With an original Central Campus in northwest San Antonio, the UTHSCSA has grown to include six campuses throughout a 38-county region stretching from San Antonio to the Texas-Mexico border. The UTHSCSA is the primary provider of medical education for this entire region.

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