HSC TEAM STUDIES NEW TB THERAPIES

November 1, 2002

New data released from the national Tuberculosis Trials Consortium indicates that a regimen of medication therapy for active TB disease utilizing a new combination of drugs just once a week is a viable option to the current twice-weekly treatment regimen.

Stephen Weis, DO, an infectious disease specialist with the health science centerâ??s Physicians & Surgeons Medical Group and director of tuberculosis services at the Tarrant County Public Health Department, is principal investigator for the nationwide, multi-year clinical trial of new methods for the treatment and prevention of TB. His clinical teamâ??s participation as one of 23 sites in the consortium study is supported by a 10-year grant for more than $5 million from the Centers for Disease Control.

A leading clinical researcher in TB, Dr. Weis is credited with initiating the first use of directly observed therapy for the control of tuberculosis in the United States. Directly observed therapy, or DOT, is now the recommended course of treatment for all patients with TB in the country and is being adopted by other areas of the world, many dealing with TB as an epidemic among their populations. His work with DOT resulted in a 70 to 80 percent decline in relapse rates among Tarrant County study subjects.

The data from the consortiumâ??s new study confirms that a once-weekly TB regimen, initiated after the first eight weeks of therapy, is a viable option for some patients being treated for active TB disease. The results were published in the Aug. 17 issue of the medical journal The Lancet. The new, less frequent regimen could improve patientsâ?? compliance to therapy, helping to cure more TB patients and prevent further transmission, according to the report.

Investigators evaluated a regimen of once-weekly drug therapy using a new drug, rifapentine, in combination with the drug isoniazid during the continuation phase of therapy from the ninth to the 24th week of treatment. The new combination and regimen was evaluated in comparison to the current twice-weekly regimen of the drug rifampin combined with isoniazid.

More than 1,000 patients with active TB disease completed eight weeks of intensive TB therapy with the four frontline TB drugs â?? isoniazid, rifampin, pyrazinamide and ethambutol â?? before being randomly assigned to one of two groups during the 16-week continuation phase of TB treatment. One trial group received isoniazid and rifapentine, the first new TB-specific drug approved by the Food and Drug Administration in 30 years, once a week. The other group received the standard therapy of twice-weekly isoniazid and rifampin. Patients included in the study were HIV-negative and had no signs of advanced tuberculosis.

The progress of both groups of patients was followed for two years to monitor the relapse or treatment failure rates. While the relapse rate in the once-weekly group was slightly higher, researchers found that for patients without lung cavities the once-a-week therapy was comparable in results and would be as successful as other currently approved treatment regimens.

TB is an infectious disease spread on airborne droplets, released from deep within the lungs when a TB sufferer coughs or sneezes. Unlike flu or measles â?? diseases that can be contracted just by walking through a room where the virus is airborne â?? the average TB infection results from long-term, constant exposure. People with compromised immune systems, substance abusers, people living in shelters or on the streets, those in poor living conditions and people who travel internationally are most likely at risk. After decades of decline and the lowest TB incidence rate in the world, the number of TB cases in the United States has escalated with the increase of these populations and their interaction with the general public.

Dr. Weis said participation in the consortium is crucial to local TB efforts. â??By exploring new ideas and working with other investigators, weâ??re on the cutting edge of research to diagnose, treat, and prevent TB,â? he said.

The World Health Organization has declared TB a global emergency and estimates that nearly two million people die each year from the contagious infection. Based on current trends, WHO estimates that one billion people could become infected with TB by 2020.

Dr. Weis said local efforts and those of the national consortium could avert the fulfillment of such dire prophecies. â??Hopefully, weâ??ll be able to make some findings here that will be able to affect tuberculosis throughout the world, in addition to helping individuals here in Tarrant County.â?

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John Licciardone Hsc Fort Worth Fc
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