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Posts Tagged ‘TB drugs’

In a small new study, researchers found that linezolid, an antibiotic first approved in 2000, may be an effective component in the treatment of multidrug-resistant drug-resistant tuberculosis. But as previous research of this drug has suggested, linezolid is far from a perfect cure for the global epidemic of drug-resistant TB, and the findings reinforce the need for a ramped-up research and development effort to combat this deadly germ.

The most recent study, published in Clinical Infectious Diseases, involved 30 patients in California who were diagnosed with MDR-TB. Most of the patients were successfully cured. But nine patients experienced side effects, with symptoms including peripheral and optic neuropathy, anemia, rash, and diarrhea. Three patients stopped therapy.

The results are an indication that linezolid needs to be used carefully, the researchers concluded. “While receiving linezolid, patients should be closely monitored for signs or symptoms of bone marrow toxicity and peripheral and optic neuropathy,” the scientists write in the CID article.

“We found that linezolid … can play an important role in the management of MDR-TB, as long as it is used carefully and with appropriate monitoring, while we wait for better and less toxic drugs,” lead investigator Dr. Gisela F. Schecter said, according to a Reuters Health story. “Use of this drug has allowed the treatment and cure of patients who might otherwise have been deemed incurable.”

In another caveat, the authors note in CID that none of the patients in their study were known to have HIV infection and that more research was needed to investigative the efficacy and tolerability of linezolid in HIV-positive persons.  That is particularly crucial given the deadly syngery of the HIV and TB epidemics.

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, delivered a forceful message on the need for a “storm” of attention and resources devoted to developing new TB treatment and prevention efforts.

“It is imperative that we transform the way we diagnose, treat, prevent, and control TB — through biomedical research and public health measures — to the same extent that we have done and will continue to do with HIV/AIDS,” Fauci writes in this commentary on MSNBC’s website today. “We are beginning to see the winds of change, but what we really need is a storm.”

In an echo of the speech he delivered this summer at the Pacific Health Summit in Seattle, Fauci, a powerful leader in infectious disease research, outlined the need for a robust new TB research agenda. “The TB research effort will require a sustained and long-term commitment from government, academia, industry and philanthropy.”

Click here to read the whole piece and here to read our earlier post on Fauci’s remarks in Seattle.

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A Food and Drug Administration advisory committee has decided that the threat posed by MDR-TB merits a fast-track approval process for potential new treatments.

The clock is ticking, as drug-resistant TB spreads across the globe and scientists search for new drugs to combat this virulent germ. Given that background, the FDA’s Anti-Infective Drugs Advisory Committee concluded on June 3 that sputum culture conversion could be the basis to support accelerated approval of drugs to treat MDR- TB.

Carol Dukes Hamilton, MD, co-chair of the Center for Global Health Policy’s Scientific Advisory Committee, was among the TB experts urging the FDA committee to approve the fast-track process. Sputum culture conversion is “the best we have” as a surrogate for measuring efficacy in MDR-TB drugs, Hamilton told the panel on Wednesday.

 The FDA panel’s action is a significant step forward for doctors and scientists who are on the front lines of battling the global TB epidemic. According to a story in the Pink Sheet Daily, the advisory committee “supported culture conversion, with improvement/resolution of signs and symptoms, as an acceptable surrogate endpoint for accelerated approval” by an 18-to-1 vote.

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Two troubling TB stories this morning:

First, a study in the Lancet reports that MDR-TB is an increasing threat in the former Soviet Union and China.

“The countries of the former Soviet Union are facing a serious and widespread epidemic with the highest prevalence of MDR-TB ever reported in 13 years of global data collection,” the study concluded.

Click here to read the summary in the Lancet, or here to read an AFP story on the article.

Second, there’s the news that Burma will face a severe shortage of TB drugs next year unless emergency funding is secured. Talk about a recipe for a new outbreak of drug-resistant TB. The Global Drug Facility currently supplies Burma with its TB drugs, but GDF decided to end the program because the Global Fund to Fight AIDS, Tuberculosis and Malaria was supposed to step in. Except that the Global Fund’s program won’t start until 2011.

So that leaves a one-year gap in which potentially thousands of Burmese citizens with active TB won’t get needed medication. Here’s a story on the situation from the Irrawaddy.

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