New, simpler treatment for latent tuberculosis

Current nine-month regimen reduced to only 12 weekly doses

December 08, 2011

RESEARCH TRIANGLE PARK, NC — Recommendations announced today by the U.S. Centers for Disease Control and Prevention (CDC) give physicians in the United States a new, simpler way to treat patients with latent tuberculosis (TB) infection. The new treatment regimen consists of only 12 once-a-week doses, which is significantly shorter and easier to administer than the current regimen, which requires patients to take 270 daily doses for nine full months.

People with latent TB infection have TB bacteria present in their bodies but do not experience symptoms and cannot transmit the disease to others. However, the bacteria can become active at a later time. The person will then develop TB disease, express symptoms and begin to spread TB to others around them. Not everyone with latent TB will develop active TB disease. However, people with weakened immune systems caused by HIV infection, malnutrition, immunosuppressant treatment, cancer chemotherapy or other causes have heightened risk of conversion to active disease.

"This regimen has the potential to be a game-changer in the United States when it comes to fighting TB," said CDC Director Thomas R. Frieden, M.D., M.P.H. "It gives us a new, effective option that will reduce by two-thirds – from nine months to three months -- the length of time someone needs to take medicine to prevent latent TB infection from progressing to active TB disease."

The CDC published its new U.S. recommendations today in its Morbidity and Mortality Weekly Report. They were based on the results of three clinical trials, as well as expert opinions. The CDC-funded Tuberculosis Trials Consortium conducted the largest of those trials, PREVENT TB. The consortium first announced the outcome of the PREVENT TB trial in May, 2011 and will be publishing the results this week in the New England Journal of Medicine.

The Tuberculosis Trials Consortium is a network of University and public health-based investigators that currently includes 11 domestic and 9 international clinical sites. FHI 360, in collaboration with public health clinics in North Carolina and investigators at Duke University, led a North Carolina-based clinical trial site. The FHI 360 Principal Investigator for the TB Trials Consortium, Carol Dukes Hamilton, MD, MHS, is a founding member of the Consortium and was the former medical director for the North Carolina TB Control Program.

"Many people with latent TB infection have been unwilling to even consider starting a nine-month long prevention regimen," said Dr. Hamilton. "We think that many of these individuals will be willing to begin, and finish, the shorter regimen, which can get us closer to our goal of eliminating TB in the US."

The PREVENT TB study was carried out over a 10-year period, enrolling over 8000 participants. PREVENT TB compared the current TB prevention regimen – nine months of single drug, isoniazid (INH) – to a combination of INH and another drug, rifapentine, given once a week for 12 weeks. The new drug combination was administered as a "directly-observed treatment," which means that a health provider confirmed that the patient took each dose in a clinic setting.

The 12-dose combination regimen was found to be as effective as the current nine-month INH regimen. Investigators also showed an improved safety profile in the shorter regimen overall, including less liver toxicity.

FHI 360 was honored to contribute to this study. We also congratulate other investigators and clinical trial participants for their decade-long dedication to developing enhanced TB treatments and the CDC for coming forward with important, new recommendations to push us along the path to eradicating TB.