This article is more than 5 years old. Information may no longer be current.
4-month regimen effective in treating less severe TB cases
Click Here to Manage Email Alerts
A new analysis of three pivotal tuberculosis trials showed that a shorter treatment regimen — 4 months instead of 6 — is effective in patients with minimal disease.
TB kills more people than any other infectious disease. Writing in Nature Medicine, Payam Nahid, MD, MPH, professor of medicine in the division of pulmonary and critical care at the University of California, San Francisco School of Medicine, and colleagues summarized three recent international randomized phase 3 trials that evaluated shorter treatment courses for TB. According to Nahid and colleagues, in all three trials, a 4-month fluoroquinolone-containing regimen failed to achieve noninferiority compared with a 6-month control regimen in adults with pulmonary, drug-susceptible TB.
“However, the experimental 4-month regimens did cure approximately four-fifths of the participants, suggesting that a large proportion of global tuberculosis cases could be successfully treated with shorter duration,” they wrote.
The researchers explained that the failure of the earlier trials was due to an inadequate “one-size-fits-all” approach: All patients, regardless of the severity of their disease, were treated the same.
According to the analysis, of the 3,411 participants included in the modified intent-to-treat analyses of the three studies, 2,001 received one of four fluoroquinolone-containing 4-month regimens and 1,404 received the standard 6-month regimen. Nahid and colleagues retrospectively stratified participants from the three trials into minimal, moderate and severe disease categories.
They found that although a 4-month treatment course was ineffective for patients with moderate or severe TB, the shorter regimen was highly effective for 47% of patients with minimal TB. Additionally, the 6-month treatment course was insufficient for those with the most extensive TB, the researchers observed.
They also found that missing just one in 10 doses of medication led to a fivefold greater risk for treatment failure, challenging current TB treatment guidelines in the United States and internationally that say patients can occasionally miss doses, according to a news release.
"Our study shows a stratified medicine approach can be feasibly applied to achieve treatment shortening for many patients with TB,” Nahid said in the release. "A one-size-fits-all approach leads to undertreatment of patients with severe forms of disease, and overtreatment, with the potential that the drugs will cause harm, for patients who have less extensive disease." – by Marley Ghizzone
Disclosures: The authors report no relevant financial disclosures.
Click Here to Manage Email Alerts