The CDC, American Thoracic Society and the Infectious Diseases Society of America have released updated clinical practice guidelines for the treatment and control of drug-susceptible TB infection.
The new guidance retains many of the core principles of TB care described in the 2003 version, but contains recommendations to initiate treatment prior to testing in high-risk patients, information on preferred treatment regimens and appropriate variations, and detailed care suggestions for patients with other compromising conditions, particularly HIV coinfection.
“Data from numerous trials have made it very clear that patients with HIV should begin treatment with [ART] during TB treatment, and not wait until after TB therapy is completed,” Payam Nahid, MD, MPH, professor of medicine at the University of California, San Francisco School of Medicine, said in a press release. “Research shows that all patients with TB and HIV should receive treatment for both conditions, with HIV treatment beginning within 8 to 12 weeks of the start of TB therapy. Some patients may need treatment even sooner.”
The guidelines — which are also endorsed by the European Respiratory Society and the U.S. National Tuberculosis Controllers Association — were developed by a panel of specialists in pulmonary medicine, infectious disease, pediatrics, pharmacokinetics, primary care and public health. Unlike the prior guidance, the experts developed their recommendations using evidence appraised with the GRADE system of evaluation. The guidance is intended for children and adults in settings where mycobacterial cultures, molecular and phenotypic drug susceptibility tests, radiographic studies and other diagnostics are routinely available. Practice guidelines for drug-resistant TB are not described, and will be covered in a separate document currently under development.
The experts advocated a four-drug, 2-month regimen of isoniazid, rifampin, pyrazinamide and ethambutol, followed by 4 months of isoniazid and rifampin. Treatment should be initiated empirically for patients who are severely ill or have high likelihood of infection, and treatment should not be delayed due to negative acid-fast bacilli smears.
For all patients, the panel recommended practicing comprehensive case management and, if agreed upon by the patient, directly observed therapy.
“Case management, including [directly observed therapy] and patient education and counseling, is vital to reducing the risk of non-adherence to treatment, and consequently the risks of TB relapse, drug-resistance and other illnesses,” Philip LoBue, MD, director of the CDC’s Division of Tuberculosis Elimination, said in the release. “We now have clear evidence to show that the benefits of case management are real.”
Special care is required for aged patients, and for those with renal, hepatic or other diseases, according to the panel’s recommendations. In contrast to the previous recommendations, patients with HIV coinfection should begin ART as early as possible, except in some cases of TB meningitis where it may need to be temporarily delayed. If the patient does not initiate ART during their treatment for TB, therapy should be extended to 8 months or longer to reduce the risk of relapse.
Other areas covered by the guidelines include pediatric therapies, treatment during pregnancy and clinical care for extrapulmonary TB. However, the panel noted that further research is still required to identify new anti-TB drugs, biomarkers of effective treatment and practices to maximize the delivery of care in underserved areas.
Disclosure: Nahid and LoBue report no relevant financial disclosures. Please see the full guidelines for a complete list of disclosures.