Missing an early clinic visit for tuberculosis (TB) treatment, treatment type, and other social, cultural, and educational factors are indicators that patients may experience TB treatment noncompletion, according to a study published in Clinical Infectious Diseases.
Ruth N Moro, MD, MPH Medical Epidemiologist and US Centers for Disease Control and Prevention field employee and colleagues performed a post hoc analysis of the randomized, open label PREVENT-TB trial to determine factors that contribute to noncompletion of treatment (NCT).
Working on this study through the CDC’s Division of Tuberculosis Elimination, Dr Moro and colleagues examined 6232 patients and reported that 22.6% (1406) did not complete latent tuberculosis (LTBI) treatment.
Two types of TB treatment were evaluated in the study: directly observed once-weekly rifapentine with a maximum dose of 900 mg plus isoniazid with the same maximum dose (3HP-DOT), and daily self-administered isoniazid with a maximum dose of 300 mg (9H-SAT). Researchers noted 18% noncompliance for a 3-month period with 3HP-DOT and 31% noncompliance over a 9-month period for 9H-SAT.
Only 317 NCT patients were due to adverse reactions (NCT-AE), and the researchers reported this was found to be similar for each group (3HP-DOT = 6.4% vs 9H-SAT = 5.9%; P = .23). Dr Moro and colleagues reported that “being non-Hispanic and receiving 3HP-DOT, having cirrhosis and receiving 9H-SAT, alcohol consumption among men and use of concomitant medication were associated with NCT-AE.”
NCT-AE causes in the remaining LBTI patients included receiving 9H-SAT, missing 1 or more early visits, men receiving 9H-SAT, men who had been incarcerated, abuse of alcohol, use of IV drugs, younger age receiving 9H-SAT and smoking.
“The most important finding was that among persons who discontinued for reasons other than an AE, those who missed an early visit and returned at least once later were more likely to discontinue the treatment regimen,” the researchers wrote.
In an editorial commentary in the same issue of Clinical Infectious Diseases, Maria J Garcia and M Rosario Lopez, both of the Department of Preventive Medicine and Public Health and Microbiology in the School of Medicine at Autonoma University of Madrid said, “These data should be used to achieve early identification of contacts and to perform close monitoring during the initiation of preventive treatment for tuberculosis. This effort is likely to help improve the epidemiological effect of the preventive treatment used in LTBI.”2
In an interview with Infectious Disease Advisor, lead study author Dr Moro said that, “Although the results of this study are from clinical trial data, the population enrolled in the United States was so diverse that these results might be relevant in clinical practice settings. Patient characteristics associated with a higher likelihood of noncompletion of LTBI treatment can be identified at the first visit.”
Dr Moro emphasized during the interview the impact of a missed clinic visit early in treatment, and that “patients with clinical, social and demographic characteristics associated with noncompletion, such as concomitant medications, cirrhosis, smoking, alcohol use, intravenous drug use, history of incarceration, homelessness, and unemployment may need close monitoring for their risk to discontinue treatment.”
“This insight can help identify patients who may benefit from targeted interventions to improve completion of LTBI treatment, she told IDA.
Dr Moro said that additional evaluation of the associations linked to noncompletion “is warranted both in clinical trials and in TB treatment program settings.”
“It is estimated that up to 13 million people in the United States have latent TB infection,” Dr Moro explained. “Identifying and treating those at highest risk for developing TB disease will help move toward elimination of the disease. Health care providers play a key role in achieving the goal of TB elimination because of their access to high-risk populations.”
1. Moro RN, Borisov AS, Saukkonen J. Factors associated with noncompletion of latent tuberculosis infection treatment: experience from the PREVENT TB trial in the United States and Canada. Clin Infect Dis. 2016;62(11):1390-1400.
2. Garcia MJ and Lopez MR. Do we have strategies to improve the preventive treatment of latent tuberculosis infection? Clin Infect Dis. 2016;62(11):1401-1402.