Symptoms and Systemic Drug Reactions in Persons Receiving Weekly Rifapentine Plus Isoniazid (3HP) Treatment for Latent Tuberculosis Infection

Author:

Sadowski Claire123ORCID,Belknap Robert4,Holland David P5,Moro Ruth N67,Chen Michael P8,Wright Alicia9,Millet Joan Pau101112,Caylà Joan A12,Scott Nigel A2,Borisov Andrey2,Gandhi Neel R1

Affiliation:

1. Department of Epidemiology, Rollins School of Public Health, Emory University , Atlanta, Georgia , USA

2. Clinical Research Branch, Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), US Centers for Disease Control and Prevention , Atlanta , Georgia , USA

3. Oak Ridge Institute for Science and Education , Oak Ridge, Tennessee , USA

4. Denver Metro Tuberculosis Program, Denver Public Health , Denver, Colorado , USA

5. Department of Medicine, Division of Infectious Diseases, Emory University , Atlanta, Georgia , USA

6. CDC Foundation, Research Collaboration , Atlanta , Georgia , USA

7. Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), US Centers for Disease Control and Prevention , Atlanta, Georgia , USA

8. Immunization Services Division, National Center for Immunization and Respiratory Diseases (NCIRD), US Centers for Disease Control and Prevention , Atlanta, Georgia , USA

9. Division of Infectious Diseases, Vanderbilt University Medical Centers , Nashville, Tennessee , USA

10. Epidemiology Service, Public Health Agency of Barcelona , Barcelona , Spain

11. CIBER de Epidemiología y Salud Pública (CIBERESP) , Barcelona , Spain

12. Foundation of Tuberculosis Research Unit of Barcelona , Barcelona , Spain

Abstract

Abstract Background Three months of weekly rifapentine plus isoniazid (3HP) therapy for latent tuberculosis infection (LTBI) is recommended worldwide. The development of symptoms and systemic drug reactions (SDRs) on 3HP have not been fully characterized. We aimed to determine the patterns of symptom development and identify SDRs and associated factors in patients taking 3HP. Methods We analyzed symptoms data in participants receiving 3HP in the Tuberculosis Trials Consortium's iAdhere study (Study 33). We examined the patterns of symptom reporting across participants from baseline and 4 monthly visits. Bivariate analyses and multivariable regression models were used to identify factors associated with SDRs. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. Results Among 1002 participants receiving 3HP, 768 (77%) reported at least 1 symptom; 97% of these symptoms were grade 1 (79%) or grade 2 (18%). Most symptoms developed in the first month and resolved. A total of 111 (11%) participants had symptoms that met criteria for SDRs; however, 53 (48%) of these participants completed therapy. Factors associated with SDRs and discontinuation included female sex (RR: 2.05; 95% CI: 1.19–3.54), age ≥45 years (RR: 1.99; 95% CI: 1.19–3.31), and use of concomitant medications (RR: 2.26; 95% CI: 1.15–4.42). Conclusions Although most patients receiving 3HP reported symptoms, most were mild, occurred early, and resolved without stopping treatment. Among patients experiencing SDRs, nearly half were able to complete therapy. Patient and provider education should focus on differentiating severe reactions where 3HP should be stopped from minor symptoms that will resolve. Clinical Trials Registration. NCT01582711.

Funder

TBTC Study 33

US Centers for Disease Control and Prevention

Sanofi

US National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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