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High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection.
Clin Infect Dis. 2017 10 01; 65(7):1085-1093.CI

Abstract

Background

Randomized controlled trials have demonstrated that the newest latent tuberculosis (LTBI) regimen, 12 weekly doses of directly observed isoniazid and rifapentine (3HP), is as efficacious as 9 months of isoniazid, with a greater completion rate (82% vs 69%); however, 3HP has not been assessed in routine healthcare settings.

Methods

Observational cohort of LTBI patients receiving 3HP through 16 US programs was used to assess treatment completion, adverse drug reactions, and factors associated with treatment discontinuation.

Results

Of 3288 patients eligible to complete 3HP, 2867 (87.2%) completed treatment. Children aged 2-17 years had the highest completion rate (94.5% [155/164]). Patients reporting homelessness had a completion rate of 81.2% (147/181). In univariable analyses, discontinuation was lowest among children (relative risk [RR], 0.44 [95% confidence interval {CI}, .23-.85]; P = .014), and highest in persons aged ≥65 years (RR, 1.72 [95% CI, 1.25-2.35]; P < .001). In multivariable analyses, discontinuation was lowest among contacts of patients with tuberculosis (TB) disease (adjusted RR [ARR], 0.68 [95% CI, .52-.89]; P = .005) and students (ARR, 0.45 [95% CI, .21-.98]; P = .044), and highest with incarceration (ARR, 1.43 [95% CI, 1.08-1.89]; P = .013) and homelessness (ARR, 1.72 [95% CI, 1.25-2.39]; P = .001). Adverse drug reactions were reported by 1174 (35.7%) patients, of whom 891 (76.0%) completed treatment.

Conclusions

Completion of 3HP in routine healthcare settings was greater overall than rates reported from clinical trials, and greater than historically observed using other regimens among reportedly nonadherent populations. Widespread use of 3HP for LTBI treatment could accelerate elimination of TB disease in the United States.

Authors+Show Affiliations

Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Mississippi State Department of Health, Jackson.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Connecticut Department of Public Health, Hartford.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Mississippi State Department of Health, Jackson. University of Mississippi Medical Center, Jackson.Ohio State University Medical Center, Columbus.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Kansas Department of Health and Environment, Topeka.Nationwide Children's Hospital, Columbus, Ohio.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. California Department of Public Health, San Francisco ; and.Arkansas Department of Health, Little Rock.Arkansas Department of Health, Little Rock.Arkansas Department of Health, Little Rock.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.

Pub Type(s)

Journal Article
Observational Study
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

28575208

Citation

Sandul, Amy L., et al. "High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium Tuberculosis Infection." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 65, no. 7, 2017, pp. 1085-1093.
Sandul AL, Nwana N, Holcombe JM, et al. High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection. Clin Infect Dis. 2017;65(7):1085-1093.
Sandul, A. L., Nwana, N., Holcombe, J. M., Lobato, M. N., Marks, S., Webb, R., Wang, S. H., Stewart, B., Griffin, P., Hunt, G., Shah, N., Marco, A., Patil, N., Mukasa, L., Moro, R. N., Jereb, J., Mase, S., Chorba, T., Bamrah-Morris, S., & Ho, C. S. (2017). High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 65(7), 1085-1093. https://doi.org/10.1093/cid/cix505
Sandul AL, et al. High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium Tuberculosis Infection. Clin Infect Dis. 2017 10 1;65(7):1085-1093. PubMed PMID: 28575208.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection. AU - Sandul,Amy L, AU - Nwana,Nwabunie, AU - Holcombe,J Mike, AU - Lobato,Mark N, AU - Marks,Suzanne, AU - Webb,Risa, AU - Wang,Shu-Hua, AU - Stewart,Brock, AU - Griffin,Phil, AU - Hunt,Garrett, AU - Shah,Neha, AU - Marco,Asween, AU - Patil,Naveen, AU - Mukasa,Leonard, AU - Moro,Ruth N, AU - Jereb,John, AU - Mase,Sundari, AU - Chorba,Terence, AU - Bamrah-Morris,Sapna, AU - Ho,Christine S, PY - 2017/02/22/received PY - 2017/05/26/accepted PY - 2017/6/3/pubmed PY - 2019/7/3/medline PY - 2017/6/3/entrez SP - 1085 EP - 1093 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 65 IS - 7 N2 - Background: Randomized controlled trials have demonstrated that the newest latent tuberculosis (LTBI) regimen, 12 weekly doses of directly observed isoniazid and rifapentine (3HP), is as efficacious as 9 months of isoniazid, with a greater completion rate (82% vs 69%); however, 3HP has not been assessed in routine healthcare settings. Methods: Observational cohort of LTBI patients receiving 3HP through 16 US programs was used to assess treatment completion, adverse drug reactions, and factors associated with treatment discontinuation. Results: Of 3288 patients eligible to complete 3HP, 2867 (87.2%) completed treatment. Children aged 2-17 years had the highest completion rate (94.5% [155/164]). Patients reporting homelessness had a completion rate of 81.2% (147/181). In univariable analyses, discontinuation was lowest among children (relative risk [RR], 0.44 [95% confidence interval {CI}, .23-.85]; P = .014), and highest in persons aged ≥65 years (RR, 1.72 [95% CI, 1.25-2.35]; P < .001). In multivariable analyses, discontinuation was lowest among contacts of patients with tuberculosis (TB) disease (adjusted RR [ARR], 0.68 [95% CI, .52-.89]; P = .005) and students (ARR, 0.45 [95% CI, .21-.98]; P = .044), and highest with incarceration (ARR, 1.43 [95% CI, 1.08-1.89]; P = .013) and homelessness (ARR, 1.72 [95% CI, 1.25-2.39]; P = .001). Adverse drug reactions were reported by 1174 (35.7%) patients, of whom 891 (76.0%) completed treatment. Conclusions: Completion of 3HP in routine healthcare settings was greater overall than rates reported from clinical trials, and greater than historically observed using other regimens among reportedly nonadherent populations. Widespread use of 3HP for LTBI treatment could accelerate elimination of TB disease in the United States. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/28575208/High_Rate_of_Treatment_Completion_in_Program_Settings_With_12_Dose_Weekly_Isoniazid_and_Rifapentine_for_Latent_Mycobacterium_tuberculosis_Infection_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/cix505 DB - PRIME DP - Unbound Medicine ER -