High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection

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 asse...

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Veröffentlicht in:Clinical infectious diseases 2017-10, Vol.65 (7), p.1085-1093
Hauptverfasser: Sandul, Amy L., Nwana, Nwabunie, Holcombe, J. Mike, Lobato, Mark N., Marks, Suzanne, Webb, Risa, Wang, Shu-Hua, Stewart, Brock, Griffin, Phil, Hunt, Garrett, Shah, Neha, Marco, Asween, Patil, Naveen, Mukasa, Leonard, Moro, Ruth N., Jereb, John, Mase, Sundari, Chorba, Terence, Bamrah-Morris, Sapna, Ho, Christine S.
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container_end_page 1093
container_issue 7
container_start_page 1085
container_title Clinical infectious diseases
container_volume 65
creator Sandul, Amy L.
Nwana, Nwabunie
Holcombe, J. Mike
Lobato, Mark N.
Marks, Suzanne
Webb, Risa
Wang, Shu-Hua
Stewart, Brock
Griffin, Phil
Hunt, Garrett
Shah, Neha
Marco, Asween
Patil, Naveen
Mukasa, Leonard
Moro, Ruth N.
Jereb, John
Mase, Sundari
Chorba, Terence
Bamrah-Morris, Sapna
Ho, Christine S.
description 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.
doi_str_mv 10.1093/cid/cix505
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Mike ; Lobato, Mark N. ; Marks, Suzanne ; Webb, Risa ; Wang, Shu-Hua ; Stewart, Brock ; Griffin, Phil ; Hunt, Garrett ; Shah, Neha ; Marco, Asween ; Patil, Naveen ; Mukasa, Leonard ; Moro, Ruth N. ; Jereb, John ; Mase, Sundari ; Chorba, Terence ; Bamrah-Morris, Sapna ; Ho, Christine S.</creator><creatorcontrib>Sandul, Amy L. ; Nwana, Nwabunie ; Holcombe, J. Mike ; Lobato, Mark N. ; Marks, Suzanne ; Webb, Risa ; Wang, Shu-Hua ; Stewart, Brock ; Griffin, Phil ; Hunt, Garrett ; Shah, Neha ; Marco, Asween ; Patil, Naveen ; Mukasa, Leonard ; Moro, Ruth N. ; Jereb, John ; Mase, Sundari ; Chorba, Terence ; Bamrah-Morris, Sapna ; Ho, Christine S.</creatorcontrib><description>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 &lt; .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.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/cix505</identifier><identifier>PMID: 28575208</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Adolescent ; Adult ; Aged ; Antibiotics ; Antibiotics, Antitubercular - adverse effects ; Antibiotics, Antitubercular - therapeutic use ; Antitubercular Agents - adverse effects ; Antitubercular Agents - therapeutic use ; ARTICLES AND COMMENTARIES ; Child ; Child, Preschool ; Children ; Clinical trials ; Confidence intervals ; Dosage ; Drug Administration Schedule ; Drug dosages ; Drug Therapy, Combination - adverse effects ; Drug Therapy, Combination - methods ; Drug-Related Side Effects and Adverse Reactions - etiology ; Female ; Health care ; Historical account ; Homeless people ; Homeless Persons ; Homelessness ; Humans ; Isoniazid ; Isoniazid - adverse effects ; Isoniazid - therapeutic use ; Latent Tuberculosis - drug therapy ; Male ; Medical research ; Medical treatment ; Middle Aged ; Mycobacterium tuberculosis - drug effects ; Patients ; Rifampin - adverse effects ; Rifampin - analogs &amp; derivatives ; Rifampin - therapeutic use ; Side effects ; Students ; Tuberculosis ; United States ; Young Adult</subject><ispartof>Clinical infectious diseases, 2017-10, Vol.65 (7), p.1085-1093</ispartof><rights>Copyright © 2017 Oxford University Press on behalf of the Infectious Diseases Society of America</rights><rights>Copyright Oxford University Press, UK Oct 1, 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-a7f72f576e23a37a52f3c347819b72690893a16fc27ec421b464585796ab258c3</citedby><cites>FETCH-LOGICAL-c428t-a7f72f576e23a37a52f3c347819b72690893a16fc27ec421b464585796ab258c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/26375709$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/26375709$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>230,314,776,780,799,881,27901,27902,57992,58225</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28575208$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sandul, Amy L.</creatorcontrib><creatorcontrib>Nwana, Nwabunie</creatorcontrib><creatorcontrib>Holcombe, J. Mike</creatorcontrib><creatorcontrib>Lobato, Mark N.</creatorcontrib><creatorcontrib>Marks, Suzanne</creatorcontrib><creatorcontrib>Webb, Risa</creatorcontrib><creatorcontrib>Wang, Shu-Hua</creatorcontrib><creatorcontrib>Stewart, Brock</creatorcontrib><creatorcontrib>Griffin, Phil</creatorcontrib><creatorcontrib>Hunt, Garrett</creatorcontrib><creatorcontrib>Shah, Neha</creatorcontrib><creatorcontrib>Marco, Asween</creatorcontrib><creatorcontrib>Patil, Naveen</creatorcontrib><creatorcontrib>Mukasa, Leonard</creatorcontrib><creatorcontrib>Moro, Ruth N.</creatorcontrib><creatorcontrib>Jereb, John</creatorcontrib><creatorcontrib>Mase, Sundari</creatorcontrib><creatorcontrib>Chorba, Terence</creatorcontrib><creatorcontrib>Bamrah-Morris, Sapna</creatorcontrib><creatorcontrib>Ho, Christine S.</creatorcontrib><title>High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>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 &lt; .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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics</subject><subject>Antibiotics, Antitubercular - adverse effects</subject><subject>Antibiotics, Antitubercular - therapeutic use</subject><subject>Antitubercular Agents - adverse effects</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>ARTICLES AND COMMENTARIES</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Dosage</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Drug Therapy, Combination - adverse effects</subject><subject>Drug Therapy, Combination - methods</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Female</subject><subject>Health care</subject><subject>Historical account</subject><subject>Homeless people</subject><subject>Homeless Persons</subject><subject>Homelessness</subject><subject>Humans</subject><subject>Isoniazid</subject><subject>Isoniazid - adverse effects</subject><subject>Isoniazid - therapeutic use</subject><subject>Latent Tuberculosis - drug therapy</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Mycobacterium tuberculosis - drug effects</subject><subject>Patients</subject><subject>Rifampin - adverse effects</subject><subject>Rifampin - analogs &amp; derivatives</subject><subject>Rifampin - therapeutic use</subject><subject>Side effects</subject><subject>Students</subject><subject>Tuberculosis</subject><subject>United States</subject><subject>Young Adult</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV1rFDEYhQdRbK3eeK8EvJHC1HxOMjeCrB9d2KLUSi-HTPbNbtaZZE0y4vo3-ofNsrV-XIQE3ifnPYdTVU8JPiO4Za-MW5bzQ2Bxrzomgsm6ES25X95YqJorpo6qRyltMCZEYfGwOqJKSEGxOq5uzt1qjS51BhQsuoqg8wg-o1kYtwNkFzxyHn2KYRX1iD5Dzs6vErp2eY0Ird-GBOga4OuwQ_MUvNM_3RJpv0SXzuptUXIekA0RLcqKonuxM6HXJkN004jy1EM00xCSS2juLZj9xsfVA6uHBE9u75Pqy_t3V7PzevHxw3z2ZlEbTlWutbSSWiEboEwzqQW1zDAuFWl7SZsWq5Zp0lhDJZQfpOcNFyV42-ieCmXYSfX6oLud-hGWpviLeui20Y067rqgXffvxLt1twrfOyFxS5kqAi9vBWL4NkHK3eiSgWHQHsKUOtJiIRnnzR598R-6CVP0JV6hBOeUK9wU6vRAmRhSimDvzBDc7bvuStfdoesCP__b_h36u9wCPDsAm5RD_DNvmNwnYL8Anp6xKw</recordid><startdate>20171001</startdate><enddate>20171001</enddate><creator>Sandul, Amy L.</creator><creator>Nwana, Nwabunie</creator><creator>Holcombe, J. Mike</creator><creator>Lobato, Mark N.</creator><creator>Marks, Suzanne</creator><creator>Webb, Risa</creator><creator>Wang, Shu-Hua</creator><creator>Stewart, Brock</creator><creator>Griffin, Phil</creator><creator>Hunt, Garrett</creator><creator>Shah, Neha</creator><creator>Marco, Asween</creator><creator>Patil, Naveen</creator><creator>Mukasa, Leonard</creator><creator>Moro, Ruth N.</creator><creator>Jereb, John</creator><creator>Mase, Sundari</creator><creator>Chorba, Terence</creator><creator>Bamrah-Morris, Sapna</creator><creator>Ho, Christine S.</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20171001</creationdate><title>High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection</title><author>Sandul, Amy L. ; Nwana, Nwabunie ; Holcombe, J. Mike ; Lobato, Mark N. ; Marks, Suzanne ; Webb, Risa ; Wang, Shu-Hua ; Stewart, Brock ; Griffin, Phil ; Hunt, Garrett ; Shah, Neha ; Marco, Asween ; Patil, Naveen ; Mukasa, Leonard ; Moro, Ruth N. ; Jereb, John ; Mase, Sundari ; Chorba, Terence ; Bamrah-Morris, Sapna ; Ho, Christine S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-a7f72f576e23a37a52f3c347819b72690893a16fc27ec421b464585796ab258c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics</topic><topic>Antibiotics, Antitubercular - adverse effects</topic><topic>Antibiotics, Antitubercular - therapeutic use</topic><topic>Antitubercular Agents - adverse effects</topic><topic>Antitubercular Agents - therapeutic use</topic><topic>ARTICLES AND COMMENTARIES</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Dosage</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Drug Therapy, Combination - adverse effects</topic><topic>Drug Therapy, Combination - methods</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Female</topic><topic>Health care</topic><topic>Historical account</topic><topic>Homeless people</topic><topic>Homeless Persons</topic><topic>Homelessness</topic><topic>Humans</topic><topic>Isoniazid</topic><topic>Isoniazid - adverse effects</topic><topic>Isoniazid - therapeutic use</topic><topic>Latent Tuberculosis - drug therapy</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Mycobacterium tuberculosis - drug effects</topic><topic>Patients</topic><topic>Rifampin - adverse effects</topic><topic>Rifampin - analogs &amp; derivatives</topic><topic>Rifampin - therapeutic use</topic><topic>Side effects</topic><topic>Students</topic><topic>Tuberculosis</topic><topic>United States</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sandul, Amy L.</creatorcontrib><creatorcontrib>Nwana, Nwabunie</creatorcontrib><creatorcontrib>Holcombe, J. 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Mike</au><au>Lobato, Mark N.</au><au>Marks, Suzanne</au><au>Webb, Risa</au><au>Wang, Shu-Hua</au><au>Stewart, Brock</au><au>Griffin, Phil</au><au>Hunt, Garrett</au><au>Shah, Neha</au><au>Marco, Asween</au><au>Patil, Naveen</au><au>Mukasa, Leonard</au><au>Moro, Ruth N.</au><au>Jereb, John</au><au>Mase, Sundari</au><au>Chorba, Terence</au><au>Bamrah-Morris, Sapna</au><au>Ho, Christine S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2017-10-01</date><risdate>2017</risdate><volume>65</volume><issue>7</issue><spage>1085</spage><epage>1093</epage><pages>1085-1093</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><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 &lt; .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.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>28575208</pmid><doi>10.1093/cid/cix505</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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source Jstor Complete Legacy; MEDLINE; Oxford University Press Journals Current; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection
subjects Adolescent
Adult
Aged
Antibiotics
Antibiotics, Antitubercular - adverse effects
Antibiotics, Antitubercular - therapeutic use
Antitubercular Agents - adverse effects
Antitubercular Agents - therapeutic use
ARTICLES AND COMMENTARIES
Child
Child, Preschool
Children
Clinical trials
Confidence intervals
Dosage
Drug Administration Schedule
Drug dosages
Drug Therapy, Combination - adverse effects
Drug Therapy, Combination - methods
Drug-Related Side Effects and Adverse Reactions - etiology
Female
Health care
Historical account
Homeless people
Homeless Persons
Homelessness
Humans
Isoniazid
Isoniazid - adverse effects
Isoniazid - therapeutic use
Latent Tuberculosis - drug therapy
Male
Medical research
Medical treatment
Middle Aged
Mycobacterium tuberculosis - drug effects
Patients
Rifampin - adverse effects
Rifampin - analogs & derivatives
Rifampin - therapeutic use
Side effects
Students
Tuberculosis
United States
Young Adult
title High Rate of Treatment Completion in Program Settings With 12-Dose Weekly Isoniazid and Rifapentine for Latent Mycobacterium tuberculosis Infection
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