Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in Botswana
BACKGROUND The World Health Organization recommends 36 months of isoniazid preventive therapy (36IPT) for adults infected with HIV living in TB-endemic countries. We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT. METHODS One thousand six adults infect...
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| Veröffentlicht in: | Chest 2015-05, Vol.147 (5), p.1376-1384 |
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| creator | Tedla, Zegabriel, MD Nguyen, Minh-Ly, MD Sibanda, Thabisa, MBChB Nyirenda, Samba, MD Agizew, Tefera B., MPhil, MD Girde, Sonali, MD Rose, Charles E., PhD Samandari, Taraz, MD, PhD |
| description | BACKGROUND The World Health Organization recommends 36 months of isoniazid preventive therapy (36IPT) for adults infected with HIV living in TB-endemic countries. We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT. METHODS One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care. Enrollment exclusion criteria included jaundice or elevations of serum transaminases (ESTs) > 2.5-fold the upper limit of normal (ULN). Participants with any CD4+ lymphocyte count were eligible and received antiretroviral therapy (ART) when CD4+ < 200 cells/μL. 36IPT was stopped for severe hepatitis (more than fivefold ULN EST) but not for moderate hepatitis (2.5-fold to fivefold ULN EST). RESULTS Pharmacy refill records showed 2,237 person-years of isoniazid receipt; 48% of participants initiated ART by 36 months. A total of 1.9% (19 of 1,006) of participants were diagnosed with severe hepatitis; three had jaundice and two of these developed hepatic encephalopathy. Another 3.1% (31 of 1,006) of participants experienced moderate hepatitis. Thirty-eight percent (19 of 50) of participants with moderate to severe hepatitis concomitantly received ART. Forty percent (20 of 50) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline (hazard ratio, 1.49; 95% CI, 0.20-11.1; P = .70). CONCLUSIONS Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV, people not infected with HIV in trials or public health programs. Compared with participants not receiving ART, the risk of moderate to severe hepatitis was not increased by ART. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT00164281; URL: www.clinicaltrials.gov |
| doi_str_mv | 10.1378/chest.14-0215 |
| format | Article |
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We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT. METHODS One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care. Enrollment exclusion criteria included jaundice or elevations of serum transaminases (ESTs) > 2.5-fold the upper limit of normal (ULN). Participants with any CD4+ lymphocyte count were eligible and received antiretroviral therapy (ART) when CD4+ < 200 cells/μL. 36IPT was stopped for severe hepatitis (more than fivefold ULN EST) but not for moderate hepatitis (2.5-fold to fivefold ULN EST). RESULTS Pharmacy refill records showed 2,237 person-years of isoniazid receipt; 48% of participants initiated ART by 36 months. A total of 1.9% (19 of 1,006) of participants were diagnosed with severe hepatitis; three had jaundice and two of these developed hepatic encephalopathy. Another 3.1% (31 of 1,006) of participants experienced moderate hepatitis. Thirty-eight percent (19 of 50) of participants with moderate to severe hepatitis concomitantly received ART. Forty percent (20 of 50) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline (hazard ratio, 1.49; 95% CI, 0.20-11.1; P = .70). CONCLUSIONS Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV, people not infected with HIV in trials or public health programs. Compared with participants not receiving ART, the risk of moderate to severe hepatitis was not increased by ART. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT00164281; URL: www.clinicaltrials.gov</description><identifier>ISSN: 0012-3692</identifier><identifier>EISSN: 1931-3543</identifier><identifier>DOI: 10.1378/chest.14-0215</identifier><identifier>PMID: 25340318</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Antitubercular Agents - adverse effects ; Antitubercular Agents - therapeutic use ; Botswana ; Chemical and Drug Induced Liver Injury - etiology ; Double-Blind Method ; Female ; HIV Infections - complications ; Humans ; Isoniazid - adverse effects ; Isoniazid - therapeutic use ; Male ; Pulmonary/Respiratory ; Time Factors ; Tuberculosis - etiology ; Tuberculosis - prevention & control</subject><ispartof>Chest, 2015-05, Vol.147 (5), p.1376-1384</ispartof><rights>The American College of Chest Physicians</rights><rights>2015 The American College of Chest Physicians</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-a58af6642ec8123e188194a53cfa9dccd49baeb629e8f1ad2fa388554909b51f3</citedby><cites>FETCH-LOGICAL-c396t-a58af6642ec8123e188194a53cfa9dccd49baeb629e8f1ad2fa388554909b51f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25340318$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tedla, Zegabriel, MD</creatorcontrib><creatorcontrib>Nguyen, Minh-Ly, MD</creatorcontrib><creatorcontrib>Sibanda, Thabisa, MBChB</creatorcontrib><creatorcontrib>Nyirenda, Samba, MD</creatorcontrib><creatorcontrib>Agizew, Tefera B., MPhil, MD</creatorcontrib><creatorcontrib>Girde, Sonali, MD</creatorcontrib><creatorcontrib>Rose, Charles E., PhD</creatorcontrib><creatorcontrib>Samandari, Taraz, MD, PhD</creatorcontrib><title>Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in Botswana</title><title>Chest</title><addtitle>Chest</addtitle><description>BACKGROUND The World Health Organization recommends 36 months of isoniazid preventive therapy (36IPT) for adults infected with HIV living in TB-endemic countries. We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT. METHODS One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care. Enrollment exclusion criteria included jaundice or elevations of serum transaminases (ESTs) > 2.5-fold the upper limit of normal (ULN). Participants with any CD4+ lymphocyte count were eligible and received antiretroviral therapy (ART) when CD4+ < 200 cells/μL. 36IPT was stopped for severe hepatitis (more than fivefold ULN EST) but not for moderate hepatitis (2.5-fold to fivefold ULN EST). RESULTS Pharmacy refill records showed 2,237 person-years of isoniazid receipt; 48% of participants initiated ART by 36 months. A total of 1.9% (19 of 1,006) of participants were diagnosed with severe hepatitis; three had jaundice and two of these developed hepatic encephalopathy. Another 3.1% (31 of 1,006) of participants experienced moderate hepatitis. Thirty-eight percent (19 of 50) of participants with moderate to severe hepatitis concomitantly received ART. Forty percent (20 of 50) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline (hazard ratio, 1.49; 95% CI, 0.20-11.1; P = .70). CONCLUSIONS Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV, people not infected with HIV in trials or public health programs. Compared with participants not receiving ART, the risk of moderate to severe hepatitis was not increased by ART. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT00164281; URL: www.clinicaltrials.gov</description><subject>Adult</subject><subject>Antitubercular Agents - adverse effects</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Botswana</subject><subject>Chemical and Drug Induced Liver Injury - etiology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>HIV Infections - complications</subject><subject>Humans</subject><subject>Isoniazid - adverse effects</subject><subject>Isoniazid - therapeutic use</subject><subject>Male</subject><subject>Pulmonary/Respiratory</subject><subject>Time Factors</subject><subject>Tuberculosis - etiology</subject><subject>Tuberculosis - prevention & control</subject><issn>0012-3692</issn><issn>1931-3543</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9v0zAUgC3ExLrBkSvykUuGX-y49gWpTLBW2jTEz6PlOi_UI7VLXjIofz0JHTtM4mRZ_t4n-XuMPQdxBnJuXoUNUn8GqhAlVI_YDKyEQlZKPmYzIaAspLblMTshuhHjHax-wo7LSiohwcwYrSin6H_HulgQ5RB9jzVf4s73sY_EY-KLemh74qvUYJgev8Z-w5erL_wDBoy3MX3jUvOrnPoN8dzweyN_3-XdZt_6XwfRm9zTT5_8U3bU-Jbw2d15yj6_e_vpfFlcXl-szheXRZBW94WvjG-0ViUGA6VEMAas8pUMjbd1CLWya49rXVo0Dfi6bLw0pqqUFXZdQSNP2cuDd9flH8OYyW0jBWxbnzAP5EAbAXOlRTWixQENXSbqsHG7Lm59t3cg3NTZ_e3sQLmp88i_uFMP6y3W9_S_sCMwPwA4fvA2YucoREwB69iNGV2d43_Vrx9MhjamGHz7HfdIN3no0ljNgaPSCfdxWvK043HUSK1A_gEPZaI2</recordid><startdate>20150501</startdate><enddate>20150501</enddate><creator>Tedla, Zegabriel, MD</creator><creator>Nguyen, Minh-Ly, MD</creator><creator>Sibanda, Thabisa, MBChB</creator><creator>Nyirenda, Samba, MD</creator><creator>Agizew, Tefera B., MPhil, MD</creator><creator>Girde, Sonali, MD</creator><creator>Rose, Charles E., PhD</creator><creator>Samandari, Taraz, MD, PhD</creator><general>Elsevier Inc</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>7X8</scope></search><sort><creationdate>20150501</creationdate><title>Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in Botswana</title><author>Tedla, Zegabriel, MD ; Nguyen, Minh-Ly, MD ; Sibanda, Thabisa, MBChB ; Nyirenda, Samba, MD ; Agizew, Tefera B., MPhil, MD ; Girde, Sonali, MD ; Rose, Charles E., PhD ; Samandari, Taraz, MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-a58af6642ec8123e188194a53cfa9dccd49baeb629e8f1ad2fa388554909b51f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antitubercular Agents - adverse effects</topic><topic>Antitubercular Agents - therapeutic use</topic><topic>Botswana</topic><topic>Chemical and Drug Induced Liver Injury - etiology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>HIV Infections - complications</topic><topic>Humans</topic><topic>Isoniazid - adverse effects</topic><topic>Isoniazid - therapeutic use</topic><topic>Male</topic><topic>Pulmonary/Respiratory</topic><topic>Time Factors</topic><topic>Tuberculosis - etiology</topic><topic>Tuberculosis - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tedla, Zegabriel, MD</creatorcontrib><creatorcontrib>Nguyen, Minh-Ly, MD</creatorcontrib><creatorcontrib>Sibanda, Thabisa, MBChB</creatorcontrib><creatorcontrib>Nyirenda, Samba, MD</creatorcontrib><creatorcontrib>Agizew, Tefera B., MPhil, MD</creatorcontrib><creatorcontrib>Girde, Sonali, MD</creatorcontrib><creatorcontrib>Rose, Charles E., PhD</creatorcontrib><creatorcontrib>Samandari, Taraz, MD, PhD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Chest</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tedla, Zegabriel, MD</au><au>Nguyen, Minh-Ly, MD</au><au>Sibanda, Thabisa, MBChB</au><au>Nyirenda, Samba, MD</au><au>Agizew, Tefera B., MPhil, MD</au><au>Girde, Sonali, MD</au><au>Rose, Charles E., PhD</au><au>Samandari, Taraz, MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in Botswana</atitle><jtitle>Chest</jtitle><addtitle>Chest</addtitle><date>2015-05-01</date><risdate>2015</risdate><volume>147</volume><issue>5</issue><spage>1376</spage><epage>1384</epage><pages>1376-1384</pages><issn>0012-3692</issn><eissn>1931-3543</eissn><abstract>BACKGROUND The World Health Organization recommends 36 months of isoniazid preventive therapy (36IPT) for adults infected with HIV living in TB-endemic countries. We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT. METHODS One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care. Enrollment exclusion criteria included jaundice or elevations of serum transaminases (ESTs) > 2.5-fold the upper limit of normal (ULN). Participants with any CD4+ lymphocyte count were eligible and received antiretroviral therapy (ART) when CD4+ < 200 cells/μL. 36IPT was stopped for severe hepatitis (more than fivefold ULN EST) but not for moderate hepatitis (2.5-fold to fivefold ULN EST). RESULTS Pharmacy refill records showed 2,237 person-years of isoniazid receipt; 48% of participants initiated ART by 36 months. A total of 1.9% (19 of 1,006) of participants were diagnosed with severe hepatitis; three had jaundice and two of these developed hepatic encephalopathy. Another 3.1% (31 of 1,006) of participants experienced moderate hepatitis. Thirty-eight percent (19 of 50) of participants with moderate to severe hepatitis concomitantly received ART. Forty percent (20 of 50) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline (hazard ratio, 1.49; 95% CI, 0.20-11.1; P = .70). CONCLUSIONS Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV, people not infected with HIV in trials or public health programs. Compared with participants not receiving ART, the risk of moderate to severe hepatitis was not increased by ART. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT00164281; URL: www.clinicaltrials.gov</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25340318</pmid><doi>10.1378/chest.14-0215</doi><tpages>9</tpages></addata></record> |
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| subjects | Adult Antitubercular Agents - adverse effects Antitubercular Agents - therapeutic use Botswana Chemical and Drug Induced Liver Injury - etiology Double-Blind Method Female HIV Infections - complications Humans Isoniazid - adverse effects Isoniazid - therapeutic use Male Pulmonary/Respiratory Time Factors Tuberculosis - etiology Tuberculosis - prevention & control |
| title | Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in Botswana |
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