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      Safety and Effectiveness of Isoniazid Preventive Therapy in Pregnant Women Living with Human Immunodeficiency Virus on Antiretroviral Therapy: An Observational Study Using Linked Population Data

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          Abstract

          Background

          Isoniazid preventive therapy (IPT) is widely used to protect against tuberculosis (TB) in people living with human immunodeficiency virus (HIV). Data on the safety and efficacy of IPT in pregnant women living with HIV (PWLHIV) are mixed. We used an individual-level, population-wide health database to examine associations between antenatal IPT exposure and adverse pregnancy outcomes, maternal TB, all-cause mortality, and liver injury during pregnancy through 12 months postpartum.

          Methods

          We used linked routine electronic health data generated in the public sector of the Western Cape, South Africa, to define a cohort of PWLHIV on antiretroviral therapy. Pregnancy outcomes were assessed using logistic regression; for maternal outcomes we applied a proportional hazards model with time-updated IPT exposure.

          Results

          Of 43 971 PWLHIV, 16.6% received IPT. Women who received IPT were less likely to experience poor pregnancy outcomes (adjusted odds ratio [aOR], 0.83 [95% confidence interval {CI}, .78–.87]); this association strengthened with IPT started after the first trimester compared with none (aOR, 0.71 [95% CI, .65–.79]) or with first-trimester exposure (aOR, 0.64 [95% CI, .55–.75]). IPT reduced the risk of TB by approximately 30% (aHR, 0.71 [95% CI, .63–.81]; absolute risk difference, 1518/100 000 women). The effect was modified by CD4 cell count with protection conferred if CD4 count was ≤350 cells/μL (aHR, 0.51 [95% CI, .41–.63]) vs 0.93 [95% CI, .76–1.13] for CD4 count >350 cells/µL).

          Conclusions

          This analysis of programmatic data is reassuring regarding the safety of antenatal IPT, with the greatest benefits against TB disease observed in women with CD4 count ≤350 cells/μL.

          Abstract

          Analysis of individual-level population-wide data is reassuring regarding the safety and efficacy of isoniazid preventive therapy to prevent tuberculosis disease in a cohort of >43 000 pregnant women living with HIV on antiretroviral therapy in South Africa.

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          6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial.

          In accordance with WHO guidelines, people with HIV infection in Botswana receive daily isoniazid preventive therapy against tuberculosis without obtaining a tuberculin skin test, but duration of prophylaxis is restricted to 6 months. We aimed to assess effectiveness of extended isoniazid therapy. In our randomised, double-blind, placebo-controlled trial we enrolled adults infected with HIV aged 18 years or older at government HIV-care clinics in Botswana. Exclusion criteria included current illness such as cough and an abnormal chest radiograph without antecedent tuberculosis or pneumonia. Eligible individuals were randomly allocated (1:1) to receive 6 months' open-label isoniazid followed by 30 months' masked placebo (control group) or 6 months' open-label isoniazid followed by 30 months' masked isoniazid (continued isoniazid group) on the basis of a computer-generated randomisation list with permuted blocks of ten at each clinic. Antiretroviral therapy was provided if participants had CD4-positive lymphocyte counts of fewer than 200 cells per μL. We used Cox regression analysis and the log-rank test to compare incident tuberculosis in the groups. Cox regression models were used to estimate the effect of antiretroviral therapy. The trial is registered at ClinicalTrials.gov, number NCT00164281. Between Nov 26, 2004, and July 3, 2009, we recorded 34 (3·4%) cases of incident tuberculosis in 989 participants allocated to the control group and 20 (2·0%) in 1006 allocated to the continued isoniazid group (incidence 1·26% per year vs 0·72%; hazard ratio 0·57, 95% CI 0·33-0·99, p=0·047). Tuberculosis incidence in those individuals receiving placebo escalated approximately 200 days after completion of open-label isoniazid. Participants who were tuberculin skin test positive (ie, ≥5 mm induration) at enrolment received a substantial benefit from continued isoniazid treatment (0·26, 0·09-0·80, p=0·02), whereas participants who were tuberculin skin test-negative received no significant benefit (0·75, 0·38-1·46, p=0·40). By study completion, 946 (47%) of 1995 participants had initiated antiretroviral therapy. Tuberculosis incidence was reduced by 50% in those receiving 360 days of antiretroviral therapy compared with participants receiving no antiretroviral therapy (adjusted hazard ratio 0·50, 95% CI 0·26-0·97). Severe adverse events and death were much the same in the control and continued isoniazid groups. In a tuberculosis-endemic setting, 36 months' isoniazid prophylaxis was more effective for prevention of tuberculosis than was 6-month prophylaxis in individuals with HIV infection, and chiefly benefited those who were tuberculin skin test positive. US Centers for Disease Control and Prevention and US Agency for International Development. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            Treatment of Latent Tuberculosis Infection : An Updated Network Meta-analysis

            Treatment of latent tuberculosis infection (LTBI) is an important component of tuberculosis (TB) control, and this study updates a previous network meta-analysis of the best LTBI treatment options to inform public health action and programmatic management of LTBI.
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              Data Centre Profile: The Provincial Health Data Centre of the Western Cape Province, South Africa

              Abstract Introduction The Western Cape Provincial Health Data Centre (PHDC) consolidates person-level clinical data across government services, leveraging sustained investments in patient registration systems, a unique identifier, and maturation of administrative and clinical digital health systems. Objectives The PHDC supports clinical care directly through tools for clinicians which integrate patient data or identify patients in need of interventions, and indirectly through supporting operational and epidemiological analyses. Methods The PHDC is housed entirely within government. Data are processed from a range of source systems, usually daily, through distinct harmonisation and curation, beneficiation, and reporting processes. Linkage is predominantly through the unique identifier which doubles as a pervasive folder number, augmented by other identifiers. Further data processing includes triangulation of multiple data sources for enumerating health conditions, with assignment of certainty levels for each enumeration. Outputs include patient-specific email alerts, a web-based consolidated patient clinical viewing platform, filterable line-listings of patients with specific conditions and associated characteristics and outcomes, management reports and dashboards, and data releases in response to operational and research data requests. Strict architectural, administrative and governance processes ensure privacy protection. Results In the past decade 8 million unique people are recorded as having sought healthcare in the provincial public sector health services, with current utilisation at 15 million attendances or admissions a year. Cross-sectional enumeration of health conditions includes over 430 000 people with HIV, 500 000 with hypertension, 235 000 with diabetes. Annually 110 000 pregnancies and 54 000 patients with tuberculosis are enumerated. Over 50 data requests are processed each year for internal and external requesters in accordance with data request and release governance processes. Conclusions The single consolidated environment for person-level health data in the Western Cape has created new opportunities for supporting patient care, while improving the governance around access to and release of sensitive patient data.
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                Author and article information

                Journal
                Clin Infect Dis
                Clin Infect Dis
                cid
                Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Oxford University Press (US )
                1058-4838
                1537-6591
                15 October 2020
                04 January 2020
                04 January 2020
                : 71
                : 8
                : e351-e358
                Affiliations
                [1 ] Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town , Cape Town, South Africa
                [2 ] Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town , Cape Town, South Africa
                [3 ] Health Impact Assessment, Provincial Government of the Western Cape , Cape Town, South Africa
                [4 ] Division of Public Health Medicine, School of Public Health and Family Medicine, University of Cape Town , Cape Town, South Africa
                [5 ] Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
                [6 ] Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town , Cape Town, South Africa
                Author notes
                Correspondence: E. Kalk, Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town Faculty of Health Sciences, Anzio Road, Observatory, 7925 Cape Town, South Africa ( emma.kalk@ 123456uct.ac.za ).
                Author information
                http://orcid.org/0000-0001-7706-6866
                http://orcid.org/0000-0003-3080-6606
                Article
                ciz1224
                10.1093/cid/ciz1224
                7643738
                31900473
                5ddf8c76-bf70-4738-82ee-a121823b992b
                © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 14 October 2019
                : 31 December 2019
                : 15 December 2019
                : 25 February 2020
                Page count
                Pages: 8
                Funding
                Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development, DOI 10.13039/100009633;
                Award ID: R01 HD080465
                Funded by: University of Cape Town’s Research Committee;
                Categories
                Online Only Articles
                Major Articles
                AcademicSubjects/MED00290

                Infectious disease & Microbiology
                isoniazid preventive therapy,pregnancy,hiv
                Infectious disease & Microbiology
                isoniazid preventive therapy, pregnancy, hiv

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