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Impact of three empirical anti-tuberculosis treatment strategies for people initiating antiretroviral therapy.

ABSTRACT: Early mortality in people initiating antiretroviral treatment (ART) remains high. Empirical anti-tuberculosis treatment strategies aim to reduce early mortality by initiating anti-tuberculosis treatment in individuals at high risk of death from undiagnosed TB.Using data from 16?913 individuals starting ART under program conditions, we simulated the impact of three empirical treatment strategies (two clinical trials and a pragmatic approach), assuming that 50% of early deaths and 100% of incident TB are averted in those eligible.Compared to starting anti-tuberculosis treatment on clinical or mycobacteriological grounds, 4.4-31.4% more individuals were eligible for anti-tuberculosis treatment, 5.5-25.4% of deaths were averted and 10.9-57.3% of incident TB cases were prevented under empirical anti-tuberculosis treatment strategies. The proportion receiving any anti-tuberculosis treatment during the first 6 months of ART increased from the observed 24.0% to an estimated 27.5%, 40.4% and 51.3%, under the PrOMPT, REMEMBER and pragmatic approach, respectively.The impact of empirical anti-tuberculosis treatment strategies depends greatly on the eligibility criteria chosen. The additional strain placed on anti-tuberculosis treatment facilities and the relatively limited impact of some empirical TB strategies raise the question as to whether the benefits will outweigh the risks at population level.

SUBMITTER: Van Rie A

PROVIDER: S-EPMC5022588 | biostudies-other | 2014 Nov

REPOSITORIES: biostudies-other

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Impact of three empirical anti-tuberculosis treatment strategies for people initiating antiretroviral therapy.

Van Rie A A Westreich D D Sanne I I

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease 20141101 11

<h4>Background</h4>Early mortality in people initiating antiretroviral treatment (ART) remains high. Empirical anti-tuberculosis treatment strategies aim to reduce early mortality by initiating anti-tuberculosis treatment in individuals at high risk of death from undiagnosed TB.<h4>Methods</h4>Using data from 16 913 individuals starting ART under program conditions, we simulated the impact of three empirical treatment strategies (two clinical trials and a pragmatic approach), assuming that 50% o ...[more]

PMID: 25299868

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Project description:BACKGROUND:Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical tuberculosis can be difficult to diagnose. We aimed to assess whether empirical tuberculosis treatment would reduce early mortality compared with isoniazid preventive therapy in high-burden settings. METHODS:We did a multicountry open-label randomised clinical trial comparing empirical tuberculosis therapy with isoniazid preventive therapy in HIV-positive outpatients initiating antiretroviral therapy with CD4 cell counts of less than 50 cells per ?L. Participants were recruited from 18 outpatient research clinics in ten countries (Malawi, South Africa, Haiti, Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda). Individuals were screened for tuberculosis using a symptom screen, locally available diagnostics, and the GeneXpert MTB/RIF assay when available before inclusion. Study candidates with confirmed or suspected tuberculosis were excluded. Inclusion criteria were liver function tests 2·5 times the upper limit of normal or less, a creatinine clearance of at least 30 mL/min, and a Karnofsky score of at least 30. Participants were randomly assigned (1:1) to either the empirical group (antiretroviral therapy and empirical tuberculosis therapy) or the isoniazid preventive therapy group (antiretroviral therapy and isoniazid preventive therapy). The primary endpoint was survival (death or unknown status) at 24 weeks after randomisation assessed in the intention-to-treat population. Kaplan-Meier estimates of the primary endpoint across groups were compared by the z-test. All participants were included in the safety analysis of antiretroviral therapy and tuberculosis treatment. This trial is registered with ClinicalTrials.gov, number NCT01380080. FINDINGS:Between Oct 31, 2011, and June 9, 2014, we enrolled 850 participants. Of these, we randomly assigned 424 to receive empirical tuberculosis therapy and 426 to the isoniazid preventive therapy group. The median CD4 cell count at baseline was 18 cells per ?L (IQR 9-32). At week 24, 22 (5%) participants from each group died or were of unknown status (95% CI 3·5-7·8) for empirical group and for isoniazid preventive therapy (95% CI 3·4-7·8); absolute risk difference of -0·06% (95% CI -3·05 to 2·94). Grade 3 or 4 signs or symptoms occurred in 50 (12%) participants in the empirical group and 46 (11%) participants in the isoniazid preventive therapy group. Grade 3 or 4 laboratory abnormalities occurred in 99 (23%) participants in the empirical group and 97 (23%) participants in the isoniazid preventive therapy group. INTERPRETATION:Empirical tuberculosis therapy did not reduce mortality at 24 weeks compared with isoniazid preventive therapy in outpatient adults with advanced HIV disease initiating antiretroviral therapy. The low mortality rate of the trial supports implementation of systematic tuberculosis screening and isoniazid preventive therapy in outpatients with advanced HIV disease. FUNDING:National Institutes of Allergy and Infectious Diseases through the AIDS Clinical Trials Group.

Project description:BACKGROUND:Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical. METHODS:A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only "control" phase and an active "intervention" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group. RESULTS:Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants. Few participants in the intervention group received consistent depression treatment over their first 6 months in care. In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)]. CONCLUSIONS:While it is feasible to integrate depression screening and treatment initiation into ART initiation, providing ongoing depression treatment over time is challenging. Similar implementation science studies focused on maintaining depression management will be increasingly important as we strive to understand and test the best ways to implement evidence-based depression treatment within HIV care.

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Impact of three empirical anti-tuberculosis treatment strategies for people initiating antiretroviral therapy.

Publications

Impact of three empirical anti-tuberculosis treatment strategies for people initiating antiretroviral therapy.

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