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Withholding primary PcP prophylaxis in virologically suppressed HIV patients: An emulation of a pragmatic trial in COHERE

Atkinson, A; Zwahlen, M; Barger, D; d'Arminio Monforte, A; De Wit, S; Ghosn, J; Girardi, E; ... Opportunistic Infections Project Working Group of the Collaborat, .; + view all (2020) Withholding primary PcP prophylaxis in virologically suppressed HIV patients: An emulation of a pragmatic trial in COHERE. Clinical Infectious Diseases 10.1093/cid/ciaa615. (In press). Green open access

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Abstract

BACKGROUND: Using data from the COHERE collaboration, we investigated whether primary prophylaxis for Pneumocystis Pneumonia (PcP) might be withheld in all patients on antiretroviral therapy with suppressed plasma HIV RNA (≤ 400c/mL) irrespective of CD4 count. METHODS: We implemented an established causal inference approach whereby observational data is used to emulate a randomised trial. Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤ 200 cells/µL in line with existing recommendations. We compared the following two strategies for stopping prophylaxis: i.) when CD4 count was above 200 cells/µL for more than 3 months, or ii.) when the patient was virologically suppressed (two consecutive HIV RNA ≤ 400c/mL). Patients were artificially censored if they did not comply with these stopping rules. We estimated the risk of primary PcP in patients on ART, using the hazard ratio to compare the stopping strategies by fitting a pooled logistic model, including inverse probability weights to adjust for the selection bias introduced by the artificial censoring. RESULTS: 4'813 patients (10'324 person years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as endpoint, the adjusted hazard ratio (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared to the existing guidelines (aHR 0.8 with 95% CI [0.6, 1.1], p = 0.2). CONCLUSIONS: The study suggests that primary PcP prophylaxis might be safely withheld in confirmed ART-virologically suppressed patients, regardless of their CD4 count.

Type: Article
Title: Withholding primary PcP prophylaxis in virologically suppressed HIV patients: An emulation of a pragmatic trial in COHERE
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/cid/ciaa615
Publisher version: https://doi.org/10.1093/cid/ciaa615
Language: English
Additional information: © 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 AttributionNonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/).
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
URI: https://discovery.ucl.ac.uk/id/eprint/10099241
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