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Withholding Primary Pneumocystis Pneumonia Prophylaxis in Virologically Suppressed Patients With Human Immunodeficiency Virus: An Emulation of a Pragmatic Trial in COHERE

2020; Oxford University Press; Volume: 73; Issue: 2 Linguagem: Inglês

10.1093/cid/ciaa615

1537-6591

Andrew Atkinson, Marcel Zwahlen, Diana Barger, Antonella d’Arminio Monforte, Christoph Stephan, Jade Ghosn, Enrico Girardi, Veronica Svedhem, Philippe Morlat, Cristina Mussini, Antoni Noguera‐Julián, Christoph Stephan, Giota Touloumi, Ole Kirk, Amanda Mocroft, Peter Reiss, José M. Miró, James R. Carpenter, Hansjakob Furrer, Ali Judd, Robert Zangerle, Giota Touloumi, Josiane Warszawski, Laurence Meyer, François Dabis, Murielle Mary Krause, Jade Ghosn, Catherine Leport, Linda Wittkop, Peter Reiss, Ferdinand W.N.M. Wit, Jan M. Prins, Heiner Bucher, Diana M. Gibb, Gerd Fätkenheuer, Julia del Amo, Niels Obel, Claire Thorne, Amanda Mocroft, Ole Kirk, Christoph Stephan, Santiago Pérez‐Hoyos, Osamah Hamouda, Barbara Bartmeyer, Nikoloz Chkhartishvili, Antoni Noguera‐Julián, Andrea Antinori, Antonella d’Arminio Monforte, Norbert H. Brockmeyer, Luis Prieto, Pablo Rojo Conejo, Antoni Soriano‐Arandes, Manuel Battegay, Roger D. Kouyos, Cristina Mussini, Jordi Casabona, José M. Miró, Antonella Castagna, Deborah Konopnick, Tessa Goetghebuer, Anders Sönnerborg, Carlo Torti, Caroline Sabin, Ramón Teira, Myriam Garrido, David Haerry, José M. Miró, Dominique Costagliola, Antonella d’Arminio Monforte, Antonella Castagna, Julia del Amo, Amanda Mocroft, Dorthe Raben, Geneviève Chêne,

HIV/AIDS drug development and treatment

Using data from the COHERE collaboration, we investigated whether primary prophylaxis for pneumocystis pneumonia (PcP) might be withheld in all patients on antiretroviral therapy (ART) with suppressed plasma human immunodeficiency virus (HIV) RNA (≤400 copies/mL), irrespective of CD4 count.We implemented an established causal inference approach whereby observational data are used to emulate a randomized 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 2 strategies for stopping prophylaxis: (1) when CD4 count was >200 cells/µL for >3 months or (2) when the patient was virologically suppressed (2 consecutive HIV RNA ≤400 copies/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 (HR) 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.A total of 4813 patients (10 324 person-years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as an endpoint, the adjusted HR (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared with the existing guidelines (aHR, .8; 95% confidence interval, .6-1.1; P = .2).This study suggests that primary PcP prophylaxis might be safely withheld in confirmed virologically suppressed patients on ART, regardless of their CD4 count.