TY  - JOUR
A1  - Atkinson, Andrew
A1  - Zwahlen, Marcel
A1  - Barger, Diana
A1  - d’Arminio Monforte, Antonella
A1  - Wit, Stephane de
A1  - Girardi, Enrico
A1  - Svedhem, Veronica
A1  - Morlat, Philippe
A1  - Mussini, Cristina
A1  - Noguera-Julian, Antoni
A1  - Stephan, Christoph
A1  - Touloumi, Giota
A1  - Kirk, Ole
A1  - Mocroft, Amanda
A1  - Reiss, Peter
A1  - Miró, Jose Maria
A1  - Carpenter, James R.
A1  - Furrer, Hansjakob
T1  - Withholding primary pneumocystis pneumonia prophylaxis in virologically suppressed patients with human immunodeficiency virus: an emulation of a pragmatic trial in COHERE
T2  - Clinical infectious diseases
N2  - 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 (ART) with suppressed plasma human immunodeficiency virus (HIV) RNA (≤400 copies/mL), irrespective of CD4 count.
Methods: 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.
Results: 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).
Conclusions: This study suggests that primary PcP prophylaxis might be safely withheld in confirmed virologically suppressed patients on ART, regardless of their CD4 count.
KW  - human immunodeficiency virus
KW  - pneumocystis pneumonia
KW  - prophylaxis
KW  - HIV-RNA
KW  - hiv
KW  - cd4 count determination procedure
KW  - pneumonia
KW  - pneumocystis carinii
KW  - guidelines
KW  - blood hiv rna
KW  - anti-retroviral agents
KW  - prevention
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/62917
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-629170
SN  - 1537-6591
N1  - The COHERE study group has received unrestricted funding from Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS), France; HIV Monitoring Foundation, The Netherlands; and the Augustinus Foundation, Denmark. The research leading to these results received funding from the European Union Seventh Framework Program (FP7/2007–2013) under EuroCoord grant agreement number 260694. A list of the funders of the participating cohorts can be found at www.COHERE.org. Research reported in this publication was supported by the Swiss National Science Foundation (grant number 324730_149792, principal investigator: H. F.), specifically for H. F. and A. A.
N1  - Data availability
Data used for the analysis will generally not be publicly available but can be made available based on the approval by the chair of the executive committee of COHERE (Stephane De Wit; refer to author list).
VL  - 73
IS  - 2
SP  - 195
EP  - 202
PB  - Oxford Journals
CY  - Oxford
ER  -