INTRODUCTION: Since the beginning of the HIV epidemic in resource-rich countries, Pneumocystis jirovecii pneumonia (PjP) is one of the most frequent opportunistic AIDS-defining infections. The Collaboration of Observational HIV Epidemiological Research Europe (COHERE) has shown that primary Pneumocystis jirovecii Pneumonia (PjP) prophylaxis can be safely withdrawn in patients with CD4 counts of 100 to 200 cells/µL if plasma HIV-RNA is suppressed on combination antiretroviral therapy. Whether this holds true for secondary prophylaxis is not known, and this has proved difficult to determine due to the much lower population at risk. METHODS: We estimated the incidence of secondary PjP by including patient data collected from 1998 to 2015 from the COHERE cohort collaboration according to time-updated CD4 counts, HIV-RNA and use of PjP prophylaxis in persons >16 years of age. We fitted a Poisson generalized additive model in which the smoothed effect of CD4 was modelled by a restricted cubic spline, and HIV-RNA was stratified as low (<400), medium (400 to 10,000) or high (>10,000copies/mL). RESULTS: There were 373 recurrences of PjP during 74,295 person-years (py) in 10,476 patients. The PjP incidence in the different plasma HIV-RNA strata differed significantly and was lowest in the low stratum. For patients off prophylaxis with CD4 counts between 100 and 200 cells/µL and HIV-RNA below 400 copies/mL, the incidence of recurrent PjP was 3.9 (95% CI: 2.0 to 5.8) per 1000 py, not significantly different from patients on prophylaxis in the same stratum (1.9, 95% CI: 0.1 to 3.7). CONCLUSIONS: HIV viraemia importantly affects the risk of recurrent PjP. In virologically suppressed patients on ART with CD4 counts of 100 to 200/µL, the incidence of PjP off prophylaxis is below 10/1000 py. Secondary PjP prophylaxis may be safely withheld in such patients. While European guidelines recommend discontinuing secondary PjP prophylaxis only if CD4 counts rise above 200 cells/mL, the latest US Guidelines consider secondary prophylaxis discontinuation even in patients with a CD4 count above 100 cells/µL and suppressed viral load. Our results strengthen and support this US recommendation.

4th Department of Internal Medicine ATTIKON University Hospital National and Kapodistrian University of Athens Athens Greece

Amsterdam Institute for Global Health and Development and HIV Monitoring Foundation Amsterdam The Netherlands

Centre for Clinical Research Epidemiology Modelling and Evaluation Institute for Global Health UCL London UK

CHIP Department of Infectious Diseases Rigshospitalet University of Copenhagen Copenhagen Denmark

Clinic of Infectious Diseases University of Modena and Reggio Emilia Modena Italy

Clinical Epidemiology Unit National Institute for Infectious Diseases L Spallanzani IRCCS Rome Italy

Department of Global Health Amsterdam University Medical Centers University of Amsterdam Amsterdam The Netherlands

Department of Infectious Diseases Bern University Hospital Inselspital University of Bern Bern Switzerland

Department of Infectious Diseases St Pierre University Hospital Université Libre de Bruxelles Brussels Belgium

Department of Mathematics and Statistics Masaryk University Brno Czech Republic

Infectious Diseases Service Hospital Clinic IDIBAPS University of Barcelona Barcelona Spain

Infectious Diseases Unit at Medical Center no 2 Frankfurt University Hospital Goethe University Frankfurt Germany

INSERM U 1137 IAME Université de Paris Paris France

Institute of Social and Preventive Medicine University of Bern Bern Switzerland

Internal Medicine and Infectious Diseases Department University Hospital of Bordeaux Bordeaux France

Paediatric Infectious Diseases Unit St George's University Hospital London UK

Service des Maladies Infectieuses et Tropicales Groupe Hospitalier Universitaire Bichat Claude Bernard Paris France

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