Universität zu Köln

Lundgren, Jens D., Babiker, Abdel G., Gordin, Fred, Emery, Sean ORCID: 0000-0001-6072-8309, Sharma, Shweta, Avihingsanon, An-Chalee, Cooper, David A., Faetkenheuer, Gerd, Llibre, Josep M., Moli-Na, Jean-Michel, Munderi, Paula, Schechter, Mauro, Wood, Robin, Klingman, Karin L., Collins, Simon, Lane, H. Clifford, Phillips, Andrew N. and Neaton, James D. (2015). Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N. Engl. J. Med., 373 (9). S. 795 - 808. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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Abstract

BACKGROUND Data from randomized trials are lacking on the benefits and risks of initiating antiretroviral therapy in patients with asymptomatic human immunodeficiency virus (HIV) infection who have a CD4+ count of more than 350 cells per cubic millimeter. METHODS We randomly assigned HIV-positive adults who had a CD4+ count of more than 500 cells per cubic millimeter to start antiretroviral therapy immediately (immediate-initiation group) or to defer it until the CD4+ count decreased to 350 cells per cubic millimeter or until the development of the acquired immunodeficiency syndrome (AIDS) or another condition that dictated the use of antiretroviral therapy (deferred-initiation group). The primary composite end point was any serious AIDS-related event, serious non-AIDS-related event, or death from any cause. RESULTS A total of 4685 patients were followed for a mean of 3.0 years. At study entry, the median HIV viral load was 12,759 copies per milliliter, and the median CD4+ count was 651 cells per cubic millimeter. On May 15, 2015, on the basis of an interim analysis, the data and safety monitoring board determined that the study question had been answered and recommended that patients in the deferred-initiation group be offered antiretroviral therapy. The primary end point occurred in 42 patients in the immediate-initiation group (1.8%; 0.60 events per 100 person-years), as compared with 96 patients in the deferred-initiation group (4.1%; 1.38 events per 100 person-years), for a hazard ratio of 0.43 (95% confidence interval [CI], 0.30 to 0.62; P<0.001). Hazard ratios for serious AIDS-related and serious non-AIDS-related events were 0.28 (95% CI, 0.15 to 0.50; P<0.001) and 0.61 (95% CI, 0.38 to 0.97; P = 0.04), respectively. More than two thirds of the primary end points (68%) occurred in patients with a CD4+ count of more than 500 cells per cubic millimeter. The risks of a grade 4 event were similar in the two groups, as were the risks of unscheduled hospital admissions. CONCLUSIONS The initiation of antiretroviral therapy in HIV-positive adults with a CD4+ count of more than 500 cells per cubic millimeter provided net benefits over starting such therapy in patients after the CD4+ count had declined to 350 cells per cubic millimeter.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Lundgren, Jens D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Babiker, Abdel G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gordin, Fred UNSPECIFIED UNSPECIFIED UNSPECIFIED Emery, Sean UNSPECIFIED orcid.org/0000-0001-6072-8309 UNSPECIFIED Sharma, Shweta UNSPECIFIED UNSPECIFIED UNSPECIFIED Avihingsanon, An-Chalee UNSPECIFIED UNSPECIFIED UNSPECIFIED Cooper, David A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Llibre, Josep M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moli-Na, Jean-Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Munderi, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Schechter, Mauro UNSPECIFIED UNSPECIFIED UNSPECIFIED Wood, Robin UNSPECIFIED UNSPECIFIED UNSPECIFIED Klingman, Karin L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Collins, Simon UNSPECIFIED UNSPECIFIED UNSPECIFIED Lane, H. Clifford UNSPECIFIED UNSPECIFIED UNSPECIFIED Phillips, Andrew N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Neaton, James D. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-396174
DOI:	10.1056/NEJMoa1506816
Journal or Publication Title:	N. Engl. J. Med.
Volume:	373
Number:	9
Page Range:	S. 795 - 808
Date:	2015
Publisher:	MASSACHUSETTS MEDICAL SOC
Place of Publication:	WALTHAM
ISSN:	1533-4406
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLINICAL-OUTCOMES; CELL COUNTS; BASE-LINE; RISK; INTERRUPTION; PARTICIPANTS; DEATH; ART Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39617