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Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study
Author(s)
Asociación Civil Impacta Salud y Educación
Rachel Bender Ignacio
University of Washington
Ricardo Alfaro
National University of San Marcos
Jessica Ríos
Asociación Civil Impacta Salud y Educación
Jorge A. Gallardo-Cartagena
National University of San Marcos
Rogelio Valdez
Fred Hutch Cancer Center
Carolyn Bain
Program for Appropriate Technology in Health
Karin Sosa Barbarán
National University of San Marcos
Manuel Villarán
Asociación Civil Impacta Salud y Educación
Christopher D. Pilcher
University of California, San Francisco
Pedro Gonzáles
Asociación Civil Impacta Salud y Educación
Jorge Sánchez
National University of San Marcos
Ann Duerr
University of Washington
Date Issued
26 de febrero de 2020
Type
Article
Volume
72
Issue
6
Series/Report No.
Clinical Infectious Diseases
Start Page
1042
End Page
1050
ISSN
1058-4838
1537-6591
Abstract
BACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI). RESULTS: Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; P = .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (P = .09 overall), but differences between those initiating ART ≤ 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiating > 90 days (0.88, IQR 0.61, 1.11) remained, P = .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART > 90 days from EDDI versus those starting within 30 or 90 days (both P < .001). CONCLUSIONS: To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580.
Keywords