Plasma HIV-1 RNA Detection Below 50 Copies/mL and Risk of Virologic Rebound in Patients Receiving Highly Active Antiretroviral Therapy

T. Doyle, C. Smith, P. Vitiello, V. Cambiano, M. Johnson, A. Owen, A. N. Phillips, A. M. Geretti
2012 Clinical Infectious Diseases  
Background. Plasma human immunodeficiency virus type 1 (HIV-1) RNA suppression ,50 copies/mL is regarded as the optimal outcome of highly active antiretroviral therapy (HAART). Current viral load (VL) assays show increased sensitivity, but the significance of RNA detection ,50 copies/mL is unclear. Methods. This study investigated the virologic outcomes of 1247 patients with VL ,50 copies/mL at an arbitrary time point during HAART (5 T0), according to whether the actual, unreported T0 VL was
more » ... ported T0 VL was 40-49 copies/mL, RNA detected ,40 copies/mL (RNA 1 ), or RNA not detected (RNA 2 ), as measured by the Abbott Real Time assay. Predictors of rebound .50 and .400 copies/mL over 12 months following T0 were analyzed with Cox proportional hazards models incorporating the T0 VL and demographic and clinical data. Results. Rebound rates .50 copies/mL were 34.2% for T0 VL 40-49 copies/mL, 11.3% for RNA 1 , and 4.0% for RNA 2 ; rebound rates .400 copies/mL were 13.0%, 3.8%, and 1.2%, respectively. The adjusted hazard ratios for rebound .50 copies/mL were 4.67 (95% confidence interval, 2.91-7.47; P , .0001) and 1.97 (1.25-3.11; P , .0001) with T0 VL 40-49 copies/mL and RNA 1 , respectively, relative to RNA 2 , and 6.91 (2.90-16.47; P , .0001) and 2.88 (1.24-6.69; P , .0001), respectively, for rebound .400 copies/mL. The association was independent of adherence levels. Conclusions. In treated patients monitored by RealTime, a VL of 40-49 copies/mL and, to a lesser extent, RNA detection ,40 copies/mL predict rebound .50 and .400 copies/mL independently of other recognized determinants. The goal of HAART may need to be revised to a lower cutoff than 50 copies/mL.
doi:10.1093/cid/cir936 pmid:22238167 fatcat:nrnr5sbyivalxou3ujwo3y73fy