Safety and efficacy of a raltegravir‐based dual antiretroviral therapy in clinical practice

Abstract

BackgroundHAART has revolutionized HIV disease management and increased life expectancy for most HIV‐infected individuals on treatment. A nucleoside/tide reverse transcriptase (NRTI) inhibitor backbone is a recommended component of standard first‐line HAART. Nevertheless, NRTI‐sparing alternatives are warranted in order to reduce long‐term toxicities in many patients (pts). Aim of the study was to evaluate safety of raltegravir‐based dual antiretroviral therapy (DUAL) in a clinical practice setting.MethodsAll pts on DUAL regimen followed at our outpatient HIV service on May 31st 2012 were recruited. Their clinical files were retrospectively studied. Collected data included: demographics, CDC staging, reason to DUAL switching, cholesterol (total and HDL), creatinine, CK, CD4+ count and HIV RNA were recorded at switch and every six months after for the first year. Change in CD4 count after the switch was evaluated by Student t‐test.ResultsThe cohort included 55 pts (27 M); mean age was 54 years (38–72). HIV infection was acquired through: injective drug abuse (25), unprotected homosexual (24) and heterosexual (16) intercourse. CDC staging was: A=16, B=26, C=13. Mean previous treatment regimens were 4. At time of study pts had been on DUAL regimen for 23 months. They had been switched to DUAL therapy for: drug resistance (14; 25.5%) (DRR) or drug toxicity (41; 74.5%). The most frequently associated drug was darunavir/rtv (19; 34.5%), followed by atazanavir (13; 23.6%; 5 were unboosted); lopinavir/rtv (12; 21.8%), and NVP (11; 20%). DRR pts presented at baseline a mean viral load of 40,153 copies of HIV‐RNA/ml; after at 12 months all but 3 showed undetectable (<40 copies) viral load and a mean CD4 gain of 142 cells/ml. Pts switched to DUAL for toxicity presented persistent undetectable viral load and a mean CD4+gain of 94 cells/ml. The observed CD4+ increase in both groups (DRR and toxicity) presented a statistical significance (p<0.01). Total and HDL cholesterol, and creatinine did not present significant variations. CK remained stable and no toxicity episode was observed.ConclusionDUAL approach showed good safety and also remarkable results in terms of viral suppression and immunological recovery. Notwithstanding the potential low genetic barrier of some combinations (e.g. NVP+RAL) this strategy demonstrated to be effective. The long term reliability of DUAL should be confirmed by studies with a longer follow up and a wider sample.