Observational study on HIV‐1‐infected patients treated with an ARV combination therapy including raltegravir: the RACING cohort results at month 12

Abstract

The French RACING cohort study is a 24‐month, observational, longitudinal, prospective, multicenter study on HIV‐1 infected patients being treated with an antiretroviral combination therapy containing raltegravir. The objectives of this study are to describe the viro‐immunological course, characterize and document adverse events (AEs), describe patient adherence at M6 (month 6) and examine clinical‐biological data for patients undergoing ARV therapy including raltegravir at M12 (month 12). Demographic, viro‐immunological, safety and clinical‐biological data were collected at M6 and M12 and self‐reported patient adherence to treatment regimen at M6. Data from 478 of 482 patients were available at M12. The median age was 45.9 years (IQR: 40.0–52.2), 64.1% were male and the median duration of infection was 13.2 years (IQR: 5.5–21). At the baseline, 64.1% of patients had a cardiovascular risk factor or a history of cardiovascular events and 65.2% had received concomitant treatment (psychotropic drugs: 33.5%, lipid‐lowering drugs: 30% and antihypertensive agents: 24.8%). The virological response, viral load and CD4 cell count are shown in Table 1 (based on data available at M6 and M12). Of the 134 reported and treatment‐related AEs, the symptoms most frequently described (>5%) were myalgia (6.7%) and nausea (5.2%). A total of 34 serious adverse events were reported, of which 5 were possibly or probably related to raltegravir. Self‐reported patient adherence at M6 is described as follows: ‘high’ for 56% of patients, ‘average’ for 36% of patients and ‘low’ for 8% of patients (205 questionnaires). To conclude, in a real‐life setting concerning patients with a strong proportion of co‐morbidity and variation in adherence, the efficacy and safety data observed after 12 months are comparable to the data observed (not shown) in clinical studies. Viro‐immunological data Naïve No previous treatment n=65 Switch Previous treatment with a viral load<50 copies/mL n=258 Failure Previous treatment with a viral load>50 copies/Ml n=151 Median Viral Load (copies/mL) at baseline 64,513 – 1,891 Median CD4 (cells/mm3) at baseline 308 556 365 M6 M12 M6 M12 M6 M12 Virological Response% (HIV‐RNA<50 copies/mL) 77% n=56 87% n=62 92% n=191 94% n=211 70% n=112 73% n=125 Immunological Response Median CD4 count (cells/mm3) 461 n=58 514 n=63 592 n=205 591 n=209 451 n=124 490 n=126