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

Incidence of cancer and overall risk of mortality in individuals treated with raltegravir‐based and non‐raltegravir‐based combination antiretroviral therapy regimens

“…A total of 34 serious AEs were reported, of which five were possibly or probably related to RAL. In general, a favourable tolerability profile has been demonstrated for RAL since the earlier registration studies, with headache and gastrointestinal complaints representing the most common reported AEs . In contrast, mild neuropsychiatric disorders have been infrequently recorded (usually reported on a subjective basis), and cases of rhabdomyolisis and hypersensitivity reactions have been extremely rare.…”