Test for CCR5 tropism and treatment with maraviroc in Sicily: an observational retrospective multicentre study.

urpose of the study Maraviroc (MVC) is the first CCR5 inhibitor licensed for clinical use. A pre-treatment test is mandatory to identify R5 tropic patients. Aim of this study is to detect indications and results of tropism test and to evaluate efficacy and tolerability of MVCbased regimen. Methods An observational retrospective multicentre study was performed in Sicily in 15 Infectious Diseases Units. Clinical records of 213 screened for tropism HIV subjects were reviewed for age, sex, risk, clinical stage (CDC, CD4 cell count, HIV RNA viral load), therapeutic line, indication and result of test for tropism; within subjects treated with MVC, HIV RNA, CD4 cell count and metabolic parameters trend and adverse events were analysed. Summary of results Median age 44 (IQR 3050) years, 67.1% males; 46.3% heterosexuals, 28.6% MSMs, 21.4% IVDUs; 23.7% CDC A, 32.1% CDC B, 44.2% CDC C; median CD4 was 217 (IQR 121374) cells/ml and mean of HIV RNA was 4.72 (Cl 95% 4.074.67) log10 copies/ml; median therapeutic line was 4 (IQR 27). 80.8% were submitted to TrofileTM test, 19.2% to genotypic test, 75.5% after a therapeutic failure. 56.8% of subjects screened were R5, 7.5% X4, 21.6% DM, 14% undefined. All X4 patients were tested after a therapeutic failure; patients screened for toxicity were more frequently R5 (75%) (pB0.01). 76 (35.7%) multi-experienced (at baseline 8% HIV RNAB50 copies/ml, median CD4 cell count 219 (IQR 124345) cells/ml) subjects were treated with MVC plus an optimized background treatment: MVC was associated in 74% of cases with a protease inhibitors (56% darunavir/ritonavir), in 42% with raltegravir, in 56% with a NUC-sparing regimen. After 12 months of treatment 56.8% (ITT analysis) and 61.7% (AT) of patients had HIV RNAB50 copies/ml; median CD4 cell count was 387 (IQR 222455) cells/ml. After 24 months 64.8% (ITT) 80% (AT) had HIV-RNAB50 copies/ml. Median CD4 cell count was 381 (IQR 218.515) cells/ml with a median increase of 168 (IQR 54274) cells/ml. At 24 months median value of total and HDL cholesterol and triglycerides were within the normal range. 7 patients stopped the treatment: 2 died, 1 adverse event, 4 virological failure. Conclusions Although the test has been proposed to patients with long treatment history and failure, only 3/5 of R5 tropic patients were treated with MVC. An high number of multi-experienced subjects treated with a MVC-based regimen obtained HIV RNAB50 copies/ml and a satisfactory increase of CD4 cell count.