Use of maraviroc in clinical practice: a multicenter observational study

Purpose of the study: Promising research suggest that maraviroc (MVC) has favourable clinical outcome in HIV-infected patients (pts). Aim of the study is to assess: durability, safety profile and immunovirological recovery in a large MVC-based cohort. Methods: All HIV pts treated with antiretroviral therapy (ART) containing MVC for at least 6 months were recruited (all viruses CCR-5 tropic analyzed by genopytic and phenotypic test) in an observational multicenter study. Eight Infectious Diseases Center in Liguria and Piedmont (Italy) collected at baseline and every 3 months demographics, clinical and immunovirological data on a web-based system (by MedinfoDist, University of Genoa). We used SPSS for Pearson Chi square test and for generalized estimating equation (GEE); in this model for longitudinal data and frequency analysis we considered altered: TCD4+ < 350/mm³, HIVRNA > 50 cp/ml, total cholesterol >200 mg/dl, triglycerides >160 mg/dl, transaminase > 40 mg/dl, creatinine > 1,3 mg/dl and we divided data in 5 time periods: baseline,1-6, 9-12, 15-24 and 24-45 months . Summary of results We enrolled 55 pts: 36 (65%) males, median age 49.6 years (yrs) (range [r] 18.2-76.6, IQR 44,5-53,3), 11 (20%) HCVRNA positive, 4 (7%) HBsAg positive, 1 both infection. Twenty-four (44%) pts were classified as CDC C stage, median nadir TCD4+ was 219/mm³(r 11-529, IQR 125-317), median duration of ART was 15,3 yrs (r 1,3-27,3, IQR 12-16,8), median duration of treatment with MVC was 23 months (r 6-47, IQR 14-36). At baseline 42 (76%) pts had HIVRNA > 50 cp/ml, 11 (20%) HIVRNA < 50 cp/ml, 2 (4%) pts no data; on treatment at the last examination 53 pts (96%) had HIVRNA < 50 cp/ml, 2 pts still had HIVRNA > 50 cp/ml (CCR5 tropic) and median TCD4+ count was 469/mm³ (r 73-1802, IQR 302-592). One pt died and only 2 pts shifted to X4. Chi square test at 9-12 months showed p=0.0001 and the 80% of pts had TCD4+ ≥350/mmc; at the same observation time 83,3% of pts had HIVRNA < 50 cp/ml (p= 0.0001). About cholesterol, triglycerides, liver function and creatinine we didn’t found any significative differences and the median value showed no changes. Conclusions: In our study a majority of pts treated with ART containing MVC achieved a count of TCD4 ≥350/mm³ and HIVRNA undetectable within 9-12 months. This regimen is a safe, feasible option and in pts with a poor immunological stage, MVC offered a remarkable TCD4+ count gain with limited X4 strains onset.