Use of maraviroc in clinical practice: a multicenter observational study

Abstract

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 (all viruses CCR-5 tropic analyzed by genotypic and phenotypic test) were recruited in an observational multicenter study. Eight Infectious Diseases Centers 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/mmc, 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/mmc (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/mmc (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, transaminase and creatinine no significative differences were found 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/mmc 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.