Use of maraviroc in clinical practice: a multicenter observational study

Abstract

Purpose of the studyPromising 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.MethodsAll 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 resultsWe 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.ConclusionsIn 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.