
Open‐label study of maraviroc+lamivudine/zidovudine in treatment‐naïve adults infected with HIV‐1, predominantly subtype A, by population genotyping
Author(s) -
Portsmouth S,
Valluri S,
Craig C,
Lewis M,
Pokrovsky V,
Gartland M,
Heera J
Publication year - 2012
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.15.6.18261
Subject(s) - maraviroc , lamivudine , medicine , zidovudine , viral load , population , genotyping , virology , ccr5 receptor antagonist , gastroenterology , immunology , hepatitis b virus , human immunodeficiency virus (hiv) , virus , viral disease , genotype , biology , receptor , biochemistry , chemokine , environmental health , chemokine receptor , gene
HIV‐1 subtype A infection predominates in Russia; however, little experience of response to maraviroc in this subtype exists and population genotyping in this setting requires further exploration. One hundred and twenty‐one treatment‐naïve HIV‐1‐infected individuals from seven centres in Russia were screened using V3 loop population genotyping with a false‐positive rate of 10% (geno2pheno); 75% of patients were confirmed to have CCR5 (R5)‐tropic HIV‐1, 21% of patients had non‐R5 HIV‐1, and 4% of tests were non‐reportable. Seventy‐seven patients met the inclusion criteria and were treated with maraviroc 300 mg twice daily (BID) in combination with lamivudine/zidovudine. Virologic and immunologic responses were assessed in this 24‐week planned interim analysis. Fifty‐one male (66.2%) and 26 (33.8%) female patients were enrolled. In total, 76.3% of patients had subtype A infection, and 28.6% were co‐infected with hepatitis C virus. At baseline, the mean (± standard deviation [SD]) CD4 count was 404±122 cells/mm 3 , and the mean viral load was 4.77±0.74 log 10 copies/mL, with 38% of patients having viral loads ≥100,000 copies/mL. At Week 24, 80.5% of patients had viral loads <50 copies/mL and the mean (±SD) CD4 cell count was 411±124 cells/mm 3 . No treatment‐emergent adverse events were attributed to maraviroc, and three patients experienced Grade 4 anaemia associated with lamivudine/zidovudine. Seven patients discontinued from the study, but only one of these discontinuations was due to an insufficient clinical response. Two patients had 3TC resistance at the time of discontinuation. Virologic responses to a maraviroc‐based regimen in patients infected with R5‐tropic HIV‐1 subtype A, determined using population genotyping, were confirmed.