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Efficacy and safety of once‐daily maraviroc plus ritonavir‐boosted darunavir in pretreated HIV ‐infected patients in a real‐life setting
Author(s) -
Macías J,
Recio E,
Márquez M,
García C,
Jiménez P,
Merino D,
Muñoz L,
Pasquau J,
Ojeda G,
Bancalero P,
Chueca N,
Pineda JA
Publication year - 2014
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12129
Subject(s) - darunavir , medicine , maraviroc , ritonavir , interquartile range , adverse effect , atazanavir , viral load , enfuvirtide , clinical endpoint , raltegravir , gastroenterology , pharmacology , human immunodeficiency virus (hiv) , virology , immunology , clinical trial , antiretroviral therapy , antigen , gp41 , epitope
Objectives Nucleoside reverse transcriptase inhibitor ( NRTI )‐sparing regimens may be needed in patients with NRTI toxicity. Maraviroc ( MVC ) plus ritonavir‐boosted darunavir ( DRV ‐r) or atazanavir is associated with slightly lower response rates than triple therapy in drug‐naïve patients. No information is available on these combinations in pretreated patients. The aim of this study was to assess the efficacy and safety of MVC plus DRV /r once‐daily (qd) in HIV ‐infected pretreated patients. Methods A retrospective cohort study including patients starting MVC 150 mg plus DRV /r 800/100 mg qd, with CCR5 tropism and no resistance mutations for DRV /r, was performed. The primary efficacy endpoint was the achievement of plasma HIV RNA < 50 HIV ‐1 RNA copies/mL after 48 weeks. The frequency of serious adverse effects was investigated. Results Sixty patients were recruited to the study, of whom 48 (80%) had HIV RNA < 50 copies/mL at baseline. Reasons for starting MVC plus DRV /r were: adverse effects in 38 individuals (63%), simplification in 15 (25%) and virological failure in seven (12%). The main analysis (intention to treat, noncompleter = failure) showed that 47 patients (78%) achieved HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). On‐treatment analysis showed that 42 (86%) of 49 patients presented HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). Median (interquartile range) CD4 cell counts increased from 491 (301−729) to 561 (367−793) cells/μL at 48 weeks ( P = 0.013). Only one patient discontinued therapy because of adverse effects. Conclusions Most individuals starting MVC plus DRV /r qd because of simplification or adverse effects maintained HIV suppression after 48 weeks of follow‐up.