Safety and Immunovirologic Outcomes with Maraviroc Combination Regimens in Patients with a History of Past Treatment Failures and Virologic Resistance in Brazil: An Open-Label, Multicenter Phase 3b Study

Safety and Immunovirologic Outcomes with Maraviroc Combination Regimens in Patients with a History of Past Treatment Failures and Virologic Resistance in Brazil: An Open-Label, Multicenter Phase 3b Study

Author Furtado, Juvencio Google Scholar
Madruga, Jose V. Google Scholar
Bicudo, Eliana L. Google Scholar
Eira, Margareth da Google Scholar
Lopes, Max I. B. F. Google Scholar
Netto, Eduardo M. Google Scholar
Santini-Oliveira, Marilia Google Scholar
Leite, Olavo H. M. Google Scholar
Machado, Alcyone A. Google Scholar
Tupinambas, Unai Google Scholar
Andrade Neto, Jose L. de Google Scholar
Lima, Maria P. J. S. Google Scholar
Pedro, Rogerio de Jesus Google Scholar
Miranda, Antonio F. B. Google Scholar
Lewi, David S. Autor UNIFESP Google Scholar
Santos, Breno R. Google Scholar
Portsmouth, Simon Google Scholar
Wajsbrot, Dalia B. Google Scholar
Cassoli, Lourenia M. Google Scholar
Institution ABC
Hosp Heliopolis
Ctr Referencia & Treinamento DST AIDS
Day Hosp
Inst Infectol Emilio Ribas
Universidade de São Paulo (USP)
Universidade Federal da Bahia (UFBA)
Hosp Geral Nova Iguacu
Fac Med Ribeirao Preto
Universidade Federal de Minas Gerais (UFMG)
Pontificia Univ Catolica Parana
Pontificia Univ Catolica Campinas
Universidade Estadual de Campinas (UNICAMP)
Hosp Nereu Ramos
Universidade Federal de São Paulo (UNIFESP)
Pfizer Inc
Pfizer Brazil
Abstract Maraviroc is a first-in-class chemokine coreceptor type-5 (CCR5) antagonist with demonstrated immunovirologic activity in treatment-experienced (TE) patients with CCR5 (R5)-tropic HIV-1; however, experience in regimens containing newer antiretroviral agents is limited. the primary objective of this 96-week open-label, noncomparative, multicenter Phase 3b study (NCT00478231) was to assess the safety of maraviroc in combination with optimized background therapy (OBT), which could include recently introduced agents such as darunavir and raltegravir in TE patients in Brazil with R5 HIV-1 and limited therapeutic options. Immunovirologic activity was a secondary endpoint. of 638 patients screened, 206 were treated and 125 completed the study. Approximately 70% were male; the mean age was 43.2 years. Most patients (65.0%) received an OBT combination of protease inhibitor plus nucleoside reverse transcriptase inhibitor. Adverse event (AE) and treatment-related AE incidence was 91.3% and 36.9%, respectively. the most common AEs were diarrhea, nasopharyngitis, and headache. Serious AEs and treatment-related serious AEs occurred in 16.5% and 4.4% of patients. Only eight patients (3.9%) discontinued due to AEs. Few AIDS-defining events were observed (4.9%). the proportion of patients with viral load <400 copies/ml increased from 2.4% at baseline to 43.9% at week 8, remaining >40% until week 48. At the end of treatment, 26.7% of patients had a viral load <400 copies/ml. Median CD4(+) cell count increased throughout the study; the mean change from baseline to end of treatment was 174.1 cells/mu l. in conclusion, maraviroc, combined with different agents from multiple classes, was well tolerated in highly TE patients. Maraviroc plus OBT was associated with an immunovirologic response in this population.
Language English
Sponsor Pfizer, Inc.
ViiV Healthcare
Date 2013-09-01
Published in Aids Research and Human Retroviruses. New Rochelle: Mary Ann Liebert, Inc, v. 29, n. 9, p. 1203-1210, 2013.
ISSN 0889-2229 (Sherpa/Romeo, impact factor)
Publisher Mary Ann Liebert, Inc
Extent 1203-1210
Origin http://dx.doi.org/10.1089/aid.2012.0330
Access rights Closed access
Type Article
Web of Science ID WOS:000323372600005
URI http://repositorio.unifesp.br/handle/11600/36725

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