Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1: 5-year findings

David A. Cooper, Jayvant Heera, Prudence Ive, Mariette Botes, Edwin Dejesus, Robert Burnside, Nathan Clumeck, Sharon Walmsley, Adriano Lazzarin, Geoffrey Mukwaya, Michael Saag, Elna Van Der Ryst

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objective: Maraviroc, a chemokine co-receptor type 5 (CCR5) antagonist, has demonstrated comparable efficacy and safety to efavirenz, each in combination with zidovudine/lamivudine, over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy (MERIT) study. Here we report 5-year findings. Design: A randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase. Methods: Treatment-naive patients with CCR5-tropic HIV-1 infection (Trofile) received maraviroc 300mg twice daily or efavirenz 600mg once daily, and zidovudine/lamivudine 300 mg/150mg twice daily. After the last patient's week 96 visit, the study was unblinded and patients could enter a nominal 3-year open-label phase. Endpoints at the 5-year nominal visit (week 240) included proportion of patients (CCR5 tropism reconfirmed by enhanced sensitivity Trofile) with viral load (plasma HIV-1 RNA) below 50 and 400 copies/ml, and change from baseline in CD4+ cell count, as well as safety. Results: The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 (maraviroc 50.8% vs. efavirenz 45.9%). Maraviroc-treated patients had a greater increase from baseline in mean CD4+ cell count than efavirenz-treated patients at week 240 (293 vs. 271 cells/μl, respectively). Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events (68.9 vs. 81.7%) and discontinued as a result of any adverse event (10.6 vs. 21.3%). Conclusion: Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1. Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns.

Original languageEnglish
Pages (from-to)717-725
Number of pages9
JournalAIDS (London, England)
Volume28
Issue number5
DOIs
Publication statusPublished - Mar 13 2014

Fingerprint

efavirenz
HIV-1
Safety
Chemokine Receptors
Lamivudine
Therapeutics
Zidovudine
CD4 Lymphocyte Count
Viral Load
maraviroc
Tropism

Keywords

  • Antiretroviral therapy
  • Efavirenz
  • HIV-1
  • Long term
  • Maraviroc
  • Randomized controlled trial
  • Treatment-naive

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases
  • Medicine(all)

Cite this

Cooper, D. A., Heera, J., Ive, P., Botes, M., Dejesus, E., Burnside, R., ... Van Der Ryst, E. (2014). Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1: 5-year findings. AIDS (London, England), 28(5), 717-725. https://doi.org/10.1097/QAD.0000000000000131

Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1 : 5-year findings. / Cooper, David A.; Heera, Jayvant; Ive, Prudence; Botes, Mariette; Dejesus, Edwin; Burnside, Robert; Clumeck, Nathan; Walmsley, Sharon; Lazzarin, Adriano; Mukwaya, Geoffrey; Saag, Michael; Van Der Ryst, Elna.

In: AIDS (London, England), Vol. 28, No. 5, 13.03.2014, p. 717-725.

Research output: Contribution to journalArticle

Cooper, DA, Heera, J, Ive, P, Botes, M, Dejesus, E, Burnside, R, Clumeck, N, Walmsley, S, Lazzarin, A, Mukwaya, G, Saag, M & Van Der Ryst, E 2014, 'Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1: 5-year findings', AIDS (London, England), vol. 28, no. 5, pp. 717-725. https://doi.org/10.1097/QAD.0000000000000131
Cooper, David A. ; Heera, Jayvant ; Ive, Prudence ; Botes, Mariette ; Dejesus, Edwin ; Burnside, Robert ; Clumeck, Nathan ; Walmsley, Sharon ; Lazzarin, Adriano ; Mukwaya, Geoffrey ; Saag, Michael ; Van Der Ryst, Elna. / Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1 : 5-year findings. In: AIDS (London, England). 2014 ; Vol. 28, No. 5. pp. 717-725.
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abstract = "Objective: Maraviroc, a chemokine co-receptor type 5 (CCR5) antagonist, has demonstrated comparable efficacy and safety to efavirenz, each in combination with zidovudine/lamivudine, over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy (MERIT) study. Here we report 5-year findings. Design: A randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase. Methods: Treatment-naive patients with CCR5-tropic HIV-1 infection (Trofile) received maraviroc 300mg twice daily or efavirenz 600mg once daily, and zidovudine/lamivudine 300 mg/150mg twice daily. After the last patient's week 96 visit, the study was unblinded and patients could enter a nominal 3-year open-label phase. Endpoints at the 5-year nominal visit (week 240) included proportion of patients (CCR5 tropism reconfirmed by enhanced sensitivity Trofile) with viral load (plasma HIV-1 RNA) below 50 and 400 copies/ml, and change from baseline in CD4+ cell count, as well as safety. Results: The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 (maraviroc 50.8{\%} vs. efavirenz 45.9{\%}). Maraviroc-treated patients had a greater increase from baseline in mean CD4+ cell count than efavirenz-treated patients at week 240 (293 vs. 271 cells/μl, respectively). Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events (68.9 vs. 81.7{\%}) and discontinued as a result of any adverse event (10.6 vs. 21.3{\%}). Conclusion: Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1. Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns.",
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AU - Botes, Mariette

AU - Dejesus, Edwin

AU - Burnside, Robert

AU - Clumeck, Nathan

AU - Walmsley, Sharon

AU - Lazzarin, Adriano

AU - Mukwaya, Geoffrey

AU - Saag, Michael

AU - Van Der Ryst, Elna

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N2 - Objective: Maraviroc, a chemokine co-receptor type 5 (CCR5) antagonist, has demonstrated comparable efficacy and safety to efavirenz, each in combination with zidovudine/lamivudine, over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy (MERIT) study. Here we report 5-year findings. Design: A randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase. Methods: Treatment-naive patients with CCR5-tropic HIV-1 infection (Trofile) received maraviroc 300mg twice daily or efavirenz 600mg once daily, and zidovudine/lamivudine 300 mg/150mg twice daily. After the last patient's week 96 visit, the study was unblinded and patients could enter a nominal 3-year open-label phase. Endpoints at the 5-year nominal visit (week 240) included proportion of patients (CCR5 tropism reconfirmed by enhanced sensitivity Trofile) with viral load (plasma HIV-1 RNA) below 50 and 400 copies/ml, and change from baseline in CD4+ cell count, as well as safety. Results: The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 (maraviroc 50.8% vs. efavirenz 45.9%). Maraviroc-treated patients had a greater increase from baseline in mean CD4+ cell count than efavirenz-treated patients at week 240 (293 vs. 271 cells/μl, respectively). Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events (68.9 vs. 81.7%) and discontinued as a result of any adverse event (10.6 vs. 21.3%). Conclusion: Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1. Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns.

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