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 language | English |
|---|---|
| Pages (from-to) | 717-725 |
| Number of pages | 9 |
| Journal | AIDS (London, England) |
| Volume | 28 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Mar 13 2014 |
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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
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 journal › Article
}
TY - JOUR
T1 - Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1
T2 - 5-year findings
AU - Cooper, David A.
AU - Heera, Jayvant
AU - Ive, Prudence
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
PY - 2014/3/13
Y1 - 2014/3/13
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.
AB - 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.
KW - Antiretroviral therapy
KW - Efavirenz
KW - HIV-1
KW - Long term
KW - Maraviroc
KW - Randomized controlled trial
KW - Treatment-naive
UR - http://www.scopus.com/inward/record.url?scp=84898755496&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84898755496&partnerID=8YFLogxK
U2 - 10.1097/QAD.0000000000000131
DO - 10.1097/QAD.0000000000000131
M3 - Article
C2 - 24983542
AN - SCOPUS:84898755496
VL - 28
SP - 717
EP - 725
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 5
ER -