Maraviroc has maintained similar long-term antiviral efficacy to Efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1


Maraviroc ( Celsentri, Selzentry ), a chemokine co-receptor type 5 ( CCR5 ) antagonist, has demonstrated comparable efficacy and safety to Efavirenz ( Sustiva ), each in combination with Zidovudine / Lamivudine, over 96 weeks in the Maraviroc vs Efavirenz Regimens as Initial Therapy (MERIT) study.
Here researchers have reported 5-year findings.

MERIT is a randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase.

Treatment-naive patients with CCR5-tropic HIV-1 infection ( Trofile ) received Maraviroc 300 mg twice daily or Efavirenz 600 mg once daily, and Zidovudine / Lamivudine 300 mg/150 mg 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 re-confirmed 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.

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/microl, 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% ).

In 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. ( Xagena )

Cooper DA et al, AIDS 2014; 28: 717-725

XagenaMedicine_2014



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