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Yes, look how Maraviroc got approved for naive po

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Post# of 154141
(Total Views: 465)
Posted On: 09/07/2019 3:14:28 AM
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Posted By: trding
Re: misiu143 #7500
Yes, look how Maraviroc got approved for naive population. 68% had VL <50 at 48 weeks with Maraviroc plus Zidovudine and Lamivudine... yes 68%. It was 65% before the ruled some ineligible.

It’s looking like monotherapy 525mg Leonlimab is going to beat all three of those drugs combined—Maraviroc, Zidovudine and Lamivudine.

What is taking the FDA so long to decide if 525mg is good enough for combo for MDR2 patients?


https://academic.oup.com/jid/article/201/6/803/886212

Quote:
Virologic and immunologic outcomes. The proportions of patients with an HIV-1 RNA level of !<50 copies/mL by study visit and week 48 treatment differences for the coprimary end points are shown in Figure 2A. Maraviroc noninferiority to efavirenz was established for the <400 copies/mL end point: 70.6% of patients receiving maraviroc versus 73.1% of patients receiving efavirenz responded, and the lower bound of the adjusted 1-sided 97.5% CI was above −10%. For the <50 copies/mL end point, the proportions responding were 65.3% versus 69.3%



The story of maraviroc

https://www.frontiersin.org/articles/10.3389/...00277/full


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