Switching to Stribild From Non-Nuke or Protease Inhibitor Regimens Works Well
March 14, 2014
So with all the positive news about integrase inhibitors in initial HIV treatment, is it safe to switch patients from other NNRTI (non-nucleoside reverse transcriptase inhibitor)- or PI (protease inhibitor)-based regimens to integrase inhibitor regimens? Our previous lesson from the SWITCHMRK and SPIRAL studies reminds us to be cautious, particularly when switching drug-resistant patients receiving a boosted PI (lopinavir).
The open-label STRATEGY studies -- incredibly accepted only as poster presentations despite reporting the final results of nearly 900 patients in phase-3 studies -- presented at CROI 2014 learned this lesson by restricting participants to patients on first- or second-line treatment regimens with no previous virologic failure.
In these well-powered studies, patients were randomized 2:1 to switch to elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild) or continue stable NNRTI or PI regimens. Patients with an eGFR (estimated glomerular filtration rate -- one method for assessing kidney health) greater than 70 were excluded.
Overall, switching to elvitegravir/cobicistat/emtricitabine/tenofovir from NNRTIs (78% efavirenz [Sustiva, Stocrin], 17% nevirapine [Viramune]) was non-inferior, while switching from boosted PIs (40% darunavir [Prezista]/ritonavir [Norvir], 40% atazanavir [Reyataz]/ritonavir) showed statistical superiority over elvitegravir/cobicistat/emtricitabine/tenofovir.
Virologic failure was rare in all study arms and no resistance was selected at failure in any participants treated with elvitegravir/cobicistat/emtricitabine/tenofovir. Not surprisingly, neuropsychiatric symptoms improved after switching off efavirenz, lipid values improved following switching from lopinavir/ritonavir (Kaletra), and gastrointestinal symptoms improved after PI switch.
While these open-label studies have inherent limitations by virtue of their design, the implications are clear: In patients without viral drug resistance, switching from NNRTI- or PI-based treatment to elvitegravir/cobicistat/emtricitabine/tenofovir appears safe and may result in desired improvements in symptoms or toxicity. Will these lessons extend to switches to other integrase inhibitors? Quite probably, though this remains a largely data-free area yet with dolutegravir (Tivicay, DTG).
Which other studies presented at CROI 2014 will have lasting impact? Read more of Dr. Llibre and Dr. Young's top picks.
Copyright © 2014 Remedy Health Media, LLC. All rights reserved.
Antiretroviral Studies at ICAAC 2014: Darunavir-Based FDC With TAF, Cobicistat, Doravirine, Stribild and Gel Formulation PrEP
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