Efficacy, safety, and tolerability of etravirine with and without darunavir/ritonavir or raltegravir in treatment-experienced patients: analysis of the etravirine early access program in the United States

Journal of Acquired Immune Deficiency Syndromes : JAIDS
William TownerJames Witek

Abstract

Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval. The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus a background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States through week 48, including subgroups receiving etravirine +/- darunavir/ritonavir and/or raltegravir. The intent-to-treat population included 2578 patients; 62.4% and 56.7% of patients received darunavir/ritonavir and raltegravir, respectively, in their BR. At week 48, 62.3% of patients achieved viral loads <75 copies per milliliter; responses across subgroups were similar. Median CD4 count increase from baseline was >100 cells per cubic millimeter. No unexpected safety concerns emerged; serious AEs and deaths due to AEs, considered possibly related to etravirine, occurred in 2.0% and 0.3% of patients, respectively. Discontinuations due to AEs were low overall (4.4%) and comparable across subgroups. Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, ...Continue Reading

Citations

Mar 28, 2013·AIDS Research and Treatment·Kelly Gebo Hiv Research Network
Oct 17, 2013·Enfermedades infecciosas y microbiología clínica·M Eulalia Valencia OrtegaLuz Martín Carbonero
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Apr 13, 2012·The Annals of Pharmacotherapy·Kristina E E RokasSharon B Weissman
Apr 9, 2013·Expert Opinion on Pharmacotherapy·Rik Schrijvers

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