BACKGROUND:Etravirine (ETR), a non-nucleoside reverse transcriptase inhibitor approved for 200 mg twice-daily dosing in conjunction with other antiretrovirals (ARVs), has pharmacokinetic properties which support once-daily dosing. METHODS: In this single-arm, open-label study, 79 treatment-naive HIV-infected adults were assigned to receive ETR 400 mg plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300/200 mg once daily to assess antiviral activity, safety and tolerability. ARV activity at 48 weeks was determined by proportion of subjects with HIV-1 RNA<50 copies/ml (intention-to-treat, missing = failure). RESULTS: Of 79 eligible subjects, 90% were men, 62% African-American and 29% Caucasian. At baseline, median (Q1, Q3) age was 29 years (23, 44) and HIV-1 RNA 4.52 log10 copies/ml (4.07, 5.04). A total of 69 (87%) completed a week 48 visit and 61 (77%, 95% CI 66%, 86%) achieved HIV-1 RNA<50 copies/ml at week 48. At time of virological failure, genotypic resistance-associated mutations were detected in three participants, two with E138K (one alone and one with additional mutations). Median (95% CI) CD4(+) cell count increase was 163 (136, 203) cells/µl. Fifteen (19.0%) participants reported a new sign/symptom or lab abnormality ≥ Grade 3 and three participants (3.8%) permanently discontinued ETR due to toxicity. Two participants had psychiatric symptoms of any grade. There were no deaths. CONCLUSIONS: In this study of ARV-naive HIV-positive adults, once-daily ETR with TDF/FTC had acceptable antiviral activity and was well-tolerated. Once-daily ETR may be a plausible option as part of a combination ARV regimen for treatment-naive individuals. ClinicalTrials.gov NCT00959894.
RCT Entities:
BACKGROUND:Etravirine (ETR), a non-nucleoside reverse transcriptase inhibitor approved for 200 mg twice-daily dosing in conjunction with other antiretrovirals (ARVs), has pharmacokinetic properties which support once-daily dosing. METHODS: In this single-arm, open-label study, 79 treatment-naive HIV-infected adults were assigned to receive ETR 400 mg plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300/200 mg once daily to assess antiviral activity, safety and tolerability. ARV activity at 48 weeks was determined by proportion of subjects with HIV-1 RNA<50 copies/ml (intention-to-treat, missing = failure). RESULTS: Of 79 eligible subjects, 90% were men, 62% African-American and 29% Caucasian. At baseline, median (Q1, Q3) age was 29 years (23, 44) and HIV-1 RNA 4.52 log10 copies/ml (4.07, 5.04). A total of 69 (87%) completed a week 48 visit and 61 (77%, 95% CI 66%, 86%) achieved HIV-1 RNA<50 copies/ml at week 48. At time of virological failure, genotypic resistance-associated mutations were detected in three participants, two with E138K (one alone and one with additional mutations). Median (95% CI) CD4(+) cell count increase was 163 (136, 203) cells/µl. Fifteen (19.0%) participants reported a new sign/symptom or lab abnormality ≥ Grade 3 and three participants (3.8%) permanently discontinued ETR due to toxicity. Two participants had psychiatric symptoms of any grade. There were no deaths. CONCLUSIONS: In this study of ARV-naive HIV-positive adults, once-daily ETR with TDF/FTC had acceptable antiviral activity and was well-tolerated. Once-daily ETR may be a plausible option as part of a combination ARV regimen for treatment-naive individuals. ClinicalTrials.gov NCT00959894.
Authors: Slim Fourati; Isabelle Malet; Sidonie Lambert; Cathia Soulie; Marc Wirden; Philippe Flandre; Djeneba B Fofana; Sophie Sayon; Anne Simon; Christine Katlama; Vincent Calvez; Anne-Geneviève Marcelin Journal: AIDS Date: 2012-08-24 Impact factor: 4.177
Authors: Christine Katlama; Bonaventura Clotet; Anthony Mills; Benoit Trottier; Jean-Michel Molina; Beatriz Grinsztejn; William Towner; Richard Haubrich; Steven Nijs; Johan Vingerhoets; Brian Woodfall; James Witek Journal: Antivir Ther Date: 2010
Authors: Giovanni Di Perri; Bruce Green; Glynn Morrish; Andrew Hill; Gerd Faetkenheuer; Markus Bickel; Yvon van Delft; Michael Kurowski; Thomas Kakuda Journal: HIV Clin Trials Date: 2013 May-Jun
Authors: Cesar Fisac; Emilio Fumero; Manuel Crespo; Beatriz Roson; Elena Ferrer; Nuria Virgili; Esteban Ribera; Jose Maria Gatell; Daniel Podzamczer Journal: AIDS Date: 2005-06-10 Impact factor: 4.177
Authors: Frank van Leth; Prahpan Phanuphak; Erik Stroes; Brian Gazzard; Pedro Cahn; François Raffi; Robin Wood; Mark Bloch; Christine Katlama; John J P Kastelein; Mauro Schechter; Robert L Murphy; Andrzej Horban; David B Hall; Joep M A Lange; Peter Reiss Journal: PLoS Med Date: 2004-10-19 Impact factor: 11.069
Authors: Cynthia L Gay; Dayna T Neo; Aaron S Devanathan; Joann D Kuruc; Kara S McGee; John L Schmitz; Joe Sebastian; Nicholas J Shaheen; Guido Ferrari; Mehri McKellar; Susan A Fiscus; Charles B Hicks; Kevin Robertson; Angela D M Kashuba; Joseph J Eron; David M Margolis Journal: AIDS Date: 2020-11-01 Impact factor: 4.632