271
Views
57
CrossRef citations to date
0
Altmetric
Original Articles

Rilpivirine Versus Efavirenz in HIV-1–Infected Subjects Receiving Emtricitabine/Tenofovir DF: Pooled 96-Week Data from ECHO and THRIVE Studies

, , , , , , , , , , , , & show all
Pages 81-91 | Published online: 22 Dec 2014

REFERENCES

  • DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. February 12, 2013. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdo-lescentGL.pdf. Accessed February 12, 2013.
  • Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral treatment of adult HIV infection, 2012 recommendations of the International AIDS Society—USA Panel. JAMA. 2012;308(4):387–402.
  • Mathias A, Menning M, Wei X, Dave A, Chuck S, Kearney BR Bioequivalence of the coformulation of emtricitabine/ rilpivirine/tenofovir DF. Poster session presented at: 18th International AIDS Conference; July 18–23, 2012; Vienna, Austria. Poster LBPE17.
  • EDURANT (rilpivirine) 25-mg film-coated tablets. Summary of product characteristics. Beerse, Belgium: Janssen-Cilag International NV; 2012.
  • Lachau-Durand S, Mamidi R, Cuyckens F, Michlova V, Mannens G, Raoof A. Absorption, metabolism and excretion of TMC278, an NNRTI, after a single oral dose of 150 mg in healthy male volunteers. Presented at: 12th European AIDS Clinical Society Conference; November 11–14, 2009; Cologne, Germany. Abstract PE7.1/3.
  • Crauwels HM, van Heeswijk RPG, BoIlen A, et al. The effect of different types of food on the bioavailability of TMC278, an investigational NNRTI. Poster session presented at: 9th International Workshop on Clinical Pharmacology of HIV Therapy; April 7–9, 2008; New Orleans, LA, USA. Poster P32.
  • Desmidt M, Willems B, Dom P, et al. Absence of a tera-togenic potential from a novel next-generation NNRTI, TMC278. Presented at: 12th European AIDS Conference; Cologne, Germany; November 11–14, 2009; Abstract PE7.1/4.
  • Molina J-M, Cahn P, Grinsztein B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011;378:238–246.
  • Cohen CJ, Andrade-Villanueva J, Bonaventura C, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011;378:229–237.
  • Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements - Guidance for Industry. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2002.
  • Division of Acquired Immune Deficiency Syndrome (DAIDS) table for grading the severity of adult and pedi-atric adverse events. Version 1. December 28, 2004. http://www.hptn.org/web%20documents/hptn046/ssp/appendices/appendixe-toxicitytables_daids_ae_gradingtable_finaldec2004.pdf
  • Nelson M, Behrens G, Cohen C, et al. Sustained efficacy with low and similar rates of virologic failures in second year observed with rilpivirine (RPV) versus efavirenz (EFV) plus emtricitabine/tenofovir DF (FTC/TDF) in treatment-naive, HIV-1 infected adults - pooled 96-week ECHO and THRIVE analysis. Poster session presented at: 13th European AIDS Conference (EACS); October 12–15, 2011; Belgrade, Serbia. Poster LBPE7.3/7.
  • Jayaweera D, Elion R, Hodder S, et al. Differential impact of non-adherence on week 96 outcomes in the FTC/TDF subset of pooled ECHO and THRIVE studies comparing rilpivirine (RPV) vs. efavirenz (EFV) in treatment-naïve, HIV-1 infected adults. Oral presentation at: International Association of Physicians in AIDS Care; June 3–5, 2012; Miami, FL, USA.
  • Johnson VA, Brun-Vezinet F, Clotet B, et al. Update of the drug resistance mutations in HIV-1: December 2009. Top HIV Med. 2009;17(5): 138–145.
  • Tambuyzer L, Azijn H, Rimsky LT, et al. Compilation and prevalence of mutations associated with resistance to non-nucleoside reverse transcriptase inhibitors. Antivir Ther 2009;14:103–109.
  • Tebas P, Henry K, Nelson Metal. Results from the pooled DEXA substudies of the double-blind, randomised, Phase III trials comparing rilpivirine (RPV, TMC278) versus efavirenz (EFV) in treatment-naive, HIV-1-infected adults. Presented at: 13th International Workshop on Adverse Reactions and Co-morbidities in HIV 13th Annual Work-shop; July 14–16, 2011; Rome, Italy. Abstract 23.
  • Elion R, Vanveggel S, Williams P, Boven K, Fralich T, Guyer B. Pooled week 48 safety, efficacy, and adherence results from ECHO and THRIVE Phase III trials comparing TMC278 versus EFV in treatment-naïve HIV-1-infected patients receiving FTC/TDF. Oral presentation at: Interna-tional Association of Physicians in AIDS Care Conference; May 22–24, 2011; Miami, FL, USA. Oral Presentation 70365.
  • Brochot A, De La Rosa G, Vis P, et al. Generalised additive modelling of virologic response to the NNRTIs rilpivirine (RPV, TMC278) and efavirenz (EFV) in treatment-naïve HIV-infected patients: pooled data from ECHO and THRIVE. Presented at: 13th European AIDS Conference (EACS); October 12–15, 2011; Belgrade, Serbia. Abstract PS12/7.
  • Kulkarni R, Babaoglu K, Lansdon E, et al. HIV-1 Reverse transcriptase M184I mutation enhances the E138K-associated resistance to rilpivirine and decreases viral fitness. J Acquir Immune Defic Syndr. 2012;59:47–54.
  • Hu Z, Kuritzkes DR. Interaction of reverse transcriptase (RT) mutations conferring resistance to lamivudine and etravirine: effects on fitness and RT activity of human immunodeficiency virus type 1. J Virol. 201185(21): 11309–11314.
  • Xu H-T, Asahchop EL, Oliveira M, et al. Compensation by the E138K mutation in HIV-1 reverse transcriptase for deficits in viral replication capacity and enzyme proces-sivity associated with the M184I1V mutations. J Virol. 2011 ;85(21):11300–11308.
  • SUSTIVA (efavirenz) 600-mg film-coated tablets. Summary of product characteristics. Uxbridge, UK: Bristol-Myers Squibb House; June 2012.
  • Rockstroh J, Streinu-Cercel A, Pokrovsky V, Turner D. The SENSE trial: final 48 week analysis of etravirine versus efavirenz in treatment naive patients. Presented at: Sixth IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 2011; Rome, Italy.
  • Waters L, Fisher M, Winston A, et al. A phase IV, double-blind, multicentre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine. AIDS. 2011;25:65–71.
  • Gazzard B, Duvivier C, Zagler C, et al. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treat-ment-naïve patients: 48-week results. AIDS. 2011;25: 2249–2258.
  • Scourfield A, Zheng J, Chinthapalli S, et al. Discontinuation of Atripla as first-line therapy in HIV-1 infected individuals. AIDS. 2012;26. doi:10.1097/QAD.0b013e328353b047
  • Rashbaum B, Girard P-M, Rachlis A, et al. Rilpivirine (1MC278) tolerability over the first 12 weeks of treatment in the Phase III ECHO and THRIVE studies. Poster session presented at: 51st Interscience Conference on Antimicro-bial Agents and Chemotherapy; September 17–20, 2011; Chicago, IL, USA. Poster H2–805.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.