Abstract
Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (tenofovir DF) [Eviplera® (EU); Complera® (USA)] is a convenient and effective addition to the other single-tablet regimens currently available for the treatment of HIV-1 infection. Once-daily emtricitabine/rilpivirine/tenofovir DF was noninferior to once-daily emtricitabine/efavirenz/tenofovir DF in establishing virological suppression in treatment-naïve adults. Switching to the once-daily single tablet maintained virological suppression and was noninferior to remaining on a more complex multiple-tablet regimen in treatment-experienced patients already virologically suppressed with an antiretroviral regimen and without prior virological failure. Emtricitabine/rilpivirine/tenofovir DF was generally well tolerated, with a more favourable overall tolerability profile than emtricitabine/efavirenz/tenofovir DF.
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References
Arts EJ, Hazuda DJ. HIV-1 antiretroviral drug therapy. Cold Spring Harb Perspect Med. 2012;2(4):a007161.
Detels R, Munoz A, McFarlane G, et al. Effectiveness of potent antiretroviral therapy on time to AIDS and death in men with known HIV infection duration. JAMA. 1998;280(17):1497–503.
Williams I, Churchill D, Anderson J, et al. British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2012 (updated November 2013). 2014. http://www.bhiva.org. Accessed 6 May 2015.
European AIDS Clinical Society. Guidelines version 7.1. 2014. http://eacsociety.org. Accessed 6 May 2015.
Stone VE, Jordan J, Tolson J, et al. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy: self-report of the relative importance of multiple attributes of highly active antiretroviral therapy (HAART) regimens in predicting adherence. JAIDS. 2004;36(3):808–16.
Kaya S. HIV treatment with once-daily single tablet regimens. J Virol Antivir Res. 2013;2(1). doi:10.4172/2324-8955.1000105.
Molina JM. Efficacy and safety of once-daily regimens in the treatment of HIV infection. Drugs. 2008;68(5):567–78.
Eviplera 200 mg/25 mg/245 mg film-coated tablets: EU summary of product characteristics. London: European Medicines Agency, 2015.
Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarat) tablets, for oral use: US prescribing information. Foster City: Gilead Sciences Inc, 2014.
Kulkarni R, Feng JY, Miller MD, et al. Dead-end complexes contribute to the synergistic inhibition of HIV-1 RT by the combination of rilpivirine, emtricitabine, and tenofovir. Antiviral Res. 2014;101:131–5.
Cohen C, Wohl D, Arribas JR, et al. Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults. AIDS. 2014;28(7):989–97.
Cohen C, Wohl D, Arribas J, et al. STaR study: single tablet regimen rilpivirine/emtricitabine/tenofovir DF maintains non-inferiority to efavirenz/emtricitabine/tenofovir DF in ART-naive adults through week 96 [abstract no. LBPE7/17 plus poster]. In: 14th European AIDS Conference; 2013
Nelson MR, Elion RA, Cohen CJ, et al. Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE studies. HIV Clin Trials. 2013;14(3):81–91.
Nelson M, Gazzard B, Walmsley S, et al. Pooled week 48 safety and efficacy results from ECHO and THRIVE phase III trials comparing rilpivirine vs. efavirenz in treatment-naïve HIV-1-infected patients receiving FTC/TDF [poster no. P175]. In: 17th Annual Conference of the British HIV Association; 2011
Cohen C, Wohl D, Arribas J, et al. STaR: rilpivirine/emtricitabine/tenofovir DF is noninferior to efavirenz/emtricitabine/tenofovir DF in naive adults Latino, Black and White subpopulations—week 48 results (poster no. P24). In: HIV Drug Therapy in the Americas Congress; 2013.
Brinson C, Segal-Maurer S, Brar I, et al. Star: virologic outcomes and safety in ART-naive adult females for single-tablet regimen rilpivirine/emtricitabine/tenofovir DF compared to efavirenz/emtricitabine/tenofovir DF at week 48 [abstract no. H-655 plus oral presentation]. In: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2013.
Creticos C, McDonald C, Segal-Maurer S, et al. STaR: single-tablet regimen rilpivirine/emtricitabine/tenofovir DF is safe and well-tolerated with efficacy comparable to efavirenz/emtricitabine/tenofovir DF in ART-naive females at week 96 (poster no. 16). In: 4th International Workshop on HIV and Women, from Adolescence through Menopause; 2014.
Henry K, Wohl D, Cohen C, et al. STaR: single tablet regimen rilpivirine/emtricitabine/tenofovir DF maintains noninferiority to efavirenz/emtricitabine/tenofovir DF through week 48 in subjects >50 years old (poster no. P_27). In: 4th International Workshop on HIV & Aging; 2013.
Cohen C, Wohl D, Arribas J, et al. STaR study: single-tablet regimen rilpivirine/emtricitabine/tenofovir DF is noninferior to efavirenz/emtricitabine/tenofovir DF in ART-naive adults co-infected with HBV or HCV (poster no. P_14). In: 9th International Workshop on HIV & Hepatitis Co-Infection; 2013.
Wilkins E, Cohen C, Wohl D, et al. STaR Study: single tablet regimen rilpivirine/emtricitabine/tenofovir DF is non-inferior to efavirenz/emtricitabine/tenofovir DF in ART-naive adults regardless of baseline viral load and CD4+ count [abstract no. P136]. HIV Med. 2013;14:55. Plus poster presented at the 19th Annual Conference of the British HIV Association; 2013.
Cohen C, Wohl D, Arribas J, et al. STaR study: single tablet regimen rilpivirine/emtricitabine/tenofovir DF has non-inferior efficacy compared to efavirenz/emtricitabine/tenofovir DF and improves patient reported outcomes [abstract no. TUPE284 plus poster]. In: 7th International AIDS Society Conference on HIV Pathogenesis and Treatment; 2013.
Palella FJJ, Fisher M, Tebas P, et al. Simplification to rilpivirine/emtricitabine/tenofovir disoproxil fumarate from ritonavir-boosted protease inhibitor antiretroviral therapy in a randomized trial of HIV-1 RNA-suppressed participants. AIDS. 2014;28(3):335–44.
Wilkins E, Fisher M, Palella F, et al. SPIRIT: switching to rilpivirine/emtricitabine/tenofovir DF single-tablet regimen from boosted protease inhibitor maintains HIV suppression at week 48 regardless of viral load or CD4 + count prior to initiation of ARV therapy (abstract). HIV Med. 2013;14:54–55. Plus poster presented at the 19th Annual Conference of the British HIV Association; 2013.
Shamblaw D, Palella F, Ruane P, et al. Switching to the single-tablet regimen (STR) emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) from a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors maintains HIV suppression and is well tolerated in HIV-1 subjects at week 24 regardless of age: SPIRIT study (abstract no. H-556 plus oral presentation). In: 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2012.
Mounzer K, Palella F, Slim J, et al. SPIRIT: simplifying to rilpivirine/emtricitabine/tenofovir DF single-tablet regimen from boosted protease inhibitor regimen maintains HIV suppression in the Black subgroup (abstract no. H-656 plus poster). In: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2013.
Morales-Ramirez J, Fisher M, Palella F, et al. SPIRIT: simplifying to rilpivirine/emtricitabine/tenofovir DF single-tablet regimen from boosted protease inhibitor maintains HIV suppression through week 48 in the Hispanic/Latino subpopulation (oral presentation no. 34). In: 16th Pan-American Infectious Disease Conference; 2013.
Palella F, Fisher M, Tebas P, et al. SPIRIT: switching to rilpivirine/emtricitabine/tenofovir DF single-tablet regimen from boosted protease inhibitor maintains HIV suppression through week 48 in patients co-infected with HBV or HCV (poster no. P_21). In: 9th International Workshop on HIV & Hepatitis Co-Infection; 2013.
Pallela F, Tebas P, Fisher M, et al. Efficacy of switching to rilpivirine/emtricitabine/tenofovir DF from boosted PI in HIV-1 virologically suppressed patients with or without the K103N (abstract). J Int AIDS Soc. 2013;16:23. Plus poster presented at the HIV Drug Therapy in the Americas Congress; 2013.
Brunetta J, Moreno Guillen S, Antinori A, et al. Patient-reported outcomes after a switch to a single-tablet regimen of rilpivirine, emtricitabine, and tenofovir DF in HIV-1-positive, virologically suppressed individuals: additional findings from a randomized, open-label, 48-week trial. Patient. 2015;8(3):257–67.
Mills A, Cohen C, Dejesus E, et al. Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens. HIV Clin Trials. 2013;14(5):216–23.
Gilead Sciences. ClinicalTrials.gov identifier NCT01286740. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 16 Oct 2014.
Surgers L, Valin N, Viala C, et al. Evaluation of the efficacy and safety of switching to tenofovir, emtricitabine, and rilpivirine in treatment-experienced patients. JAIDS. 2015;68(1):e10–2.
Charpentier C, Joly V, Le P, et al. Immuno-virological and pharmacological follow-up of virologically-suppressed patients switching to RPV/TDF/FTC in a clinical cohort: week 24 interim analysis [poster no. PE9/18]. In: European AIDS Society Conference; 2013
Gantner P, Reinhart S, Partisani M, et al. Switching to emtricitabine, tenofovir and rilpivirine as single tablet regimen in virologically suppressed HIV-1-infected patients: a cohort study. HIV Med. 2015;16(2):132–6.
Monczor A, Yu X, Vigil KJ, et al. A retrospective study to evaluate the effect of switching anmtiretroviral therapy to a fixed-dose emtricitabine/rilpivirine/tenofovir disoproxil fumarate in HIV infected patients with suppressed viral load in a clinical setting: the switch to Complera (TSC) study [oral presentation no. 107-AB]. In: IDWeek; 2014
Maigren Steffensson C, Skoglund G, Svedhem Johansson V. Treatment outcomes among HIV-1 infected patients in Sweden after receiving Eviplera for ≥6 months [poster no. P3]. In: HIV NORDIC Conference; 2014
Perez-Hernandez IA, Palacios R, Mayorga M, et al. Lipid changes in HIV-patients switching to the coformulated single tablet TDF/FTC/RPV (Eviplera). Efficacy and safety analysis. GeSida study 8114 [poster no. P-263]. In: HIV Drug Therapy Conference; 2014
Saxon C, Haidari G, Alexander H, et al. Safety and efficacy of the single tablet regimen rilpivirine-tenofovir-emtricitabine (Eviplera®) in clinical practice: experience from the UK and Ireland [poster no. PE8-22]. In: European AIDS Clinical Society Conference; 2013
Rappold M, Rieger A, Steuer A, et al. Treatment modification in HIV-infected individuals starting antiretroviral therapy between 2011 and 2014 [poster no. 236]. In: HIV Drug Therapy Conference; 2014
Bernardini C, Maggiolo F. Triple-combination rilpivirine, emtricitabine, and tenofovir (complera/eviplera) in the treatment of HIV infection. Patient Prefer Adherence. 2013;7:531–42.
Sweet DE. Real-world persistence with single versus multiple tablet regimens for HIV-1 treatment [poster no. P005]. In: HIV Drug Therapy Conference; 2014.
Trottier B, Machouf N, Huchet E, et al. Tolerability is more important than simplicity for treatment durability [poster no. P233]. In: HIV Drug Therapy Conference; 2014
Patel N, Miller CD. New option for management of HIV-1 infection in treatment-naive patients: once-daily, fixed-dose combination of rilpivirine-emtricitabine-tenofovir. HIV AIDS. 2012;4:61–71.
Deeks ED. Emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen: a review of its use in HIV infection. Drugs. 2014;74(17):2079–95.
Acknowledgments
The manuscript was reviewed by: C. Bernardini, Infectious Disease Division, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; D. M. Burger, Radboud University Medical Centre, Nijmegen, The Netherlands; F. Maggiolo, Division di Malattie Infettive, Ospedali Riuniti, Bergamo, Italy.
Disclosure
This article was updated from Drugs 2014;74(17):2079–95 [44] by a salaried employee of Adis/Springer and was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from comments received were made by the author on the basis of scientific merit.
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Deeks, E.D. Emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen in HIV-1 infection: a guide to its use in the EU. Drugs Ther Perspect 31, 251–258 (2015). https://doi.org/10.1007/s40267-015-0224-y
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DOI: https://doi.org/10.1007/s40267-015-0224-y