Dolutegravir and rilpivirine for the maintenance treatment of virologically suppressed HIV-1 infection

References

• Panel of Experts of GeSIDA and PNS. Executive summary of the GESIDA/national AIDS plan consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2017). Enferm Infecc Microbiol Clin. 2017 May 31. pii: S0213-005X(17)30131–3. doi: 10.1016/j.eimc.2017.04.001.
   Google Scholar
• Costagliola D. Demographics of HIV and aging. Curr Opin HIV AIDS. 2014;9(4):294–301.
   PubMed Web of Science ®Google Scholar
• Kaplan-Lewis E, Aberg JA, Lee M. Aging with HIV in the ART era. Semin Diagn Pathol. 2017;34(4):384–397.
   PubMed Web of Science ®Google Scholar
• Guaraldi G, Zona S, Brothers TD, et al. Aging with HIV vs. HIV seroconversion at older age: a diverse population with distinct comorbidity profiles. PLoS One. 2015;10(4):e0118531.
   PubMed Web of Science ®Google Scholar
• Cihlar T, Fordyce M. Current status and prospects of HIV treatment. Curr Opin Virol. 2016;18:50–56.
   PubMed Web of Science ®Google Scholar
• Margolis AM, Heverling H, Pham PA, et al. A review of the toxicity of HIV medications. J Med Toxicol. 2014;10(1):26–39.
   PubMedGoogle Scholar
• Casado JL, Santiuste C, Vazquez M, et al. Bone mineral density decline according to renal tubular dysfunction and phosphaturia in tenofovir-exposed HIV-infected patients. AIDS. 2016;30(9):1423–1431.
   PubMed Web of Science ®Google Scholar
• Casado JL, Banon S, Santiuste C, et al. Prevalence and significance of proximal renal tubular abnormalities in HIV-infected patients receiving tenofovir. AIDS. 2016;30(2):231–239.
   PubMed Web of Science ®Google Scholar
• Bedimo R, Tebas P. Increased fracture risk with HIV infection–a growing concern. Nat Rev Endocrinol. 2013;9(5):260–261.
   PubMed Web of Science ®Google Scholar
• Marcus JL, Neugebauer RS, Leyden WA, et al. Use of abacavir and risk of cardiovascular disease among HIV-infected individuals. J Acquir Immune Defic Syndr. 2016;71(4):413–419.
   PubMed Web of Science ®Google Scholar
• Dorjee K, Baxi SM, Reingold AL, et al. Risk of cardiovascular events from current, recent, and cumulative exposure to abacavir among persons living with HIV who were receiving antiretroviral therapy in the United States: a cohort study. BMC Infect Dis. 2017;17(1):708.
   PubMed Web of Science ®Google Scholar
• Baril JG, Angel JB, Gill MJ, et al. Dual therapy treatment strategies for the management of patients infected with HIV: a systematic review of current evidence in ARV-naive or ARV-experienced, virologically suppressed patients. PLoS One. 2016;11(2):e0148231.
   PubMed Web of Science ®Google Scholar
• Pasquau J, Hidalgo-Tenorio C. Nuke-sparing regimens for the long-term care of HIV infection. AIDS Rev. 2015;17(4):220–230.
   PubMed Web of Science ®Google Scholar
• Havlir DV, Marschner IC, Hirsch MS, et al. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. AIDS clinical trials group study 343 team. N Engl J Med. 1998;339(18):1261–1268.
   PubMed Web of Science ®Google Scholar
• Pialoux G, Raffi F, Brun-Vezinet F, et al. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1-infected patients. Trilege (Agence Nationale de Recherches sur le SIDA 072) study team. N Engl J Med. 1998;339(18):1269–1276.
   PubMed Web of Science ®Google Scholar
• Raffi F, Babiker AG, Richert L, et al. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014;384(9958):1942–1951.
   PubMed Web of Science ®Google Scholar
• Reynes J, Trinh R, Pulido F, et al. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013;29(2):256–265.
   PubMed Web of Science ®Google Scholar
• Cahn P, Andrade-Villanueva J, Arribas JR, et al. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014;14(7):572–580.
   PubMed Web of Science ®Google Scholar
• Perez-Molina JA, Rubio R, Rivero A, et al. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015;15(7):775–784.
   PubMed Web of Science ®Google Scholar
• Arribas JR, Girard PM, Landman R, et al. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015;15(7):785–792.
   PubMed Web of Science ®Google Scholar
• Di Giambenedetto S, Fabbiani M, Quiros Roldan E, et al. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M). J Antimicrob Chemother. 2017;72(4):1163–1171.
   PubMed Web of Science ®Google Scholar
• Pulido F, Ribera E, Lagarde M, et al. Dual therapy with darunavir and ritonavir plus lamivudine vs triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of human immunodeficiency virus type 1 viral suppression: randomized, open-label, noninferiority DUAL-GESIDA 8014-RIS-EST45 trial. Clin Infect Dis. 2017;65(12):2112–2118.
   PubMed Web of Science ®Google Scholar
• Calza L, Danese I, Magistrelli E, et al. Dual raltegravir-darunavir/ritonavir combination in virologically suppressed HIV-1-infected patients on antiretroviral therapy including a ritonavir-boosted protease inhibitor plus two nucleoside/nucleotide reverse transcriptase inhibitors. HIV Clin Trials. 2016;17(1):38–47.
   PubMed Web of Science ®Google Scholar
• Jackson A, Else L, Higgs C, et al. Pharmacokinetics and pharmacodynamics of the nucleoside sparing dual regimen containing rilpivirine plus darunavir/ritonavir in treatment-naive HIV-1-infected individuals. HIV Clin Trials. 2017;19(1):31-37, doi: 10.1080/15284336.2017.1408928.
   PubMed Web of Science ®Google Scholar
• Casado JL, Banon S, Rodriguez MA, et al. Efficacy and pharmacokinetics of the combination of etravirine plus raltegravir as novel dual antiretroviral maintenance regimen in HIV-infected patients. Antiviral Res. 2015;113:103–106.
   PubMed Web of Science ®Google Scholar
• Calza L, Magistrelli E, Colangeli V, et al. Dual raltegravir-etravirine combination as maintenance regimen in virologically suppressed HIV-1-infected patients. AIDS Res Hum Retroviruses. 2017;33(7):632–638.
   PubMed Web of Science ®Google Scholar
• Katlama C, Assoumou L, Valantin MA, et al. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014;69(6):1648–1652.
   PubMed Web of Science ®Google Scholar
• Achhra AC, Mwasakifwa G, Amin J, et al. Efficacy and safety of contemporary dual-drug antiretroviral regimens as first-line treatment or as a simplification strategy: a systematic review and meta-analysis. Lancet HIV. 2016;3(8):e351–e360.
   PubMed Web of Science ®Google Scholar
• Curtis L, Nichols G, Stainsby C, et al. Dolutegravir: clinical and laboratory safety in integrase inhibitor-naive patients. HIV Clin Trials. 2014;15(5):199–208.
   PubMed Web of Science ®Google Scholar
• Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1):254–258.
   PubMed Web of Science ®Google Scholar
• Ribera E, Podzamczer D. [Mechanisms of action, pharmacology and interactions of dolutegravir]. Enferm Infecc Microbiol Clin. 2015;33(Suppl 1):2–8.
   PubMedGoogle Scholar
• DeAnda F, Hightower KE, Nolte RT, et al. Dolutegravir interactions with HIV-1 integrase-DNA: structural rationale for drug resistance and dissociation kinetics. PLoS One. 2013;8(10):e77448.
   PubMed Web of Science ®Google Scholar
• Hightower KE, Wang R, Deanda F, et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild-type and integrase inhibitor-resistant HIV-1 integrase-DNA complexes. Antimicrob Agents Chemother. 2011;55(10):4552–4559.
   PubMed Web of Science ®Google Scholar
• Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381(9868):735–743.
   PubMed Web of Science ®Google Scholar
• Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807–1818.
   PubMed Web of Science ®Google Scholar
• Molina JM, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2(4):e127–136.
   PubMed Web of Science ®Google Scholar
• Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014;210(3):354–362.
   PubMed Web of Science ®Google Scholar
• Keeshin SW, Feinberg J. Evaluation of dolutegravir safety for the treatment of HIV-1. Expert Opin Drug Saf. 2015;14(1):141–147.
   PubMed Web of Science ®Google Scholar
• Shah BM, Schafer JJ, Desimone JA Jr. Dolutegravir: a new integrase strand transfer inhibitor for the treatment of HIV. Pharmacotherapy. 2014;34(5):506–520.
   PubMed Web of Science ®Google Scholar
• Yombi JC, Jones R, Pozniak A, et al. Monitoring of kidney function in HIV-positive patients. HIV Med. 2015;16(8):457–467.
   PubMed Web of Science ®Google Scholar
• Yombi JC, Pozniak A, Boffito M, et al. Antiretrovirals and the kidney in current clinical practice: renal pharmacokinetics, alterations of renal function and renal toxicity. AIDS. 2014;28(5):621–632.
   PubMed Web of Science ®Google Scholar
• de Boer MG, van den Berk GE, van Holten N, et al. Intolerance of dolutegravir-containing combination antiretroviral therapy regimens in real-life clinical practice. AIDS. 2016;30(18):2831–2834.
   PubMed Web of Science ®Google Scholar
• Hoffmann C, Welz T, Sabranski M, et al. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med. 2017;18(1):56–63.
   PubMed Web of Science ®Google Scholar
• Gubavu C, Prazuck T, Niang M, et al. Dolutegravir-based monotherapy or dual therapy maintains a high proportion of viral suppression even in highly experienced HIV-1-infected patients. J Antimicrob Chemother. 2016;71(4):1046–1050.
   PubMed Web of Science ®Google Scholar
• Rojas J, Blanco JL, Marcos MA, et al. Dolutegravir monotherapy in HIV-infected patients with sustained viral suppression. J Antimicrob Chemother. 2016;71(7):1975–1981.
   PubMed Web of Science ®Google Scholar
• Blanco J,Oldenbuettel C, Thomas R, et al. Pathways of resistance in subjects failing dolutegravir monotherapy. CROI 2017; 2017 Feb 13–16; Seattle, WA, USA. Oral abstract 42.
   Google Scholar
• Wijting I, Rokx C, Boucher C, et al. Dolutegravir as maintenance monotherapy for HIV (DOMONO): a phase 2, randomised non-inferiority trial. Lancet HIV. 2017;4(12):e547–e554.
   PubMed Web of Science ®Google Scholar
• Kobayashi M, Yoshinaga T, Seki T, et al. In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor. Antimicrob Agents Chemother. 2011;55(2):813–821.
   PubMed Web of Science ®Google Scholar
• Yoshinaga T, Miki S, Seki T, et al. Comparison of two-drug combination passage in vitro for drug resistance emergence among dolutegravir, rilpivirine, elvitegravir, and 3TC. 13th European Workshop on HIV and Hepatitis; 2015 Jun 3–5; Barcelona, Spain. [abstract 9].
   Google Scholar
• Casado JL, Banon S. Recent advances in rilpivirine: new data and promising treatment option. AIDS Rev. 2014;16(3):172–181.
   PubMed Web of Science ®Google Scholar
• Aouri M, Barcelo C, Guidi M, et al. Population pharmacokinetics and pharmacogenetics analysis of rilpivirine in HIV-1-infected individuals. Antimicrob Agents Chemother. 2017;61(1).
   PubMed Web of Science ®Google Scholar
• Deeks ED. Emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen: a review of its use in HIV infection. Drugs. 2014;74(17):2079–2095.
   PubMed Web of Science ®Google Scholar
• Porter DP, Toma J, Tan Y, et al. Clinical outcomes of virologically-suppressed patients with pre-existing HIV-1 drug resistance mutations switching to rilpivirine/emtricitabine/tenofovir disoproxil fumarate in the SPIRIT study. HIV Clin Trials. 2016;17(1):29–37.
   PubMed Web of Science ®Google Scholar
• Haggblom A, Lindback S, Gisslen M, et al. HIV drug therapy duration; a Swedish real world nationwide cohort study on InfCareHIV 2009-2014. PLoS One. 2017;12(2):e0171227.
   PubMed Web of Science ®Google Scholar
• Ford SL, Gould E, Chen S, et al. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother. 2013;57(11):5472–5477.
   PubMed Web of Science ®Google Scholar
• Gantner P, Cuzin L, Allavena C, et al. Efficacy and safety of dolutegravir and rilpivirine dual therapy as a simplification strategy: a cohort study. HIV Med. 2017;18(9):704–708.
   PubMed Web of Science ®Google Scholar
• Capetti AF, Sterrantino G, Cossu MV, et al. Switch to dolutegravir plus rilpivirine dual therapy in cART-experienced subjects: an observational cohort. PLoS One. 2016;11(10):e0164753.
   PubMed Web of Science ®Google Scholar
• Capetti AF, Cossu MV, Sterrantino G, et al. Dolutegravir plus rilpivirine as a switch option in cART-experienced patients: 96-week data. Ann Pharmacother. 2018 Feb 1;1060028018761600. doi: 10.1177/1060028018761600.
   Google Scholar
• Diaz A, Casado JL, Dronda F, et al. Dolutegravir plus rilpivirine in suppressed heavily pre-treated HIV-infected patients. 21st International AIDS Conference (AIDS 2016); 2016 Jul 18–22; Durban, South Africa. Abstract TUPDB0106.
   Google Scholar
• Revuelta-Herrero JL, Chamorro-de-Vega E, Rodriguez-Gonzalez CG, et al. Effectiveness, safety, and costs of a treatment switch to dolutegravir plus rilpivirine dual therapy in treatment-experienced HIV patients. Ann Pharmacother. 2018;52(1):11–18.
   PubMed Web of Science ®Google Scholar
• Palacios R, Mayorga M, Gonzalez-Domenech CM, et al. Safety and efficacy of dolutegravir plus rilpivirine in treatment-experienced HIV-infected patients: the DORIVIR study. J Int Assoc Provid AIDS Care. 2018;17:2325958218760847.
   Google Scholar
• Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839∓849. doi: 10.1016/S0140-6736(17)33095-7.
   PubMed Web of Science ®Google Scholar
• McComsey GA, Lupo S, Parks D, et al. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018;32(4):477–485.
   PubMed Web of Science ®Google Scholar
• Masia M, Padilla S, Barber X, et al. Comparative impact of suppressive antiretroviral regimens on the CD4/CD8 T-cell ratio: a cohort study. Medicine (Baltimore). 2016;95(11):e3108.
   PubMed Web of Science ®Google Scholar
• Orkin C, Llibre JM, Kahl L, et al. Renal, inflammatory, and bone biomarkers following switch to the DTG+RPV 2-drug regimen: the SWORD-1 and SWORD-2 studies. 16th European AIDS Conference; 2017 Oct 25–27; Milan, Italy. [BPD 2/10].
   Google Scholar
• Oglesby A, Punekar AS, Angelis K, et al. Patient reported outcomes after switching to a 2 drug regimen of dolutegravir + rilpivirine: results from the SWORD-1 and SWORD-2 studies. 16th European AIDS Conference; 2017 Oct 25–27; Milan, Italy. [BPD 1/2].
   Google Scholar