Maintenance of virologic suppression in individuals on antiretroviral therapy after switching to dual therapy: a cohort study
DOI:
https://doi.org/10.33448/rsd-v11i7.29606Keywords:
HAART; Antiretroviral therapy; HIV.Abstract
Objective: To evaluate the effectiveness of dual therapy in individuals who underwent exchange, by maintaining a viral load < 50 copies/ml and in cases of exchange due to impaired renal function. If there was a change in creatinine clearance, serum creatinine and serum phosphorus. Methods: Retrospective cohort of individuals > 18 years, who switched to dual therapy, followed up for up to 116 weeks and outcomes were evaluated up to 48 and/or up to 96 weeks after switching. Data were collected from July 2020 to June 2021, through clinical records and consultation with the Laboratory Examination Control System (Siscel) and the Medication Logistic Control System (Siclom). Analyzes were performed using SPSS software. Results: Most individuals were male (65.5%), the mean age at exchange was 54.4 years. The most used dual therapy regimen was the association of DTG+3TC (73.6%). The main reason for switching was impaired renal function (40%), the most discontinued drug was TDF (55.79%). Most subjects maintained viral suppression for up to 48 weeks after switching (n=84, 96.8%). Two individuals (2.3%) did not achieve CV suppression in this period, with values of 51 and 55 copies/ml of virus. There was no significant change in GFR comparing baseline levels with those at 48 weeks post-switch. As for phosphorus, comparing the baseline value with the value measured 48-96 weeks post-exchange, there was a slight increase, with statistical significance (2.70 ± 0.76 mg/dl vs. 3.14 ± 0.47; p=0.026). Conclusion: Most subjects maintained viral suppression at 48 and 96 weeks, demonstrating the effectiveness of dual therapy. Among those who switched due to impaired renal function, there was no improvement in glomerular filtration rate at 48 weeks, but an increase in phosphorus excretion was observed, which requires further studies, with a larger sample and longer follow-up.
References
analysis of cohort studies. The Lancet. HIV, 4(8), e349–e356. https://doi.org/10.1016/S2352-3018(17)30066-8
Baldin, G., Ciccullo, A., Borghetti, A., & Di Giambenedetto, S. (2019). Virological efficacy of dual therapy with lamivudine and dolutegravir in HIV-1-infected virologically suppressed patients: long-term data from clinical practice. The Journal of antimicrobial chemotherapy, 74(5), 1461–1463. https://doi.org/10.1093/jac/dkz009
Barrios, A., García-Benayas, T., González-Lahoz, J., & Soriano, V. (2004). Tenofovir-related nephrotoxicity in HIV-infected patients. AIDS (London, England), 18(6), 960–963. https://doi.org/10.1097/00002030-200404090-00019
Brasil. (2018). Ministério da Saúde. Protocolo Clínico e Diretrizes Terapêuticas para o Manejo da Infecção pelo HIV em Adultos. http://www.aids.gov.br/pt-br/pub/2013/protocolo-clinico-e-diretrizes-terapeuticas-para-manejo-da-infeccao-pelo-hiv-em-adultos
Brasil. (2019). Ministério da Saúde. Ofício circular nº 48/2019/CGAHV/. DCCI/SVS/MS. 18 de dezembro de 2019. https://siclom.aids.gov.br/informativo/Informe%20n%C2%BA%2001_20%20-%20Of%C3%ADcio%20circular%2048_19%20-%20Dupla%20terapia.pdf.
Brasil. (2021). Ministério da Saúde. Nota Informativa 28/2021/CGAHV/. DCCI/SVS/MS. 16 de dezembro de 2021. http://www.aids.gov.br/system/tdf/legislacao/2021/-notas_informativas/nota_informativa_no_28-2021-cgahv-.dcci-svs-ms_1.pdf?file=1&type=node&id=68335&force=1
Brenner, B. G., & Wainberg, M. A. (2017). Clinical benefit of dolutegravir in HIV-1 management related to the high genetic barrier to drug resistance. Virus research, 239, 1–9. https://doi.org/10.1016/j.virusres.2016.07.006
Cahn, P., Madero, J. S., Arribas, J. R., Antinori, A., Ortiz, R., Clarke, A. E., Hung, C. C., Rockstroh, J. K., Girard, P. M., Sievers, J., Man, C., Currie, A., Underwood, M., Tenorio, A. R., Pappa, K., Wynne, B., Fettiplace, A., Gartland, M., Aboud, M., Smith, K., … GEMINI Study Team (2019). Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet (London, England), 393(10167), 143–155. https://doi.org/10.1016/S0140-6736(18)32462-0
Cohen, S. D., Kopp, J. B., & Kimmel, P. L. (2017). Kidney Diseases Associated with Human Immunodeficiency Virus Infection. The New England journal of medicine, 377(24), 2363–2374. https://doi.org/10.1056/NEJMra1508467
Erlandson, K. M., & Karris, M. Y. (2019). HIV and Aging: Reconsidering the Approach to Management of Comorbidities. Infectious disease clinics of North America, 33(3), 769–786. https://doi.org/10.1016/j.idc.2019.04.005
European Aids Clinical Society. (2016). Guidelines. (Version 8.1). http://www.eacsociety.org/files/guidelines_8.1-english.pdf.
Gagliardini, R., Ciccullo, A., Borghetti, A., Maggiolo, F., Bartolozzi, D., Borghi, V., Pecorari, M., Di Biagio, A., Callegaro, A. P., Bruzzone, B., Saladini, F., Paolucci, S., Maserati, R., Zazzi, M., Di Giambenedetto, S., De Luca, A., & ARCA Study Group (2018). Impact of the M184V Resistance Mutation on Virological Efficacy and Durability of Lamivudine-Based Dual Antiretroviral Regimens as Maintenance Therapy in Individuals With Suppressed HIV-1 RNA: A Cohort Study. Open forum infectious diseases, 5(6), ofy113. https://doi.org/10.1093/ofid/ofy113
Gimeno-Gracia, M., Crusells-Canales, M. J., Javier Armesto-Gómez, F., & Rabanaque-Hernández, M. J. (2015). Prevalence of concomitant medications in older HIV+ patients and comparison with general population. HIV clinical trials, 16(3), 117–124. https://doi.org/10.1179/1528433614Z.0000000012
Hernández-Ramírez, R. U., Shiels, M. S., Dubrow, R., & Engels, E. A. (2017). Cancer risk in HIV-infected people in the USA from 1996 to 2012: a population-based, registry-linkage study. The lancet. HIV, 4(11), e495–e504. https://doi.org/10.1016/S2352-3018(17)30125-X
Hidalgo-Tenorio, C., Cortés, L. L., Gutiérrez, A., Santos, J., Omar, M., Gálvez, C., Sequera, S., Jesús, S. E., Téllez, F., Fernández, E., García, C., & Pasquau, J. (2019). DOLAMA study: Effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients. Medicine, 98(32), e16813. https://doi.org/10.1097/MD.0000000000016813
Hsue, P. Y., Deeks, S. G., & Hunt, P. W. (2012). Immunologic basis of cardiovascular disease in HIV-infected adults. The Journal of infectious diseases, 205 Suppl 3(Suppl 3), S375–S382. https://doi.org/10.1093/infdis/jis200
Huang, Y. S., Chan, C. K., Tsai, M. S., Lee, K. Y., Lin, S. W., Chang, S. Y., Hung, C. C., & Chang, S. C. (2017). Kidney dysfunction associated with tenofovir exposure in human immunodeficiency virus-1-infected Taiwanese patients. Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi, 50(5), 595–603. https://doi.org/10.1016/j.jmii.2015.08.019
Jose, S., Hamzah, L., Campbell, L. J., Hill, T., Fisher, M., Leen, C., Gilson, R., Walsh, J., Nelson, M., Hay, P., Johnson, M., Chadwick, D., Nitsch, D., Jones, R., Sabin, C. A., Post, F. A., & UK Collaborative HIV Cohort Study Steering Committee (2014). Incomplete reversibility of estimated glomerular filtration rate decline following tenofovir disoproxil fumarate exposure. The Journal of infectious diseases, 210(3), 363–373. https://doi.org/10.1093/infdis/jiu107
Llibre, J. M., Hung, C. C., Brinson, C., Castelli, F., Girard, P. M., Kahl, L. P., Blair, E. A., Angelis, K., Wynne, B., Vandermeulen, K., Underwood, M., Smith, K., Gartland, M., & Aboud, M. (2018). 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 (London, England), 391(10123), 839–849. https://doi.org/10.1016/S0140-6736(17)33095-7
Lopes, S., O'Day, K., Meyer, K., Van Stiphout, J., Punekar, Y., Radford, M., & Haas, J. S. (2020). Comedication prescription patterns and potential for drug-drug interactions with antiretroviral therapy in people living with human immunodeficiency virus type 1 infection in Germany. Pharmacoepidemiology and drug safety, 29(3), 270–278. https://doi.org/10.1002/pds.4928
Mocroft, A., Lundgren, J., Ross, M., Law, M., Reiss, P., Kirk, O., Smith, C., Wentworth, D., Heuhaus, J., Fux, C., Moranne, O., Morlat, P., Johnson, M., Ryom, L., & Data on Adverse Events (D:A:D) study group, the Royal Free Hospital Clinic Cohort and the INSIGHT study group (2014). A clinically useful risk-score for chronic kidney disease in HIV infection. Journal of the International AIDS Society, 17(4 Suppl 3), 19514. https://doi.org/10.7448/IAS.17.4.19514
Nachega, J. B., Hsu, A. J., Uthman, O. A., Spinewine, A., & Pham, P. A. (2012). Antiretroviral therapy adherence and drug-drug interactions in the aging HIV population. AIDS (London, England), 26 Suppl 1, S39–S53. https://doi.org/10.1097/QAD.0b013e32835584ea
Arancón Pardo, A., Moreno Palomino, M., Jiménez-Nácher, I., Moreno, F., González Fernández, M. Á., González-García, J., & Herrero Ambrosio, A. (2021). Real-World Experience with Two-Drug Regimens in HIV-1-Infected Patients Beyond the Indication of Clinical Trials: 48 Weeks' Results. AIDS research and human retroviruses, 37(10), 761–767. https://doi.org/10.1089/AID.2021.0041
Pérez-Valero, I., Pasquau, J., Rubio, R., Rivero, A., Santos, J., Sanz, J., Mariño, A., Crespo, M., Hernández-Quero, J., Iribarren, J. A., Gutiérrez, F., Terrón, A., Esteban, H., Pérez-Molina, J. A., & GESIDA 7011 Study Group members (2018). Neurocognitive safety after 96 weeks on dual therapy with atazanavir/ritonavir plus lamivudine: results of the neurocognitive substudy of the SALT randomized clinical trial. The Journal of antimicrobial chemotherapy, 73(9), 2444–2451. https://doi.org/10.1093/jac/dky212
Pulido, F., Ribera, E., Lagarde, M., Pérez-Valero, I., Palacios, R., Iribarren, J. A., Payeras, A., Domingo, P., Sanz, J., Cervero, M., Curran, A., Rodríguez-Gómez, F. J., Téllez, M. J., Ryan, P., Barrufet, P., Knobel, H., Rivero, A., Alejos, B., Yllescas, M., Arribas, J. R., … DUAL-GESIDA-8014-RIS-EST45 Study Group (2017). 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. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 65(12), 2112–2118. https://doi.org/10.1093/cid/cix734
Romanelli, R. M. C., Pinto, J. A., Melo, L. J., Vasconcelos, M. A., & Pereira, R. M. (2006). Efectiviness of dual and triple antiretroviral therapy in the treatment of HIV- infected children. Jornal de Pediatria, 82, 206-205. https://doi.org/10.2223/JPED.1505
Sanmarti, M., Ibáñez, L., Huertas, S., Badenes, D., Dalmau, D., Slevin, M., Krupinski, J., Popa-Wagner, A., & Jaen, A. (2014). HIV-associated neurocognitive disorders. Journal of molecular psychiatry, 2(1), 2. https://doi.org/10.1186/2049-9256-2-2
Wensing, A. M., Calvez, V., Günthard, H. F., Johnson, V. A., Paredes, R., Pillay, D., Shafer, R. W., & Richman, D. D. (2016). 2017 Update of the Drug Resistance Mutations in HIV-1. Topics in antiviral medicine, 24(4), 132–133.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Simone Furtado dos Santos; Micheline Rosa Silveira; Juliana de Oliveira Costa; Alexandre Sampaio Moura; Márcio Afonso Cruz; Jullye Campos Mendes; Kennedy Crepalde Ribeiro; Maria das Graças Braga
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
1) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
2) Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
3) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
