medigraphic.com
SPANISH

MEDICC Review

ISSN 1527-3172 (Electronic)
  • Contents
  • View Archive
  • Information
    • General Information        
    • Directory
  • Publish
    • Instructions for authors        
  • medigraphic.com
    • Home
    • Journals index            
    • Register / Login
  • Mi perfil

2021, Number 2

<< Back Next >>

MEDICC Review 2021; 23 (2)

Adverse Reactions to Antiretrovirals in Cuban Patients Living with HIV/AIDS

Morales-Pérez M
Full text How to cite this article

Language: English
References: 41
Page: 21-26
PDF size: 151.93 Kb.


Key words:

Drug-related side effects and adverse reactions, antiretroviral agents, secondary prevention, tertiary prevention, Cuba.

ABSTRACT

INTRODUCTION Disease and deaths from HIV/AIDS have decreased since antiretroviral treatment was introduced in 1996. Since 2005, as treatment availability has increased worldwide, deaths from HIV/AIDS have declined 48%. As of November 2019, 26,952 cases have been reported in Cuba, of which 5159 (19.1%) are deceased. The country has experienced a reduction in mortality rates since 2002, when antiretroviral treatment became available. Although there are clearly benefi ts to treatment, it is important to understand antiretroviral safety profiles as their toxicity may lower treatment adherence.
OBJECTIVE Describe adverse reactions attributable to antiretrovirals used in Cuban patients living with HIV/AIDS.
METHODS I studied notifi cations of adverse reactions to antiretrovirals used in Cuban patients with HIV/AIDS from January 2003 to December 2017. The sample consisted of 352 notifications in the National Pharmacovigilance Database regarding adverse reactions attributed to antiretrovirals. The variables considered were sex, notification year, antiretroviral drug, and number, type, frequency and severity of adverse reactions, whether or not they were preventable, and the reasons for categorizing them as they were.
RESULTS Antiretrovirals reported an average adverse reaction rate of 2.1 per million population per year, representing 24.2% of adverse reactions produced by the antiviral drug group in that period. Adult males represented 75% (264/352) of patients who had adverse reactions to antiretrovirals. Most adverse reactions were in response to nevirapine (29.0%; 102/352) and zidovudine (26.7%; 94/352). The most frequent reactions were hypersensitivity (24.4%; 86/352), digestive disorders (15.9%; 56/352) and anemia (15.6%; 55/352). Reactions were common (62.5%; 220/352) and moderate in severity (70.4%; 248/352). Preventable reactions made up 52.6% (185/352) of adverse reactions. Of preventable reactions, 68.1% (126/185) were associated with drug interactions and 16.2% (30/185) with improper dosage or prescription errors.
CONCLUSIONS Adverse reactions to antiretrovirals in Cuban patients are common and moderate in severity. The drug with the most notifications was nevirapine, and the most common adverse reaction was hypersensitivity. More than half of adverse reactions are considered preventable, and their main causes are prescription errors.


REFERENCES

  1. Soto Ramírez LE. Guía de manejo antirretroviralde las personas con VIH. 5th ed [Internet].Mexico City: Conasida; 2012 [cited 2018 Apr 1].5 p. Available at: www.salud.gob.mx/conasida.Spanish.

  2. HIVinfo.NIH.gov [Internet]. Washington, D.C.:U.S Department of Health and Human Services;c2021. Tratamiento del VIH. Tratamiento del VIH:conceptos básicos; 2018 [cited 2018 Mar 27];[about 3 p.]. Available at: https://infosida.nih.gov/understanding-hiv-aids/. Spanish.

  3. Pan American Health Organization. Tratamientode las enfermedades infecciosas 2017-2018.7th ed [Internet]. Washington, D.C.: Pan AmericanHealth Organization; 2016 [cited 2018 Apr1]. 316 p. Available at: https://iris.paho.org/bitstream/handle/10665.2/51590/9789275319161_spa.pdf?sequence=1&isAllowed=y. Spanish.

  4. Zhao Y, Wu Z, Mc Googan JM, Shi CX, Li A,Dou Z, et al. Immediate antiretroviral therapydecreases mortality among patients with highCD4 counts in China: a nationwide, retrospectivecohort study. Clin Infect Dis [Internet]. 2018 Mar1 [cited 2018 Apr 2];66(5):727–34. Available at:doi.org/10.1093/cid/cix878

  5. UNAIDS [Internet]. Geneva: UNAIDS; c2021.Nuestra Acción. Datos. UNAIDS Data; 2018 Jul26 [cited 2018 Aug 10]. Available at: https://www.unaids.org/es/topic/dataUNAIDS. Spanish.

  6. UNAIDS; c2021. Centro de Prensa. Hoja informativa– Últimas estadísticas sobre el estado dela epidemia de SIDA; 2020 [cited 2020 Dec 23].Available at: www.unaids.org/es/resources/fact-sheet. Spanish.

  7. U.S Department of Health and Human Services.Visión general de la infección por el VIH[Internet]. infoSIDA; 2018 [cited 2018 Mar 29].Available at: https://infosida.nih.gov/understanding-hiv-aids/. Spanish.

  8. UNAIDS. Estrategias ONUSIDA para 2016-2021.Acción acelerada para acabar con el sida [Internet].Geneva: UNAIDS; 2016 [cited 2018 Apr 1].130 p. Available at: www.unaids.org/sites/default/fi les/media_asset/UNAIDS-strategy-2016-2021_es.pdf. Spanish.

  9. INFOMED [Internet]. Havana: Ministry of PublicHealth (CU); c1999-2021. Legislación parael Sistema Nacional de Salud. Plan EstratégicoNacional para la Prevención y Control de lasITS, el VIH y las Hepatitis. 2019-2023 Resoluciónministerial 56/2019; 2019 [cited 2020 Dec23]. Available at: http://legislacion.sld.cu/index.php?P=FullRecord&ID=362. Spanish.

  10. European Commission; World Health Organization,Pan American Health Organization.Experiencia cubana en la producción local demedicamentos, transferencia de tecnología ymejoramiento en el acceso a la salud [Internet].Geneva: World Health Organization; 2015 [cited2020 Dec 23]. Available at: https://www.who.int/phi/publications/sp-cuban_experience_local_prod_medstech_transfer/en/. Spanish.

  11. Collazo Herrera M, Pérez Ávila J, Tápanes PerezaR, Pérez Correa D, Martínez Rodríguez A,Castro Peraza O, et al. Impacto económicosocialde la terapia antirretroviral de producciónnacional para el VIH/sida en Cuba. PharmacoEconom Spanish Res Art [Internet]. 2013 Mar7 [cited 2020 Dec 25];6(1):1–12. Available at:https://doi.org/ 10.1007/BF03320847. Spanish.

  12. World Health Organization [Internet]. Geneva:World Health Organization; c2021. Publicaciones.VIH. Tratamiento de la infección por el VIH.Transición hacia los nuevos antirretrovirales enlos programas contra el VIH. Sinopsis política;2017 Jul [cited 2020 Dec 23]. 8 p. Available at:www.who.int/hiv/pub/toolkits/transition-to-new-arv/es/. Spanish, English.

  13. Martínez Rodríguez A, Duque Vizcaíno M, CastroPeraza O, Alfonso Orta I, Jiménez LópezG, Acosta Reynaldo ED. Notifi caciones espontáneasde sospechas de reacciones adversas alos medicamentos. Instituto “Pedro Kouri”. RevCubana Farm [Internet]. 2016 Jan–Mar [cited2018 Apr 2];50(1):53–67. Available at: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152016000100006. Spanish.

  14. HIVinfo.NIH.gov [Internet]. Washington, D.C.:U.S Department of Health and Human Services;c2021. El VIH/SIDA. Hojas informativas. Medicamentoscontra el VIH y sus efectos secundarios;2018 [cited 2018 Mar 29]. Available at: https://hivinfo.nih.gov/es/understanding-hiv/fact-sheets/medicamentos-contra-el-vih-y-sus-efectos-secundarios. Spanish.

  15. Santos Corraliza E, Fuertes Martín A. Efectosadversos de los fármacos antirretrovirales:Fisiopatología, manifestaciones clínicas ytratamiento. An Med Interna (Madrid) [Internet].2006 Jul [cited 2018 Mar 29];23(7):338–44. Available at: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S0212-71992006000700010&lng=es. Spanish.

  16. Pharmacovigilance National Coordination Unit(CU). Balance Anual 2014 [Internet]. Havana:Ministry of Public Health (CU); 2014 Jan [cited2018 Apr 5]. 3 p. Available at: https://fi les.sld.cu/cdfc/files/2015/01/farmacovigilancia-cuba-ano-2014.pdf. Spanish.

  17. Morales Pérez M. Reacciones adversas a losantivirales. Sistema Cubano de Farmacovigilancia,2003-2013 [Internet]. Havana: Convenciónde Salud para Todos 2015; 2015 [cited2018 Apr 8]. 9 p. Available at: http://www.convencionsalud2015.sld.cu/index.php/convencionsalud/2015/paper/view/819/758. Spanish.

  18. Pérez-Rodríguez I, Pérez-Salgado D, Compeán-Dardón MS, Staines-Orozco MG, Ortíz-HernándezL. Side effects of antiretroviral treatment andadherence in patients with HIV from two publicinstitutions at Mexico City. Med Int Méx [Internet].2016 Jul [cited 2020 Dec 22];32(4):396–406.Available at: https://www.mediagraphic.com/pdfs/medintmex/mim-2016164d.pdf. Spanish.

  19. Frometa Báez M, Alfonso Orta I, Martínez RodríguezA. Reacciones adversas a los antirretroviralesen pacientes VIH/SIDA. Instituto PedroKourí, 2015. Rev Cub Tecnol Salud [Internet]. 2016 [cited 2018 Apr 9];8(1):12–9. Available at:http://www.medigraphic.com/pdfs/revcubtecsal/cts-2017/cts171c.pdf. Spanish.

  20. Martínez Rodríguez A, Duque Vizcaíno M, CastroPeraza O, Alfonso Orta I, Jiménez LópezG, Acosta Reynaldo ED. Notifi caciones espontáneasde sospechas de reacciones adversasa los medicamentos. Instituto “Pedro Kourí”.Rev Cubana Farm [Internet]. 2016 [cited2018 Apr 8];50(1):53–67. Available at: https://www.medigraphic.com/cgi-bin/new/resumen.cgi?IDARTICULO=72063. Spanish.

  21. Mendo Alcolea N, Mesa Pérez EJ, Neyra BarriosR, Berenguer Gournaluses L, Nieto MuñizG. Reacciones adversas a medicamentos antirretroviralesen pacientes con virus de inmunodefiencia humana. MEDISAN [Internet]. 2018 [cited2020 Dec 22];22(8):674–82. Available at: http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S1029-30192018000800674&lng=pt&nrm=iso. Spanish.

  22. Jiménez López G, Alfonso Orta I. Normas y procedimientosde trabajo del Sistema Cubano deFarmacovigilancia [Internet]. Havana: Ministry ofPublic Health (CU), National PharmacovigilanceCoordination Unit (CU); 2011 Dec [cited 2018Jan 7]. 98 p. Available at: https://www.cecmed.cu/file/2623/download?token=yRWtlJD6.Spanish.

  23. World Health Organization [Internet]. Geneva:World Health Organization; c2021. All of IRIS.This Collection. International monitoring ofadverse reaction to drugs. Adverse reaction terminology.31 December 1992. The Uppsala MonitoringCentre Uppsala, Sweden [updated 2017Sep 26; cited 2018 Dec 23]. Available at: https://apps.who.int/iris/handle/10665/61056

  24. Shumock GT, Thorton JP. Focusing on preventabilityof adverse drug reactions. Hosp Pharm.1992 Jun;27(6):538.

  25. Otero López MJ, Alonso Hernández P, MaderueloFernández JA, Ceruelo Bermejo J, Domínguez-Gil Hurlé A, Sánchez Rodríguez A. Prevalencia yfactores asociados a los acontecimientos adversosprevenibles por medicamentos que causanel ingreso hospitalario. Farm Hosp. 2006 May–Jun;30(3):161–70. Spanish.

  26. National Health Statistics and Medical RecordsDivision (CU). Anuario Estadístico de Salud 2016[Internet]. Havana: Ministry of Public Health (CU);2017 Apr 13 [cited 2018 May 22]. Available at:http://www.sld.cu/noticia/2017/04/13/publicado-el-anuario-estadistico-de-salud-2016. Spanish.

  27. Zacarías Leguizamón J. Reacciones adversasmás frecuentes de los fármacos antirretrovirales.Rev Virtual Soc Paraguaya Med Intern [Internet].2014 Aug 18 [cited 2016 Oct 8];1(2):13–27.Available at: http://dx.doi.org/10.18004/rvspmi/2312-3893/2014.01(02)13-027. Spanish.

  28. Morales Pérez M, García Milian AJ. Reaccionesadversas evitables graves por antivirales. SistemaCubano de Farmacovigilancia, 2008-2017.Horiz Sanitario [Internet]. 2019 Jan–Apr [cited2019 Jan 8];18(1):57–66. Available at: https://doi:10.19136/hs.a18n1.2402. Spanish.

  29. Cruz Rojas PJ. Potenciales efectos adversosproducidos tras la instauración de la terapiaantirretroviral en pacientes ambulatorios infectadoscon VIH-SIDA [thesis] [Internet]. [Quito]: UniversidadTécnica de Machala (EC); 2017 [cited2018 Apr 6]. Available at: http://repositorio.utmachala.edu.ec/handle/48000/10070. Spanish.

  30. Diariomedico.com [Internet]. Madrid: GrupoRecoletos; c2021. Microbiología y EnfermedadesInfecciosas. 10 años de VIH. La terapiadel VIH evoluciona para adaptarse a cadapaciente; 2017 Nov 21 [cited 2020 Dec 23].Available at: https://www.diariomedico.com/medicina/enfermedades-infecciosas/la-terapia-del-vih-evoluciona-para-adaptarse-a-cada-paciente.html. Spanish.

  31. Marinho TM, Rodrigues PM, Caixas U, AntunesAMM, Branco T, Harjivan SG, et al. Differencesin nevirapine biotransformation as a factor for itssex-dependent dimorphic profi le of adverse drugreactions. J Antimicrob Chemother [Internet].2014 Feb [cited 2018 May 21];69(2):476–82.Available at: https://doi.org/10.1093/jac/dkt359

  32. Bastida C, Grau A, Márquez M, Tuset M, deLazzari E, Martínez E, et al. Polifarmacia e interaccionesfarmacológicas potenciales en unapoblación envejecida con infección por el VIH.Farm Hosp [Internet]. 2017 Sep 1 [cited 2018Apr 8];41(5):618–24. Available at: https://dx.doi.org/10.7399/fh.10778. Spanish.

  33. Rodríguez Roque GJ. Respuesta clínica einmunovirológica a la terapia antirretroviralcombinada al año en una cohorte de pacientescon diagnóstico de VIH atendidos en el hospitalDr. Roberto Calderón Gutiérrez en el periodoenero-diciembre 2015 [thesis] [Internet]. [Managua]:Universidad Nacional Autónoma de Nicaragua;2017 [cited 2018 Apr 6]. 63 p. Availableat: http://repositorio.unan.edu.ni/4304/1/96901.pdf. Spanish.

  34. Serrano López de la Hazas JI. Interaccionesfarmacológicas de los nuevos antirretrovirales.Farm Hosp [Internet]. 2011 Jan–Feb [cited2018 May 21];35(1):36–43. Available at: https://www.sciencedirect.com/science/article/abs/pii/S1130634310002308. Spanish, English.

  35. Puertas MC, Ploumidis G, Ploumidis M, FumeroE, Clotet B, Walwort CM, et al. Pan-resistantHIV-1 emergence in the era of integrasestrand-transfer inhibitors: a case report. LancetMicrobe [Internet]. 2020 Jul 1 [cited 2020Dec 23];1(3):e130–5. Available at: https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30006-9/fulltext

  36. Margot NA, Wong P, Kulkarni R, White K, PorterD, Abram ME, et al. Commonly transmittedHIV-1 drug resistance mutations in reverse-transcriptaseand protease in antiretroviral treatment–naive patients and response to regimenscontaining Tenofovir Disoproxil Fumarate orTenofovir Alafenamide. J Infect Dis [Internet].2017 [cited 2018 May 20];215(6):920–7. Availableat: https://doi.org/10.1093/infdis/jix015

  37. Morales Pérez M, García Milian AJ. Papel dela superfamilia ABC en la resistencia farmacológica.Horiz Sanitario [Internet]. 2017 [cited2020 Dec 27];16(2):93–101. Available at: https://revistas.ujat.mx/index.php/horizonte/article/view/1469. Spanish.

  38. World Health Organization [Internet]. Geneva:World Health Organization; c2021. Publications.HIV drug resistance report 2019; [updated2019 Jul; cited 2020 Dec 23]. 68 p. Available at:http://www.who.int/hiv/pub/drugresistance/hivdr-report-2019/en/

  39. Gupta RK, Gregson J, Parkin N, Haile-SalassieH, Tanuri A, Andrade Forero A, et al. HIV-1drug resistance before initiation or re-initiationof fi rst-line antiretroviral therapy in low-incomeand middle-income countries: a systematicreview and meta-regression analysis. LancetInfect Dis [Internet]. 2018 [cited 2020 Dec23];18(2):139. Available at: https://dx.doi.org/10.1016/S1473-3099(17)30702-8

  40. Hamers RL, Rinke de Wit TF, Holmes CB. HIVdrug resistance in low-income and middle-incomecountries. Lancet HIV [Internet]. 2018 [Cited 2020Dec 23];5(10):e588–e596. Available at: https://dx.doi.org/10.1016/S2352-3018(18)30173-5

  41. Hamers RL, Inzaule S. Pan-resistant HIV-1:what´s next? Lancet Microbe [Internet]. 2020 Jul1 [cited 2020 Dec 23];1(3):e97–e8. Available at:https://doi.org/10.1016/S2666-5247(20)30058-6.Spanish.




2020     |     www.medigraphic.com

Mi perfil

C?MO CITAR (Vancouver)

MEDICC Review. 2021;23