SAVREMENE OPCIJE LEČENJA DECE I ADOLESCENATA KOJI ŽIVE SA HIV INFEKCIJOM
PEDIATRIC HIV TREATMENT
Sažetak
Cilj lečenja infekcije virusom humane imunodeficijencije (engl. human immunodeficiency virus – HIV) i kod odraslih i kod dece i adolescenata jeste postizanje stabilnog odgovora imunosistema na infekciju virusom, koji podrazumeva činjenicu da virus nije detektovan u krvi duže od šest meseci i oporavak imuniteta. Lečenje dece i adolescenata koji žive sa HIV-om (engl. children and adolescents living with HIV – C/ALHIV) specifičnije je i teže zbog slabijeg pridržavanja terapije, dužeg trajanja infekcije i posledičnih toksičnih efekata, kao i zbog hronične mikroinflamacije. Još jedan otežavajući faktor predstavlja nedostatak adekvatnih pedijatrijskih farmaceutskih koformulacija u zavisnosti od regiona. Napredak i pojava inovativnih vidova terapije i jasnih smernica doveli su do poboljšanja kvaliteta života i imunološkog statusa dece i adolescenata koji žive sa HIV-om. Kao najčešće korišćene zvanične smernice izdvajaju se preporuke Evropskog kliničkog udruženja za AIDS (engl. European AIDS Clinical Society ‒ EACS), Svetske zdravstvene organizacije (SZO) i Centra za kontrolu i prevenciju bolesti (engl. Center for Disease Control and Prevention − CDC). Na osnovu pomenutih smernica i lokalnih uslova i mogućnosti formiraju se i nacionalni vodiči na nivou pojedinih država.
Reference
Abbas M, Bakhthyar A, Bazzi R. Neonatal HIV [Internet]. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2022 Sep 20 [cited 2024 Jan]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK55879
Amuge P, Lugemwa A, Wynne B, Mujuru HA, Violari A, Kityo CM, et al. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial. Lancet HIV 2022 ;9(9):e638-48. [CrossRef] [PubMed]
Arage G, Assefa M, Worku T, Semahegn A. Survival rate of HIV-infected children after initiation of the antiretroviral therapy and its predictors in Ethiopia: A facility-based retrospective cohort. SAGE Open Med 2019;7:2050312119838957. [CrossRef] [PubMed]
Atta CA, Fiest KM, Frolkis AD, Jette N, Pringsheim T, St Germaine-Smith C et al. Global birth prevalence of spina bifida by folic acid fortification status: a systematic review and metaanalysis. Am J Public Health 2016;106(1):e24–34. [CrossRef] [PubMed]
Centers for Disease Control and Prevention. Revised classification system for human immunodeficiency virus infection in children less than 13 years of age [Internet]. MMWR. 1994;43(No. RR‑12). Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/00032890.htm
Centers for Disease Control and Prevention. Revised surveillance case definition for HIV infection—United States, 2014 [Internet]. MMWR. 2014;63(No. RR‑3):11‑10. Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm
Cerrone M, Wang X, Neary M, Weaver C, Fedele S, DayWeber I et al. Pharmacokinetics of efavirenz 400 mg once daily coadministered with isoniazid and rifampicin in human immunodeficiency virus–infected individuals. Clin Infect Dis 2018;68(3):446–52. [CrossRef] [PubMed]
Cottrell ML, Hadzic T, Kashuba AD. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clin Pharmacokinet 2013;52:981–94. [CrossRef] [PubMed]
Dirajlal-Fargo S, Koay WLA, Rakhmanina N. Pediatric Antiretroviral Therapy. Handb Exp Pharmacol 2020;261:285-323. [CrossRef] [PubMed]
Dooley KE, Kaplan R, Mwelase N, Grinsztejn B, Ticona E, Lacerda M et al. Dolutegravir-based antiretroviral therapy for patients co-infected with tuberculosis and HIV: a multicenter, noncomparative, open-label, randomized trial. Clin Infect Dis 2020;70(4):549–56. [CrossRef] [PubMed]
Dooley KE, Sayre P, Borland J, Purdy E, Chen S, Song I et al. Safety, tolerability, and pharmacokinetics of the HIV integrase inhibitor dolutegravir given twice daily with rifampin or once daily with rifabutin: results of a phase 1 study among healthy subjects. J Acquir Immune Defic Syndr 2013;62(1):21–7. [CrossRef] [PubMed]
Dugdale CM, Ciaranello AL, Bekker L-G, Stern ME, Myer L, Wood R et al. Risks and benefits of dolutegravir-and efavirenz-based strategies for South African women with HIV of child-bearing potential: a modeling study. Ann Intern Med 2019;170(9):614–25. [CrossRef] [PubMed]
European AIDS Clinical Society. EACS Guidelines. Version 11.1 [Internet]. Brussels: EACS; 2022 [cited 2024 Dec 12]. Available from: https://www.eacsociety.org/media/guidelines-11.1_final_09-10.pdf
European AIDS Clinical Society. EACS Guidelines. Version 12.0 [Internet]. Brussels: EACS; 2023 [cited 2024 Dec 12]. Available from: https://www.eacsociety.org/media/guidelines-12.0.pdf
European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Long-term trends in mortality and AIDS-defining events after combination ART initiation among children and adolescents with perinatal HIV infection in 17 middle- and high-income countries in Europe and Thailand: a cohort study. PLoS Med 2018; 15: e1002491. [CrossRef] [PubMed]
Fortuny C, Deyà-Martínez Á, Chiappini E, Galli L, de Martino M, Noguera-Julian A. Metabolic and renal adverse effects of antiretroviral therapy in HIV-infected children and adolescents. Pediatr Infect Dis J 2015;34(5 Suppl 1):S36-43. [CrossRef] [PubMed]
Hill A, Waters L, Pozniak A. Are new antiretroviral treatments increasing the risks of clinical obesity? J Virus Erad 2019;5(1):e45–7. [CrossRef] [PubMed]
Jacobs TG, Schouwenburg S, Penazzato M, Archary M, Ruel TD, van den Anker J, et al. What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies. Lancet HIV 2022;9(9):e649-57. [CrossRef] [PubMed]
Katusiime MG, Van Zyl GU, Cotton MF, Kearney MF. HIV-1 Persistence in Children during Suppressive ART. Viruses. 2021; 13(6):1134. [CrossRef] [PubMed]
Lamorde M, Wang X, Neary M, Bisdomini E, Nakalema S, Byakika-Kibwika P et al. Pharmacokinetics, pharmacodynamics, and pharmacogenetics of efavirenz 400 mg once daily during pregnancy and post-partum. Clin Infect Dis 2018;67:785–90. [CrossRef] [PubMed]
Lee C, Sapasap J, LaRochelle J, Smith RO, Badowski ME. Antiretroviral Therapy in Children and Adolescents: A Look Into Modern Single Tablet Regimens. J Pediatr Pharmacol Ther 2021;26(8):783-94. [CrossRef] [PubMed]
Llibre JM, Pulido F, García F, Garcia Deltoro M, Blanco JL, Delgado R. Genetic barrier to resistance for dolutegravir. AIDS Rev 2015;17(1):56–64. [PubMed]
Morris SE, Strehlau R, Shiau S, Abrams EJ, Tiemessen CT, Kuhn L, et al. Healthy dynamics of CD4 T cells may drive HIV resurgence in perinatally-infected infants on antiretroviral therapy. PLoS Pathog 2022;18(8):e1010751. [CrossRef] [PubMed]
Nalwanga D, Musiime V. Children living with HIV: a narrative review of recent advances in pediatric HIV research and their implications for clinical practice. Ther Adv Infect Dis 2022;9:20499361221077544. [CrossRef] [PubMed]
Panel on Antiretroviral Therapy and Medical Management of HIV‑Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection [Internet]. U.S. Department of Health and Human Services; 2022 Apr 11 [cited 2024 Dec 12]. Available from: https://aidsinfo.nih.gov/guidelines/html/2/pediatric-treatment-guidelines/0
Panel on Antiretroviral Therapy and Medical Management of HIV‑Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection [Internet]. U.S. Department of Health and Human Services; 2022 Apr 11 [cited 2024 Dec 12]. Available from: https://aidsinfo.nih.gov/guidelines/html/2/pediatric-treatment-guidelines/0
Phillips AN, Venter F, Havlir D, Pozniak A, Kuritzkes D, Wensing A et al. Risks and benefits of dolutegravir-based antiretroviral drug regimens in sub-Saharan Africa: a modelling study. Lancet HIV 2019;6(2):e116–27. [CrossRef] [PubMed]
Ranin J, Brkić S, Marić D, Vrbić M, Ranković A, Popović Dragonjić L, et al. Operating group for the development of the guide. National Guide to Good Clinical Practice. Treatment of people living with HIV infection. Belgrade, 2024. Academy of Medical Sciences of the Serbian Medical Association. Ministry of Health of the Republic of Serbia, Belgrade.
Ruggiero A, Pascucci GR, Cotugno N, Domínguez-Rodríguez S, Rinaldi S, Tagarro A, et al. Determinants of B-Cell Compartment Hyperactivation in European Adolescents Living With Perinatally Acquired HIV-1 After Over 10 Years of Suppressive Therapy. Front Immunol 2022;13:860418. [CrossRef] [PubMed]
Sheahan A, Feinstein L, Dube Q, Edmonds A, Chirambo CM, Smith E, et al. Early Antiretroviral Therapy Initiation and Mortality Among Infants Diagnosed With HIV in the First 12 Weeks of Life: Experiences From Kinshasa, DR Congo and Blantyre, Malawi. Pediatr Infect Dis J 2017;36(7):654-8. [CrossRef] [PubMed]
Smith RA, Raugi DN, Pan C, Sow PS, Seydi M, Mullins JI et al. In vitro activity of dolutegravir against wild-type and integrase inhibitor-resistant HIV-2. Retrovirology 2015;12:10. [CrossRef] [PubMed]
Treviño A, Cabezas T, Lozano AB, García-Delgado R, Force L, Fernández-Montero JM et al. Dolutegravir for the treatment of HIV-2 infection. J Clin Virol 2015;64:12–5. [CrossRef] [PubMed]
Turkova A, Waalewijn H, Chan MK, Bollen PDJ, Bwakura-Dangarembizi MF, Kekitiinwa AR, et al. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. Lancet HIV 2022;9(9):e627-37. [CrossRef] [PubMed]
Turkova A, White E, Mujuru HA, Kekitiinwa AR, Kityo CM, Violari A, et al. Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children. N Engl J Med 2021;385(27):2531-2543. [CrossRef] [PubMed]
Vitoria M, Hill A, Ford N, Doherty M, Clayden P, Venter F et al. The transition to dolutegravir and other new antiretrovirals in low- and middle-income countries – what are the issues? AIDS. 2018;32:1551–61. [CrossRef] [PubMed]
Waalewijn H, Chan MK, Bollen PDJ, Mujuru HA, Makumbi S, Kekitiinwa AR, et al. Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. Lancet HIV 2022;9(5):e341-52. [CrossRef] [PubMed]
Wang X, Cerrone M, Ferretti F, Castrillo N, Maartens G, McClure M et al. Pharmacokinetics of dolutegravir 100 mg once daily with rifampicin. Int J Antimicrob Agents 2019;54(2):202-6. [CrossRef] [PubMed]
World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach [Internet]. Geneva: WHO; 2021 Jul 16 [cited 2024 Dec 12]. Available from: https://www.who.int/news/item/16-07-2021-who-publishes-new-consolidated-hiv-guidelines-for-prevention-testing-treatment-service-delivery-monitoring
World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach [Internet]. Geneva: WHO; 2021 Jul 16 [cited 2024 Dec 12]. Available from: https://www.who.int/publications/i/item/9789240031593
World Health Organization. Guidelines on the public health response to pretreatment HIV drug resistance: supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection [Internet]. Geneva: WHO; 2017 [cited 2024 Dec 12]. Available from: https://www.who.int/hiv/pub/guidelines/hivdr-guidelines-2017/en
World Health Organization. Update of recommendations on first- and second-line antiretroviral regimens [Internet]. Geneva: WHO; 2019 [cited 2024 Dec 12]. Available from: https://www.who.int/publications/i/item/WHO-CDS-HIV-19.15
Zash R, Makhema J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med 2018;378:979–81. [CrossRef] [PubMed]
