Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients

Introduction. Antiretroviral therapy (ART) is used in human immunodeficiency virus (HIV)-infected patients, to suppress viral replication and slow disease progression. The side effects of ART, milder or more serious, frequently occur, thus the main challenge for specialists is to find a balance betw...

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Main Authors: Ruxandra C. MARIN, Adrian STREINU-CERCEL, Simona BUNGAU
Format: Article
Language:English
Published: Balkan Medical Union 2021-09-01
Series:Archives of the Balkan Medical Union
Subjects:
Online Access:https://umbalk.org/wp-content/uploads/2021/09/05.MILD-SELF%E2%80%91DECLARED-SIDE-EFFECTS.pdf
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author Ruxandra C. MARIN
Adrian STREINU-CERCEL
Simona BUNGAU
author_facet Ruxandra C. MARIN
Adrian STREINU-CERCEL
Simona BUNGAU
author_sort Ruxandra C. MARIN
collection DOAJ
description Introduction. Antiretroviral therapy (ART) is used in human immunodeficiency virus (HIV)-infected patients, to suppress viral replication and slow disease progression. The side effects of ART, milder or more serious, frequently occur, thus the main challenge for specialists is to find a balance between the benefits of long-term viremia suppression and the risks of toxicity. The objective of the study was to compare the frequency of mild side effects after administration of a regimen containing darunavir (DRV) boosted with ritonavir (RTV) (DRV/r 600 mg/100 mg, twice daily), vs DRV boosted with cobicistat (COBI) (DRV/c – 800 mg/150 mg, once a day) and perform a profile of the patient at risk of developing these types of adverse reactions during ARV treatment. Materials and methods. 462 patients were enrolled in the study and divided into two groups: 384 received DRV/r, and 78 DRV/c. This was a retrospective, non-interventional study using the database of the National Institute of Infectious Diseases “Prof. Dr. Matei Bals”, Bucharest, Romania. The self-declared mild side effects were collected from patients’ medical files and a comparison between the frequency of these in the two groups have been made. The main self-declared mild side effect was statistically correlated with the characteristic parameters of the cohort. Results. The statistical description of the most frequent self-declared mild side effects in the two groups showed that all parameters were found in a greater proportion in DRV/r group than in DRV/c group, with a statistically significant difference of p<0.05. Myalgia and sleep disorders correlate strongly positive (p<0.01) with age, and fatigue correlates strongly positive with age and with number of ARV regimens (p<0.01), and positively with pills’ burden (p<0.05). Conclusions. The results of this study demonstrated that ART regimens containing DRV/c have a higher tolerability than those containing DRV/r. They also emphasize the importance of the management of mild self-declared side effects, to increase patients’ adherence to treatment.
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spelling doaj.art-da8542d4c769491190016e49637b5c452022-12-21T18:36:25ZengBalkan Medical UnionArchives of the Balkan Medical Union1584-92442558-815X2021-09-01563317328https://doi.org/10.31688/ABMU.2021.56.3.05Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patientsRuxandra C. MARIN0Adrian STREINU-CERCEL1Simona BUNGAU2Doctoral School of Biological and Biomedical Sciences, University of Oradea, Oradea, Romania2 “Carol Davila” University of Medicine and Pharmacy, Infectious Diseases Department, Bucharest, Romania; “Matei Bals” National Institute of Infectious Diseases, Bucharest, RomaniaDoctoral School of Biological and Biomedical Sciences, University of Oradea, Oradea, Romania; Faculty of Medicine and Pharmacy, University of Oradea, Oradea, RomaniaIntroduction. Antiretroviral therapy (ART) is used in human immunodeficiency virus (HIV)-infected patients, to suppress viral replication and slow disease progression. The side effects of ART, milder or more serious, frequently occur, thus the main challenge for specialists is to find a balance between the benefits of long-term viremia suppression and the risks of toxicity. The objective of the study was to compare the frequency of mild side effects after administration of a regimen containing darunavir (DRV) boosted with ritonavir (RTV) (DRV/r 600 mg/100 mg, twice daily), vs DRV boosted with cobicistat (COBI) (DRV/c – 800 mg/150 mg, once a day) and perform a profile of the patient at risk of developing these types of adverse reactions during ARV treatment. Materials and methods. 462 patients were enrolled in the study and divided into two groups: 384 received DRV/r, and 78 DRV/c. This was a retrospective, non-interventional study using the database of the National Institute of Infectious Diseases “Prof. Dr. Matei Bals”, Bucharest, Romania. The self-declared mild side effects were collected from patients’ medical files and a comparison between the frequency of these in the two groups have been made. The main self-declared mild side effect was statistically correlated with the characteristic parameters of the cohort. Results. The statistical description of the most frequent self-declared mild side effects in the two groups showed that all parameters were found in a greater proportion in DRV/r group than in DRV/c group, with a statistically significant difference of p<0.05. Myalgia and sleep disorders correlate strongly positive (p<0.01) with age, and fatigue correlates strongly positive with age and with number of ARV regimens (p<0.01), and positively with pills’ burden (p<0.05). Conclusions. The results of this study demonstrated that ART regimens containing DRV/c have a higher tolerability than those containing DRV/r. They also emphasize the importance of the management of mild self-declared side effects, to increase patients’ adherence to treatment.https://umbalk.org/wp-content/uploads/2021/09/05.MILD-SELF%E2%80%91DECLARED-SIDE-EFFECTS.pdfantiretroviral therapydarunavirritonavircobicistatmild side reactions
spellingShingle Ruxandra C. MARIN
Adrian STREINU-CERCEL
Simona BUNGAU
Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
Archives of the Balkan Medical Union
antiretroviral therapy
darunavir
ritonavir
cobicistat
mild side reactions
title Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
title_full Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
title_fullStr Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
title_full_unstemmed Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
title_short Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients
title_sort mild self declared side effects of boosted darunavir associated with other antiretrovirals in romanian hiv 1 infected patients
topic antiretroviral therapy
darunavir
ritonavir
cobicistat
mild side reactions
url https://umbalk.org/wp-content/uploads/2021/09/05.MILD-SELF%E2%80%91DECLARED-SIDE-EFFECTS.pdf
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