ISSN ONLINE: 2558-815X
ISSN PRINT: 1584-9244
ISSN-L: 1584-9244

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 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.
Keywords: antiretroviral therapy, darunavir, ritonavir, cobicistat, mild side reactions.

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Address for correspondence:
Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, Romania
Address: N. Jiga St., no. 29, 410028, Oradea, Romania


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Marin RC, Streinu-Cercel A, Bungau S. Mild self-declared side effects of boosted darunavir associated with other antiretrovirals in Romanian HIV-1 infected patients. Arch Balk Med Union. 2021;56(3):317-328.