Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database

Tian, Xiaojiang; Yao, Yao; He, Guanglin; Jia, Yuntao; Wang, Kejing; Chen, Lin

doi:10.1038/s41598-021-91549-w

Cited by 5 publications

(6 citation statements)

References 41 publications

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“…1 Moreover, second-generation PIs, such as darunavir, are well tolerated, although gastrointestinal side effects and metabolic complications are not infrequent. 2 Currently, a larger number of therapeutic options are available; in particular, integrase strand transfer inhibitors (InSTI) are one of the latest antiretroviral drug classes approved and now widely recommended in international guidelines for ART-naïve and -experienced people living with HIV (PLWH) due to their high efficacy and safety. 3,4 However, discontinuations of non-nucleoside reverse transcriptase inhibitors (NNRTI) and InSTI-based regimens have been observed in clinical practice, mainly secondary to drug-related adverse events and virological failure.…”

Section: Introductionmentioning

confidence: 99%

Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice

Ranzenigo¹,

Gianotti²,

Galli³

et al. 2022

DDDT

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Background:The primary objective of this study was to estimate the proportion of people living with HIV (PLWH) who switched from a non-protease inhibitor (PI)-based regimen [integrase strand transfer inhibitor (InSTI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen] to darunavir, cobicistat, emtricitabine, tenofovir alafenamide (D/C/F/TAF). Methods: This was a retrospective study on PLWH treated with a non-PI regimen in January 2017, who switched to D/C/F/TAF or to another antiretroviral therapy (ART) within November 2019. Follow-up was from the start date of D/C/F/TAF until the last available visit or discontinuation for any reason of this regimen. Virological failure (VF) was defined as 2 consecutive HIV-RNA values >50 copies/mL. Characteristics were reported as median (interquartile range) or frequency (%). A univariate Poisson regression model was used to measure the incidence rate of switch to D/C/F/TAF. Changes in laboratory parameters during D/C/F/TAF were assessed by univariate mixed linear models. Results: Overall, 3076 PLWH were included; 83% were male, median age at ART switch was 50 (42-56) years and median time on ART was 5.2 (0.3-13.0) years. PLWH had a median follow-up of 4. 76 (3.70-6.38) years; during 17,099 person-years of follow-up (PYFU), 423/3076 (14%) participants discontinued the non-PI-based regimen and 106/423 (25%) switched to D/C/F/TAF, with an overall incidence rate of switch to D/C/F/TAF of 6.2 per 1000-PYFU (95% CI: 5.0-7.4). Among PLWH who switched to D/C/F/TAF, the ongoing regimen was based on NNRTIs in 37 (35%) and on InSTIs in 69 (65%). Main reasons leading to switch to D/C/F/TAF included neuropsychiatric adverse events (37%), VF (26%) and Kaposi sarcoma progression (5%). Conclusion:In the last years, a non-negligible proportion of patients on an NNRTI-or an InSTI-based regimen switched to D/C/F/ TAF.

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Section: Introductionmentioning

confidence: 99%

Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice

Ranzenigo¹,

Gianotti²,

Galli³

et al. 2022

DDDT

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“…After applying the inclusion and exclusion criteria, we found 56 new suspected ADRs arising from 24 drugs (involving a wide range of antibiotics, biologics and CNS drugs) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. We then narrowed down the search to focus on more recent articles published within the years 2017-2021.…”

Section: Resultsmentioning

confidence: 99%

New Adverse Drug Reaction Signals from 2017 to 2021—Genuine Alerts or False Alarms?

Loke,

Mattishent,

Navaneetharaja

2024

Pharmacy

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Spontaneous adverse events reporting systems are used internationally to flag new or unexpected adverse drug reactions (ADRs). Disproportionality analysis is a recognised technique, but false alarms may arise. We aimed to determine whether these new ADR signals had subsequently been followed-up with detailed hypothesis-testing studies. We searched PubMed to identify published studies (years 2017–2021) where the authors reported findings of new ADR signals from disproportionality analyses. We used PubMed and forward citation tracking (Google Scholar) to identify any subsequent confirmatory studies of these ADR signals. We screened 414 titles and abstracts and checked the full-text articles of 57 studies. We found signals for 56 suspected new ADRs from 24 drugs. Google Scholar showed that the ADR studies had been cited a median of seven times (range 0–61). However, none of the suspected new ADRs had undergone detailed evaluation in the citing literature. Similarly, our PubMed search did not find any confirmation studies for the 56 suspected new ADRs. Although many suspected new ADR signals have been identified through disproportionality analysis, most signals have not been further verified as being either genuine ADRs or false alarms. Researchers must focus on follow-up studies for these new signals.

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“…Moreover, many previous studies and papers have used these methods to detect adverse event signals in spontaneous reporting systems. 52 – 54 …”

Section: Discussionmentioning

confidence: 99%

“…They calculate the reporting risk rather than the risk of DILD occurrence. 52 There are differences in drug use and race in various countries and regions. Nevertheless, the FAERS database lacks ethnicity data, an indispensable part of considering the environmental and genetic factors that lead to adverse events.…”

Section: Limitationsmentioning

confidence: 99%

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

Jiang,

Su,

et al. 2024

Therapeutic Advances in Drug Safety

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Background: Drug-induced interstitial lung disease (DILD) is an increasingly common cause of morbidity and mortality. However, due to the lack of specificity, DILD detection remains an unsolved public health challenge. Objectives: For the first time, we aimed to examine DILD reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to identify demographic characteristics and top drugs associated with DILD at a group level (including age, sex, drug class, and country stratification) and individual drug level. Design: A retrospective analysis of the FAERS database was examined by disproportionality analysis. Methods: We reviewed the FAERS database from 2004 to 2021, using search terms ‘interstitial lung disease’ and sorting cases by generic drug name. The reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network were calculated as the measure of strength of association. Results: There were 32,821 DILD reports in the FAERS. After excluding reports without age, sex, or country data according to the specific measurement, the median age of patients was 68 (interquartile range: 59), 54.77% were male, and 46.00% of reports came from Japan. The top drug classes related to DILD in the FAERS were antineoplastic, followed by cardiovascular and antirheumatic agents, in varying order in different sexes. Fam-trastuzumab deruxtecan-nxki, ramucirumab, and eribulin were the top three drugs with the highest strength of association. We also found some drugs without DILD in the labels, such as amiodarone, temsirolimus, and ursodiol. There are significant differences in DILD reports in various countries. For example, the United States and France reported more cardiovascular agents, whereas Canada reported more antirheumatic agents. Conclusion: We found the top drugs and drug classes that were associated with DILD in the FAERS, which provides a real-world window for different ages, sexes, and countries to formulate precise pharmacovigilance policies.

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Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database

Cited by 5 publications

References 41 publications

Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice

Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice

New Adverse Drug Reaction Signals from 2017 to 2021—Genuine Alerts or False Alarms?

Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021

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