Association between Direct Acting Agents used for chronic hepatitis C virus infection and the occurrence of acute leukaemia – A disproportionality analysis - 27/04/24
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Highlights |
• | Since 2016, the World Health Organization (WHO) recommends DAAs as first-line treatment for any patient with chronic HCV infection |
• | As of their recent marketing authorization, DAAs should remain monitored in order to detect possible side effects |
• | This disproportionality analysis of the WHO Pharmacovigilance database did not find any significant association between DAA exposure and the development of acute leukemia |
• | One should remain vigilant concerning rare types of leukemia, especially mixed phenotype after DAA exposure as these rare events of very difficult to identify. |
Abstract |
BACKGROUND AND AIMS |
A recent single-center study reported a significant increase in acute myeloid leukaemia (AML) cases, including mixed-phenotype acute leukaemia (MPAL), after exposure to direct acting agents (DAA). We investigated whether DAA use increased the risk of AML in patients with chronic hepatitis C virus (HCV) infection.
METHODS |
We conducted a disproportionality analysis of the WHO Pharmacovigilance database Vigibase up to 2020. Queries focused on all DAAs, subclasses, combinations or each DAA separately as well as interferon and ribavirin as negative controls. The primary outcome was AML. Secondary outcomes were AML without MPAL, MPAL, acute lymphoid leukemia (ALL) and acute leukemia (AL, high-level term encompassing AML, ALL, MPAL and unspecified acute leukemia [UAL]). The information component (IC0.25) and proportional reporting ratio (PRR0.25) were computed to assess a potential pharmacovigilance signal.
RESULTS |
We identified 49 notifications reporting any AL occurrence after anti-HCV treatments from June 1997 to December 2020: 23 (47%) involved a DAA, 24 (49%) interferon and 12 (24%) ribavirin. The DAAs sofosbuvir and ledipasvir were suspected in 74% (n=17) and 39% (n=9) of cases. The events reported were AML (n=22), ALL (n=11), AML and ALL (n=1) and UAL (n=15) and no MPAL. DAA, interferon or ribavirin were not significantly associated with AML, ALL or AL.
CONCLUSION |
This study did not find any association between DAA exposure and the occurrence of AML. Nevertheless, vigilance should remain, particularly for MPAL, which may not have been well captured in our study because of its rareness and high risk of misclassification.
Le texte complet de cet article est disponible en PDF.Keywords : Chronic Hepatitis C, Acute Biphenotypic Leukaemia, Acute Myeloid Leukemia, Acute Leukemia, Direct Acting Agent, Pharmacovigilance
Abbreviations in order of appearance in the main text : HCV, DAA, HM, AML, MPAL, AL, ISCR, ADR, ATC, ALL, UAL, NS3/4A, NS5A, PRR0.25
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