Signal detection on a patient cohort: A disproportionality analysis of the ANRS CO22 HEPATHER cohort to identify associations between direct acting antivirals and adverse events in patients with hepatitis C virus chronic infection

Feldman, Sarah; Lapidus, Nathanaël; Dorival, Céline; Diallo, Alpha; Amri, Imane; Fontaine, Hélène; Pol, Stanislas; Carrat, Fabrice

doi:10.1002/pds.4552

Cited by 3 publications

(2 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…CHC was defined as testing positive for anti‐HCV antibodies for at least 6 months and a positive HCV‐RNA test. The design of ANRS CO22 HEPATHER is detailed in full elsewhere 33,34 …”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness of direct‐acting antivirals for chronic hepatitis C treatment in migrant and non‐migrant populations in France

Carrieri

Fontaine

Baudoin

et al. 2021

Liver International

Self Cite

View full text Add to dashboard Cite

Despite universal health coverage in France, migrants face specific socioeconomic barriers that increase the likelihood of a suboptimal cascade of care for chronic hepatitis C virus (HCV) infection and impaired treatment effectiveness in this sub‐population. We selected data collected from 2012 to 2018 from the ANRS CO22 HEPATHER prospective cohort study for chronic HCV participants with available data on treatment failure (defined as the presence of a detectable HCV‐RNA load 12 weeks after their first DAA treatment ended). We performed multivariable Poisson regression models to test whether treatment failure rates differed significantly between HCV‐infected migrants and non‐migrants receiving DAA in France (cross‐sectional analysis), while taking into account the former's world region of birth and other potential social vulnerability factors. Among the study population's 7,879 patients, 5,829 (74%) were non‐migrants and 2,050 (26%) migrants. Median [interquartile range] age was 57 [51‐65] years, 4433 (56%) were men and 369 (5%) of the entire study population had treatment failure. After multivariable adjustment, only migrants from Central Asia were at higher risk of treatment failure than non‐migrants (aIRR = 2.83; 95% CI [1.72, 4.65]). Results from this large‐scale study performed in France suggest a higher risk of DAA treatment failure in migrants from Central Asia than in non‐migrants and confirm the overall low treatment failure rate in chronic HCV patients treated with DAA (whether migrants or not). Simplified models of care taking into account language and cultural barriers are needed to improve DAA effectiveness in migrants from Central Asia.

show abstract

“…CHC was defined as testing positive for anti‐HCV antibodies for at least 6 months and a positive HCV‐RNA test. The design of ANRS CO22 HEPATHER is detailed in full elsewhere 33,34 …”

Section: Methodsmentioning

confidence: 99%

“…The design of ANRS CO22 HEPATHER is detailed in full elsewhere. 33,34 Sociodemographic, behavioural, clinical and biological data were collected at cohort enrolment using a dedicated electronic casereport form and biological samples. Historical patient data were imported from existing medical files in each centre.…”

Section: Lay Summarymentioning

confidence: 99%

Effectiveness of direct‐acting antivirals for chronic hepatitis C treatment in migrant and non‐migrant populations in France

Carrieri

Fontaine

Baudoin

et al. 2021

Liver International

Self Cite

View full text Add to dashboard Cite

show abstract

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study

El-Marakby,

Solayman,

Sabri

2023

Ther Innov Regul Sci

View full text Add to dashboard Cite

Background Hepatitis C virus (HCV) is the primary contributor to chronic hepatic diseases. A rapid change in the situation took place with the advent of oral direct-acting antivirals (DAAs). However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking. This cross-sectional study aimed to analyze the reported Adverse Drug Reactions (ADRs) with DAA treatment using data from VigiBase, the WHO Individual Case Safety Report (ICSR) database. Methods All ICSRs reported to VigiBase with sofosbuvir (SOF), daclatasvir (DCV), sofosbuvir /ledipasvir (SOF/LDV) and ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in Egypt were extracted. Descriptive analysis was performed to summarize patients’ and reactions’ characteristics. Information components (ICs) and proportional reporting ratios (PRRs) for all reported ADRs were calculated to identify signals of disproportionate reporting. Logistic regression analysis was performed to identify the DAAs association with serious events of concern while adjusting for age, gender, pre-existing cirrhosis, and ribavirin use. Results Out of 2925 reports, 1131 (38.6%) were serious. The most commonly reported reactions; anaemia (21.3%), HCV relapse (14.5%) and headache (14%). For the disproportionality signals; HCV relapse was reported with SOF/DCV (IC 3.65, 95% CrI 3.47–3.79) and SOF/RBV (IC 3.69, 95% CrI 3.37–3.92), while anaemia (IC 2.85, 95% CrI 2.26–3.27) and renal impairment (IC 2.12, 95% CrI 0.7–3.03) were reported with OBV/PTV/r. Conclusion The highest severity index and seriousness were reported with SOF/RBV regimen. A significant association was found for OBV/PTV/r with renal impairment and anaemia although being the superior regimen in terms of efficacy. The study findings call for further population-based studies for clinical validation.

show abstract

Making sense of gut feelings in the traumatic brain injury pathogenesis

Royes

Gómez‐Pinilla

2019

Neuroscience & Biobehavioral Reviews

View full text Add to dashboard Cite

Traumatic brain injury (TBI) is a devastating condition which often initiates a sequel of neurological disorders that can last throughout lifespan. From metabolic perspective, TBI also compromises systemic physiology including the function of body organs with subsequent malfunctions in metabolism. The emerging panorama is that the effects of TBI on the periphery strike back on the brain and exacerbate the overall TBI pathogenesis. An increasing number of clinical reports are alarming to show that metabolic dysfunction is associated with incidence of long-term neurological and psychiatric disorders. The autonomic nervous system, associated hypothalamic-pituitary axis, and the immune system are at the center of the interface between brain and body and are central to the regulation of overall homeostasis and disease. We review the strong association between mechanisms that regulate cell metabolism and inflammation which has important clinical implications for the communication between body and brain. We also discuss the integrative actions of lifestyle interventions such as diet and exercise on promoting brain and body health and cognition after TBI.

show abstract

Signal detection on a patient cohort: A disproportionality analysis of the ANRS CO22 HEPATHER cohort to identify associations between direct acting antivirals and adverse events in patients with hepatitis C virus chronic infection

Abstract: The disproportionality method can help with early detection of potential ADRs in patient cohorts. Detected associations need to be confirmed by a review of clinical data.

Cited by 3 publications

References 37 publications

Effectiveness of direct‐acting antivirals for chronic hepatitis C treatment in migrant and non‐migrant populations in France

Effectiveness of direct‐acting antivirals for chronic hepatitis C treatment in migrant and non‐migrant populations in France

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study

Making sense of gut feelings in the traumatic brain injury pathogenesis

Contact Info

Product

Resources

About