Late HCC onset after DAAs therapy in patients with SVR: a type D ADR that requires a longer follow-up?

Nappi, Antonio; Perrella, Alessandro; Rinaldi, Luca; Izzi, Antonio; Punzi, Rodolfo; Adinolfi, Luigi Elio; Sbeglia, Costanza; Bellopede, Pasquale; Maddaloni, Adelaide; Papa, Nunzia; Spatarella, Micaela

doi:10.1136/ejhpharm-2019-001975

Cited by 3 publications

(3 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…PTUDS, percent time up-to-date surveillance; IQR, interquartile range with LI-RAD 2-5 observations, which was not performed in most studies. [46][47][48] Additional strengths included the extended follow-up time and the use of PTUDS for reporting surveillance. [28][29][30] The limitations include the single-site design, which might reduce generalizability; however, the cohort was racially and ethnically diverse.…”

Section: Discussionmentioning

confidence: 99%

“…The strengths of our study include our monitoring of surveillance in patients in the clinical setting whose pre‐SVR liver images were reviewed rigorously to exclude patients with LI‐RAD 2–5 observations, which was not performed in most studies. 46 , 47 , 48 Additional strengths included the extended follow‐up time and the use of PTUDS for reporting surveillance. 28 , 29 , 30 …”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Hepatocellular carcinoma surveillance, incidence, and tumor doubling times in patients cured of hepatitis C

et al. 2022

View full text Add to dashboard Cite

Background Hepatocellular carcinoma (HCC) incidence and mortality vary by race/ethnicity and both are higher in Black patients than in Whites. For HCC surveillance, all cirrhotic patients are advised to undergo lifelong twice‐annual abdominal imaging. We investigated factors associated with surveillance and HCC incidence in a diverse HCC risk group, cirrhotic patients recently cured of hepatitis C virus (HCV) infection. Methods In this observational cohort study, all participants (n = 357) had advanced fibrosis/cirrhosis and were cured of HCV with antiviral treatment. None had Liver Imaging Reporting and Data System (LI‐RADS) 2–5 lesions prior to HCV cure. Ultrasound, computed tomography, and/or magnetic resonance imaging were used for surveillance. Results At a median follow‐up of 40 months [interquartile range (IQR) = 28–48], the median percentage of time up‐to‐date with surveillance was 49% (IQR) = 30%–71%. The likelihood of receiving a first surveillance examination was not significantly associated with race/ethnicity, but was higher for patients with more advanced cirrhosis, for example, bilirubin [odds ratio (OR) = 3.8/mg/dL, p = 0.002], private insurance (OR = 3.4, p = 0.006), and women (OR = 2.3, p = 0.008). The likelihood of receiving two or three examinations was significantly lower for non‐Hispanic Blacks and Hispanics versus non‐Hispanic Whites (OR = 0.39, and OR = 0.40, respectively, p < 0.005 for both) and for patients with higher platelet counts (OR = 0.99/10,000 cells/µl, p = 0.01), but higher for patients with private insurance (OR = 2.8, p < 0.001). Incident HCC was associated with higher bilirubin (OR = 1.7, p = 0.02) and lower lymphocyte counts (OR = 0.16, p = 0.01). Conclusions Contrary to best practices, HCC surveillance was associated with sociodemographic factors (insurance status and race/ethnicity) among patients cured of HCV. Guideline‐concordant surveillance is needed to address healthcare disparities.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Hepatocellular carcinoma surveillance, incidence, and tumor doubling times in patients cured of hepatitis C

et al. 2022

View full text Add to dashboard Cite

show abstract

“…In light of these data and literature evidence on antimicrobial stewardship too ( Munez Rubio et al, 2019 ), antibiotics require an active follow-up from clinicians and hospital pharmacists not only to avoid an inappropriate use of these antibiotics and, therefore, the onset of resistance but also to minimize the risk of ADR. As we previously strongly suggested for antivirals ( Nappi et al, 2019 ), a close collaboration among ID specialists, clinicians, and hospital pharmacists should be managed throughout the creation of a network that will allow greater monitoring of the safety profile of antibiotics.…”

Section: Discussionmentioning

confidence: 99%

Hypernatremia During Intravenous Treatment With Fosfomycin: A Retrospective Medical Record Review Study and an Analysis of Spontaneous Reports in the EudraVigilance Database

Scavone

Mascolo

Bernardi³

et al. 2022

Front. Pharmacol.

Self Cite

View full text Add to dashboard Cite

Background: Hypernatremia is a serious event that can occur during intravenous (IV) treatment with fosfomycin, and it can also be caused by a wrong drug preparation. Considering the clinical significance of hypernatremia, we decided to carry out two studies by using two different data sources with the aim to evaluate cases of IV fosfomycin-induced hypernatremia.Methods: A retrospective medical record review was performed from June 2017 to June 2019 using data from two hospitals in Southern Italy. The information collected was related to the patients, the antibiotic treatment regimen, type of adverse drug reaction (ADR), hypernatremia severity classification, and drug withdrawal due to ADRs. Moreover, a pharmacovigilance study was performed from the date of the European marketing authorization of fosfomycin to October 11, 2021, using data reported on the European website of suspected ADRs. Information related to the patient characteristics, treatment, hypernatremia, and type of reporter was retrieved.Results: From the retrospective medical record review, a total of 62 patients (48 men and 14 women) in treatment with fosfomycin were identified, of which 17 experienced ADRs. Specifically, 11 patients experienced hypernatremia. During the period from June 2017 to June 2018, a total of 63.7% of hypernatremia events were related to the wrong reconstitution of the drug. According to these results, a surveillance and training campaign about the correct drug reconstitution was managed. However, from June 2018 to June 2019, we still had four new hypernatremia cases. Drug withdrawal occurred in only one patient with hypernatremia. From the pharmacovigilance study, a total of 25 cases of IV fosfomycin-induced hypernatremia were retrieved. No substantial difference was found for patients’ distribution by sex. Most cases were classified as serious (68%) and reported “Recovered/resolved” as the outcome (44%). In the majority of cases, fosfomycin was the only suspected drug reported (72%).Conclusion: Our results show that training campaigns on the correct drug preparation need to be strengthened to allow a reduction of hypernatremia cases. Moreover, when close monitoring and management is performed by the infectious disease (ID) specialist and hospital pharmacist, there also is a reduction in antibiotic withdrawal due to hypernatremia.

show abstract

Assessment of hepatic fibrosis, portal hemodynamic changes, and disease severity in patients with HCV-related liver cirrhosis after sustained virologic response to direct-acting antiviral drugs (DAAs)

Hassan,

Kamel,

Mahmoud

et al. 2023

Egypt Liver Journal

View full text Add to dashboard Cite

Background Regression of fibrosis and improvement of portal hemodynamics after achievement of sustained viral response (SVR) in patients with chronic hepatitis C (HCV) is a subject of debate in different studies. Some studies reported improvement in the degree of fibrosis, while others did not find significant changes. Objective We aimed to evaluate changes in liver fibrosis, portal hemodynamics and clinical outcomes in patients with chronic HCV-related liver cirrhosis after the achievement of SVR with direct-acting antiviral drugs (DAAs). Patients and methods In our prospective longitudinal study, a total of 100 patients with chronic HCV infection-related liver cirrhosis were recruited, received DAAs, and completed the follow-up period. Clinical evaluation for assessment of liver disease severity using MELD and Child–Pugh class and scores were done. A noninvasive assessment of liver fibrosis using serum biomarkers (APRI index & FIB4 score) and share wave elastography (SWE) was done. Portal hemodynamic evaluation using Doppler ultrasound was done. All were done at baseline and 3 and 12 months after the end of therapy. Results A significant reduction in the degree of fibrosis was observed. Share wave elastography (SWE) readings showed 19.79% and 30.45% reduction 3 and 12 months after the end of therapy respectively (P < 0.001). Regarding the FIB4 score, the percentage of score reduction was 19.8% and 26.46% 3 and 12 months after the end of therapy, respectively (P < 0.01). APRI scores showed 22.6% and 41.09% reduction 3 and 12 months after the end of therapy respectively (P < 0.001). Significant improvement in Child–Pugh scores 3 and 12 months after the end of treatment was observed. Doppler ultrasound showed a significant increase in portal vein flow velocity, a significant decrease in time average mean velocity, and cross-section area 12 months after the end of treatment. Conclusion There was a considerable degree of reduction of liver fibrosis, improvement of portal hemodynamics, and Child–Pugh score in cirrhotic HCV patients who achieved SVR after DAAs. Trial registration ClinicalTrials.gov, ID: NCT03241823. Registered on 08 May 2017.

show abstract

Late HCC onset after DAAs therapy in patients with SVR: a type D ADR that requires a longer follow-up?

Cited by 3 publications

References 6 publications

Hepatocellular carcinoma surveillance, incidence, and tumor doubling times in patients cured of hepatitis C

Hepatocellular carcinoma surveillance, incidence, and tumor doubling times in patients cured of hepatitis C

Hypernatremia During Intravenous Treatment With Fosfomycin: A Retrospective Medical Record Review Study and an Analysis of Spontaneous Reports in the EudraVigilance Database

Assessment of hepatic fibrosis, portal hemodynamic changes, and disease severity in patients with HCV-related liver cirrhosis after sustained virologic response to direct-acting antiviral drugs (DAAs)

Contact Info

Product

Resources

About