Tarek Saadi1,2,3, Johad Khoury1,4. 1. Liver Unit. 2. Department of Gastroenterology. 3. Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel. 4. Internal Medicine B, Rambam Health Care Campus.
Abstract
BACKGROUND AND AIMS: Direct antiviral agents (DAAs) have become the treatment of choice for patients with chronic hepatitis C virus (HCV) infection. As these drugs are new, it is important to learn the adverse events of these drugs in the short and long terms. We report on 7 patients who developed malignancies during treatment with DAAs or a short time after finishing treatment. METHODS: We treated 133 patients with DAAs in our unit between January 2015 and June 2016, 100 (75%) of whom were treated with the combination of paritaprevir/ritonavir/ombitasvir with/without dasabuvir (PrOD). The distribution of HCV genotypes was as follow: G1b 114 (85.7%), G1a 3 (2.2%), G2 3 (2.2%), G3 10 (7.5%), G4 2 (1.5%). One hundred ten (82.7%) patients finished treatment. Adverse events were recorded during treatment and after finishing treatment. Efficacy was determined by assessment of serum HCV RNA. RESULTS: We observed malignancies in 7 patients: 1 developed laryngeal carcinoma, 1 developed pancreatic adenocarcinoma, 1 developed oropharyngeal lymphoma, 1 developed recurrent aggressive transitional cell carcinoma of the urinary bladder, 1 developed recurrent aggressive hepatocellular carcinoma, and 2 patients developed de novo hepatocellular carcinoma. All of these patients had advanced liver disease. CONCLUSIONS: This report raises questions about DAAs and the possible development of malignancies. It will be important to look at large clinical trial data and real-world experience to determine if this relationship is real.
BACKGROUND AND AIMS: Direct antiviral agents (DAAs) have become the treatment of choice for patients with chronic hepatitis C virus (HCV) infection. As these drugs are new, it is important to learn the adverse events of these drugs in the short and long terms. We report on 7 patients who developed malignancies during treatment with DAAs or a short time after finishing treatment. METHODS: We treated 133 patients with DAAs in our unit between January 2015 and June 2016, 100 (75%) of whom were treated with the combination of paritaprevir/ritonavir/ombitasvir with/without dasabuvir (PrOD). The distribution of HCV genotypes was as follow: G1b 114 (85.7%), G1a 3 (2.2%), G2 3 (2.2%), G3 10 (7.5%), G4 2 (1.5%). One hundred ten (82.7%) patients finished treatment. Adverse events were recorded during treatment and after finishing treatment. Efficacy was determined by assessment of serum HCV RNA. RESULTS: We observed malignancies in 7 patients: 1 developed laryngeal carcinoma, 1 developed pancreatic adenocarcinoma, 1 developed oropharyngeal lymphoma, 1 developed recurrent aggressive transitional cell carcinoma of the urinary bladder, 1 developed recurrent aggressive hepatocellular carcinoma, and 2 patients developed de novo hepatocellular carcinoma. All of these patients had advanced liver disease. CONCLUSIONS: This report raises questions about DAAs and the possible development of malignancies. It will be important to look at large clinical trial data and real-world experience to determine if this relationship is real.
Authors: Carmen M Preda; Cristian Baicus; Irina Sandra; Alexandru Oproiu; Teodora Manuc; Ileana Constantinescu; Daniel Gavrila; Mircea Diculescu; Radu Dumitru; Catalin Vasilescu; Cristian Tieranu; Doina Istratescu; Theodor Voiosu; Mircea Manuc Journal: United European Gastroenterol J Date: 2019-03-29 Impact factor: 4.623
Authors: Julia L Marcus; Michael J Silverberg; Jennifer O Lam; Leo B Hurley; Jennifer B Lai; Varun Saxena; Suk Seo; Scott Chamberland; Charles P Quesenberry; Jamila H Champsi; Joanna Ready; Elizabeth Y Chiao Journal: Cancer Epidemiol Biomarkers Prev Date: 2021-09-28 Impact factor: 4.090