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Hepatitis C Virus Treatment by Direct-Acting Antivirals In ’Original article Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact Mohamed Hassanya, Aisha Elsharkawyc, Amr Mageda, Mai Mehreza, Noha Asemd, Ahmed Gomaag, Zeinab Mostafab, Bahaa Abbasf, Mohamad Solimane and Gamal Esmatc Background and aims Treatment of hepatitis C virus (HCV) after successfully treated hepatocellular carcinoma (HCC) becomes possible with the introduction of direct-acting antivirals because of their favorable efficacy, safety, and short period of treatment. Few data are available on the results of treatment using different direct-acting antiviral regimens in successfully treated HCC and a lot of debate about its role in tumor recurrence. Methods Sixty-two HCV-related HCC patients were enrolled in the study after successfully treated HCC; the studied population included either Child–Pugh ‘A’ or ‘B7’. The patients were subcategorized to receive one of the following regimens: group 1: sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks, group 2: SOF + simeprevir for 12 weeks, group 3: SOF + daclatasvir for 24 weeks, and group 4: SOF + daclatasvir + RBV for 12 weeks. The overall median follow-up period is 12 months after treatment initiation (ClinicalTrials.gov no: NCT02771405). Results All treatment regimens were tolerable for all patients, with no reported major adverse events during treatment. The overall sustained virologic response rate was 64.5%, with the highest result in group 4 and the lowest result in group 1; 87.5 and 26.7%, respectively. HCC recurrence was observed in 42% of patients; 80.7% of these patients developed recurrence within 6 months of treatment initiation. Conclusion Treatment of HCV in successfully treated HCC is feasible, with the best results achieved using multiple direct-acting antivirals and RBV; a high rate of HCC recurrence was observed, especially within the first 6 months of treatment initiation. Eur J Gastroenterol Hepatol 00:000–000 Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Background HCV represents a major cause of HCC development in HCV-related cirrhotic patients [6]. Before the introduction Egypt has one of the highest prevalence rates of hepatitis C of HCV direct-acting antiviral drugs (DAAs), pegylated globally [1]. In 2008, a demographic health survey (DHS) interferon (PegIFN) and ribavirin (RBV) were the corner- documented the prevalence of chronic hepatitis C viremia stone and standard of care therapy for HCV; yet, its use among 10% of the population between 15 and 59 years of was limited to a certain groups of patients with compen- age [2]; however, the prevalence decreased in the following sated liver functions and could not be used safely for DHS in 2015, with only 7% of viremic patients among the decompensated patients or those who have HCC, except same age group [3]. Genotype 4 is the major infecting under certain conditions. The use of pegylated interferon genotype in Egypt, representing more than 90% of those for HCV treatment in that era had a positive impact in with chronic hepatitis C virus (HCV) [4,5]. reducing the incidence of HCC in patients who achieved a HCC is the fifth most common cancer worldwide and sustained virologic response (SVR) [7,8]. the third leading cause of death among cancer mortalities. Treatment of HCV in patients with advanced liver disease becomes available with DAAs under the umbrella European Journal of Gastroenterology & Hepatology 2018, 00:000–000 of its safety, efficacy, and short duration of therapy; to this Keywords: direct-acting antivirals, hepatitis C virus, hepatocellular extent, inclusion of HCC patients within the treatment carcinoma, recurrence groups becomes realistic, with a high efficacy, reaching aTropical Medicine Department, bRadiology Department, National Hepatology and 90% SVR 12 [9]. Tropical Medicine Research Institute (NHTMRI), cEndemic Medicine and Recurrence of HCC after a radiological complete Hepatogastroentrology Department, dCommunity Medicine Department, response may be either early or remote recurrence; there e f Hepatology and Gastroenterology, Liver Unit, Cairo University, Military Medical are conflicting data on the clear cut-off period for differ- Academy, Cairo and gTropical Medicine Department, Faculty of Medicine, Fayoum University, Fayoum, Egypt entiating the early recurrence, which could be related to Correspondence to Mohamed Hassany, MD, Tropical Medicine Department, inadequate tumor treatment, poor differentiation, or vas- National Hepatology and Tropical Medicine Research Institute (NHTMRI), cular invasion from late recurrence, which could be related 10 Kasr Al Aini Street, Cairo 11441, Egypt to the underlying liver disease. Yamamoto et al. [10] Tel: + 20 223 642 494; fax: + 20 223 683 723; defined 17 months as a cut-off period to differentiate e-mail: [email protected] between early and remote recurrence in HCC patients Received 2 February 2018 Accepted 1 April 2018 treated with hepatectomy, whereas Poon [11] described a 0954-691X Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MEG.0000000000001152 1 Copyright r 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 2 European Journal of Gastroenterology & Hepatology Month 2018 • Volume 00 • Number 00 longer duration of up to 24 months. Tumor recurrence received one of the following DAAs regimens for HCV was described in different studies based on the modality treatment: used for HCC management; in hepatic resection, tumor recurrence varies from 51% of patients after 34 months (1) Group 1: received sofosbuvir (SOF) + RBV for 24 weeks. [12] and 83.6% [13] and 82.8% [14] after 36 months. In (2) Group 2: received SOF + simeprevir (SIM) for 12 weeks. radiofrequency ablation (RFA), recurrence was observed (3) Group 3: received SOF + daclatasvir (DAC) for 24 weeks. in 20% [15] and 28% [16] after 36 months, and 26% after (4) Group 4: received SOF + DAC + RBV for 12 weeks. 52 months [17], whereas in transarterial chemoemboliza- tion (TACE), recurrence was observed in 72.6% [13] and The patients were enrolled on the basis of the following 68.9% [14] after 36 months. inclusion criteria: An important alarm was raised about the unexpected high HCC recurrence rates after HCV treatment using (1) Age between 18 and 70 years. DAAs [18] followed by a strong wave of contradictory (2) Child ‘A’ or ‘B7’ liver cirrhosis. data. (3) Controlled diabetes mellitus defined by HBA1C level In the current study, we describe the results of treatment of up to 8%, controlled hypertension, stable cardiac of 62 chronic HCV patients with successfully managed condition, no other malignancies, and no combined HCC and their follow-up after treatment. HIV or HBV infection. Objective The treatment regimens were allocated on the basis of the waves of availability of DAAs in Egypt through the national The aim of this study was to explore the results of HCV treatment program of HCV (the first wave was 12 weeks of treatment with DAAs in HCC patients who achieved a PegIFN/RBV + SOF for PegIFN-eligible patients or 24 weeks complete radiological response and the possible mutual of SOF + RBV for those who were not ineligible for PegIFN, impact. the second wave comprised of 12 weeks of SOF + SIM, and the third wave included 12 weeks of SOF + DAC + RBV or 24 weeks of SOF + DAC for RBV-ineligible patients). Methods Study design Safety and efficacy assessment for hepatocellular carcinoma status The study was reviewed and approved by an independent ethics committee and carried out in accordance with the After HCC management, the patients were subjected to a Declaration of Helsinki and good clinical practice guide- review of their clinical condition and laboratory parameters, fi lines (ClinicalTrials.gov no.: NCT02771405). All authors and were tested for the tumor response to treatment (de ned had access to the study data, and reviewed and approved as the absence of neoplastic enhancement in dynamic studies the final manuscript. All enrolled patients provided writ- and normalization of AFP levels) after 4 weeks of interven- ten, informed consent before the start of the study. This tion; then, reassessment was repeated every 3 months. Tumor was a prospective nonrandomized open-label study that recurrence was detected by the reappearance of tumor enrolled 62 patients with genotype 4 HCV after success- enhancement/washout pattern and/or AFP progressive fi fully managed HCC; all enrolled patients had confirmed elevation. Local recurrence is de ned as the reappearance of chronic HCV by positivity of HCV antibodies and viral the radiological enhancement/washout inside the previously managed tumor; de-novo recurrence is defined as the devel- RNA by PCR for more than 6 months. – HCC was diagnosed by the presence of neoplastic cri- opmentofnew(13) lesion(s) with/without radiological teria (arterial enhancement and delayed wash out) in either enhancement/washout inside the previously managed tumor; and multicentric recurrence is defined as the development a multiphase multislice spiral computed tomography scan > or a dynamic contrast-enhanced MRI examination with or of new multiple ( 3) lesions with/without radiological without α-feto protein (AFP) elevation. enhancement/washout inside the previously managed tumor; Tumor staging and selection of the treatment modality metastatic recurrence is the appearance of either lymphatic, were performed according to the Barcelona Clinic of Liver vascular, or extrahepatic tumor spread with/without radiological
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