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      Effectiveness, tolerability and safety of Direct Acting Antivirals in Mexican individuals with Hepatitis C virus genotype-1 and previous pegylated interferon and ribavirin therapy

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          Abstract

          Background

          Direct Acting Antivirals (DAAs) represent a large improvement in the treatment of chronic hepatitis C, resulting in <90% sustained virological response (SVR). There are no reports on the real-world DAA response for Mexico and few reports exist for Latin America. The aim of the study was to report SVR, and immediate benefits with the DAA treatments sofosbuvir, ledispavir, with/without ribavirin (SOF/LDV ± RBV) and ombitasvir, paritaprevir, ritonavir, dasabuvir with/without RBV (OBV/PTV/r/DSV ± RBV) in patients with viral genotype 1a or 1b, and who did not respond to previous peginterferon/ribavirin (PegIFNα2a+RBV) therapy.

          Methods

          A descriptive, ambispective, longitudinal study was conducted. A cohort of 261 adult patients received PegIFNα2a+RBV therapy before 2014; 167 (64%) did not respond, 83 of these were subsequently treated with SOF/LDV ± RBV or OBV/PTV/r/DSV ± RBV. Child-Pugh-Score (CPS), Fibrosis-4 (FIB-4), and AST to Platelet Ratio Index (APRI) were evaluated before and after treatment.

          Results

          SVR with PegIFNα2a+RBV was 36%, and 97.5% with DAAs. CPS, FIB-4 and APRI improved significantly after DAA treatment, mainly because of liver transaminase reduction.

          Conclusions

          DAA treatment showed excellent SVR rates in Mexican patients who had not responded to PegIFNα2a+RBV therapy. Improvement in CPS, FIB-4 and APRI without improvement in fibrosis was observed in cirrhotic and non-cirrhotic patients, as well as considerable reduction in liver transaminases, which suggests a reduction in hepatic necroinflammation.

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          Most cited references34

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          Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial.

          Compared with other countries, patients with chronic hepatitis C infection in Japan tend to be older, have more advanced liver disease, and are more likely to have been previously treated for hepatitis C. We aimed to assess the efficacy and safety of an all-oral, fixed-dose combination of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with chronic genotype 1 hepatitis C virus infection.
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            Hepatocellular carcinoma risk following direct-acting antiviral HCV therapy: A systematic review, meta-analyses, and meta-regression

            The risk of hepatocellular carcinoma (HCC) occurrence or recurrence following direct-acting antiviral (DAA) hepatitis C virus (HCV) therapy remains unclear. The aims of this study were to compare the rate of HCC occurrence in patients with HCV-related cirrhosis, following DAA vs. interferon (IFN)-based cure, and to compare the rate of HCC recurrence in patients who received curative HCC treatment, following DAA vs. IFN-based cure.
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              • Record: found
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              Direct antiviral agent treatment of chronic hepatitis C results in rapid regression of transient elastography and fibrosis markers fibrosis-4 score and aspartate aminotransferase-platelet ratio index

              Novel direct antiviral agents (DAA) targeting hepatitis C virus (HCV) have revolutionized the treatment of chronic hepatitis C infection (CHC). Rates of sustained virological response (SVR) to treatment have drastically improved since introduction of DAA. Transient Elastography (TE) is an ultrasound based, non-invasive technique to assess liver stiffness (LS). We examined the changes in TE values and fibrosis scores FIB-4 and APRI after DAA treatment of CHC.
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                Author and article information

                Contributors
                Journal
                PeerJ
                PeerJ
                peerj
                PeerJ
                PeerJ Inc. (San Diego, USA )
                2167-8359
                17 September 2021
                2021
                : 9
                : e12051
                Affiliations
                [1 ]Centro Interdisciplinario de Posgrados, Facultad de Medicina, Universidad Popular Autonóma del Estado de Puebla , Puebla, Puebla, Mexico
                [2 ]Servicio de Gastroenterología, Centro Médico Nacional General de División Manuel Ávila Camacho, Instituto Mexicano del Seguro Social , Puebla, Puebla, Mexico
                [3 ]Decanato de Ciencias Médicas, Universidad Popular Autonóma del Estado de Puebla , Puebla, Puebla, Mexico
                [4 ]Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social , Ciudad de México, Mexico
                [5 ]Banco de Sangre, Centro Médico Nacional General de División Manuel Ávila Camacho, Instituto Mexicano del Seguro Social , Puebla, Puebla, Mexico
                [6 ]Instituto de Ciencias, Benemerita Universidad Autónoma de Puebla , Puebla, Puebla, Mexico
                [7 ]Hospital General Regional # 1, Instituto Mexicano del Seguro Social , Tarímbaro, Michoacán, Mexico
                [8 ]Laboratorio de Biología Molecular y Virología, Centro de Investigación Biomédica de Oriente, Instituto Mexicano del Seguro Social , Metepec, Puebla, Mexico
                [9 ]Laboratorio de Biología Celular, Centro de Investigación Biomédica de Oriente, Instituto Mexicano del Seguro Social , Metepec, Puebla, Mexico
                Article
                12051
                10.7717/peerj.12051
                8451435
                8ac7708b-72cc-463c-96b1-f7cbae1e32b3
                ©2021 Melendez-Mena et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. For attribution, the original author(s), title, publication source (PeerJ) and either DOI or URL of the article must be cited.

                History
                : 21 April 2021
                : 3 August 2021
                Funding
                Funded by: Instituto Mexicano del Seguro Social
                Funded by: Fundación IMSS A.C., Mexico
                Costs of medical attention and diagnosis were covered by Instituto Mexicano del Seguro Social. Julio Reyes-Leyva received a research fellowship from Fundación IMSS A.C., Mexico. There was no additional external funding received for this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Virology
                Drugs and Devices
                Gastroenterology and Hepatology
                Infectious Diseases

                hepatitis c,sustained viral response,direct acting antivirals,child-pugh-score,fib-4,apri index

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