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Christophe Hezode, Nancy Reau, Evguenia S Svarovskaia, Brian P Doehle, Ragavi Shanmugam, Hadas Dvory-Sobol, Charlotte Hedskog, John McNally, Anu Osinusi, Diana M Brainard, Michael D Miller, Hongmei Mo, Stuart K Roberts, Jacqueline G O'Leary, Stephen D Shafran, Stefan Zeuzem
BACKGROUND & AIMS: The fixed dose combination of sofosbuvir/velpatasvir was highly efficacious in genotype (GT) 1-6 HCV infected patients in the ASTRAL studies. This analysis evaluated the impact of baseline resistance-associated substitutions (RASs) on treatment outcome and emergence of RASs in HCV GT1-6 infected patients treated with sofosbuvir/velpatasvir. METHODS: NS5A and NS5B deep sequencing was performed at baseline for all patients in the ASTRAL 1-3, ASTRAL-5 and POLARIS-2-3 studies treated with sofosbuvir/velpatasvir for 12 weeks (n=1778) and at the time of relapse...
December 5, 2017: Journal of Hepatology
Hakan Leblebicioglu, Joop E Arends, Resat Ozaras, Giampaolo Corti, Lurdes Santos, Christoph Boesecke, Andrew Ustianowski, Ann-Sofi Duberg, Simona Ruta, Nermin N Salkic, Petr Husa, Ivana Lazarevic, Juan A Pineda, Natalia Yurievna Pshenichnaya, Tengiz Tsertswadze, Mojca Matičič, Edmond Puca, Gulzhan Abuova, Judit Gervain, Ramin Bayramli, Salih Ahmeti, Mairi Koulentaki, Badreddine Kilani, Adriana Vince, Francesco Negro, Mustafa Sunbul, Dominique Salmon
BACKGROUND: Treatment with direct acting antiviral agents (DAAs) has provided sustained virological response rates in >95% of patients with chronic hepatitis C virus (HCV) infection. However treatment is costly and market access, reimbursement and governmental restrictions differ among countries. We aimed to analyze these differences among European and Eurasian countries. METHODS: A survey including 20-item questionnaire was sent to experts in viral hepatitis...
December 4, 2017: Antiviral Research
Jara Llenas-García, Sergio Padilla, Mar Masiá, Félix Gutiérrez
No abstract text is available yet for this article.
December 4, 2017: Enfermedades Infecciosas y Microbiología Clínica
E Rosenthal, C Fougerou-Leurent, A Renault, M P Carrieri, F Marcellin, R Garraffo, E Teicher, H Aumaitre, K Lacombe, F Bailly, E Billaud, S Chevaliez, S Dominguez, M A Valantin, J Reynes, A Naqvi, L Cotte, S Metivier, V Leroy, M Dupon, T Allegre, P De Truchis, V Jeantils, J Chas, D Salmon-Ceron, P Morlat, D Neau, P Perré, L Piroth, S Pol, M Bourlière, G P Pageaux, L Alric, D Zucman, P M Girard, I Poizot-Martin, Y Yazdanpanah, F Raffi, E Le Pabic, C Tual, A Pailhé, I Amri, E Bellissant, J M Molina
OBJECTIVES: Studies evaluating the efficacy and safety of the fixed-dose combination ledipasvir (LDV)/sofosbuvir (SOF) in patients coinfected with HIV-1 and hepatitis C virus (HCV) have mainly included treatment-naïve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment-experienced patients with and without cirrhosis. METHODS: We conducted a multicentre, open-label, double-arm, nonrandomized study in patients coinfected with HIV-1 and HCV genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens...
December 7, 2017: HIV Medicine
Sajjad Iqbal, Muhammad Haroon Yousuf, Muhammad Iftikhar Yousaf
AIM: To prospectively evaluate the efficacy of sofobuvir (SOF) in hepatitis C patients infected with hepatitis C virus (HCV) genotype 3 in Pakistan. METHODS: The present study was performed with the coordination of gastroenterology and pathology departments of Shalamar Hospital Lahore from August 2014 to May 2016. The total number of patients included in this study was 1375 and all of them were infected with HCV genotype 3. On the basis of drug combinations, all the patients were separated into two groups...
November 28, 2017: World Journal of Gastroenterology: WJG
Jianhong Chen, Xiaxia Zhang, Hao Luo, Chihong Wu, Min Yu, Dan Liu, Hongli Xi, Yihang Zhou, Yaoyu An, Xiaoyuan Xu
This study aimed to explore changes in hepatic and renal function indices in chronic hepatitis C (CHC) patients treated with direct-acting antivirals (DAAs). Forty-three CHC patients treated with sofosbuvir (SOF)-containing regimens were enrolled. At the end of treatment, the estimated glomerular filtration rate (eGFR) level was significantly decreased and the serum creatinine (Scr) and uric acid (UA) levels were significantly increased compared with baseline levels (eGFR: 86.7 ± 20.4 vs 80.5 ± 21.3, P01 = 0...
October 31, 2017: Oncotarget
G W McCaughan, P A Thwaites, S K Roberts, S I Strasser, J Mitchell, B Morales, S Mason, P Gow, A Wigg, C Tallis, G Jeffrey, J George, A J Thompson, F C Parker, P W Angus
BACKGROUND: Antiviral therapy for hepatitis C has the potential to improve liver function in patients with decompensated cirrhosis. AIMS: To examine the virological response and effect of viral clearance in patients with decompensated hepatitis C cirrhosis all with MELD scores ≥15 following sofosbuvir/daclatasvir ± ribavirin. METHODS: We prospectively collected data on patients who commenced sofosbuvir/daclatasvir for 24-weeks under the Australian patient supply program (TOSCAR) and analysed outcomes including sustained viral response at 12 weeks (SVR12), death and transplant...
December 5, 2017: Alimentary Pharmacology & Therapeutics
Sandra Beinhardt, Ramona Al-Zoairy, Karin Kozbial, Albert Friedrich Stättermayer, Andreas Maieron, Rudolf Stauber, Michael Strasser, Heinz Zoller, Ivo Graziadei, Susanne Rasoul-Rockenschaub, Michael Trauner, Peter Ferenci, Harald Hofer
BACKGROUND & AIMS: Excellent efficacy and safety-profile of second generation DAA-combinations improved treatment of chronic hepatitis C (HCV) as well as in HCV-recurrence after orthothopic liver transplantation (OLT). The need of ribavirin-addition is under debate as anemia and decreased renal function are prevalent in transplant-cohorts. Aim of this study was thus to assess safety and long-term efficacy of RBV-free DAA-combinations in HCV-recurrent patients after OLT. PATIENTS & METHODS: 62 OLT-recipients (male:50/81%; age:60...
December 2, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
Zobair M Younossi, Maria Stepanova, Linda Henry, Kwang-Hyub Han, Sang Hoon Ahn, Young-Suk Lim, Wan-Long Chuang, Jia-Horng Kao, Nguyen Kinh, Ching Lung Lai, Man-Fung Yuen, Henry Lik-Yuen Chan, Wei Lai
BACKGROUND/AIM: Interferon (IFN)-based regimens cause significant impairment of health-related quality of life (HRQL). HCV cure with IFN-free regimens improves HRQL. The effect of these regimens on HRQL in East Asian HCV patients is unclear due to lack of easy access. AIM: To assess HRQL in East Asian HCV patients treated with IFN-free regimen with sofosbuvir+ribavirin. METHODS: Patients completed Short Form-36 (SF-36) before, during and after treatment...
December 2, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
Akihiro Tamori, Seigo Abiru, Hirayuki Enomoto, Kiyohide Kioka, Masaaki Korenaga, Joji Tani, Masaru Enomoto, Masaya Sugiyama, Tsutomu Masaki, Norifumi Kawada, Hiroshi Yatsuhashi, Shuhei Nishiguchi, Masashi Mizokami
To determine the clinical characteristics of hepatitis B virus (HBV) reactivation in patients undergoing interferon-free anti-hepatitis C virus (HCV) therapy, we examined HBV DNA in 25 HBV co-infected patients and 765 patients with resolved HBV infection during and after treatment with direct-acting antiviral agents (DAAs). Among those with HCV genotype 1, asunaprevir plus daclatasvir was administered to 160 patients, sofosbuvir (SOF) plus ledipasvir to 438 patients, and paritaprevir plus ombitasvir and ritonavir to 25 patients...
November 30, 2017: Journal of Viral Hepatitis
Zobair M Younossi, Maria Stepanova, Kathleen B Schwarz, Stefan Wirth, Philip Rosenthal, Regino Gonzalez-Peralta, Karen Murray, Linda Henry, Sharon Hunt
Chronic HCV infection has been associated with impairment of health-related quality of life (HRQL) in both adults and pediatric patients. Our aim was to assess the HRQL of HCV-positive children treated with SOF+RBV. The data for this post-hoc analysis was collected in a phase 2 open-label multinational study that evaluated safety and efficacy of sofosbuvir (400mg/day) plus ribavirin (weight-based up to 1400mg/day) for 12 or 24 weeks in adolescents with chronic HCV (GS-US-334-1112). Patients and their parents/guardians completed the PedsQL-4...
November 28, 2017: Journal of Viral Hepatitis
Charles Carlton-Smith, Jacinta A Holmes, Susanna Naggie, Anna Lidofsky, Georg M Lauer, Arthur Y Kim, Raymond T Chung
Interferon (IFN)-free direct-acting antiviral agents (DAAs) have revolutionized chronic hepatitis C virus (HCV) treatment; early studies suggest excellent efficacy in acute HCV. However, changes in innate immune responses during DAA therapy for acute HCV are unknown. We studied interferon-stimulated gene (ISG) expression and related cytokines/chemokines in HIV-infected patients with acute HCV receiving sofosbuvir plus ribavirin (SOF+RBV) as part of the A5327 clinical trial. ISG expression was determined from PBMCs and circulating cytokines/chemokines were quantified from serum from study participants...
November 29, 2017: Journal of Viral Hepatitis
Raffaella Lionetti, Vincenza Calvaruso, Paola Piccolo, Rossella Letizia Mancusi, Chiara Mazzarelli, Stefano Fagiuoli, Marzia Montalbano, Ilaria Lenci, Paola Carrai, Giovanni Guaraldi, Ubaldo Visco-Comandini, Martina Milana, Marco Biolato, Laura Loiacono, Giovanna Valente, Antonio Craxì, Mario Angelico, Gianpiero D'offizi
BACKGROUND: In 2012 an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. Aim of this "real-life" study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). METHODS: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12)...
November 29, 2017: Clinical Transplantation
H Omar, W El Akel, T Elbaz, M El Kassas, K Elsaeed, H El Shazly, M Said, M Yousif, A A Gomaa, A Nasr, M AbdAllah, M Korany, S A Ismail, M K Shaker, W Doss, G Esmat, I Waked, Y El Shazly
BACKGROUND: Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment. AIM: To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting. METHODS: Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented...
November 29, 2017: Alimentary Pharmacology & Therapeutics
Alessandra Latini, Diego Orsini, Marina Ambrifi, Manuela Colafigli, Mauro Zaccarelli, Antonio Cristaudo
No abstract text is available yet for this article.
November 30, 2017: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
Bushra Munir, Bilal Ahmed, Shumaila Kiran, Fatima Jalal, Muhammad Kashif Zahoor, Saba Shehzadi, Sadaf Oranab, Sayed Kashif Kamran, Abdul Ghaffar
Hepatitis C is the most common health problem worldwide and is major cause of death due to proliferation of hepatocellular carcinoma. The medicines available for HCV treatment overcome up-to 95% complications of HCV. However, liver cancer needs some additional care. Normally Sorafenib tosylate 200 mg is recommended for liver cancer. There is no such trial in which this drug could effectively be used in combination of direct acting antivirals for HCV. The study was conducted for HCV patients (n=30) with liver cancer having decompensated stage...
November 2017: Pakistan Journal of Pharmaceutical Sciences
Destin U Lenz, Effie L Crutcher, Elisa M Greene
Sexual dysfunction is a bothersome side effect of several medications, though it has not yet been reported with the use of ledipasvir/sofosbuvir for the treatment of hepatitis C. However, sexual dysfunction is a potentially unrecognized side effect of ledipasvir/sofosbuvir that could result in nonadherence and treatment failure. We report a case of a 42-year-old man with a sudden onset of sexual dysfunction with the initiation of ledipasvir/sofosbuvir for the treatment of hepatitis C. The patient had no prior history or risk factors for the development of sexual dysfunction...
January 1, 2017: Journal of Pharmacy Practice
Z M Younossi, M Stepanova, I M Jacobson, T Asselah, E J Gane, E Lawitz, G R Foster, S K Roberts, A J Thompson, B E Willems, T M Welzel, B Pearlman, I Younossi, A Racila, L Henry
BACKGROUND: Chronic hepatitis C infection leads to impairment of patient-reported outcomes (PROs). Treatment with direct-acting antiviral regimens results in short- and long-term improvement of these outcomes. AIM: To assess PROs in patients treated with a newly developed direct-acting antiviral, a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL) with/without voxilaprevir (VOX). METHODS: The PRO data were collected from participants of POLARIS-2 and POLARIS-3 clinical trials (DAA-naïve, all HCV genotypes)...
November 27, 2017: Alimentary Pharmacology & Therapeutics
Vasily Isakov, Natalia Gankina, Viacheslav Morozov, Kathryn Kersey, Sophia Lu, Anu Osinusi, Evguenia Svarovskaia, Diana M Brainard, Riina Salupere, Elena Orlova-Morozova, Konstantin Zhdanov
BACKGROUND AND OBJECTIVES: The efficacy of < 12 weeks of hepatitis C virus (HCV) treatment in patients co-infected with HCV and human immunodeficiency virus type 1 (HIV-1) has not been established. We assessed the efficacy and safety of ledipasvir-sofosbuvir for 8 weeks in HCV mono-infected and HCV/HIV-1 co-infected patients. METHODS: We enrolled patients mono-infected with genotype 1 HCV or co-infected with HCV and HIV-1 who were HCV treatment-naive and did not have cirrhosis...
November 24, 2017: Clinical Drug Investigation
Sabrina A Assoumou, Wei Huang, Kraig Young, C Robert Horsburgh, Benjamin P Linas
BACKGROUND: Little is known about real-world outcomes for new interferon-free treatment for hepatitis C virus (HCV) among underserved and diverse communities. OBJECTIVE: To identify predictors of treatment prescription and evaluate outcomes as measured by sustained virologic response (SVR) with HCV RNA testing three months after therapy completion. DESIGN: Retrospective cohort at a safety-net health care system. PARTICIPANTS: Patients with (1) at least one clinical visit between December 6, 2013, and December 31st 2014; and (2) at least three months follow-up...
2017: Journal of Health Care for the Poor and Underserved
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