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L P Zanaga, N Miotto, L C Mendes, R S B Stucchi, A G Vigani
Hepatitis C virus (HCV) genotype 3 is responsible for 30.1% of chronic hepatitis C infection cases worldwide. In the era of direct-acting antivirals, these patients have become one of the most challenging to treat, due to fewer effective drug options, higher risk of developing cirrhosis and hepatocellular carcinoma and lower sustained virological response (SVR) rates. Currently there are 4 recommended drugs for the treatment of HCV genotype 3: pegylated interferon (PegIFN), sofosbuvir (SOF), daclatasvir (DCV) and ribavirin (RBV)...
October 24, 2016: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
Adriano M Pellicelli, Valeria Pace Palitti, Pascal Vignally, Francesca Ceccherini-Silberstain, Massimo Siciliano, Valerio Giannelli, Alessandra Moretti, Pierluigi Tarquini, Gaetano Scifo, Vincenzo Messina, Antonio Ascione, Antonio Izzi, Massimo Marignani, Cecilia D'Ambrosio, Lucia Fondacaro, Giuseppe M Ettorre, Pasquale Ialongo, Rodolfo Sacco, Carlo Federico Perno, Giorgio Barbarini
BACKGROUND AND AIMS: The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir (SOF) and Simeprevir (SMV) plus a flat dose of 800 mg/d ribavirin (RBV) in elderly patients with liver cirrhosis compared to younger patients. METHODS: Retrospective observational multicenter real life investigation study of SOF/SMV/RBV for a duration of 12 weeks in HCV genotype 1-infected patients with liver cirrhosis...
October 26, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
Feng Su, Pamela K Green, Kristin Berry, George N Ioannou
: Black race and Hispanic ethnicity were associated with lower rates of sustained virologic response (SVR) to interferon (IFN)-based treatments for chronic hepatitis C virus (HCV) infection whereas Asian race was associated with higher SVR rates compared to white patients. We aimed to describe the association between race/ethnicity and effectiveness of new direct-acting antiviral (DAA) regimens in the Veterans Affairs (VA) healthcare system nationally. We identified 21,095 HCV-infected patients (11,029 [52%] white, 6,171 [29%] black, 1,187 [6%] Hispanic, 348 [2%] Asian/Pacific Islander/American Indian/Alaska Native [Asian/PI/AI/AN] and 2,360 [11%] declined/missing race or ethnicity) who initiated antiviral treatment with regimens containing sofosbuvir (SOF), simeprevir + sofosbuvir (SMV+SOF), ledipasvir/sofosbuvir (LDV/SOF) or paritaprevir/ombitasvir/ritonavir/dasabuvir (PrOD), during the 18-month period from 01/01/2014 to 06/30/2015...
October 24, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Eric Lawitz, Fred Poordad, Julio A Gutierrez, Jennifer T Wells, Carmen E Landaverde, Barbara Evans, Anita Howe, Hsueh-Cheng Huang, Jerry Jing Li, Peggy Hwang, Frank J Dutko, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber
Direct-acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C-SWIFT study was to identify the minimum effective treatment duration across multiple genotypes. C-SWIFT was an open-label, single-center trial in treatment-naïve patients with chronic HCV genotype (GT)1 or 3 infection. All patients received elbasvir (EBR) 100 mg/grazoprevir (GZR) 50 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks...
October 22, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Gavin Cloherty, Stephane Chevaliez, Christoph Sarrazin, Christine Herman, Vera Holzmayer, George Dawson, Benjamin Maasoumy, Johannes Vermehren, Heiner Wedemeyer, Jordan J Feld, Jean-Michel Pawlotsky
Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV) includes the truncation of therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic patients with baseline HCV RNA levels <6 million IU/mL (6.8 log10 IU/mL). The aim of this study was to evaluate this clinical cutoff with a different widely used commercially available HCV RNA test. Results from samples tested prospectively with Roche High Pure TaqMan HCV 2.0 test (HPS) were compared to those tested retrospectively with the Abbott RealTime HCV RNA test (ART)...
October 20, 2016: Scientific Reports
Jérôme Dumortier, François Bailly, Georges-Philippe Pageaux, Anaïs Vallet-Pichard, Sylvie Radenne, François Habersetzer, Marie-Claude Gagnieu, Jean-Didier Grangé, Anne Minello, Olivier Guillaud, Nassim Kamar, Laurent Alric, Vincent Leroy
BACKGROUND: Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, second-generation direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCV-infected patients with severe renal failure [including haemodialysis (HD) patients]...
October 19, 2016: Nephrology, Dialysis, Transplantation
Y Wang, P Liu
WHAT IS KNOWN AND THE OBJECTIVE: Sofosbuvir (SOF) and daclatasvir (DCV) have revolutionized the treatment of hepatitis C virus and now represent the preferred therapy for this disease. Limited data are available on the dermatological side effects resulting from co-administration of SOF and DCV. CASE DESCRIPTION: We report a case of an erythema multiforme drug eruption associated with erythrodermic psoriasis induced by SOF and DCV. After ceasing treatment, the skin condition significantly improved...
October 18, 2016: Journal of Clinical Pharmacy and Therapeutics
Michele B Kaufman
Obeticholic acid (Ocaliva) for primary biliary cholangitis; sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa) for chronic hepatitis C virus infection; and daclizumab (Zinbryta) for relapsing multiple sclerosis.
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
Naoshi Nishida, Masashi Kono, Tomohiro Minami, Hirokazu Chishina, Tadaaki Arizumi, Masahiro Takita, Norihisa Yada, Hiroshi Ida, Satoru Hagiwara, Yasunori Minami, Kazuomi Ueshima, Tashiharu Sakurai, Masatoshi Kudo
BACKGROUND: An interferon-free regimen including sofosbuvir and ribavirin (RBV) for patients with hepatitis C virus (HCV) genotype 2 (G2) infection leads to a drastic improvement of sustained virological response (SVR). However, the safety, tolerability, and efficacy in patients aged 75 or older have not been completely understood. SUMMARY: Fifty-six patients with HCV G2 infection who were treated with sofosbuvir and weight-based dose of RBV were enrolled. Thirty-seven patients aged ≥75 and 19 patients aged ≤74 were classified as the aged and non-aged groups, respectively...
2016: Digestive Diseases
Kayo Sugimoto, Soo Ki Kim, Soo Ryang Kim, Mana Kobayashi, Airi Kato, Eri Morimoto, Susumu Imoto, Chi Wan Kim, Yasuhito Tanaka, Masatoshi Kudo, Yoshihiko Yano, Yoshitake Hayashi
OBJECTIVES: The efficacy of sofosbuvir plus ribavirin (RBV) treatment for hepatitis C virus (HCV) genotype 2 focusing on virological response was compared with that of pegylated interferon (peg-IFN) plus RBV treatment. Safety of the former focusing on the decline in hemoglobin levels was compared with that of the latter and assessed in terms of age and inosine triphosphatase (ITPA). METHODS: Patients (n = 17) receiving sofosbuvir plus RBV and those (n = 24) receiving peg-IFN plus RBV diagnosed with chronic HCV genotype 2 were enrolled in this study, and the efficacy and safety of both treatments were assessed...
2016: Digestive Diseases
Yundong Qu, Ying Guo, Tao Li, Qian Ye, Chao Sun, Lei Wang, Baohua Yang
BACKGROUND AND AIM: To assess the efficacy and safety of sofosbuvir-based interferon-free therapies in liver transplantation recipients with hepatitis C virus infection recurrence. METHODS: A systematic literature search was conducted in PubMed, EMBASE, Web of Science, and CENTRAL on the Cochrane Library without time or language limitation. The search strategy used was "sofosbuvir AND transplantation". Sustained virologic response at 12 weeks after the end of treatment (SVR12) rate, incidence of serious adverse events (SAEs) and/or adverse events (AEs), discontinuation rate with 95% confidence intervals (CI) were pooled with random-effects model...
October 17, 2016: Journal of Gastroenterology and Hepatology
Kendall R Beck, Nicole Kim, Mandana Khalili
BACKGROUND: Vulnerable populations are disproportionately affected by hepatitis C virus (HCV) infection and experience high rates of health disparity. There are no data on real-world experience with highly efficacious direct-acting anti-HCV treatment in this population. AIMS: We aimed to evaluate the real-world experience with sofosbuvir-based regimens among a vulnerable HCV-infected population. METHODS: HCV treatment response was assessed among 204 patients who completed 12-24 weeks of sofosbuvir-based regimens (in combination with pegylated interferon and ribavirin, simeprevir, ledipasvir, or daclatasvir) at the San Francisco safety-net healthcare system liver specialty clinic between January 2014 and December 2015...
October 14, 2016: Digestive Diseases and Sciences
L Benítez-Gutiérrez, C de Mendoza, I Baños, A Duca, A Arias, A Treviño, S Requena, M J Citores, V Cuervas-Mons
New direct-acting antivirals (DAAs) have dramatically improved sustained virologic response (SVR) rates in patients treated for chronic hepatitis C. Although the safety of these agents has been very good in registration trials, unexpected side effects have been reported after much broader use of DAAs on marketing. We retrospectively examined all liver transplant recipients with chronic hepatitis C that received sofosbuvir-based regimens at our clinic. A total of 24 liver transplant recipients with recurrent chronic hepatitis C had received sofosbuvir up to April 2015...
September 2016: Transplantation Proceedings
Zobair M Younossi, Haesuk Park, Douglas Dieterich, Sammy Saab, Aijaz Ahmed, Stuart C Gordon
BACKGROUND: New direct-acting antiviral (DAA) therapy has dramatically increased cure rates for patients infected with hepatitis C virus (HCV), but has also substantially raised treatment costs. AIM: The aim of this analysis was to evaluate the therapeutic benefit and net costs (i.e. efficiency frontier) and the quality-adjusted cost of care associated with the evolution of treatment regimens for patients with HCV genotype 1 in the United States. DESIGN: A decision-analytic Markov model...
October 2016: Medicine (Baltimore)
Christoph Sarrazin, Vasily Isakov, Evguenia Svarovskaia, Charlotte Hedskog, Ross Martin, Krishna Chodavarapu, Diana M Brainard, Michael D Miller, Hongmei Mo, Jean-Michel Molina, Mark S Sulkowski
BACKGROUND:  Development of direct-acting antivirals in recent years has dramatically enhanced rates of viral eradication to >90% in patients with chronic hepatitis C virus (HCV) infection. To determine true treatment efficacy and to define the most appropriate retreatment, it is important to distinguish virologic relapse from reinfection where patients who achieve HCV eradication during treatment become infected with a new HCV strain posttreatment. METHODS:  Here, we investigated prevalence of late recurrent viremia (patients who achieved SVR12 but had detectable HCV RNA at follow up week 24) and used refined phylogenetic analysis of multiple HCV genes to distinguish virologic relapse from reinfection...
October 12, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Yun Tong, Ye Kyung Song, Stephen Tyring
No abstract text is available yet for this article.
October 12, 2016: JAMA Dermatology
E B Tapper, B R Bacon, M P Curry, D T Dieterich, S L Flamm, L E Guest, K V Kowdley, Y Lee, N C Tsai, Z M Younossi, N H Afdhal
Early data regarding the "real-world" experience with novel therapies for hepatitis C (HCV) are encouraging. Data are still limited, however, regarding real-world rates of sustained virologic response (SVR) for ledipasvir-sofosbuvir (LDV-SOF), particularly for patients with prior treatment failure. We performed a retrospective cohort study of 1597 patients with chronic genotype 1 HCV who were treated using 12 weeks of the following regimens LDV-SOF±ribavirin (RBV) (n=1521 without RBV, n=76 with RBV). The primary outcome was SVR-determined at 12 weeks in an intention-to-treat design...
October 11, 2016: Journal of Viral Hepatitis
M P Economides, P Mahale, A Kyvernitakis, F Turturo, H Kantarjian, A Naing, J Hosry, T L Shigle, A Kaseb, H A Torres
BACKGROUND: Antiviral therapy improves hepatic outcomes in hepatitis C virus (HCV)-infected cancer patients. However, such patients are not treated simultaneously with antivirals and chemotherapy, owing to overlapping toxicities with previous standard of care treatment of pegylated interferon and ribavirin. AIM: To examine the safety and clinically-significant drug-drug interactions observed in patients who received simultaneous treatment with direct-acting antivirals (DAAs) and chemotherapy...
October 11, 2016: Alimentary Pharmacology & Therapeutics
Sarah L Greig
A once-daily, single-tablet, pangenotypic regimen comprising the hepatitis C virus (HCV) NS5B polymerase inhibitor sofosbuvir and the HCV NS5A inhibitor velpatasvir (sofosbuvir/velpatasvir; Epclusa(®)) was recently approved for the treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in the USA, EU and Canada. In the phase III ASTRAL trials, once-daily oral sofosbuvir/velpatasvir for 12 weeks provided very high rates of sustained virological response at 12 weeks post treatment (SVR12) in treatment-naive and -experienced patients with chronic HCV genotype 1-6 infection, including those with compensated cirrhosis or HIV-1 co-infection...
October 11, 2016: Drugs
Reina Sasaki, Tatsuo Kanda, Masayuki Ohtsuka, Shin Yasui, Yuki Haga, Masato Nakamura, Masayuki Yokoyama, Shuang Wu, Shingo Nakamoto, Makoto Arai, Hitoshi Maruyama, Masaru Miyazaki, Osamu Yokosuka
Direct-acting antivirals (DAAs) are relatively safe and highly effective for the eradication of hepatitis C virus (HCV) in liver transplant recipients. In this case study, we present a female with a graft reinfected with HCV genotype 2 who was treated with a combination of sofosbuvir and ribavirin after living donor liver transplantation (LDLT). Because the graft was from a hepatitis B core antibody-positive donor, passive immunization with hyperimmune hepatitis B immunoglobulin (HBIG) and entecavir were also provided to prevent hepatitis B virus (HBV) reactivation...
May 2016: Case Reports in Gastroenterology
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