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Direct antiviral agents

Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
Daniel Todt, Stephanie Walter, Richard J P Brown, Eike Steinmann
Hepatitis E virus (HEV), an important agent of viral hepatitis worldwide, can cause severe courses of infection in pregnant women and immunosuppressed patients. To date, HEV infections can only be treated with ribavirin (RBV). Major drawbacks of this therapy are that RBV is not approved for administration to pregnant women and that the virus can acquire mutations, which render the intra-host population less sensitive or even resistant to RBV. One of the proposed modes of action of RBV is a direct mutagenic effect on viral genomes, inducing mismatches and subsequent nucleotide substitutions...
October 13, 2016: Viruses
Emma Hathorn, Ahmed M Elsharkawy
Genotype 4 chronic hepatitis C (G4 HCV) accounts for 13% of worldwide HCV infections; with 10 million people infected with the virus across the world. Up to the end of 2013, the only treatment option for G4 HCV was treatment with pegylated interferon and ribavirin for 24-48 weeks. Since late 2013, treatment of G4 HCV has been transformed by the licensing of many directly acting antiviral agents (DAA). It is an exciting time to be involved in the management of HCV generally and G4 particularly. Interferon-free DAA regimens are now a reality for G4 HCV...
2016: BMJ Open Gastroenterology
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
Perica Davitkov, Apoorva Krishna Chandar, Amy Hirsch, Anita Compan, Marina G Silveira, Donald D Anthony, Suzanne Smith, Clare Gideon, Robert A Bonomo, Yngve Falck-Ytter
BACKGROUND: Clinicians often face dilemmas with decisions related to formulary choices when two similar drugs are simultaneously available in the market. We studied the comparative safety, effectiveness, and treatment costs of the two first generation direct-acting antiviral agents (DAA), boceprevir and telaprevir as uncertainty existed regarding the drug of choice between these two seemingly equally Hepatitis-C treatment options. METHODS: We randomly assigned 50 patients in an open-label, pragmatic randomized controlled trial (RCT) at a VA Medical Center to either boceprevir or telaprevir in combination with peginterferon and ribavirin, stratified by the presence of cirrhosis and prior treatment experience...
2016: PloS One
Maria Stepanova, Trevor Locklear, Nila Rafiq, Alita Mishra, Chapy Venkatesan, Zobair M Younossi
BACKGROUND: Chronic HCV infection is often considered a contraindication for receiving a heart transplantation. METHODS: From the Scientific Registry of Transplant Recipients, we selected all adults with and without HCV infection who underwent a single organ heart transplantation in 1995-2013; the mortality status was updated in September 2015. RESULTS: A total of 32,812 heart transplant recipients were included; N=756 (2.30%) HCV-positive...
October 14, 2016: Clinical Transplantation
Zhuoran Zhang, Enzhuo Yang, Chunmiao Hu, Han Cheng, Crystal Y Chen, Dan Huang, Richard Wang, Yue Zhao, Lijun Rong, Marco Vignuzzi, Hongbo Shen, Ling Shen, Zheng W Chen
While we are approaching the global eradication of circulating wild-type polioviruses(PV), vaccination with oral poliovirus vaccine (OPV) has led to emergence of circulating vaccine-derived poliovirus (cVDPV) and vaccine-associated paralytic poliomyelitis (VAPP). Complete cessation of all poliovirus infections may require stopping use of OPV and formulating improved vaccines and new antiviral drugs. Currently, no licensed drugs are available to treat chronically infected poliovirus excretors. Here, we created a modified PV expressing Gaussia Luciferase (PV-GLuc) and developed a cell-based high-throughput screening (HTS) antiviral assay...
October 12, 2016: ACS Infectious Diseases
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
Iain A Kaan, Geoffrey McCaughan, Tracey Jones
OBJECTIVE: To determine the likely current capacity of accredited treatment centres in treating hepatitis C (HCV) patients with Interferon free Direct Acting (DAA) Antiviral agents in Australia. METHOD: Data was collected from 22 centres before the introduction of DAA therapy - 11 sites from the Study 1 survey and an additional 11 sites from the Study 2 survey. The sites were selected based on consensus by viral hepatitis experts, in consultation with the NSW Agency for Clinical Innovation...
September 26, 2016: Internal Medicine Journal
L Rostaing, L Alric, N Kamar
In some parts of the world, hepatitis C virus (HCV) infection remains a huge problem for kidney-transplant candidates and kidney-transplant (KT) recipients. Until 2 years ago, anti-HCV treatment for the general population relied on pegylated-alpha-interferon plus ribavirin, but led to a sustained viral response (SVR) in <50% of cases. This treatment was contraindicated in KT patients because of acute-rejection issues and was poorly tolerated in patients with end-stage renal disease. Over the last year, direct-acting antiviral agents (DAAs) have entered the market and are associated in the general population with a SVR of >90%, whatever the patient's HCV genotype...
October 7, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
Rasha Eletreby, Wafaa Elakel, Mohamed Said, Mohamed Elkassas, Sameh Seif, Tamer Elbaz, Maissa El Raziky, Siham Abdel Rehim, Samy Zaky, Rabab Fouad, Hadeel Gamal, Mahmoud Abdo, Mohamed Korany, Ayman Yosry, Magdy El Serafy, Manal Hamdy El-Sayed, Yehia ElShazly, Imam Waked, Wahid Doss, Gamal Esmat
BACKGROUND & AIM: Major changes have emerged during the last few years in the therapy of chronic HCV. Several direct acting antiviral agents have been developed showing potent activity with higher rates of sustained virological response (SVR), even in difficult-to-treat patients. This study explores real life experience concerning efficacy, safety and possible predictors of response for the first cohort of Egyptian patients with chronic HCV genotype IV treated with Sofosbuvir / Simprevir combination therapy...
October 6, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
Ennio Polilli, Valeria Cento, Umberto Restelli, Francesca Ceccherini-Silberstein, Marianna Aragri, Velia Chiara Di Maio, Antonina Sciacca, Fiorenzo Santoleri, Paolo Fazii, Alberto Costantini, Carlo Federico Perno, Giustino Parruti
Available commercial assays may yield inaccurate hepatitis C virus (HCV) genotype assignment in up to 10% of cases. We investigated the cost-effectiveness of re-evaluating HCV genotype by population sequencing, prior to choosing a direct acting antiviral (DAA) regimen. Between March and September 2015, HCV sequence analysis was performed in order to confirm commercial LiPA-HCV genotype (Versant(®) HCV Genotype 2.0) in patients eligible for treatment with DAAs. Out of 134 consecutive patients enrolled, sequencing yielded 21 (15...
2016: ClinicoEconomics and Outcomes Research: CEOR
Asuncion Mejias, Cristina Garcia-Maurino, Rosa Rodriguez-Fernandez, Mark E Peeples, Octavio Ramilo
Respiratory syncytial virus (RSV) remains a significant cause of morbidity and mortality in infants and young children, immunocompromised patients and the elderly. Despite the high disease burden, an effective and safe vaccine is lacking, although several candidates are currently in development. Current treatment for RSV infection remains largely supportive and RSV-specific options for prophylaxis are limited to palivizumab. In the past few years, novel therapeutic options including nanobodies, polyclonal and monoclonal antibodies have emerged and there are several products in preclinical and Phase-I, -II or -III clinical trials...
September 27, 2016: Vaccine
Stefan Mauss, Florian Berger, Malte H Wehmeyer, Patrick Ingiliz, Dietrich Hueppe, Thomas Lutz, Karl G Simon, Knud Schewe, Juergen K Rockstroh, Axel Baumgarten, Stefan Christensen
HCV has complex interactions with human lipid metabolism leading to down regulation of cholesterol levels. Interferon therapy has been shown to decrease cholesterol even further. With the availability of second generation direct acting antiviral agents (DAA) the effect of suppressing and eliminating HCV on lipid metabolism warrants reevaluation. 
Methods: Prospective German multicenter cohort on HCV- and HIV/HCV-infected patients treated with direct antiviral agents (GECCO). Lipids were assessed at baseline, during and after therapy...
September 29, 2016: Antiviral Therapy
Patrícia Andrade, Fernando Príncipe, Guilherme Macedo
No abstract text is available yet for this article.
September 28, 2016: Journal of Clinical Gastroenterology
Jacqueline A Bachofner, Piero V Valli, Arne Kröger, Irina Bergamin, Patrizia Künzler, Adriana Baserga, Dominique Braun, Burkhardt Seifert, Anja Moncsek, Jan Fehr, David Semela, Lorenzo Magenta, Beat Müllhaupt, Benedetta Terziroli Beretta-Piccoli, Joachim C Mertens
BACKGROUND: 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. METHODS: 549 patients who received a DAA based treatment for CHC were screened and 392 were included...
September 28, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
Sven Mensing, Doerthe Eckert, Shringi Sharma, Akshanth R Polepally, Amit Khatri, Thomas J Podsadecki, Walid M Awni, Rajeev M Menon, Sandeep Dutta
AIM: To characterize the population pharmacokinetics of a triple direct-acting antiviral (DAA) regimen (3D) (ombitasvir, paritaprevir-ritonavir, and dasabuvir) and adjunctive ribavirin and estimate covariate effects in a broad spectrum of subjects with hepatitis C virus (HCV) genotype 1 infection. METHODS: Pharmacokinetic data from six phase 3 studies and one phase 2 study in subjects receiving the currently approved doses of the 3D ± ribavirin regimen for treating HCV genotype 1 infection for 12 or 24 weeks were characterized using separate population pharmacokinetic models built using each component of the regimen from non-linear mixed-effects methodology in NONMEM 7...
September 23, 2016: British Journal of Clinical Pharmacology
Mohamed El Kassas, Tamer Elbaz, Enas Hafez, Gamal Esmat
Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introduction of various directly acting antiviral agents. Areas covered: Recent direct antiviral agents (DAAs) primarily target the non-structural proteins of the virus and affect its replication. These agents successfully achieve a sustained virologic response...
October 6, 2016: Expert Opinion on Drug Safety
Jagpreet Chhatwal, Tianhua He, Chin Hur, Maria A Lopez-Olivo
BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are effective in treatment of hepatitis C virus (HCV) genotype 1 infection, but their cost and value have been debated. We performed a systematic review of published cost-effectiveness analyses of DAAs, synthesized their results with updated drug prices, and calculated the maximum price at which DAA therapy for HCV genotype 1 infection is cost effective (increased quality-adjusted life-years [QALYs]) and increased cost that the society is willing to pay) and cost saving (increased QALYs and decreased costs)...
September 17, 2016: Clinical Gastroenterology and Hepatology
Manuel Tsiang, Gregg S Jones, Joshua Goldsmith, Andrew Mulato, Derek Hansen, Elaine Kan, Luong Tsai, Rujuta A Bam, George Stepan, Kirsten M Stray, Anita Niedziela-Majka, Stephen R Yant, Helen Yu, George Kukolj, Tomas Cihlar, Scott Lazerwith, Kirsten L White, Haolun Jin
Bictegravir (BIC; GS-9883), a novel potent, once-daily, unboosted inhibitor of HIV-1 integrase (IN) specifically targets IN strand transfer activity (IC50 = 7.5 ± 0.3 nM) and HIV-1 integration in cells. BIC exhibits potent and selective in vitro antiretroviral activity in both T-cell lines and primary human T-lymphocytes with EC50 values ranging from 1.5 to 2.4 nM and selectivity indices up to 8800 relative to cytotoxicity. BIC exhibits synergistic in vitro antiviral effects in pairwise combinations with tenofovir alafenamide, emtricitabine or darunavir and maintains potent antiviral activity against HIV-1 variants resistant to other classes of antiretrovirals...
September 19, 2016: Antimicrobial Agents and Chemotherapy
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