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Stanton R Mehr
After the introductions of sofosbuvir (Sovaldi) and ledipasvir plus sofosbuvir (Harvoni) for the treatment of hepatitis C, employers have become very sensitive to new, and especially unforeseen, factors that significantly raise healthcare costs. With the recent launch of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, self-insured and fully insured employers have been seeking information on this drug class and its potential for off-label use, which could amount to up to $23 billion in healthcare expenditures, according to a report from Prime Therapeutics...
May 2016: American Health & Drug Benefits
(no author information available yet)
No abstract text is available yet for this article.
June 2016: Prescrire International
S N Zhou, N Zhang, Z W Liu, D L Zhang, R J Tang, H B Su, M Zhang
No abstract text is available yet for this article.
May 20, 2016: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
Lisa Baumann, Susanne Haen, Christoph Berg, Ferruh Artunc, Reimer Riessen, Werner Spengler, Falko Fend, Michael Haap
HISTORY AND ADMISSION FINDINGS: We report on a 48-year-old man presenting with progressive hepatopathy and encephalopathy for two weeks based on a chronic hepatitis C. He takes ledipasvir and sofosbuvir (Harvoni) and ribavirin for almost 24 weeks. After admission to hospital his state deteriorated rapidly. He is directly transferred to the medical intensive care unit, where he died on day 3. INVESTIGATIONS: During the physical examination, a pronounced jaundice and significant peripheral edema were found...
July 2016: Deutsche Medizinische Wochenschrift
Guo-Feng Chen, Lai Wei, Jing Chen, Zhong-Ping Duan, Xiao-Guang Dou, Qing Xie, Wen-Hong Zhang, Lun-Gen Lu, Jian-Gao Fan, Jun Cheng, Gui-Qiang Wang, Hong Ren, Jiu-Ping Wang, Xing-Xiang Yang, Zhan-Sheng Jia, Qing-Chun Fu, Xiao-Jin Wang, Jia Shang, Yue-Xin Zhang, Ying Han, Ning Du, Qing Shao, Dong Ji, Fan Li, Bing Li, Jia-Liang Liu, Xiao-Xia Niu, Cheng Wang, Vanessa Wu, April Wong, Yu-Dong Wang, Jin-Lin Hou, Ji-Dong Jia, Hui Zhuang, George Lau
BACKGROUND: Little is known on the cost-effectiveness of novel regimens for hepatitis C virus (HCV) compared with standard-of-care with pegylated interferon (pegIFN) and ribavirin (RBV) therapy in developing countries. We evaluated cost-effectiveness of sofosbuvir/ledipasvir for 12 weeks compared with a 48-week pegIFN-RBV regimen in Chinese patients with genotype 1b HCV infection by economic regions. METHODS: A decision analytic Markov model was developed to estimate quality-adjusted-life-years, lifetime cost of HCV infection and incremental cost-effectiveness ratios (ICERs)...
2016: PloS One
Polina German, Anita Mathias, Diana Brainard, Brian P Kearney
Ledipasvir/sofosbuvir (Harvoni(®)), a fixed-dose combination tablet of an NS5A inhibitor ledipasvir and an NS5B polymerase inhibitor sofosbuvir, is approved in the US, European Union, Canada, and other regions for the treatment of chronic hepatitis C virus infection in adults. Following absorption, ledipasvir reaches maximum plasma concentrations (T max) 4-4.5 h post-dose and is eliminated with a terminal half-life (t 1/2) of 47 h. Sofosbuvir undergoes intracellular activation to an active triphosphate GS-461203 (not detected in plasma) and ultimately to GS-331007, a predominant circulating metabolite, which is the primary analyte of interest in clinical pharmacology studies...
May 18, 2016: Clinical Pharmacokinetics
(no author information available yet)
No abstract text is available yet for this article.
January 4, 2016: Medical Letter on Drugs and Therapeutics
Xingquan Zhang
Unlike human immunodeficiency virus (HIV) and hepatitis B virus (HBV), hepatitis C virus (HCV) infection is a curable disease. Current direct antiviral agent (DAA) targets are focused on HCV NS3/4A protein (protease), NS5B protein (polymerase) and NS5A protein. The first generation of DAAs includes boceprevir and telaprevir, which are protease inhibitors and were approved for clinical use in 2011. The cure rate for genotype 1 patients increased from 45% to 70% when boceprevir or telaprevir was added to standard PEG-IFN/ribavirin...
January 2016: Acta Pharmaceutica Sinica. B
Guofeng Cheng, Yang Tian, Brian Doehle, Betty Peng, Amoreena Corsa, Yu-Jen Lee, Ruoyu Gong, Mei Yu, Bin Han, Simin Xu, Hadas Dvory-Sobol, Michel Perron, Yili Xu, Hongmei Mo, Nikos Pagratis, John O Link, William Delaney
Ledipasvir (LDV; GS-5885), a component of Harvoni (a fixed-dose combination of LDV with sofosbuvir [SOF]), is approved to treat chronic hepatitis C virus (HCV) infection. Here, we report key preclinical antiviral properties of LDV, including in vitro potency, in vitro resistance profile, and activity in combination with other anti-HCV agents. LDV has picomolar antiviral activity against genotype 1a and genotype 1b replicons with 50% effective concentration (EC50) values of 0.031 nM and 0.004 nM, respectively...
March 2016: Antimicrobial Agents and Chemotherapy
(no author information available yet)
Treatment for chronic hepatitis C depends on the hepatitis C virus (HCV) genotype and the patient's clinical characteristics. A fixed-dose combination of ledipasvir + sofosbuvir has been authorised in the European Union for adults with HCV genotype 1 (HCV-1), HCV-3 or HCV-4 infection. Ledipasvir targets the HCV protein NS5A, while sofosbuvir inhibits the HCV RNA polymerase NS5B. The ledipasvir+ sofosbuvircombination has not been compared directly with other antiviral drugs. No information is available on its ability to prevent hepatic complications, even in patients with cirrhosis...
December 2015: Prescrire International
Rimda Wanchoo, Jyotsana Thakkar, Daniel Schwartz, Kenar D Jhaveri
No abstract text is available yet for this article.
January 2016: American Journal of Gastroenterology
Lisa A Raedler
No abstract text is available yet for this article.
March 2015: American Health & Drug Benefits
Caitlin Mullins, Whitney Gibson, Olga M Klibanov
No abstract text is available yet for this article.
November 15, 2015: Nurse Practitioner
Thomas McQuaid, Carolyn Savini, Star Seyedkazemi
Nucleotide compounds like sofosbuvir, acyclovir, and tenofovir have proven to be amongst the most potent orally available antiviral treatments. These drugs exhibit high efficacy and a wide therapeutic index, with demonstrated utility in a number of chronic viral infections. The approval of Sovaldi™, brand name for sofosbuvir, by the U.S. Food and Drug Administration heralded improvements in chronic hepatitis C virus (HCV) treatment. Sofosbuvir was originally discovered by Pharmasset Corporation and named PSI-7977...
March 2015: Journal of Clinical and Translational Hepatology
Brian P Lam, Thomas Jeffers, Zahra Younoszai, Yousef Fazel, Zobair M Younossi
Chronic hepatitis C (CHC) affects over 185 million individuals worldwide, approximately 3% of the world's population. CHC can lead to quality of life impairment, cirrhosis, hepatocellular carcinoma (HCC), liver failure and liver-related death. While CHC has been associated with increases in HCC, liver-related mortality and all-cause mortality, being cured of CHC is associated with improvement in these outcomes. Older interferon-based regimens were complex and toxic and required 6-12 months of therapy, with cure rates averaging around 40-45% for HCV genotype 1...
September 2015: Therapeutic Advances in Gastroenterology
Albert Do, Yash Mittal, AnnMarie Liapakis, Elizabeth Cohen, Hong Chau, Claudia Bertuccio, Dana Sapir, Jessica Wright, Carol Eggers, Kristine Drozd, Maria Ciarleglio, Yanhong Deng, Joseph K Lim
BACKGROUND: New treatments for hepatitis C (HCV) infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications. MATERIALS AND METHODS: We performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/LED) from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times...
2015: PloS One
Sai Zhang, Nathaniel D Bastian, Paul M Griffin
BACKGROUND: The standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80% to 95%, though with a substantial increase in cost...
2015: BMC Gastroenterology
Hui-Chun Li, Shih-Yen Lo
More than twenty years of study has provided a better understanding of hepatitis C virus (HCV) life cycle, including the general properties of viral RNA and proteins. This effort facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. Quantization and genotyping of HCV RNAs are important to determine the optimal duration of anti-viral therapy and predict the likelihood of response...
June 8, 2015: World Journal of Hepatology
Bennett C Noell, Siddesh V Besur, Andrew S deLemos
The availability of direct-acting antiviral (DAA) therapy has launched a new era in the management of chronic hepatitis C. Sofosbuvir, a uridine nucleotide analog that inhibits the hepatitis C RNA-dependent RNA polymerase, is the backbone of chronic hepatitis C therapy. Acting at the catalytic site of the polymerase, sofosbuvir is highly potent in suppressing viral replication and has a high genetic barrier to resistance. Sofosbuvir is effective across all hepatitis C genotypes, and is a mainstay of interferon-free combination therapy...
2015: Drug Design, Development and Therapy
Massimo Colombo
The long awaited all-oral therapy for hepatitis C virus infection has officially been inaugurated by the registration of the hepatitis C nucleotide inhibitor sofosbuvir in a combination regimen with ribavirin. More recently, the oral array to treat hepatitis C has been enriched by the arrival of the NS5A inhibitors ledipasvir (also in a single formulation with sofosbuvir, Harvoni(®)) and daclatasvir; the protease inhibitor simeprevir, and the Viekirax(®)+Exviera™ regimen based on the ritonavir boosted protease inhibitor paritaprevir; the NS5A inhibitor ombitasvir, and the non-nucleoside inhibitor dasabuvir...
September 2015: Digestive and Liver Disease
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