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Tyler Gleason, Sushil Ghimire, Susmita Paladugu
A 48-year-old man with a history of intravenous drug use and chronic, untreated hepatitis C presented to the emergency room with acute bilateral lower extremity swelling, erythema and maculopapular rash. Serum C4 levels were low, but dermatology felt the rash was due to venous stasis dermatitis. The patient was discharged with compression stockings, but returned to the hospital 5 days later with no improvement in his symptoms. A more extensive laboratory workup revealed hepatitis C viral load of 4 million, elevated serum cryoglobulins, and skin biopsy showing leucocytoclastic vasculitis...
March 27, 2017: BMJ Case Reports
Nisreen F Abo-Talib, Mohamed R El-Ghobashy, Marwa H Tammam
Sofosbuvir and ledipasvir are the first drugs in a combination pill to treat chronic hepatitis C virus. Simple, sensitive, and rapid spectrophotometric methods are presented for the determination of sofosbuvir and ledipasvir in their combined dosage form. These methods were based on direct measurement of ledipasvir at 333 nm (due to the lack of interference of sofosbuvir) over a concentration range of 4.0–14.0 μg/mL, with a mean recovery of 100.78 ± 0.64%. Sofosbuvir was determined, without prior separation, by third-derivative values at 281 nm; derivative ratio values at 265...
February 10, 2017: Journal of AOAC International
Sergio Vicente-Sánchez, Laura Menéndez Naranjo
No abstract text is available yet for this article.
March 1, 2017: Farmacia Hospitalaria
Qinjie Weng, Xiao Li, Hong Ren, Jingyuan Xie, Xiaoxia Pan, Jing Xu, Nan Chen
BACKGROUND: Membranous nephropathy (MN) is the most common cause of nephrotic syndrome in adults. As many clinical cases have reported, it may be associated with hepatitis C virus (HCV) infection. Antiviral therapy can be various. CASE SUMMARY: We report a case of patient with chronic HCV infection and MN, who presented with was proteinuria. He was treated with ledipasvir and sofosbuvir (Harvoni; Gilead Sciences, Foster City, CA) and was found to be virus-free. CONCLUSION: We have reported this case to provide insight into whether Ledipasvir-Sofosbuvir should be administered for HCV-related glomerulonephritis...
March 28, 2017: Oncotarget
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...
November 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...
January 11, 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
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