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https://www.readbyqxmd.com/read/28925327/treatment-of-chronic-hepatitis-c-virus-infection-with-crushed-ledipasvir-sofosbuvir-administered-via-a-percutaneous-endoscopic-gastrostomy-tube
#1
Lauren Jindracek, Jennifer Stark
INTRODUCTION: Ledipasvir/sofosbuvir (Harvoni®) is a fixed-dose tablet indicated for the treatment of chronic hepatitis C virus (HCV) infection. There are currently no data available on the safety and efficacy of crushed ledipasvir/sofosbuvir tablets. CASE SUMMARY: This report describes the first documented case of successful treatment of chronic HCV infection in a patient crushing ledipasvir/sofosbuvir for administration via a percutaneous endoscopic gastrostomy (PEG) tube...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28901852/recent-advancement-of-direct-acting-antiviral-agents-daas-in-hepatitis-c-therapy
#2
Debasis Das, Mayank Pandya
Hepatitis C virus (HCV) infection is a major health burden worldwide. Approximately, 170-200 million individuals are chronically infected worldwide and a quarter of these patients are at increased risk of developing liver cirrhosis, hepatocellular carcinoma and even liver failure. A complete eradication of the virus is one of the most important treatment goal for antiviral research. In 2011, the first-generation protease inhibitors boceprevir (BOC) telaprevir (TVR) have been approved by FDA as the direct-acting antiviral agents...
September 12, 2017: Mini Reviews in Medicinal Chemistry
https://www.readbyqxmd.com/read/28856597/chemical-genetics-based-development-of-small-molecules-targeting-hepatitis-c-virus
#3
REVIEW
Guanghai Jin, Jisu Lee, Kyeong Lee
Hepatitis C virus (HCV) infection is a major worldwide problem that has emerged as one of the most significant diseases affecting humans. There are currently no vaccines or efficient therapies without side effects, despite today's advanced medical technology. Currently, the common therapy for most patients (i.e. genotype 1) is combination of HCV-specific direct-acting antivirals (DAAs). Up to 2011, the standard of care (SOC) was a combination of peg-IFNα with ribavirin (RBV). After approval of NS3/4A protease inhibitor, SOC was peg-IFNα and RBV with either the first-generation DAAs boceprevir or telaprevir...
August 30, 2017: Archives of Pharmacal Research
https://www.readbyqxmd.com/read/28783205/successful-treatment-of-chronic-hepatitis-c-with-ground-ledipasvir-sofosbuvir-in-a-patient-with-crohn-s-disease-and-short-bowel-syndrome
#4
Johann von Felden, Christoph Scheurich, Jin Yamamura, Diana M Brainard, Erik Mogalian, Ansgar W Lohse, Julian Schulze-Zur-Wiesch
We read the comprehensive review by Gitto et al. entitled 'NS5A inhibitors for the treatment of hepatitis C infection' (CHC) with great interest (1). Indeed, the development of direct acting antivirals (DAAs) now enables successful treatment of formerly difficult-to-treat patient populations (e.g. cirrhosis or chronic kidney disease). However, little is known about the use of DAAs in patients with short bowel syndrome, e.g. following inflammatory bowel disease (IBD), because these patients are yet excluded from clinical trials (2)...
August 7, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28724837/chemical-analysis-of-counterfeit-hepatitis-c-drug-found-in-japan
#5
Nahoko Uchiyama, Hiroyuki Kamakura, Sayaka Masada, Takashi Tsujimoto, Junko Hosoe, Hiroko Tokumoto, Takuro Maruyama, Yukihiro Goda, Takashi Hakamatsuka
<bibitem lang="en">  In January 2017, counterfeits of the hepatitis C drug 'HARVONI(®) Combination Tablets' (HARVONI(®)) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI(®) (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR...
July 19, 2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28677075/urticarial-reaction-to-ustekinumab-during-the-treatment-of-plaque-psoriasis-in-a-hepatitis-c-positive-patient
#6
Christopher H Chu, Charles Davis
A 62-year-old white woman with a history of hepatitis C and type 2 diabetes mellitus developed urticaria during treatment with ustekinumab for plaque psoriasis. The patient received two 45-mg ustekinumab injections in her first 2 months and then one 45-mg injection every 3 months for her psoriasis. After 10 months, she developed a round red rash on her skin diffusely on her body. She also complained of joint pain in her hands. Rheumatology became involved, and investigations revealed that her antinuclear antibody titer was negative, but her rheumatoid factor, erythrocyte sedimentation rate, and liver function enzymes were elevated...
December 2017: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/28348266/it-s-not-what-it-looks-like-atypical-rash-in-cryoglobulinaemic-vasculitis
#7
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
https://www.readbyqxmd.com/read/28330530/spectrophotometric-methods-for-simultaneous-determination-of-sofosbuvir-and-ledipasvir-harvoni-tablet-comparative-study-with-two-generic-products
#8
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
https://www.readbyqxmd.com/read/28236804/-debut-in-diabetic-patients-with-hepatitis-c-treatment-with-ledipasvir-sofosbuvir-harvoni%C3%A2
#9
Sergio Vicente-Sánchez, Laura Menéndez Naranjo
No abstract text is available yet for this article.
March 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28223549/membranous-nephropathy-associated-with-hepatitis-c-virus-infection-treated-with-corticosteroids-and-ledipasvir-sofosbuvir-a-case-report-and-review-of-literature
#10
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
https://www.readbyqxmd.com/read/27606041/will-the-pcsk9-inhibitors-be-employers-line-in-the-sand
#11
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
https://www.readbyqxmd.com/read/27486652/patient-leaflet-for-harvoni-sofosbuvir-ledipasvir-almost-no-information-on-adverse-effects
#12
(no author information available yet)
No abstract text is available yet for this article.
June 2016: Prescrire International
https://www.readbyqxmd.com/read/27470897/-short-term-efficacy-of-harvoni-in-treatment-of-hepatitis-c-after-liver-transplantation
#13
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
https://www.readbyqxmd.com/read/27464283/-an-unexpected-cause-of-pulmonary-hypertension
#14
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
https://www.readbyqxmd.com/read/27276081/will-sofosbuvir-ledipasvir-harvoni-be-cost-effective-and-affordable-for-chinese-patients-infected-with-hepatitis-c-virus-an-economic-analysis-using-real-world-data
#15
COMPARATIVE STUDY
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
https://www.readbyqxmd.com/read/27193156/clinical-pharmacokinetics-and-pharmacodynamics-of-ledipasvir-sofosbuvir-a-fixed-dose-combination-tablet-for-the-treatment-of-hepatitis-c
#16
REVIEW
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
https://www.readbyqxmd.com/read/27099890/new-indications-for-harvoni
#17
(no author information available yet)
No abstract text is available yet for this article.
January 4, 2016: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/26904396/direct-anti-hcv-agents
#18
REVIEW
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
https://www.readbyqxmd.com/read/26824950/in-vitro-antiviral-activity-and-resistance-profile-characterization-of-the-hepatitis-c-virus-ns5a-inhibitor-ledipasvir
#19
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
https://www.readbyqxmd.com/read/26788571/ledipasvir-sofosbuvir-harvoni-a-therapeutic-advance-in-genotype-1-hepatitis-c-virus-infection-despite-uncertainties
#20
REVIEW
(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
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