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https://www.readbyqxmd.com/read/29682307/bioequivalent-pharmacokinetics-for-generic-and-originator-hepatitis-c-direct-acting-antivirals
#1
EDITORIAL
Andrew Hill, Loai Tahat, Mohammed Khalil Mohammed, Rabab Fayez Tayyem, Giten Khwairakpam, Sanjay Nath, James Freeman, Ismahane Benbitour, Sherine Helmy
Mass production of low-cost, generic direct-acting antivirals (DAAs) will be required to achieve targets of eliminating hepatitis C (HCV) by 2030. The pharmaceutical companies Gilead and Bristol-Myers Squibb have granted voluntary licences (VLs) to generic companies to mass produce the DAAs sofosbuvir and daclatasvir at low cost. However, generic manufacturers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originator versions, to fulfil World Health Organization standards for prequalification...
April 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29681166/direct-acting-antivirals-to-prevent-vertical-transmission-of-viral-hepatitis-c-when-is-the-optimal-time-to-treat
#2
Leigh Cervino, Lauren M Hynicka
OBJECTIVE: To describe the most current evidence for the use of direct-acting antivirals (DAAs) to treat hepatitis C along the pregnancy-pediatric continuum in the United States. DATA SOURCES: The MEDLINE/PubMed databases were searched (January 1995 to February 2018) for articles in English using the terms: hepatitis C, vertical transmission, pregnancy, pediatrics, ribavirin, interferon, direct acting antivirals, daclatasvir, dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, simeprevir, sofosbuvir, and velpatasvir...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29679347/pre-emptive-treatment-of-hcv-after-living-donor-liver-transplantation-with-direct-acting-antiviral-agents
#3
Jinmin Jung, Jae Hyun Kwon, Gi-Won Song, Eun-Young Tak, Vavara A Kirchner, Sung-Gyu Lee
BACKGROUND: Hepatitis C virus (HCV) universally recurs after liver transplantation (LT). Although the introduction of direct-acting antiviral agents (DAAs) has revolutionized the treatment of HCV infection, no optimal treatment for HCV recurrence after LT has been developed. METHODS: This study retrospectively evaluated the efficacy of DAAs as a pre-emptive treatment for recurrent HCV infection after living donor liver transplantation (LDLT). From January 2010 to December 2016, 70 patients received pegylated interferon (PegIFN) and 35 patients were treated with DAA-based regimens to treat recurrent HCV after LDLT...
April 20, 2018: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
https://www.readbyqxmd.com/read/29676846/generic-sofosbuvir-based-direct-acting-antivirals-in-hepatitis-c-virus-infected-patients-with-chronic-kidney-disease
#4
Manoj Kumar Sharma, Suman Lata Nayak, Ekta Gupta, Ashish Kataria, Shiv K Sarin
BACKGROUND & AIMS: There is scant data on use of sofosbuvir containing directly acting anti-viral (DAA) regimens in chronic kidney disease (CKD) patients. Recently generic versions of DAAs have become available in low income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir, or daclatasvir in HCV infected patients with CKD including patients with advanced CKD (CKD stage 4 or 5 with an estimated glomerular filtration rate (GFR) <30 mL/min or those on dialysis)...
April 20, 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29672891/glecaprevir-pibrentasvir-treatment-in-liver-or-kidney-transplant-patients-with-hepatitis-c-virus-infection
#5
Nancy Reau, Paul Y Kwo, Susan Rhee, Robert S Brown, Kosh Agarwal, Peter Angus, Edward Gane, Jia-Horng Kao, Parvez S Mantry, David Mutimer, K Rajender Reddy, Tram T Tran, Yiran B Hu, Abhishek Gulati, Preethi Krishnan, Emily O Dumas, Ariel Porcalla, Nancy S Shulman, Wei Liu, Suvajit Samanta, Roger Trinh, Xavier Forns
Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response for 12 weeks post-treatment (SVR12) across all major HCV genotypes (GT). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months post-transplant...
April 19, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29669765/ribavirin-induced-anaemia-reduced-tacrolimus-level-in-a-hepatitis-c-patient-receiving-haemodialysis
#6
Hin-Yee Liu, Catherine Yuen Shan Cheung, Susan Elizabeth Cooper
A 37-year-old man with hepatitis C virus (HCV) genotype 3A developed renal failure. In 2007, the patient received a renal transplant and started receiving tacrolimus (Tac); the transplant subsequently failed. In April 2015, the patient restarted haemodialysis and in May initiated sofosbuvir 400 mg and ribavirin 400 mg daily. Baseline Tac level was 6.6 ng/mL and haemoglobin (Hb) was 10.3 g/dL. The patient then left the country for vacation and Hb was found to be dramatically low at 3.7 g/dL on return on 5 August...
April 18, 2018: BMJ Case Reports
https://www.readbyqxmd.com/read/29666174/ledipasvir-sofosbuvir-with-or-without-ribavirin-for-8-or-12-weeks-for-the-treatment-of-hcv-genotype-4-infection-results-from-a-randomised-phase-iii-study-in-egypt
#7
Gamal Shiha, Gamal Esmat, Mohamed Hassany, Reham Soliman, Mohamed Elbasiony, Rabab Fouad, Aisha Elsharkawy, Radi Hammad, Wael Abdel-Razek, Talaat Zakareya, Kathryn Kersey, Benedetta Massetto, Anu Osinusi, Sophia Lu, Diana M Brainard, John G McHutchison, Imam Waked, Wahid Doss
OBJECTIVE: We evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens. DESIGN: In this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin...
April 17, 2018: Gut
https://www.readbyqxmd.com/read/29665081/safety-of-sofosbuvir-based-regimens-after-liver-transplantation-longitudinal-assessment-of-renal-function-in-the-prospective-anrs-co23-cupilt-study
#8
R Anty, G Favre, A Coilly, E Rossignol, P Houssel-Debry, C Duvoux, V De Ledinghen, V Di Martino, V Leroy, S Radenne, N Kamar, V Canva, L D'Alteroche, F Durand, J Dumortier, P Lebray, C Besch, A Tran, C M Canivet, D Botta-Fridlund, H Montialoux, C Moreno, F Conti, C Silvain, P Perré, F Habersetzer, A Abergel, M Debette-Gratien, S Dharancy, V L M Esnault, C Fougerou-Leurent, C Cagnot, A Diallo, A Veislinger, H Danjou, D Samuel, G-P Pageaux, J-C Duclos-Vallée
BACKGROUND: In liver transplant recipients with hepatitis C virus recurrence, there is concern about renal safety of sofosbuvir-based regimens. Changes in serum creatinine or in the estimated glomerular filtration rate (eGFR) under treatment are used to look for possible renal toxicity. However, serum creatinine and eGFR are highly variable. AIM: To analyse renal function trajectory with numerous assays of serum creatinine over a long period of time. METHODS: In a multicentre cohort of 139 patients, the eGFR was obtained from serum creatinine using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation...
April 17, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29665069/generic-velpatasvir-plus-sofosbuvir-for-hepatitis-c-virus-infection-in-patients-with-or-without-human-immunodeficiency-virus-coinfection
#9
C-H Liu, H-Y Sun, C-J Liu, W-H Sheng, S-M Hsieh, Y-C Lo, W-C Liu, T-H Su, H-C Yang, C-M Hong, T-C Tseng, P-J Chen, D-S Chen, C-C Hung, J-H Kao
BACKGROUND: Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) for hepatitis C virus (HCV) in patients with or without human immunodeficiency virus (HIV) coinfection. AIM: To evaluate the effectiveness and safety of generic VEL/SOF-based therapy for HCV infection in patients with or without HIV coinfection in Taiwan. METHODS: Sixty-nine HIV/HCV-coinfected and 159 HCV-monoinfected patients receiving 12 weeks of generic VEL/SOF with or without ribavirin (RBV) for HCV were prospectively enrolled...
April 17, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29664710/analysis-of-host-and-viral-related-factors-associated-to-direct-acting-antiviral-response-in-hepatitis-c-virus-patients
#10
Hafsa Aziz, Muneeba Aziz, Muzaffar Lateef Gill
Hepatitis C virus (HCV) signifies an important health issue as it is a globally prevalent pathogen and poses a great threat to human health. Direct antiviral therapy became a landmark in treatment against chronic HCV infection as they have proven to increase sustained virological response (SVR) rate, provide shortened and simplified regimens. This study aimed to evaluate efficacy of Sofosbuvir and classify factors of treatment success and their function in therapy continuation decision. We studied host and viral factors in 310 patients who received Sofosbuvir (DAA) at a dose of 400 mg daily along with ribavirin 10 mg/kg body weight for 24 weeks and followed by 12 weeks after completion of treatment...
April 2018: Viral Immunology
https://www.readbyqxmd.com/read/29663115/sofosbuvir-plus-daclatasvir-with-or-without-ribavirin-for-treatment-of-chronic-hcv-genotype-4-patients-real-life-experience
#11
G Shiha, R Soliman, M ElBasiony, A A Hassan, N N H Mikhail
INTRODUCTION: New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800-1000 mg) in treating chronic hepatitis C genotype 4 patients. METHODS: This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated...
April 16, 2018: Hepatology International
https://www.readbyqxmd.com/read/29662642/successful-retreatment-with-grazoprevir-and-elbasvir-for-patients-infected-with-hepatitis-c-virus-genotype-1b-who-discontinued-prior-treatment-with-ns5a-inhibitor-including-regimens-due-to-adverse-events
#12
Tatsuo Kanda, Shin Yasui, Masato Nakamura, Shingo Nakamoto, Koji Takahashi, Shuang Wu, Reina Sasaki, Yuki Haga, Sadahisa Ogasawara, Tomoko Saito, Kazufumi Kobayashi, Soichiro Kiyono, Yoshihiko Ooka, Eiichiro Suzuki, Tetsuhiro Chiba, Hitoshi Maruyama, Mitsuhiko Moriyama, Naoya Kato
Background: Sustained virologic response (SVR) by interferon and interferon-free treatment can results in the reduction of advanced liver fibrosis and the occurrence of hepatocellular carcinoma in patients infected with hepatitis C virus (HCV). Recent interferon-free treatment for HCV shortens the duration of treatment and leads to higher SVR rates, without any serious adverse events. However, it is important to retreat patients who have had treatment-failure with HCV non-structural protein 5A (NS5A) inhibitor-including regimens...
March 23, 2018: Oncotarget
https://www.readbyqxmd.com/read/29661434/daclatasvir-and-sofosbuvir-with-or-without-ribavirin-in-liver-transplant-recipients-a-single-center-real-world-study
#13
M Mucenic, A Bandeira de Mello Brandao, C A Marroni, A Medeiros Fleck, M L Zanotelli, G Kiss, M H Meine, I Leipnitz, E Soares Schlindwein, J Martini, A M Costabeber, F K F Sacco, G P Cracco Cantisani
BACKGROUND: Treatment with direct-acting antiviral drugs in interferon-free regimens is currently recommended for viral hepatitis C recurrence after liver transplantation. There are limited data regarding its results in this population, and no optimal treatment scheme has yet been singled out. METHODS: We report our real-world results in liver transplant (LT) recipients. All patients were hepatitis C virus (HCV) monoinfected and completed a 12-week treatment course, followed 12 weeks later by HCV polymerase chain reaction testing with 12 IU/mL sensibility...
April 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29661427/hepatitis-c-virus-eradication-in-kidney-transplant-recipients-a-single-center-experience-in-portugal
#14
A Weigert, S Querido, L Carvalho, L Lebre, C Chagas, P Matias, R Birne, C Nascimento, C Jorge, T Adragão, M Bruges, D Machado
INTRODUCTION: Hepatitis C (HCV) is a major cause of liver impairment post-kidney transplantation (KT). Anti-HCV direct-acting antivirals (DAA) made viral eradication possible. METHODS: We performed a retrospective review of KT patients (n = 23) who received DAA at our hospital. Sustained viral response (SVR) was defined as absence of viral detection 12 weeks after cessation of therapy. RESULTS: From 1985 to September 2017, 1440 patients underwent transplantation at Hospital Santa Cruz...
April 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29660665/investigation-of-anti-hepatitis-c-virus-sofosbuvir-and-daclatasvir-in-pure-form-human-plasma-and-human-urine-using-micellar-monolithic-hplc-uv-method-and-application-to-pharmacokinetic-study
#15
Dalia W Zidan, Wafaa S Hassan, Manal S Elmasry, Abdalla A Shalaby
Simultaneous determination of sofosbuvir (SOF), and daclatasvir (DAC) in their dosage forms, human urine and human plasma using simple and rapid micellar high performance liquid chromatographic method coupled with UV detection (HPLC-UV) had been developed and validated. These drugs are described as co-administered for treatment of Hepatitis C virus (HCV). HCV is the cause of Hepatitis C and some cancers such as liver cancer (hepatocellular carcinoma) and lymphomas in humans. Separation and quantitation were carried out on anonyx™ C8 monolithic (100 × 4...
April 7, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29653132/sofosbuvir-inhibits-hepatitis-a-virus-replication-in-vitro-assessed-by-a-cell-based-fluorescent-reporter-system
#16
Wang Jiang, Fawad Muhammad, Pengjuan Ma, Xiyu Liu, Gang Long
Hepatitis A virus (HAV) infection remains a major cause of acute hepatitis worldwide and even leads to fulminant hepatitis. For screening antivirals against HAV in vitro, we develop a cell-based fluorescent reporter system named Huh-7.5.1-GA, in which HAV infection is visualized by green fluorescence protein (GFP) translocation from the cytosol into the nucleus. The reliability of Huh-7.5.1-GA for antiviral studies is validated by IFN-α, a known inhibitor of HAV replication, which impedes GFP translocation...
April 10, 2018: Antiviral Research
https://www.readbyqxmd.com/read/29644537/drug-drug-interaction-profile-of-the-fixed-dose-combination-tablet-regimen-ledipasvir-sofosbuvir
#17
REVIEW
Polina German, Anita Mathias, Diana M 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 for the treatment of chronic hepatitis C virus infection. Ledipasvir/sofosbuvir exhibits a favorable drug-drug interaction profile and can be administered with various medications that may be used by hepatitis C virus-infected patients, including patients with comorbidities, such as co-infection with human immunodeficiency virus or immunosuppression following liver transplantation...
April 11, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29628768/outcomes-and-predictors-of-treatment-response-with-sofosbuvir-plus-daclatasvir-with-or-without-ribavirin-in-egyptian-patients-with-genotype-4-hepatitis-c-virus-infection
#18
Ossama A Ahmed, Mohamed A Elsebaey, Mohamed Hassan A Fouad, Heba Elashry, Ahmed I Elshafie, Ahmed A Elhadidy, Noha E Esheba, Mohammed H Elnaggar, Shaimaa Soliman, Sherief Abd-Elsalam
Background and aims: Treatment of hepatitis C virus (HCV) changed dramatically with the introduction of oral direct-acting antiviral drugs due to their high antiviral potency and safety profile. Sofosbuvir plus daclatasvir combination therapy was extensively investigated in HCV genotypes 1, 2, and 3, while published data regarding its real-life application in the treatment of genotype 4 is lacking. Therefore, we conducted this study to assess the outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection...
2018: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29626296/real-world-efficacy-and-safety-of-ledipasvir-and-sofosbuvir-in-patients-with-hepatitis-c-virus-genotype-1-infection-a-nationwide-multicenter-study-by-the-japanese-red-cross-liver-study-group
#19
Keiji Tsuji, Masayuki Kurosaki, Jun Itakura, Nami Mori, Shintaro Takaki, Chitomi Hasebe, Takehiro Akahane, Kouji Joko, Hitoshi Yagisawa, Jirou Takezawa, Ryou Nakata, Atsunori Kusakabe, Yuji Kojima, Hiroyuki Kimura, Takashi Tamada, Haruhiko Kobashi, Akeri Mitsuda, Masahiko Kondou, Chikara Ogawa, Yasushi Uchida, Tetsuro Sohda, Ryouichi Narita, Namiki Izumi
BACKGROUND: We aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection. METHODS: This retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC)...
April 6, 2018: Journal of Gastroenterology
https://www.readbyqxmd.com/read/29621544/prevalence-of-ns5a-resistance-associated-variants-in-ns5a-inhibitor-treatment-failures-and-an-effective-treatment-for-ns5a-p32-deleted-hepatitis-c-virus-in-humanized-mice
#20
Yuji Teraoka, Takuro Uchida, Michio Imamura, Mitsutaka Osawa, Masataka Tsuge, Hiromi Abe-Chayama, C Nelson Hayes, Grace Naswa Makokha, Hiroshi Aikata, Daiki Miki, Hidenori Ochi, Yuji Ishida, Chise Tateno, Kazuaki Chayama
Patients with chronic hepatitis C virus (HCV) infection who have failed to respond to direct-acting antiviral (DAA) treatment often acquire drug resistance-associated variants (RAVs). The NS5A-P32 deletion (P32del) RAV confers potent resistance to NS5A inhibitors; therefore, patients who acquire this deletion are likely to fail to respond to DAA re-treatment. We investigated the prevalence of N55A-P32del in patients who failed to respond to prior NS5A inhibitor treatment using direct sequencing and analyzed the efficacy of DAA combination treatment in the presence of NS5A-P32del RAVs using human hepatocyte transplanted mice...
April 2, 2018: Biochemical and Biophysical Research Communications
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