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https://www.readbyqxmd.com/read/29676846/generic-sofosbuvir-based-direct-acting-antivirals-in-hepatitis-c-virus-infected-patients-with-chronic-kidney-disease
#1
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/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
#2
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/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
#3
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/29644537/drug-drug-interaction-profile-of-the-fixed-dose-combination-tablet-regimen-ledipasvir-sofosbuvir
#4
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/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
#5
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/29619416/early-and-late-changes-in-natural-killer-cells-in-response-to-ledipasvir-sofosbuvir-treatment
#6
Lucy Golden-Mason, Rachel H McMahan, Michael S Kriss, Alexandra L Kilgore, Linling Cheng, Rachael J Dran, Amanda Wieland, Hugo R Rosen
Chronic hepatitis C virus (HCV) infection is characterized by dysregulated natural killer (NK) cell responses. NKs play a critical role in achieving sustained responses to interferon (IFN)-α-based therapy. Rapid sustained HCV-RNA clearance is now achieved with direct-acting antivirals (DAAs). Studies of patients receiving first-wave DAAs suggest NK functional restoration. Here, we investigate the effect of mainstream DAA treatment on NKs. We collected a prospective cohort of male HCV genotype 1-infected patients treated with ledipasvir/sofosbuvir (n = 22)...
April 2018: Hepatology Communications
https://www.readbyqxmd.com/read/29606942/elbasvir-grazoprevir-an-alternative-in-antiviral-hepatitis-c-therapy-in-patients-under-amiodarone-treatment
#7
Lina Weiss, Kerstin Wustmann, Mariam Semmo, Markus Schwerzmann, Nasser Semmo
A sofosbuvir/ledipasvir combination is part of a first-line treatment of hepatitis C. However, in patients concurrently treated with amiodarone, cardiac side effects have been described, resulting in an official warning in 2015 by the American Food and Drug Administration and the European Medicines Agency when combining those substances. This deprived numerous hepatitis C patients with concurrent cardiovascular problems of receiving this highly effective treatment. Here we present a treatment alternative with an elbasvir/grazoprevir regimen, based on our successful treatment of a patient under concurrent amiodarone therapy...
January 2018: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29601403/differential-timing-of-cholesterol-increase-during-successful-hcv-therapy-impact-of-type-of-drug-combination
#8
Antonio Rivero-Juarez, Angela Camacho, Teresa Brieva, Mario Frias, Pedro Lopez-Lopez, María A Risalde, Isabel Machuca, Juan J Caston, Antonio Martínez Peinado, Antonio Rivero
OBJECTIVE: to evaluate factors associated with increased serum cholesterol levels during Interferon-free (IFN-free) Hepatitis C virus (HCV) therapy. DESIGN: Prospective longitudinal study METHODS:: HIV-infected patients who started and successfully completed IFN-free therapy for chronic HCV infection were included. Patients were treated using two different regimens, based on the clinician's opinion: sofosbuvir and ledipasvir (SOF/LDV), or paritaprevir co-administered with ombitasvir and Dasabuvir (PrOD)...
March 27, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29600429/efficacy-and-safety-of-ledipasvir-sofosbuvir-for-genotype-1b-chronic-hepatitis-c-patients-with-moderate-renal-impairment
#9
Tomomi Okubo, Masanori Atsukawa, Akihito Tsubota, Hidenori Toyoda, Noritomo Shimada, Hiroshi Abe, Keizo Kato, Korenobu Hayama, Taeang Arai, Ai Nakagawa-Iwashita, Norio Itokawa, Chisa Kondo, Chiaki Kawamoto, Etsuko Iio, Yasuhito Tanaka, Takashi Kumada, Katsuhiko Iwakiri
BACKGROUND/AIM: To evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis C patients with chronic kidney disease (CKD) stage 3. METHODS: In a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis...
March 29, 2018: Hepatology International
https://www.readbyqxmd.com/read/29599610/successful-combination-of-direct-antiviral-agents-in-liver-transplanted-patients-with-recurrent-hepatitis-c-virus
#10
Christian Rupp, Theresa Hippchen, Manuel Neuberger, Peter Sauer, Jan Pfeiffenberger, Wolfgang Stremmel, Daniel Nils Gotthardt, Arianeb Mehrabi, Karl-Heinz Weiss
AIM: To analyze the safety and efficiency of direct-acting antiviral (DAA) regimens in liver-transplanted patients with hepatitis C virus (HCV) reinfection. METHODS: Between January 2014 and December 2016, 39 patients with HCV reinfection after liver transplantation were treated at our tertiary referral center with sofosbuvir (SOF)-based regimens, including various combinations with interferon (IFN), daclatasvir (DAC), simeprivir (SIM) and/or ledipasvir (LDV). Thirteen patients were treated with SOF + IFN ± RBV...
March 28, 2018: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/29582685/-real-life-experience-with-direct-acting-antiviral-agents-for-hepatitis-c-virus-in-end-stage-renal-disease
#11
Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi
BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' group of patients with end-stage renal disease. METHODS: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29569736/safety-and-efficacy-of-ledipasvir-sofosbuvir-with-or-without-ribavirin-in-hepatitis-c-genotype-1-patients-including-those-with-decompensated-cirrhosis-who-failed-prior-treatment-with-simeprevir-sofosbuvir
#12
A A Modi, H E Nazario, G R Gonzales, S A Gonzalez
BACKGROUND: Combination therapy of simeprevir (SIM)/sofosbuvir (SOF) is an approved treatment for hepatitis C genotype (gen) 1 with overall SVR12 rate of 85%-95%. The single tablet fixed-dose combination of ledipasvir (LDV)/SOF is also approved for gen 1 with sustained virologic response at 12 weeks (SVR12) rates ≥95%. No data are available on the efficacy of retreatment with LDV/SOF in patients who failed initial treatment with SIM/SOF. AIM: Our aim was to evaluate the efficacy of retreatment with LDV/SOF ± ribavirin (RBV) in gen 1 patients who had previously failed treatment with SIM/SOF...
March 23, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29566611/treatment-of-hcv-in-the-department-of-corrections-in-the-era-of-oral-medications
#13
Richard K Sterling, Reena Cherian, Shawn Lewis, Kathleen Genther, Carolyn Driscoll, Kelly Martin, Mary Beth Goode, Scott Matherly, Mohammad S Siddiqui, Velimir A Luketic, R Todd Stravitz, Puneet Puri, Hannah Lee, Paula Smith, Vaishali Patel, Arun J Sanyal
Chronic hepatitis C virus (HCV) is widely prevalent in the Virginia Department of Corrections (DOC). However, sustained virologic response (SVR) with all oral direct-acting antiviral (DAA) therapy is unknown. HCV treatment was provided through telemedicine following guidelines of the American Association for the Study of Liver Diseases and Infectious Diseases Society of America. SVR12 in the DOC was compared in two control groups: privately insured and indigent patients receiving care in HCV treatment clinics by the same providers during the same time period...
January 1, 2018: Journal of Correctional Health Care
https://www.readbyqxmd.com/read/29554476/a-facile-synthesis-of-3d-nife-2-o-4-nanospheres-anchored-on-a-novel-ionic-liquid-modified-reduced-graphene-oxide-for-electrochemical-sensing-of-ledipasvir-application-to-human-pharmacokinetic-study
#14
Mohamed M El-Wekil, Ashraf M Mahmoud, Saad A Alkahtani, Adel A Marzouk, Ramadan Ali
Novel and sensitive electrochemical sensor was fabricated for the assay of anti-HCV ledipasvir (LEDV) in different matrices. The designed sensor was based on 3D spinel ferromagnetic NiFe2 O4 nanospheres and reduced graphene oxide (RGO) supported by morpholinium acid sulphate (MHS), as an ionic liquid (RGO/NSNiFe2 O4 /MHS). This sensor design was assigned to synergistically tailor the unique properties of nanostructured ferrites, RGO, and ionic liquid to maximize the sensor response. Electrode modification prevented aggregation of NiFe2 O4, increasing electroactive surface area and allowed remarkable electro-catalytic oxidation of LEDV with an enhanced oxidation response...
March 11, 2018: Biosensors & Bioelectronics
https://www.readbyqxmd.com/read/29536030/eight-weeks-of-ledipasvir-sofosbuvir-in-kidney-transplant-recipients-with-hepatitis-c-genotype-1-infection
#15
Jennifer S Husson, Bharath Ravichandran, Srijana Jonchhe, Shyamasundaran Kottilil, Eleanor Wilson
Short treatment duration of ledipasvir/sofosbuvir (LDV/SOF) has been successfully used to treat hepatitis C virus (HCV) genotype 1 infection in treatment-naive noncirrhotic patients with viral loads (VLs) under 6 million IU/mL. However, this short duration has not been studied in renal transplant recipients (RTRs), a patient population on lifelong immunosuppression. Here, we describe 3 RTRs who received 8 weeks of LDV/SOF, meeting the standard criteria for shortened treatment duration. All 3 patients tolerated treatment well and achieved sustained virologic response at 12 weeks (SVR 12)...
December 2017: Transplantation Direct
https://www.readbyqxmd.com/read/29535545/efficacy-and-safety-of-sofosbuvir-ledipasvir-for-treatment-of-a-cohort-of-egyptian-patients-with-chronic-hepatitis-c-genotype-4-infection
#16
Ossama A Ahmed, Hany H Kaisar, Rehab Badawi, Nehad Hawash, Hossam Samir, Sherif St Shabana, Mohamed Hassan A Fouad, Fatma H Rizk, Samy A Khodeir, Sherief Abd-Elsalam
Background and aims: Treatment of hepatitis C virus (HCV) infection has significantly changed during the last few years. The combination of ledipasvir and sofosbuvir has been shown to treat high proportions of patients with HCV genotype 1 with remarkable tolerability. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ledipasvir in treating treatment-naïve Egyptian patients with genotype 4 HCV infection. Patients and methods: In this open-label randomized study, 200 treatment-naive patients who were HCV antibody positive and HCV RNA positive by polymerase chain reaction, aged >18 years, were enrolled...
2018: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29535057/no-difference-in-effectiveness-of-8-vs-12-weeks-of-ledipasvir-and-sofosbuvir-for-treatment-of-hepatitis-c-in-black-patients
#17
Julia L Marcus, Leo B Hurley, Scott Chamberland, Jamila H Champsi, Laura C Gittleman, Daniel G Korn, Jennifer B Lai, Jennifer O Lam, Mary Patricia Pauly, Charles P Quesenberry, Joanna Ready, Varun Saxena, Suk Seo, David J Witt, Michael J Silverberg
BACKGROUND & AIMS: Treatment with the combination of ledipasvir and sofosbuvir for 12 weeks has been approved by the Food and Drug Administration for patients with genotype 1 hepatitis C virus (HCV) infection; some patients can be treated with an 8-week course. Guidelines recommend a 12-week treatment course for black patients, but studies have not compared the effectiveness of 8 vs 12 weeks in black patients who are otherwise eligible for an 8-week treatment regimen. METHODS: We conducted an observational study of Kaiser Permanente Northern California members with HCV genotype 1 infection who were eligible for 8 weeks of treatment with ledipasvir and sofosbuvir (treatment-naïve, no cirrhosis, no HIV infection, level of HCV RNA <6 million IU/mL) and were treated for 8 or 12 weeks from October 2014 through December 2016...
March 10, 2018: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29535028/baseline-factors-associated-with-improvements-in-decompensated-cirrhosis-after-direct-acting-antiviral-therapy-for-hcv-infection
#18
O El-Sherif, Z G Jiang, E B Tapper, K C Huang, A Zhong, A Osinusi, M Charlton, M Manns, N H Afdhal, K Mukamal, J McHutchison, D M Brainard, N Terrault, M P Curry
BACKGROUND & AIMS: Treatment with direct-acting antiviral (DAA) agents can reduce model for end-stage liver disease and Child-Pugh-Turcotte (CPT) scores in patients with decompensated cirrhosis caused by hepatitis C virus (HCV). However, many of these patients still die or require liver transplantation. We collected data on baseline features of patients and aimed to develop a scoring system to predict response to DAA therapy. METHODS: We performed a retrospective analysis of data from 4 trials of the effects of sofosbuvir-based therapy in patients with HCV-associated decompensated cirrhosis (502 of CPT class B and 120 of CPT class C)...
March 10, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29522085/association-of-cyp2b6-single-nucleotide-polymorphisms-altering-efavirenz-metabolism-with-hepatitis-c-virus-hcv-treatment-relapse-among-human-immunodeficiency-virus-hcv-coinfected-african-americans-receiving-ledipasvir-sofosbuvir-in-the-ion-4-trial
#19
Sarah E Kleinstein, Patrick R Shea, Luisa M Stamm, Mark Sulkowski, David B Goldstein, Susanna Naggie
In the ION-4 trial, hepatitis C virus relapse was rare, occurring only in African American patients, 80% receiving efavirenz for human immunodeficiency virus infection. We observed no indication that CYP2B6 polymorphisms associated with increased plasma efavirenz exposure explained the relapses.
March 7, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29511552/optimization-of-direct-anti-viral-agent-treatment-schedule-focus-on-hcv-genotype-3
#20
Filomena Morisco, Rocco Granata, Silvia Camera, Antonio Ippolito, Michele Milella, Fabio Conti, Chiara Masetti, Antonella Smedile, Paolo Tundo, Teresa Santantonio, Maria Rosa Valvano, Antonio Termite, Pietro Gatti, Vincenzo Messina, Angelo Iacobellis, Marta Librandi, Nicola Caporaso, Angelo Andriulli
Background and aim: Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option. Methods: Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs...
March 2018: United European Gastroenterology Journal
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