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https://www.readbyqxmd.com/read/28079269/ledipasvir-plus-sofosbuvir-as-salvage-therapy-for-hcv-genotype-1-failures-to-prior-ns5a-inhibitors-regimens
#1
Norio Akuta, Hitomi Sezaki, Fumitaka Suzuki, Shunichiro Fujiyama, Yusuke Kawamura, Tetsuya Hosaka, Masahiro Kobayashi, Mariko Kobayashi, Satoshi Saitoh, Yoshiyuki Suzuki, Yasuji Arase, Kenji Ikeda, Hiromitsu Kumada
There is little information on retreatment efficacy and predictors of the combination of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir) for patients who fail to respond to NS5A inhibitors. NS5A resistance variants are known to persist for long periods after such treatment. Here, we evaluated 54 patients with chronic HCV genotype 1b infection, free of decompensated cirrhosis and hepatocellular carcinoma, for sustained virological response after 12 weeks (SVR12) of once-daily treatment with 90 mg ledipasvir and 400 mg sofosbuvir...
January 12, 2017: Journal of Medical Virology
https://www.readbyqxmd.com/read/28078644/eight-or-12-week-treatment-of-hepatitis-c-with-ledipasvir-sofosbuvir-real-world-experience-in-a-large-integrated-health-system
#2
Jennifer B Lai, Maxwell A Witt, Mary Patricia Pauly, Joanna Ready, Michael Allerton, Suk Seo, David J Witt
BACKGROUND: Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system...
January 11, 2017: Drugs
https://www.readbyqxmd.com/read/28070175/a-special-meeting-review-edition-advances-in-the-treatment-of-hepatitis-c-virus-infection-from-the-2016-easl-meeting-the-annual-meeting-of-the-european-association-for-the-study-of-the-liver-%C3%A2-april-13-17-2016-%C3%A2-barcelona-spainspecial-reporting-on-%C3%A2-six-weeks
#3
https://www.readbyqxmd.com/read/28060446/successful-treatment-of-donor-derived-hepatitis-c-viral-infection-in-three-transplant-recipients-from-a-donor-at-increased-risk-for-bloodborne-pathogens
#4
Ashesh P Shah, Andrew Cameron, Pooja Singh, Adam M Frank, Jonathan M Fenkel
We report here the successful treatment of hepatitis C virus (HCV) transmitted from a nucleic acid testing (NAT)-negative donor to 3 HCV-negative recipients - 2 renal transplants and 1 liver. Both renal recipients underwent standard deceased-donor renal transplantation with immediate graft function. The liver recipient underwent standard orthotopic liver transplantation and recovered uneventfully. The donor was a 39-year-old woman with a terminal serum creatinine of 0.7 mg/dL. She was high risk for bloodborne pathogens, based upon a history of sexual contact with an HCV-infected male partner...
January 6, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28052633/hepatitis-c-efficacy-and-safety-in-real-life
#5
REVIEW
Robert Flisiak, Joanna Pogorzelska, Marta Flisiak-Jackiewicz
Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis...
January 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28050236/hepatitis-c-eradication-with-sofosbuvir-leads-to-significant-metabolic-changes
#6
Amilcar L Morales, Zachary Junga, Manish B Singla, Maria Sjogren, Dawn Torres
AIM: To assess the effect of sofosbuvir (SOF) based regimens on glycemic and lipid control. METHODS: This is a retrospective analysis of hepatitis C virus (HCV)-infected patients treated and cured with a SOF regimen [SOF/ribavirin/interferon, SOF/simeprevir, or SOF/ledipasvir (LDV) ± ribavirin] from January 2014 to March 2015. Patients with hemoglobin A1C (HbA1C) and lipid panels within six months before and six months after therapy were identified and included in our study...
December 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/28046099/cost-effectiveness-of-treating-hepatitis-c-with-sofosbuvir-ledipasvir-in-germany
#7
Jona T Stahmeyer, Siegbert Rossol, Sebastian Liersch, Ines Guerra, Christian Krauth
BACKGROUND: Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines...
2017: PloS One
https://www.readbyqxmd.com/read/28040553/efficacy-and-safety-of-ledipasvir-sofosbuvir-with-and-without-ribavirin-in-patients-with-chronic-hepatitis-c-virus-genotype-1-infection-a-meta-analysis
#8
Tingting Tao, Xuehua Jiang, Yuehong Chen, Yiran Song
BACKGROUND: The addition of ribavirin (RBV) to the combination treatment of Ledipasvir (LDV) and Sofosbuvir (SOF) remains controversial in the treatment of hepatitis C virus (HCV) infection. We performed a meta-analysis to assess the efficacy and safety of the LDV-SOF with and without RBV in treating HCV genotype 1 patients. METHOD: The electronical databases of PubMed Medline, EMBASE database, Cochrane Central Register of Controlled Trial (CENTRAL) and ClinicalTrials...
December 28, 2016: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28039098/efficacy-and-tolerability-of-interferon-free-antiviral-therapy-in-kidney-transplant-recipients-with-chronic-hepatitis-c
#9
Inmaculada Fernández, Raquel Muñoz-Gómez, Juan M Pascasio, Carme Baliellas, Natalia Polanco, Nuria Esforzado, Ana Arias, Martín Prieto, Lluis Castells, Valentín Cuervas-Mons, Olga Hernández, Javier Crespo, José L Calleja, Xavier Forns, María-Carlota Londoño
BACKGROUND AND AIMS: The development of direct-acting antivirals (DAAs) is a major step forward in the treatment of hepatitis C (HCV). The aims of the study were to evaluate the efficacy and tolerability of DAAs in kidney transplant (KT) recipients. METHODS: Hepa-C is a Spanish registry of patients treated with DAAs in which clinical, virological and analytical data were prospectively included. RESULTS: We report on the data from 103 KT recipients who received DAAs...
December 27, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/28029529/ledipasvir-plus-sofosbuvir-fixed-dose-combination-for-6-weeks-in-patients-with-acute-hepatitis-c-virus-genotype-1-monoinfection-hepnet-acute-hcv-iv-an-open-label-single-arm-phase-2-study
#10
Katja Deterding, Christoph D Spinner, Eckart Schott, Tania M Welzel, Guido Gerken, Hartwig Klinker, Ulrich Spengler, Johannes Wiegand, Julian Schulze Zur Wiesch, Anita Pathil, Markus Cornberg, Andreas Umgelter, Caroline Zöllner, Stefan Zeuzem, Armin Papkalla, Kristina Weber, Svenja Hardtke, Heiko von der Leyen, Armin Koch, Dorothee von Witzendorff, Michael P Manns, Heiner Wedemeyer
BACKGROUND: Early treatment of acute hepatitis C virus (HCV) infection with interferon alfa is highly effective, but can be associated with frequent side-effects. We investigated the safety and efficacy of an interferon-free regimen for treatment of acute HCV infection. METHODS: In this prospective, open-label, multicentre, single-arm pilot study, we enrolled adults (≥18 years) with acute HCV genotype 1 monoinfection from ten centres in Germany. Patients were given ledipasvir (90 mg) plus sofosbuvir (400 mg) as a fixed-dose combination tablet once daily for 6 weeks...
October 28, 2016: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28027579/eight-weeks-of-ledipasvir-sofosbuvir-is-effective-for-selected-patients-with-genotype-1-hepatitis-c-virus-infection
#11
Kris V Kowdley, Vinay Sundaram, Christie Y Jeon, Kamran Qureshi, Nyan L Latt, Amandeep Sahota, Stephen Lott, Michael P Curry, Naoki Tsai, Nathorn Chaiyakunapruk, Yoori Lee, Jorg Petersen, Peter Buggisch
: Eight weeks duration of ledipasvir/sofosbuvir (LDV/SOF) can be considered in genotype 1 hepatitis C virus (HCV) infected patients who are treatment naive, non-cirrhotic and have pre-treatment viral load < 6 million IU/ml. The effectiveness of this regimen, however, has not been fully confirmed by real-world experience. Using data from real-world cohorts, we aimed to determine the effectiveness of 8 weeks of LDV/SOF treatment, examine variables associated with relapse after treatment with this regimen, and compare the effectiveness of 8 weeks and 12 weeks of LDV/SOF treatment...
December 27, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28025084/a-profiling-study-of-a-newly-developed-hcvcc-strain-pr63cc-s-sensitivity-to-direct-acting-antivirals
#12
Wanyin Tao, Tianyu Gan, Jie Lu, Jin Zhong
The development of direct-acting antivirals (DAAs) has significantly improved hepatitis C virus (HCV) treatment. However, drug resistance remains a potential concern in the real-world DAA-based therapies. We previously developed a novel full-length genotype 2a HCVcc clone PR63cc directly from clinical isolates. Here in this study, we compared the sensitivity of PR63cc and JFH1 to 12 different DAAs most of which are either already in clinical use or in the late clinical development phase. For NS5B inhibitors, PR63cc and JFH1 displayed comparable sensitivity to nucleoside/nucleotide analogues sofosbuvir and 2'-C-methyladenosine, while PR63cc was 4-fold more sensitive than JFH1 to nesbuvir, a non-nucleoside inhibitor...
December 23, 2016: Antiviral Research
https://www.readbyqxmd.com/read/28024124/developing-therapies-to-treat-hepatitis-c-infection-in-post-liver-transplant-recipients
#13
Thomas R McCarty, Joseph K Lim
Currently, hepatitis C virus (HCV) infection remains the most common indication for liver transplant in the United States (US) with almost universal HCV recurrence in the post-liver transplant setting. Previous interferon (IFN)-related efficacy and tolerability concerns about worsening liver function have limited treatment options for many patients with HCV-associated decompensated liver disease and post-liver transplant recipients. However, the last decade has seen a seen a radical shift in the management of HCV with multiple direct-acting antiviral (DAA) treatments that provide more effective, all-oral, IFN-free alternatives...
December 26, 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28018873/restrictions-for-reimbursement-of-direct-acting-antiviral-treatment-for-hepatitis-c-virus-infection-in-canada-a-descriptive-study
#14
Alison D Marshall, Sahar Saeed, Lisa Barrett, Curtis L Cooper, Carla Treloar, Julie Bruneau, Jordan J Feld, Lesley Gallagher, Marina B Klein, Mel Krajden, Naglaa H Shoukry, Lynn E Taylor, Jason Grebely
BACKGROUND: In Canada, interferon-free, direct-acting antiviral hepatitis C virus (HCV) regimens are costly. This presents challenges for universal drug coverage of the estimated 220 000 people with chronic HCV infection nationwide. The study objective was to appraise criteria for reimbursement of 4 HCV direct-acting antivirals in Canada. METHODS: We reviewed the reimbursement criteria for simeprevir, sofosbuvir, ledipasvir-sofosbuvir and paritaprevir-ritonavir-ombitasvir plus dasabuvir in the 10 provinces and 3 territories...
October 2016: CMAJ Open
https://www.readbyqxmd.com/read/28009781/safety-and-efficacy-of-treatment-of-hepatitis-c-in-kidney-transplant-recipients-with-directly-acting-antiviral-agents
#15
Michelle Lubetzky, Soohwan Chun, Andrew Joelson, Maria Coco, Layla Kamal, Maria Ajaimy, Paul Gaglio, Enver Akalin, Graciela Deboccardo
BACKGROUND: With the development of all oral, interferon-free directly acting antiviral (DAA) medications, treatment of Hepatitis C infection (HCV) in renal transplant recipients is possible, but limited data exists on its safety and efficacy. METHODS: We performed a retrospective cohort analysis of patients transplanted at our center with HCV who have been started on DAAs. Primary endpoints included sustained virologic response (SVR) as defined as negative viral load at 12 weeks post completion of therapy and allograft function...
December 22, 2016: Transplantation
https://www.readbyqxmd.com/read/28006874/sofosbuvir-ledipasvir-and-ribavirin-tolerability-and-efficacy-in-pediatric-liver-transplant-recipients
#16
Koen Huysentruyt, Xavier Stephenne, Sharat Varma, Isabelle Scheers, Gisèle Leclercq, Françoise Smets, Etienne Sokal
No abstract text is available yet for this article.
December 22, 2016: Liver Transplantation
https://www.readbyqxmd.com/read/27997679/the-safety-and-effectiveness-of-ledipasvir-sofosbuvir-in-adolescents-12-to-17-years-old-with-hepatitis-c-virus-genotype-1-infection
#17
William F Balistreri, Karen F Murray, Philip Rosenthal, Sanjay Bansal, Lin Chuan-Hao, Kathryn Kersey, Benedetta Massetto, Yanni Zhu, Bittoo Kanwar, Polina German, Evguenia Svarovskaia, Diana M Brainard, Jessica Wen, Regino P Gonzalez-Peralta, Maureen M Jonas, Kathleen Schwarz
: No all-oral, direct-acting antiviral regimens have been approved for children with chronic hepatitis C virus (HCV) infection. We conducted a Phase 2, multi-center, open-label study to evaluate the efficacy and safety of ledipasvir-sofosbuvir in adolescents with chronic HCV genotype 1 infection. One hundred patients ages 12 to 17 years received a combination tablet of 90 mg ledipasvir and 400 mg sofosbuvir once daily for 12 weeks. On the 10(th) day following initiation of dosing, 10 patients underwent an intensive pharmacokinetic evaluation of the concentrations of sofosbuvir, ledipasvir, and the sofosbuvir metabolite GS-331007...
December 20, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27990005/ledipasvir-and-sofosbuvir-for-recurrent-hepatitis-c-after-liver-transplantation
#18
Yuki Oya, Yasuhiko Sugawara, Takehisa Watanabe, Yoko Yoshimaru, Masaki Honda, Shintaro Hashimoto, Daiki Yoshii, Kaori Isono, Shintaro Hayashida, Hidekazu Yamamoto, Motohiko Tanaka, Yutaka Sasaki, Yukihiro Inomata
Management of recurrent hepatitis C following liver transplantation still remains a challenge. Here, we report five patients who achieved viral responses following combined treatment with ledipasvir and sofosbuvir. All the patients received tacrolimus for immunosuppression. No dose adjustment was made before the ledipasvir and sofosbuvir therapy. All completed the intended 12-week treatment course with the full dose of ledipasvir and sofosbuvir. There were no significant adverse events greater than grade 2...
December 18, 2016: Bioscience Trends
https://www.readbyqxmd.com/read/27984558/the-impact-of-ledipasvir-sofosbuvir-on-hiv-positive-and-hiv-negative-japanese-hemophilia-patients-with-1-4-and-mixed-genotype-hcv
#19
Azusa Nagao, Hideji Hanabusa
INTRODUCTION: About 80% of patients with hemophilia who received non-heated coagulation factor concentrates in the early 1980s were infected with hepatitis C virus (HCV), and about 40% of them were infected with human immunodeficiency virus (HIV). AIM: We evaluated the efficacy and safety of administering ledipasvir (LDV)/sofosbuvir (SOF) to Japanese hemophilia patients. METHODS: Forty-three hemophilia patients with genotype 1 or 4 HCV were treated with LDV/SOF for 12 weeks...
December 7, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/27974712/outcome-of-combination-therapy-with-sofosbuvir-and-ledipasvir-for-chronic-type-c-liver-disease
#20
Satoru Hagiwara, Naoshi Nishida, Tomohiro Watanabe, Toshiharu Sakurai, Hiroshi Ida, Yasunori Minami, Masahiro Takita, Tomohiro Minami, Mina Iwanishi, Hirokazu Chishina, Kazuomi Ueshima, Yoriaki Komeda, Tadaaki Arizumi, Masatoshi Kudo
INTRODUCTION: Recently, the treatment of chronic hepatitis C has markedly advanced. A phase III clinical study of combination therapy with sofosbuvir (SOF) and ledipasvir (LDV) was conducted in Japan, and the additive therapeutic effects were reported. In this study, we report the results of treatment in our hospital. METHODS: Of 147 patients with chronic type C liver disease who had consulted our hospital since September 2015 and received SOF/LDV therapy, in 91 subjects a sustained virological response of 12 weeks (SVR12) could be evaluated...
December 15, 2016: Oncology
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