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https://www.readbyqxmd.com/read/29453451/prevalence-and-impact-of-baseline-resistance-associated-substitutions-on-the-efficacy-of-ledipasvir-sofosbuvir-or-simeprevir-sofosbuvir-against-gt1-hcv-infection
#1
Gary P Wang, Norah Terrault, Jacqueline D Reeves, Lin Liu, Eric Li, Lisa Zhao, Joseph K Lim, Giuseppe Morelli, Alexander Kuo, Josh Levitsky, Kenneth E Sherman, Lynn M Frazier, Ananthakrishnan Ramani, Joy Peter, Lucy Akuskevich, Michael W Fried, David R Nelson
Baseline resistance-associated substitutions (RASs) have variable impacts in clinical trials but their prevalence and impact in real-world patients remains unclear. We performed baseline resistance testing using a commercial assay (10% cutoff) for 486 patients treated with LDV/SOF or SMV/SOF, with or without ribavirin, in the multi-center, observational HCV-TARGET cohort. Linkage of RASs was evaluated in selected samples using a novel quantitative single variant sequencing assay. Our results showed that the prevalence of NS3, NS5A, NS5B RASs was 45%, 13%, and 8%, respectively, and 10% of patients harbored RASs in 2 or more drug classes...
February 16, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29450210/sofosbuvir-based-direct-acting-antiviral-therapies-for-hcv-in-people-receiving-opioid-substitution-therapy-an-analysis-of-phase-3-studies
#2
Jason Grebely, Jordan J Feld, David Wyles, Mark Sulkowski, Liyun Ni, Joe Llewellyn, Heshaam M Mir, Nika Sajed, Luisa M Stamm, Robert H Hyland, John McNally, Diana M Brainard, Ira Jacobson, Stefan Zeuzem, Marc Bourlière, Graham Foster, Nezam Afdhal, Gregory J Dore
Background: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6)...
February 2018: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/29435907/sustained-virological-response-in-special-populations-with-chronic-hepatitis-c-using-interferon-free-treatments-a-systematic-review-and-meta-analysis-of-observational-cohort-studies
#3
REVIEW
Vinicius Lins Ferreira, Letícia Paula Leonart, Fernanda Stumpf Tonin, Helena Hiemisch Lobo Borba, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C...
February 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29435197/successful-retreatment-with-sofosbuvir-plus-ledipasvir-for-cirrhotic-patients-with-hepatitis-c-virus-genotype-1b-who-discontinued-the-prior-treatment-with-asunaprevir-plus-daclatasvir-a-case-series-and-review-of-the-literature
#4
Yuki Haga, Tatsuo Kanda, Shin Yasui, Masato Nakamura, Yoshihiko Ooka, Koji Takahashi, Shuang Wu, Shingo Nakamoto, Makoto Arai, Tetsuhiro Chiba, Hitoshi Maruyama, Osamu Yokosuka, Nobuo Takada, Mitsuhiko Moriyama, Fumio Imazeki, Naoya Kato
Background: Interferon-free treatment results in higher sustained virologic response (SVR) rates, with no serious adverse events in hepatitis C virus (HCV)-infected patients. However, in some patients with treatment-failure in HCV NS5A inhibitor-including interferon-free regimens, the treatment-emergent HCV NS5A resistance-associated variants (RAVs), which are resistant to interferon-free retreatment including HCV NS5A inhibitors, are observed. In HCV-infected Japanese patients with daclatasvir and asunaprevir treatment failure, retreatment with sofosbuvir and ledipasvir could lead to only ∼70% SVR rates...
January 12, 2018: Oncotarget
https://www.readbyqxmd.com/read/29430226/a-hepatitis-c-virus-associated-chronic-hepatitis-patient-developing-various-adverse-events-including-severe-gingivitis-gingival-bleeding-and-inflammation-of-genital-vulva-during-the-course-of-antiviral-therapy-with-elbasvir-grazoprevir
#5
Kazuo Tarao, Akira Sato
Oral direct-acting antivirals comprise the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the primary agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. Ombitasvir/paritaprevir/ritonavir was also recommended as a therapy for HCV genotype 1b. More recently, elbasvir (NS5A inhibitor)/grazoprevir (NS3/4A protease inhibitor) was also recommended as a potent therapy for HCV genotype 1b infection. This agent achieved an SVR12 as high as 96...
September 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29430221/successful-treatment-of-oral-lichen-planus-with-direct-acting-antiviral-agents-after-liver-transplantation-for-hepatitis-c-virus-associated-hepatocellular-carcinoma
#6
Yumiko Nagao, Kazunori Nakasone, Tatsuji Maeshiro, Nao Nishida, Kanae Kimura, Yuji Kawahigashi, Yasuhito Tanaka, Michio Sata
Hepatitis C virus (HCV) infection is frequently associated with various extrahepatic manifestations, such as autoimmune features and immune complex deposit diseases. Oral lichen planus (OLP) is one such extrahepatic manifestation of HCV infection. Recently, direct-acting antivirals (DAA) have proved to be highly effective and safe for the eradication of HCV. Herein, we report a case of OLP accompanied by HCV-related hepatocellular carcinoma (HCC) that disappeared after liver transplantation and achievement of sustained virological response following interferon (IFN)-free treatment with ledipasvir (LDV) and sofosbuvir (SOF)...
September 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29427481/treatment-of-hepatitis-c-results-in-real-life
#7
REVIEW
Christophe Hézode
Direct-acting antivirals (DAAs) have transformed traditional treatment options for hepatitis C virus (HCV) infection. DAA combinations have been shown to be highly effective in reducing the burden of chronic HCV infection in clinical trials and have been recommended by the European Association for the Study of the Liver (EASL) treatment guidelines. This review examines the results of second-generation DAA combinations in real-life clinical practice in patients with genotypes 1-3 and in those co-infected with HIV (real-world data in genotypes 4-6 are rare)...
February 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29425404/ns5a-p32-deletion-after-failure-of-ledipasvir-sofosbuvir-in-hepatitis-c-virus-genotype-1b-infection
#8
Akira Doi, Hayato Hikita, Ryotaro Sakamori, Yuki Tahata, Yugo Kai, Ryoko Yamada, Takayuki Yakushijin, Eiji Mita, Kazuyoshi Ohkawa, Yasuharu Imai, Kunimaro Furuta, Takahiro Kodama, Tomohide Tatsumi, Tetsuo Takehara
No abstract text is available yet for this article.
February 9, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29417463/drug-interchangeability-of-generic-and-brand-products-of-fixed-dose-combination-tablets-of-sofosbuvir-and-ledipasvir-400-90%C3%A2-mg-employment-of-reference-scaled-average-bioequivalence-study-on-healthy-egyptian-volunteers
#9
Ehab Rasmy Bendas, Mamdouh R Rezk, Kamal A Badr
BACKGROUND AND OBJECTIVES: The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers. METHODS: The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks...
February 7, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29414007/ultrasensitive-spectrofluorimetric-method-for-rapid-determination-of-daclatasvir-and-ledipasvir-in-human-plasma-and-pharmaceutical-formulations
#10
Mohammad Nabil Abo-Zeid, Noha N Atia, Samia M El-Gizawy, Salwa R El-Shaboury
Direct-acting antivirals (DAAs) represent a revolution in the treatment of chronic hepatitis C which have emerged at an extremely rapid pace over the past few years. DAAs act directly on the hepatitis C virus at various points in the viral life cycle to inhibit viral production. Among these novel DAAs, are daclatasvir (DCS) and ledipasvir (LDS). Herein, a novel, fast, simple, ultrasensitive and cost-effective spectrofluorimetric method was designed for determination of DCS and LDS in miscellaneous matrices...
January 31, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29407313/development-of-duodenal-ulcers-due-to-the-discontinuation-of-proton-pump-inhibitors-after-the-induction-of-sofosbuvir-plus-ledipasvir-therapy-a-report-of-two-cases
#11
S Miuma, H Miyaaki, Y Miyazoe, T Suehiro, R Sasaki, H Shibata, N Taura, K Nakao
Sofosbuvir plus ledipasvir (SOF-LDV) combination therapy is a promising therapy for post-transplant hepatitis C virus (HCV) reinfection. It is known that gastric pH elevation induces lower absorption of ledipasvir; therefore, the use of proton pump inhibitors (PPIs) should be considered regarding dose reduction after SOF-LDV therapy induction. Here, we report two patients who developed duodenal ulcers due to the discontinuation of PPIs after the induction of SOF-LDV therapy for post-transplant HCV reinfection...
January 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29406396/safety-and-efficacy-of-anti-pd-1-therapy-for-metastatic-melanoma-and-non-small-cell-lung-cancer-in-patients-with-viral-hepatitis-a-case-series
#12
Anita Kothapalli, Muhammad A Khattak
Anti-PD-1 monoclonal antibodies have shown durable long-term survival benefit in patients with metastatic melanoma. Limited evidence exists on the safety and efficacy of PD-1 inhibitors in patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infections as these patients have traditionally been excluded from clinical trials because of a theoretical risk of immune reconstitution inflammatory syndrome. We aim to determine the safety and efficacy of treatment with PD-1 inhibitors in seven patients with HBV/HCV infection and concurrent metastatic melanoma or non-small-cell lung cancer (NSCLC)...
February 5, 2018: Melanoma Research
https://www.readbyqxmd.com/read/29404477/the-emergence-of-ns5b-resistance-associated-substitution-s282t-after-sofosbuvir-based-treatment
#13
Edward J Gane, Sophie Metivier, Ronald Nahass, Michael Ryan, Catherine A Stedman, Evguenia S Svarovskaia, Hongmei Mo, Brian Doehle, Hadas Dvory-Sobol, Charlotte Hedskog, Ming Lin, Diana M Brainard, Jenny C Yang, John G McHutchison, Mark Sulkowski, Ziad Younes, Eric Lawitz
S282T in NS5B is the primary amino acid substitution associated with resistance to sofosbuvir (SOF) but has rarely been detected in patients treated with a SOF-based regimen. Here, the emergence and fitness of the S282T substitution in virologic failure patients administered SOF-based regimens across the SOF and ledipasvir (LDV)/SOF phase 2 and 3 programs was evaluated. Plasma samples collected at baseline and at virologic failure were amplified and deep sequenced (1% cutoff). To date, over 12,000 patients have been treated in SOF or LDV/SOF phase 2 and 3 studies...
August 2017: Hepatology Communications
https://www.readbyqxmd.com/read/29399282/efficacy-of-direct-acting-antiviral-treatment-for-chronic-hepatitis-c-a-single-hospital-experience
#14
Rena Kaneko, Natsuko Nakazaki, Risa Omori, Yuichiro Yano, Masazumi Ogawa, Yuzuru Sato
AIM: To evaluate the efficacy of direct-acting antivirals (DAAs) in Kanto Rosai Hospital. METHODS: All patients with hepatitis C virus (HCV) who underwent DAA prescription were enrolled in this study. The present study was a single center retrospective analysis using patients infected with HCV genotype 1 or 2. Resistance analysis was performed by using direct sequencing and cycleave PCR in genotype 1 patients treated with interferon (IFN)-free DAA. The primary endpoint was sustained virologic response at 12 wk after therapy (SVR12)...
January 27, 2018: World Journal of Hepatology
https://www.readbyqxmd.com/read/29394727/-a-case-report-of-inguinal-malignant-lymphoma-after-surgery-for-hepatocellular-carcinoma
#15
Yuki Ohzato, Masahiro Murakami, Junzo Shimizu, Chikato Koga, Daiki Marukawa, Yuta Yoshida, Akinobu Yasuyama, Tae Matsumura, Akihiro Takada, Chizu Kameda, Ryohei Kawabata, Masaki Hirota, Shingo Noura, Hideaki Miwa, Junichi Hasegawa
An 81-year-old woman was followed up for hepatitis C from 1994. Sheh ad a previous history of hypertension and appendicitis. In October 2014, the patient underwent subsegmentectomy(S8)and cholecystectomy for hepatocellular carcinoma (HCC)(T2N0M0, Stage II ). From December 2015, the patient had taken ledipasvir-sofosbuvir orally for hepatitis C virus (HCV). In January 2016, we confirmed HCV-RNA shade transformation. In September 2016, enhanced CT showed a mass in theright lower quadrant of her abdomen. Shehad a hard 3 cm mass in thesameplaceon physical exam...
November 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/29380288/ledipasvir-sofosbuvir-a-review-in-chronic-hepatitis-c
#16
Lesley J Scott
Oral once-daily, fixed-dose, ledipasvir/sofosbuvir (Harvoni®) [± ribavirin] is approved in several countries for the treatment of chronic hepatitis C (CHC) in adults and adolescents aged 12 to < 18 years, with direct-acting antiviral (DAA) regimens resulting in a paradigm shift in the treatment of the disease. In the clinical trial and/or clinical practice setting, ledipasvir/sofosbuvir (± ribavirin) was associated with high sustained virological response rates 12 weeks post-treatment (SVR12) in treatment-naive and -experienced adults and adolescents with chronic hepatitis C virus (HCV) genotype (GT) 1 infection, including in those with compensated cirrhosis or who were co-infected with HIV...
February 2018: Drugs
https://www.readbyqxmd.com/read/29377464/efficacy-of-generic-oral-directly-acting-agents-in-patients-with-hepatitis-c-virus-infection
#17
Swatantra Gupta, Gyanranjan Rout, Arpan H Patel, Mousumi Mahanta, Nancy Kalra, Pabitra Sahu, Rahul Sethia, Ashish Agarwal, Gyan Ranjan, Saurabh Kedia, Subrat Kumar Acharya, Baibaswata Nayak, Shalimar
Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented...
January 28, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29377274/all-oral-daa-therapy-against-hcv-in-hiv-hcv-coinfected-subjects-in-real-world-practice-madrid-core-findings
#18
Juan Berenguer, Ángela Gil-Martin, Inmaculada Jarrin, Ana Moreno, Lourdes Dominguez, Marisa Montes, Teresa Aldámiz-Echevarría, María J Téllez, Ignacio Santos, Laura Benitez, José Sanz, Pablo Ryan, Gabriel Gaspar, Beatriz Alvarez, Juan E Losa, Rafael Torres-Perea, Carlos Barros, Juan V San Martin, Sari Arponen, María Teresa de Guzmán, Raquel Monsalvo, Ana Vegas, María T Garcia-Benayas, Regino Serrano, Luis Gotuzzo, María Antonia Menendez, Luis M Belda, Eduardo Malmierca, María J Calvo, Encarnación Cruz-Martos, Juan J González-García
We evaluated treatment outcomes in a prospective registry of HIV/HCV-coinfected patients treated with interferon-free direct-acting antiviral agent (DAA)-based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response (SVR) at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% were non-cirrhotic (Non-C), 33.9% had compensated cirrhosis (Co-C), and 6...
January 29, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29376623/interferon-free-treatments-in-patients-with-hepatitis-c-genotype-3-infection-in-a-tertiary-hospital
#19
J C Del Rio-Valencia, R Asensi-Diez, R Madera-Pajin, L Yunquera-Romero, I Muñoz-Castillo
OBJECTIVE: Hepatitis C virus genotype 3 represents a unique entity within HCV treatment and multiple studies have documented that HCV genotype 3 infection is associated with more rapid disease progression than other genotypes, resulting in increased risk of cirrhosis, hepatocellular carcinoma, and all-cause mortality. In the current study, we further evaluated the real-world effectiveness of 12 weeks of ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV) and sofosbuvir + daclatasvir (SOF + DCV) for treatment-naive or treatment-experienced patients infected with HCV genotype 3, with or without cirrhosis...
January 29, 2018: Revista Española de Quimioterapia: Publicación Oficial de la Sociedad Española de Quimioterapia
https://www.readbyqxmd.com/read/29359017/efficacy-and-safety-of-sofosbuvir-and-ledipasvir-in-japanese-patients-aged-75-years-or-over-with-hepatitis-c-genotype-1
#20
Yoshinori Ozono, Kenji Nagata, Satoru Hasuike, Hisayoshi Iwakiri, Kenichi Nakamura, Mai Tsuchimochi, Yuri Yamada, Yuka Takaishi, Mitsue Sueta, Tadashi Miike, Yoshihiro Tahara, Shojiro Yamamoto, Kotaro Shide, Tomonori Hidaka, Yoko Kubuki, Kazunori Kusumoto, Toshimasa Ochiai, Junya Kato, Naoto Komada, Shuichi Hirono, Kazuo Kuroki, Masafumi Shigehira, Kazuya Shimoda
AIM: To evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1. METHODS: This multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records...
December 28, 2017: World Journal of Hepatology
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