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https://www.readbyqxmd.com/read/29353349/daclatasvir-a-review-of-preclinical-and-clinical-pharmacokinetics
#1
REVIEW
Yash Gandhi, Timothy Eley, Aberra Fura, Wenying Li, Richard J Bertz, Tushar Garimella
Daclatasvir is a first-in-class, highly selective, hepatitis C virus, non-structural protein 5a polymerase replication complex inhibitor with picomolar potency and broad genotypic coverage in vitro. Daclatasvir undergoes rapid absorption, with a time to reach maximum plasma concentration of 1-2 h and an elimination half-life of ~ 10 to 14 h observed in single-ascending dose studies. Steady state was achieved by day 4 in multiple-ascending dose studies. Daclatasvir can be administered without regard to food or pH modifiers...
January 20, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29349793/the-effectiveness-and-safety-of-ledipasvir-plus-sofosbuvir-in-adolescents-with-chronic-hepatitis-c-virus-genotype-4-infection-a-real-world-experience
#2
H R El-Khayat, E M Kamal, M H El-Sayed, M El-Shabrawi, H Ayoub, A RizK, M Maher, R Y El Sheemy, Y M Fouad, D Attia
BACKGROUND: The combination of ledipasvir plus sofosbuvir was recently approved for treatment of adolescent (12-17 years) HCV genotype 1, 4, 5 & 6 patients. However, few clinical trials have been performed in genotype 1 patients. AIM: To investigate the effectiveness and safety of ledipasvir plus sofosbuvir in chronic HCV adolescent patients with genotype 4 in the real world. METHODS: This prospective multicentre (six centres) open-label study included 144 adolescent chronic HCV patients with genotype 4 (mean age 14 ± 2, 69% males)...
January 19, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29340469/sofosbuvir-and-daclatasvir-combination-therapy-for-current-hepatitis-c-virus-genotype-4-achieves-svr-a-case-report-of-hcv-genotype-4-from-the-amazon
#3
Andréa Monteiro Tarragô, Grenda Leite Pereira, Flamir da Silva Victória, Adriana Malheiro Alle Marie, Marilú Barbieri Victória
Hepatitis C is a worldwide endemic disease. However, hepatitis C virus genotype 4 (HCV GT-4) has rarely been reported in Brazil. HCV GT-4 demonstrates high sustained virological response (SVR). Here, we report the case of a 62-year-old HCV GT-4 positive woman complaining of a headache, nausea, and arthralgia. The patient was treated according to the protocol for genotype 4 (12 weeks administration of 400mg sofosbuvir and 60mg daclatasvir daily) and achieved SVR. Although this is not an Amazonas autochthonous case, the presence of genotype 4 is rarely reported in the region...
November 2017: Revista da Sociedade Brasileira de Medicina Tropical
https://www.readbyqxmd.com/read/29334502/risk-of-hepatitis-b-virus-reactivation-among-patients-treated-with-ledipasvir-sofosbuvir-for-hepatitis-c-virus-infection
#4
Beshoy T Yanny, Nyan L Latt, Sammy Saab, Steven Han, Gina Choi, Jason Kramer, Amandeep K Sahota
BACKGROUND: Direct acting antiviral (DAA) agents are the standard of care for treatment of hepatitis C virus (HCV)-infected individuals. Hepatitis B virus (HBV) reactivation during HCV treatment has been reported, the incidence and clinical outcome remains unclear. The aim of our study is to examine the risk of HBV reactivation in actively infected or previously exposed patients during or after HCV treatment with DAAs. METHODS: Adults with chronic HCV infection previously exposed or actively infected with HBV and treated with DAAs between December 2015 to 2016 were included...
January 12, 2018: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/29330728/analysis-of-plasma-tenascin-c-in-post-hcv-cirrhosis-a-prospective-study
#5
Jennifer H Benbow, April D Elam, Krista L Bossi, Danae L Massengill, Elizabeth Brandon-Warner, William E Anderson, Catherine R Culberson, Mark W Russo, Andrew S deLemos, Laura W Schrum
BACKGROUND AND AIM: Hepatitis C virus (HCV)-related cirrhosis, one of the most common etiologies of liver cirrhosis in the Western world, is a risk factor for hepatocellular carcinoma. To confirm and improve current effectiveness of screening and prognosis of patients with established cirrhosis, a credible, simple plasma biomarker is needed. Hepatic stellate cell activation, a pivotal event in cirrhosis development, results in increased secretion of extracellular matrix proteins, including tenascin-C (TnC)...
January 12, 2018: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/29327401/daclatasvir-and-reduced-dose-sofosbuvir-an-effective-and-pangenotypic-treatment-for-hepatitis-c-in-patients-with-egfr-30-ml-min
#6
Amit Goel, Dharmendra Singh Bhadauria, Anupma Kaul, Prashant Verma, Mayank Mehrotra, Amit Gupta, Raj Kumar Sharma, Praveer Rai, Rakesh Aggarwal
BACKGROUND & AIMS: Sofosbuvir is a key agent for HCV treatment. It is not recommended for patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) <30 mL/min. We report real-life experience of treating a cohort of CKD patients with eGFR <30 mL/min using daclatasvir and half-daily dose of sofosbuvir. METHODS: Adults patients who (i) had eGFR<30 ml/min and detectable HCV RNA and (ii) were treated with interferon and ribavirin free, DAA based regimens were included...
January 12, 2018: Nephrology
https://www.readbyqxmd.com/read/29317673/the-epidemiology-of-hepatitis-c-virus-in-iran-systematic-review-and-meta-analyses
#7
Sarwat Mahmud, Vajiheh Akbarzadeh, Laith J Abu-Raddad
The aim of this study was to characterize hepatitis C virus (HCV) epidemiology in Iran and estimate the pooled mean HCV antibody prevalence in different risk populations. We systematically reviewed and synthesized reports of HCV incidence and/or prevalence, as informed by the Cochrane Collaboration Handbook, and reported our findings following the PRISMA guidelines. DerSimonian-Laird random effects meta-analyses were implemented to estimate HCV prevalence in various risk populations. We identified five HCV incidence and 472 HCV prevalence measures...
January 9, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29314146/sofosbuvir-plus-daclatasvir-with-or-without-ribavirin-in-551-patients-with-hepatitis-c-related-cirrhosis-genotype-4
#8
H El-Khayat, Y Fouad, H I Mohamed, H El-Amin, E M Kamal, M Maher, A Risk
BACKGROUND: The Daclatasvir and Sofosbuvir combination therapy (SOF/DCV) has shown efficacy in patients with chronic hepatitis C in clinical trials. AIM: To investigate the efficacy and safety of SOF/DCV for treatment of patients with hepatitis C-related liver cirrhosis genotype 4. METHODS: Multicentre study involving 551 patients with liver cirrhosis genotype 4; 432 naïve patients and 119 treatment-experienced patients. All patients received SOF (400 mg) and DCV (60 mg) daily in addition to weight-based ribavirin (RBV) for 12 weeks and when RBV is contraindicated the treatment duration was extended to 24 weeks...
January 3, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29314090/development-and-validation-of-lc-ms-ms-method-for-simultaneous-determination-of-sofosbuvir-and-daclatasvir-in-human-plasma-application-to-pharmacokinetic-study
#9
Ola M Abdallah, Ahmed M Abdel-Megied, Amira S Gouda
The first simple and highly sensitive Liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method was developed and fully validated for the simultaneous determination of newly discovered antiviral drugs namely, Sofosbuvir (SOF) and Daclatasvir (DAC) in human plasma. Tadalafil (TAD) was used as internal standard (IS). SOF, DAC and TAD (IS) were extracted from plasma using liquid-liquid extraction technique with methyl tert-butyl ether. The chromatographic separation was carried out using ZorbaxSB-C18 column (4...
January 3, 2018: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29310928/sofosbuvir-and-velpatasvir-for-hepatitis-c-virus-infection-in-people-with-recent-injection-drug-use-simplify-an-open-label-single-arm-phase-4-multicentre-trial
#10
Jason Grebely, Olav Dalgard, Brian Conway, Evan B Cunningham, Philip Bruggmann, Behzad Hajarizadeh, Janaki Amin, Julie Bruneau, Margaret Hellard, Alain H Litwin, Philippa Marks, Sophie Quiene, Sharmila Siriragavan, Tanya L Applegate, Tracy Swan, Jude Byrne, Melanie Lacalamita, Adrian Dunlop, Gail V Matthews, Jeff Powis, David Shaw, Maria Christine Thurnheer, Martin Weltman, Ian Kronborg, Curtis Cooper, Jordan J Feld, Chris Fraser, John F Dillon, Phillip Read, Ed Gane, Gregory J Dore
BACKGROUND: Despite revised guidelines that no longer exclude people who inject drugs (PWID) from treatment for hepatitis C virus (HCV) infection, many clinicians are reluctant to treat recent PWID. This study aimed to evaluate the efficacy of sofosbuvir and velpatasvir therapy in people with chronic HCV infection and recent injection drug use. METHODS: In this open-label, single-arm phase 4 trial (SIMPLIFY), we recruited participants with recent injection drug use (past 6 months) and chronic HCV genotype 1-6 infection from seven countries (19 sites)...
January 5, 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29288514/high-efficacy-of-ombitasvir-paritaprevir-ritonavir-plus-dasabuvir-in-hepatitis-c-genotypes-4-and-1-infected-patients-with-severe-chronic-kidney-disease
#11
Faisal M Sanai, Abdullah S Alghamdi, Ahmad A Afghani, Khalid Alswat, Adnan AlZanbagi, Mosfer N Alghamdi, Abdallah AlMousa, Mohammed Aseeri, Abdullah M Assiri, Mohamed A Babatin
Limited data has shown high efficacy of co-formulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in the treatment of hepatitis C virus (HCV) genotype (GT)-4, and combined with dasabuvir (DSV) in GT1 patients, with chronic kidney disease (CKD) stage 4-5 (<30 mL/min/1.73 m2 ). We assessed real-world safety and efficacy of OBV/PTV/r ± DSV in GT1 and 4-infected patients. METHODS: In this observational cohort (n=67), we enrolled stage 4-5 CKD treatment-naïve or Peginterferon/RBV-experienced GT4-infected patients (n=32) treated for 12-24 weeks with OBV/PTV/r ± RBV, and plus DSV in GT1 patients (n=35, including 3 with GT1/4 co-infection)...
December 29, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29287014/treatment-of-chronic-hepatitis-c-virus-infection-in-children-a-position-paper-by-the-hepatology-committee-of-european-society-of-paediatric-gastroenterology-hepatology-and-nutrition
#12
Giuseppe Indolfi, Loreto Hierro, Antal Dezsofi, Jörg Jahnel, Dominique Debray, Nedim Hadzic, Piotr Czubowski, Girish Gupte, Yael Mozer-Glassberg, Wendy van der Woerd, Françoise Smets, Henkjan J Verkade, Björn Fischler
OBJECTIVES: In 2017, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12-17 years, weighing more than 35 kg) with chronic hepatitis C virus (HCV) genotype 1, 4, 5 and 6 and genotype 2 and 3 infections, respectively. Although trials with direct acting antivirals (DAAs) are ongoing for younger children, the only available treatment in US and Europe for those < 12 years is still the dual therapy of pegylated interferon (PEG IFN) and ribavirin...
December 28, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29283074/genetic-susceptibility-in-family-members-of-egyptian-hepatitis-c-virus-infected-patients-role-of-interleukin-12-b-gene-polymorphism
#13
Nadia Elwan, Fathia Assal, Asem Elfert, Lobna AboAli, Shaimaa Soliman, Samah Soliman, Walaa Elkhalawany, Rehab Badawy, Laila Effat, Khalda Sayed, Safinaz Shalaby, Marwa Shehab, Mohamed Abdel-Hamid, Sherief Abd-Elsalam
AIM: The research was conducted to study Interleukin (IL)-12B gene polymorphism in families of Hepatitis C virus (HCV) infected patients in Egypt. METHODS: Three hundreds HCV patients, 860 family members and 100 healthy subjects were studied. All family members were screened for HCV antibodies by enzyme-linked immunosorbent assay (ELISA). Positive cases were examined using Real-Time polymerase chain reaction (PCR) to confirm the presence of HCV ribonucleic acid (RNA) and detect the viral load...
December 27, 2017: Infectious Disorders Drug Targets
https://www.readbyqxmd.com/read/29279441/data-mining-machine-learning-algorithms-using-il28b-genotype-and-biochemical-markers-best-predicted-advanced-liver-fibrosis-in-chronic-hcv
#14
Hend Ibrahim Shousha, Abubakr Hussein Awad, Dalia Abdelhamid Omran, Mayada Mohamed Elnegouly, Mahasen Mabrouk
  IL28 single nucleotide polymorphism (rs12979860) is an aetiology-independent predictor of hepatitis C virus (HCV) related hepatic fibrosis. Data mining is a method of predictive analysis which can explore tremendous volumes of information found in health records to discover hidden patterns and relationships. The study aims to evaluate and compare the prediction accuracy of APRI, FIB-4 versus data mining for prediction of HCV related advanced fibrosis. This retrospective study included 427 patients with chronic HCV...
December 26, 2017: Japanese Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29276096/the-association-of-variations-in-tlr-genes-and-spontaneous-immune-control-of-hepatitis-b-virus
#15
Seyma Katrinli, Adil Nigdelioglu, Kamil Ozdil, Gizem Dinler-Doganay, Levent Doganay
BACKGROUND: Toll-like receptors (TLRs) are suspected to play a critical role in liver diseases and the progression of chronic hepatitis B (CHB) infection. In this study, we investigated the possible association between TLRs and hepatitis B virus (HBV) infection chronicity in Turkish population. METHODS: TLR4 (+896 A→G) (rs4986790), TLR5 (+1846 T→C) (rs5744174) and TLR9 (-1237T→C) (rs5743836) polymorphisms were screened in 131 CHB patient and 168 individuals by polymerase chain reaction (PCR) - restriction fragment length polymorphism (RFLP) technique...
December 21, 2017: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/29260001/normalizing-serum-hepcidin-but-not-%C3%AE-1-antitrypsin-level-during-effective-treatment-of-chronic-hepatitis-c
#16
Magdalena Rogalska-Taranta, Jerzy Jaroszewicz, Robert Flisiak
Aim of the study: We investigated the impact of pegylated interferon α-2 in combination with ribavirin (PEG-IFNα/RBV) treatment on hepcidin and α-1-antitrypsin concentrations in the serum of patients with chronic hepatitis C. Material and methods: We measured serum concentrations of hepcidin, prohepcidin and α-1-antitrypsin by enzyme-linked immunosorbent assays in patients with chronic hepatitis C before and during antiviral therapy. Results: Hepcidin concentrations were increased in both genotype 1b and 3a hepatitis C virus (HCV) infected patients as compared with the control group...
December 2017: Clinical and Experimental Hepatology
https://www.readbyqxmd.com/read/29247332/pharmacokinetics-safety-and-tolerability-of-single-dose-elbasvir-in-participants-with-hepatic-impairment
#17
William L Marshall, Hwa-Ping Feng, Larissa Wenning, Graigory Garrett, Xiaobi Huang, Fang Liu, Deborah Panebianco, Luzelena Caro, Christine Fandozzi, Kenneth C Lasseter, Richard A Preston, Thomas Marbury, Joan R Butterton, Marian Iwamoto, Wendy W Yeh
BACKGROUND: The combination of elbasvir and grazoprevir is approved for the treatment of hepatitis C virus genotype 1 or 4 infection. OBJECTIVE: To evaluate the pharmacokinetics and safety of single-dose elbasvir 50 mg in participants with hepatic impairment. METHODS: Participants with mild, moderate, or severe hepatic impairment and age-, sex-, and weight-matched healthy controls were enrolled in a 3-part, open-label, sequential-panel, single-dose pharmacokinetic study...
December 15, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/29229584/eliminating-hepatitis-c-within-low-income-countries-the-need-to-cure-genotypes-4-5-6
#18
REVIEW
Tarik Asselah, Tarek Hassanein, Imam Waked, Abdellah Mansouri, Geoffrey Dusheiko, Edward Gane
Around 70 to 100 million people are chronically infected with HCV worldwide. HCV anti-viral drug development has been remarkable and this revolution led to several direct-acting antiviral agents achieving an HCV cure after only 8-12 weeks of treatment duration. Drug development has focused first on HCV genotype 1 infection, since it was the most prevalent worldwide, although clinical trials included all genotypes prevalent in the US and Europe. Because the earliest in vitro assays utilised the GT 1b and 2 replicons, the initial classes of direct acting antivirals (protease inhibitors, non-nucleotide polymerase inhibitors) were genotype 1-specific, albiet had an effect on other less prevalent genotypes...
December 8, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/29228501/hcv-clearance-by-direct-acting-antiviral-treatments-reverses-insulin-resistance-in-chronic-hepatitis-c-patients
#19
Luigi E Adinolfi, Riccardo Nevola, Barbara Guerrera, Giovanni D'Alterio, Aldo Marrone, Mauro Giordano, Luca Rinaldi
BACKGROUND AND AIM: Chronic hepatitis C (HCV), particularly genotype 1, is associated with insulin resistance (IR) and diabetes. We evaluated the impact of HCV clearance by all-oral direct-acting antiviral (DAAs) treatments on IR and glycemic control. METHODS: Included in this prospective case-control study were 133 consecutive HCV-genotype 1 patients with advance liver fibrosis (F3-F4) without type 2 diabetes. Sixty-eight treated with DAAs and 65 untreated. Liver fibrosis was assessed by transient elastography...
December 11, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29225269/late-relapse-after-a-sustained-virologic-response-at-24-weeks-after-treatment-with-daclatasvir-and-asunaprevir-combination-therapy-for-chronic-hepatitis-c-virus-genotype-1b-infection-with-liver-cirrhosis
#20
Haruki Uojima, Shuko Murakami, Seigo Nakatani, Hisashi Hidaka, Atsuko Takeuchi, Yoshiaki Tanaka, Tomoyoshi Inoue, Keiko Yamane, Kousuke Kubota, Takahide Nakazawa, Akitaka Shibuya, Yasuhito Tanaka, Wasaburo Koizumi
There have been few studies on relapse after a sustained virological response in hepatitis C virus (HCV) patients treated with interferon-free regimens. Thus, the risk of late relapse in patients treated with interferon-free therapy remains unclear. A 67-year-old woman with HCV genotype 1b and liver cirrhosis received oral daclatasvir and asunaprevir. Combination therapy was stopped after 4 weeks because of an episode of encephalopathy. Nonetheless, an HCV polymerase chain reaction at 24 weeks posttreatment was negative...
December 8, 2017: Internal Medicine
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