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https://www.readbyqxmd.com/read/28332272/clinical-evaluation-of-sofosbuvir-ledipasvir-in-chronic-hepatitis-c-genotype-1-with-and-without-prior-daclatasvir-asnaprevir-therapy
#1
Etsuko Iio, Noritomo Shimada, Koichi Takaguchi, Tomonori Senoh, Yuichiro Eguchi, Masanori Atsukawa, Akihito Tsubota, Hiroshi Abe, Keizo Kato, Atsunori Kusakabe, Tomokatsu Miyaki, Kentaro Matsuura, Kayoko Matsunami, Noboru Shinkai, Kei Fujiwara, Shunsuke Nojiri, Yasuhito Tanaka
AIM: This study explored treatment outcomes of sofosbuvir (SOF)/ledipasvir (LDV) therapy for chronic hepatitis C patients with and without prior daclatasvir (DCV)/asunaprevir (ASV) therapy. METHODS: Overall, 530 Japanese patients who were infected with hepatitis C virus genotype 1 received SOF/LDV therapy for 12 weeks, and resistance-associated variants (RAVs) in the HCV NS5A and NS5B regions were assessed at baseline and virological relapse by direct sequencing...
March 22, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28330530/spectrophotometric-methods-for-simultaneous-determination-of-sofosbuvir-and-ledipasvir-harvoni-tablet-comparative-study-with-two-generic-products
#2
Nisreen F Abo-Talib, Mohamed R El-Ghobashy, Marwa H Tammam
Sofosbuvir and ledipasvir are the first drugs in a combination pill to treat chronic hepatitis C virus. Simple, sensitive, and rapid spectrophotometric methods are presented for the determination of sofosbuvir and ledipasvir in their combined dosage form. These methods were based on direct measurement of ledipasvir at 333 nm (due to the lack of interference of sofosbuvir) over a concentration range of 4.0–14.0 μg/mL, with a mean recovery of 100.78 ± 0.64%. Sofosbuvir was determined, without prior separation, by third-derivative values at 281 nm; derivative ratio values at 265...
February 10, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28328620/ledipasvir-and-sofosbuvir-combination-for-hepatitis-c-virus-infection-in-three-patients-aged-85-years-and-older
#3
Fanpu Ji, Changyin Tian, Zongfang Li, Hong Deng, Mindie H Nguyen
No abstract text is available yet for this article.
March 21, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28321163/optimizing-hepatitis-c-virus-treatment-through-pharmacist-interventions-identification-and-management-of-drug-drug-interactions
#4
Jacob A Langness, Matthew Nguyen, Amanda Wieland, Gregory T Everson, Jennifer J Kiser
AIM: To quantify drug-drug-interactions (DDIs) encountered in patients prescribed hepatitis C virus (HCV) treatment, the interventions made, and the time spent in this process. METHODS: As standard of care, a clinical pharmacist screened for DDIs in patients prescribed direct acting antiviral (DAA) HCV treatment between November 2013 and July 2015 at the University of Colorado Hepatology Clinic. HCV regimens prescribed included ledipasvir/sofosbuvir (LDV/SOF), paritaprevir/ritonavir/ombitasvir/dasabuvir (OBV/PTV/r + DSV), simeprevir/sofosbuvir (SIM/SOF), and sofosbuvir/ribavirin (SOF/RBV)...
March 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28315983/retreatment-with-sofosbuvir-ledipasvir-and-add-on-ribavirin-for-patients-who-failed-daclatasvir-and-asunaprevir-combination-therapy
#5
Goki Suda, Koji Ogawa, Yoshiya Yamamoto, Masaki Katagiri, Ken Furuya, Kenichi Kumagai, Jun Konno, Megumi Kimura, Naoki Kawagishi, Masatsugu Ohara, Machiko Umemura, Jun Ito, Takaaki Izumi, Masato Nakai, Takuya Sho, Mitsuteru Natsuizaka, Kenichi Morikawa, Akihito Tsubota, Noritomo Shimada, Etsuko Iio, Yasuhito Tanaka, Naoya Sakamoto
BACKGROUND: The optimal retreatment regimen for patients with hepatitis C virus (HCV) infection who failed interferon-free, direct-acting antiviral (DAA) therapy is undetermined. In this study, we aimed to evaluate the efficacy and safety of 12-week retreatment with ledipasvir (LDV) and sofosbuvir (SOF) with add-on ribavirin (RBV) for patients who previously failed to respond to HCV-NS5A inhibitor, daclatasvir (DCV), and HCV-NS3 inhibitor, asunaprevir (ASV), therapy. METHODS: This multicenter, prospective study enrolled 15 patients with genotype-1 HCV infection who failed DCV/ASV combination therapy...
March 18, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28286567/grazoprevir-elbasvir-combination-therapy-for-hcv-infection
#6
REVIEW
Anaïs Vallet-Pichard, Stanislas Pol
Interferon-free regimens combine different second-wave direct-acting antiviral agents (DAAs), which target the main viral proteins involved in the replication cycle of hepatitis C virus (HCV): NS3/4A protease inhibitors (simeprevir or paritaprevir boosted by ritonavir), NS5B nucleos(t)idic (sofosbuvir) and nonnucleos(t)idic (dasabuvir) polymerase inhibitors, NS5A replication complex inhibitors (daclatasvir, ledipasvir, elbasvir, velpatasvir). Combinations of two or three DAAs, given for 8-24 weeks reach sustained virology response (SVR) rates greater than 90% with good tolerance...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28286560/prevalence-of-end-of-treatment-rna-positive-sustained-viral-response-in-hcv-patients-treated-with-sofosbuvir-combination-therapies
#7
Miguel Malespin, Tamara Benyashvili, Susan L Uprichard, Alan S Perelson, Harel Dahari, Scott J Cotler
BACKGROUND: Some chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients with genotype 1 and other genotypes, as well as whether such patients achieve SVR24 remain in question. The aims of this study were to evaluate the frequency and durability of EOT+/SVR12&24 and other response categories in HCV genotype 1, 2, or 3 infected patients treated with DAA in clinical practice...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28280374/optimizing-choice-of-oral-interferon-free-treatment-for-genotype-1-hepatitis-c-virus-using-testing-for-ns5a-resistance-a-cost-utility-analysis-from-the-perspective-of-the-italian-national-health-service
#8
Kirsten Y Westerhout, Walter Bouwmeester, Inge Duchesne, Marta Pisini, Marjanne A Piena, Francesco Damele, Beatrice Gueron, Maarten Treur, Jonathan Belsey
BACKGROUND: Patients with genotype-1 hepatitis C virus infection who have failed to respond to standard therapy or who relapse following treatment may be considered for an interferon-free regimen incorporating a nonstructural protein 5A (NS5A) inhibitor. Sustained virologic response (SVR) with these regimens is typically >90%, but this is reduced in patients with NS5A resistance. European Association for Study of the Liver guidelines recommend simeprevir + sofosbuvir ± ribavirin (SMV+SOF±R) for re-treating patients failing an NS5A inhibitor-containing regimen...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28277812/considerations-on-bringing-warehoused-hcv-patients-into-active-care-following-interferon-free-direct-acting-antiviral-drug-approval
#9
Aleksandra Palak, Christine Livoti, Céline Audibert
OBJECTIVES: Until recently, lack of efficacious and tolerable hepatitis C virus (HCV) treatments prompted patient warehousing until better treatment options became available. We investigated whether the introduction of ledipasvir/sofosbuvir precipitated patient return to clinics, thereby changing HCV clinic dynamics. METHODS: Online questionnaire responses indicated the volume of HCV patients followed, the proportion of warehoused patients and those who were proactively offered new options, methods for identifying and contacting patients, and insurance authorization/reimbursement-related information...
March 9, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28276815/effectiveness-of-interferon-free-therapy-for-the-treatment-of-hcv-patients-with-compensated-cirrhosis-treated-through-the-irish-early-access-program
#10
Emma Gray, Aisling O'Leary, Colm Bergin, Suzanne Norris
BACKGROUND: We investigated the real-world effectiveness of interferon-free regimens for the treatment of patients with compensated cirrhosis infected with hepatitis C virus (HCV). METHOD: Using the Irish national HCV treatment registry, the effectiveness and safety of interferon-free regimens for HCV-infected patients treated between April 2015 and August 2016, was determined. RESULTS: A SVR12 was achieved in 86% of subjects treated with sofosbuvir/ledipasvir ± ribavirin (SOF/LDV±RBV), 93% treated with paritaprevir, ombitasvir and ritonavir combined with dasabuvir ± ribavirin (3D±RBV) and 89% treated with sofosbuvir/daclatasvir ± ribavirin (SOF/DCV±RBV)...
February 22, 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28273410/cost-effectiveness-analysis-of-ledipasvir-sofosbuvir-in-patients-with-chronic-hepatitis-c-treatment-of-patients-with-absence-or-mild-fibrosis-compared-to-patients-with-advanced-fibrosis
#11
M Buti, R Domínguez-Hernández, I Oyagüez, M A Casado, R Esteban
OBJECTIVE: To evaluate the cost-effectiveness of Ledipasvir/Sofosbuvir (LDV/SOF) in treatment-naïve patients with chronic hepatitis C (CHC) genotype 1 (GT1) in the absence or mild fibrosis (F0-F1) versus advanced fibrosis (F2-F4), from the perspective of the Spanish Health System. METHODS: A Markov model was developed to simulate disease progression, estimating costs and outcomes [life years gained, (LYG), and quality adjusted life years, (QALY)] derived from starting with LDV/SOF in patients with F0-F1 compared with F2-F4...
March 8, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28271521/transformation-of-hepatitis-c-antiviral-treatment-in-a-national-healthcare-system-following-the-introduction-of-direct-antiviral-agents
#12
A M Moon, P K Green, K Berry, G N Ioannou
BACKGROUND: Highly effective direct antiviral agents (DAAs) for hepatitis C virus (HCV) were introduced recently. Their utilisation has been limited by high cost and low access to care. AIM: To describe the effect of DAAs on HCV treatment and cure rates in the United States Veterans Affairs (VA) national healthcare system. METHODS: We identified all HCV antiviral treatment regimens initiated from 1 January 1999 to 31 December 2015 (n = 105 369) in the VA national healthcare system, and determined if they resulted in sustained virological response (SVR)...
March 8, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28270038/inf-free-sofosbuvir-based-treatment-of-post-transplant-hepatitis-c-relapse-a-swedish-real-life-experience
#13
Castedal Maria, Segenmark Michael, Cederberg Susanne, Skoglund Catarina, Weiland Ola
BACKGROUND: Relapse of hepatitis C virus (HCV) infection after liver transplantation has been universal, and the fibrosis progression faster than in non-transplanted patients. Interferon (IFN)-free treatment with direct antiviral agents (DAA) has improved the treatment outcome dramatically. We here report on the outcome of IFN-free treatment for HCV relapse after liver transplantation in a real life setting in Sweden. MATERIAL: In total, 93 patients with a mean age of 60 years (range 32-80) with HCV relapse after liver transplantation were given sofosbuvir-based treatment in combination with a protease inhibitor (simeprevir) or a NS5A inhibitor (daclatasvir or ledipasvir) with or without addition of ribavirin (RBV), or sofosbuvir and RBV only...
May 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28267900/augmentation-of-hcv-specific-immunity-and-sustained-virological-response-svr
#14
Shikha Shrivastava, E Wilson, B Poonia, L Tang, A Osinusi, A Kohli, Shyam Kottilil
BACKGROUND: Treatment for chronic hepatitis C virus (HCV) infection has rapidly evolved into interferon-free directly acting antiviral regimens (DAA) that result in high sustained-virologic-response. DAAs primarily work by suppressing HCV replication and rely less on the immune system than interferon-based therapies. However it is unclear whether the immune system recovers with suppression of HCV replication and contributes to HCV clearance with DAA therapy. We previously demonstrated HCV clearance is associated with increased HCV-specific-immunity in CHCV-GT-1 infected patients during treatment with sofosbuvir (SOF)+ribavirin (RBV)...
March 7, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28267622/effectiveness-of-hepatitis-c-antiviral-treatment-in-a-usa-cohort-of-veteran-patients-with-hepatocellular-carcinoma
#15
Lauren A Beste, Pamela K Green, Kristin Berry, Matthew J Kogut, Stephen K Allison, George N Ioannou
BACKGROUND & AIMS: Hepatitis C virus (HCV) treatment for patients with hepatocellular carcinoma (HCC) was uncommon before direct acting antiviral (DAA) medications. Real-world effectiveness of DAAs for HCV in patients with HCC is unclear. We describe rates of sustained virologic response (SVR) with DAA regimens by HCV genotype in patients with history of HCC. METHODS: We identified patients who initiated antiviral treatment between January 1, 2014 and June 30, 2015 in the national Veterans Affairs health care system...
March 3, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28261822/systematic-review-interferon-free-regimens-for-patients-with-hcv-related-child-c-cirrhosis
#16
REVIEW
M Guarino, F Morisco, M R Valvano, A M Ippolito, M Librandi, N Andriulli, M Greco, A Amoruso, A Iacobellis, G Niro, N Caporaso, A Andriulli
BACKGROUND: It is unclear whether the efficacy and long-term outcome of treating patients with hepatitis C virus (HCV)-positive cirrhosis with the new protease inhibitors will extend to those with Child C cirrhosis. AIM: To assess the effectiveness of the interferon-free regimens in Child C cirrhotic patients with HCV infection. METHODS: A systematic Medline search was conducted to retrieve studies describing the treatment of Child C patients with direct-acting agents...
March 6, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28259054/comparison-of-on-treatment-hcv-rna-during-direct-antiviral-therapy-using-two-different-cobas-taqman-hcv-assays
#17
Johannes Vermehren, Marc Bourlière, Stanislas Pol, Patrick Marcellin, Robert H Hyland, Deyuan Jiang, Diana M Brainard, Stefan Zeuzem, Tania M Welzel
BACKGROUND: Repeated measurements of hepatitis C virus (HCV) RNA levels during antiviral therapy are recommended to monitor treatment efficacy and adherence. Throughout most direct antiviral agent (DAA) approval studies, HCV RNA cutoffs and endpoints were established with the COBAS TaqMan assay for use with the High Pure System (HPS/CTM). Different assays used in clinical practice may yield different quantitative results and possibly impact treatment decisions. OBJECTIVES: The concordance of the fully-automated COBAS AmpliPrep/COBAS TaqMan assay (CAP/CTM) with HPS/CTM and its ability to predict response to DAA-treatment with ledipasvir/sofosbuvir was assessed in cirrhotic patients with HCV genotype-1-infection who had failed prior treatment with protease inhibitor-based regimens...
April 2017: Journal of Clinical Virology: the Official Publication of the Pan American Society for Clinical Virology
https://www.readbyqxmd.com/read/28258606/impact-of-hepatitis-c-virus-recombinant-form-rf1_2k-1b-on-hcv-treatment-outcomes-within-georgian-national-hepatitis-c-elimination-program
#18
Marine Karchava, Nikolozs Chkhartishvili, Lali Sharvadze, Akaki Abutidze, Natia Dvali, Lana Gatserelia, Lela Dzigua, Natalia Bolokadze, Ekaterine Dolmazashvili, Adam Kotorashvili, Paata Imnadze, Amiran Gamkrelidze, Tengiz Tsertsvadze
AIM: Hepatitis C virus (HCV) recombinant form RF1_2k/1b is common in ethnic Georgians. This chimera virus contains genomic fragments of genotype 2 and genotype 1 and is misclassified as genotype 2 by standard genotyping. We aimed to identify RF1_2k/1b strains among genotype 2 patients and assess its impact on treatment outcomes. METHODS: Study included 148 patients with HCV genotype 2 as determined by 5 untranslated region/Core (5'UTR/Core) genotyping assay. RF1_2k/1b was identified by sequencing non- structural 5B (NS5B) region...
March 4, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28249574/reactivation-of-occult-hbv-infection-in-an-hiv-hcv-co-infected-patient-successfully-treated-with-sofosbuvir-ledipasvir-a-case-report-and-review-of-the-literature
#19
Gabriele Fabbri, Ilaria Mastrorosa, Alessandra Vergori, Valentina Mazzotta, Carmela Pinnetti, Susanna Grisetti, Mauro Zaccarelli, Adriana Ammassari, Andrea Antinori
BACKGROUND: Reactivation of occult or inactive Hepatitis B virus (HBV) infection during immunosuppressant treatments is well known and widely described in literature. The same observation has been made in Hepatitis C (HCV)-infected patients previously exposed to HBV and treated with interferon-free DAA treatments. Because of common transmission routes, persons may have been exposed to HCV, HBV and HIV, but few cases have been reported in this scenario to date. Frequency of HBV reactivation in HIV/HCV co-infected patients previously exposed to HBV and treated with DAA remains unclear...
March 1, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28245654/treating-medicaid-patients-with-hepatitis-c-clinical-and-economic-impact
#20
Zobair Younossi, Stuart C Gordon, Aijaz Ahmed, Douglas Dieterich, Sammy Saab, Rachel Beckerman
OBJECTIVES: To estimate change in chronic hepatitis C virus (HCV) disease and the economic burden associated with comprehensive treatment of the chronic HCV-infected Medicaid population. STUDY DESIGN: Decision-analytic Markov model. METHODS: Treatment-naïve patients with genotype 1 chronic HCV were followed over a lifetime horizon from the third-party payer perspective. Patients entered the model insured under Medicaid and were treated under state-specific restrictions by Metavir fibrosis stage (base case) or all treated (all-patient strategy) with an approved all-oral regimen (ledipasvir/sofosbuvir [LDV/SOF] for 8 weeks or 12 weeks, depending on cirrhosis status, viral load, and state-specific LDV/SOF restrictions)...
February 2017: American Journal of Managed Care
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