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Top results for sofosbuvir

41. [Sofosbuvir/velpatasvir (chronic hepatitis C) - benefit assessment according to õ35a SGB V]

[Sofosbuvir/velpatasvir (chronic hepatitis C) - benefit assessment according to õ35a SGB V] Sofosbuvir/celpatasvir (chronische hepatitis C): nutzenbewertung gemäß § 35a SGB V; dossierbewertungen; auftrag A16-48 [Sofosbuvir/velpatasvir (chronic hepatitis C) - benefit assessment according to §35a SGB V] Sofosbuvir/celpatasvir (chronische hepatitis C): nutzenbewertung gemäß § 35a SGB V; dossierbewertungen; auftrag A16-48 [Sofosbuvir/velpatasvir (chronic hepatitis C) - benefit assessment according (...) to §35a SGB V] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Sofosbuvir/celpatasvir (chronische hepatitis C): nutzenbewertung gemäß § 35a SGB V; dossierbewertungen; auftrag A16-48. [Sofosbuvir

2017 Health Technology Assessment (HTA) Database.

42. EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals

EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals Haute Autorité de Santé - EPCLUSA (sofosbuvir/velpatasvir), association fixe d’antiviraux à action directe Développer la qualité dans le champ sanitaire, social et médico-social Recherche Évaluation & Recommandation La HAS Accréditation & Certification Outils, Guides & Méthodes Agenda Avis sur les Médicaments EPCLUSA (sofosbuvir/velpatasvir), association fixe d’antiviraux à action directe Substance active (DCI (...) ) sofosbuvir velpatasvir INFECTIOLOGIE - NOUVEAU MEDICAMENT Nature de la demande Réévaluation SMR et ASMR et Inscription Avis de la CT du 19 octobre 2016 Comme les autres antiviraux d’action directe (HARVONI, DAKLINZA, OLYSIO, VIEKIRAX, EXVIERA), progrès thérapeutique mineur dans le traitement de l’hépatite C chronique de génotypes 1 à 6. EPCLUSA a l’AMM dans le traitement de l’hépatite C chronique chez l’adulte infecté par un virus de l’hépatite C (VHC) de génotypes 1 à 6. Son efficacité virologique

2017 Haute Autorite de sante

43. Adverse effects of pseudoephedrine and sofosbuvir

Adverse effects of pseudoephedrine and sofosbuvir Prescrire IN ENGLISH - Spotlight ''In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir'', 1 January 2017 {1} {1} {1} | | > > > In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |  (...)  |  Spotlight In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir FREE DOWNLOAD In the "Adverse Effects" section of this month's issue, ischaemic colitis with the decongestant pseudoephedrine, and a risk of pulmonary arterial hypertension with the hepatitis C drug sofosbuvir. Full text available for free download. Pseudoephedrine: ischaemic colitis Sympathomimetic vasoconstrictors can provoke neurological and cardiovascular adverse effects

2017 Prescrire

44. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. (Abstract)

Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Use of interferon and ribavirin to treat chronic hepatitis C virus (HCV) infection in kidney transplant recipients is limited because of the risk for allograft rejection and poor tolerability.To evaluate the safety and efficacy of the interferon- and ribavirin-free regimen ledipasvir-sofosbuvir in kidney transplant recipients (...) with chronic genotype 1 or 4 HCV infection.Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT02251717).5 sites in Europe.Treatment-naive or -experienced kidney transplant recipients with chronic genotype 1 or 4 HCV infection, with or without compensated cirrhosis, and with an estimated glomerular filtration rate (eGFR) of 40 mL/min or greater were randomly assigned 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24 weeks.The primary end point was sustained virologic

2016 Annals of Internal Medicine Controlled trial quality: uncertain

45. Epclusa (sofosbuvir and velpatasvir) - To treat all six major forms of hepatitis C virus

Epclusa (sofosbuvir and velpatasvir) - To treat all six major forms of hepatitis C virus Epclusa Tablet U.S. Department of Health and Human Services Search FDA Submit search Epclusa Tablet Epclusa Company: Gilead Sciences, Inc. Application No.: 208341 Approval Date: 06/28/2016 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created

2016 FDA - Drug Approval Package

46. Sofosbuvir, GS-9857 and velpatasvir triple therapy for chronic hepatitis C

Sofosbuvir, GS-9857 and velpatasvir triple therapy for chronic hepatitis C Sofosbuvir, GS-9857 and velpatasvir triple therapy for chronic hepatitis C Sofosbuvir, GS-9857 and velpatasvir triple therapy for chronic hepatitis C NIHR HSRIC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation NIHR HSRIC. Sofosbuvir, GS-9857 and velpatasvir triple (...) will have it for many years and they may or may not have symptoms. If the virus is untreated, it can lead to serious liver disease, such as liver cirrhosis and cancer. Sofosbuvir, GS-9857 and velpatasvir is a new combination of drugs that is taken by mouth as a single tablet to treat hepatitis C infection. Some studies have suggested that this combination drug can clear the body of the virus at least as well as treatment already available and in a shorter time. It may also be helpful for people whose

2016 Health Technology Assessment (HTA) Database.

47. Sofosbuvir and Velpatasvir for Patients with HCV Infection. (Abstract)

Sofosbuvir and Velpatasvir for Patients with HCV Infection. 27119242 2016 05 02 2018 12 02 1533-4406 374 17 2016 04 28 The New England journal of medicine N. Engl. J. Med. Sofosbuvir and Velpatasvir for Patients with HCV Infection. 1687-8 10.1056/NEJMc1601160 Foster Graham R GR Mangia Alessandra A Sulkowski Mark M eng Letter Comment United States N Engl J Med 0255562 0028-4793 0 Antiviral Agents 0 Carbamates 0 Heterocyclic Compounds, 4 or More Rings WJ6CA3ZU8B Sofosbuvir AIM IM N Engl J Med (...) . 2015 Dec 31;373(27):2608-17 26575258 N Engl J Med. 2016 Apr 28;374(17):1687 27119243 Antiviral Agents therapeutic use Carbamates therapeutic use Female Hepacivirus genetics Hepatitis C, Chronic drug therapy Heterocyclic Compounds, 4 or More Rings therapeutic use Humans Male Sofosbuvir therapeutic use 2016 4 28 6 0 2016 4 28 6 0 2016 5 3 6 0 ppublish 27119242 10.1056/NEJMc1601160 10.1056/NEJMc1601160#SA2

2016 NEJM

48. Sofosbuvir and Velpatasvir for Patients with HCV Infection. Full Text available with Trip Pro

Sofosbuvir and Velpatasvir for Patients with HCV Infection. 27119243 2016 05 02 2018 12 02 1533-4406 374 17 2016 04 28 The New England journal of medicine N. Engl. J. Med. Sofosbuvir and Velpatasvir for Patients with HCV Infection. 1687 10.1056/NEJMc1601160 Assy Nimer N Bar-Ilan University, Safed, Israel nimer.assy@naharia.health.gov.il. Barhoum Masad M Galilee Medical Center, Nahariya, Israel. eng Letter Comment United States N Engl J Med 0255562 0028-4793 0 Antiviral Agents 0 Carbamates 0 (...) Heterocyclic Compounds, 4 or More Rings WJ6CA3ZU8B Sofosbuvir AIM IM N Engl J Med. 2015 Dec 31;373(27):2608-17 26575258 N Engl J Med. 2016 Apr 28;374(17):1688 27135094 N Engl J Med. 2016 Apr 28;374(17):1687-8 27119242 N Engl J Med. 2015 Dec 31;373(27):2618-28 26569658 N Engl J Med. 2015 Dec 31;373(27):2599-607 26571066 N Engl J Med. 2016 Apr 28;374(17):1688-9 27135095 Antiviral Agents therapeutic use Carbamates therapeutic use Female Hepacivirus genetics Hepatitis C, Chronic drug therapy Heterocyclic

2016 NEJM

49. Sofosbuvir/ velpatasvir (TBC)

Sofosbuvir/ velpatasvir (TBC) Sofosbuvir/ velpatasvir | CADTH.ca Find the information you need Sofosbuvir/ velpatasvir Sofosbuvir/ velpatasvir Last Updated: March 23, 2016 Result type: Reports Project Number: SR0486-000 Product Line: Generic Name: Sofosbuvir/ velpatasvir Brand Name: Epclusa Manufacturer: Gilead Sciences Canada, Inc. Indications: Hepatitis C, chronic Submission Type: New Project Status: Complete Date Recommendation Issued: October 26, 2016 Recommendation Type: Reimburse

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

50. ledipasvir, sofosbuvir (Harvoni)

ledipasvir, sofosbuvir (Harvoni) ledipasvir, sofosbuvir | CADTH.ca Find the information you need ledipasvir, sofosbuvir ledipasvir, sofosbuvir Last Updated: May 23, 2018 Result type: Reports Project Number: SF0465-000 Product Line: Generic Name: ledipasvir, sofosbuvir Brand Name: Harvoni Manufacturer: Gilead Sciences Canada Inc. Indications: Hepatitis C, chronic Submission Type: Request For Advice Project Status: Complete Date Recommendation Issued: May 18, 2016 Recommendation Type: Reimburse

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

51. sofosbuvir (Sovaldi)

sofosbuvir (Sovaldi) sofosbuvir | CADTH.ca Find the information you need sofosbuvir sofosbuvir Last Updated: January 6, 2016 Result type: Reports Project Number: SF0464-000 Product Line: Generic Name: sofosbuvir Brand Name: Sovaldi Manufacturer: Gilead Sciences Canada Inc. Indications: Hepatitis C, chronic Submission Type: Request For Advice Project Status: Complete Date Recommendation Issued: May 18, 2016 Recommendation Type: Reimburse with clinical criteria and/or conditions Tags hepatitis c

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

52. Sofosbuvir/velpatasvir (chronic hepatitis C) - Addendum to Commission A16-48

Sofosbuvir/velpatasvir (chronic hepatitis C) - Addendum to Commission A16-48 Sofosbuvir/Velpatasvir (chronische Hepatitis C): Addendum zum Auftrag A16-48; Auftrag A16-7 [Sofosbuvir/velpatasvir (chronic hepatitis C) - Addendum to Commission A16-48] Sofosbuvir/Velpatasvir (chronische Hepatitis C): Addendum zum Auftrag A16-48; Auftrag A16-7 [Sofosbuvir/velpatasvir (chronic hepatitis C) - Addendum to Commission A16-48] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status (...) This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Sofosbuvir/Velpatasvir (chronische Hepatitis C): Addendum zum Auftrag A16-48; Auftrag A16-7. [Sofosbuvir/velpatasvir (chronic hepatitis C) - Addendum to Commission A16-48] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG

2016 Health Technology Assessment (HTA) Database.

53. Ledipasvir + sofosbuvir (Harvoni): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties

Ledipasvir + sofosbuvir (Harvoni): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties Prescrire IN ENGLISH - Spotlight ''Ledipasvir + sofosbuvir (Harvoni°): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties '', 1 December 2015 {1} {1} {1} | | > > > Ledipasvir + sofosbuvir (Harvoni°): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties Spotlight Every month, the subjects in Prescrire’s (...) Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight Ledipasvir + sofosbuvir (Harvoni°): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties FEATURED REVIEW In seven trials including over 3000 patients with chronic HCV genotype 1 infection, the ledipasvir + sofosbuvir combination yielded a sustained virological response in nearly every case, while avoiding the use

2015 Prescrire

54. Second-wave direct-acting antivirals for hepatitis C: ledipasvir-sofosbuvir

Second-wave direct-acting antivirals for hepatitis C: ledipasvir-sofosbuvir Second-wave direct-acting antivirals for hepatitis C: ledipasvir-sofosbuvir Second-wave direct-acting antivirals for hepatitis C: ledipasvir-sofosbuvir HAYES, Inc. Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Second-wave direct-acting antivirals for hepatitis C (...) : ledipasvir-sofosbuvir. Lansdale: HAYES, Inc.. Directory Publication. 2015 Final publication URL The report may be purchased from: Indexing Status Subject indexing assigned by CRD MeSH Antiviral Agents; Benzimidazoles; Fluorenes; Hepacivirus; Hepatitis C; Humans Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215

2015 Health Technology Assessment (HTA) Database.

55. Second-wave direct-acting antivirals for hepatitis C: sofosbuvir

Second-wave direct-acting antivirals for hepatitis C: sofosbuvir Second-wave direct-acting antivirals for hepatitis C: sofosbuvir Second-wave direct-acting antivirals for hepatitis C: sofosbuvir HAYES, Inc. Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Second-wave direct-acting antivirals for hepatitis C: sofosbuvir. Lansdale: HAYES, Inc

2015 Health Technology Assessment (HTA) Database.

56. [Sofosbuvir and simeprevir-based schemes for the management of hepatitis C]

[Sofosbuvir and simeprevir-based schemes for the management of hepatitis C] Esquemas con sofosbuvir y simeprevir en hepatitis C [Sofosbuvir and simeprevir-based schemes for the management of hepatitis C] Esquemas con sofosbuvir y simeprevir en hepatitis C [Sofosbuvir and simeprevir-based schemes for the management of hepatitis C] Calderón C, Bardach A, Pichon-Riviere A, Augustovski F, García Martí S, Alcaraz A, Ciapponi A, López A, Rey-Ares L Record Status This is a bibliographic record (...) of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Calderón C, Bardach A, Pichon-Riviere A, Augustovski F, García Martí S, Alcaraz A, Ciapponi A, López A, Rey-Ares L. Esquemas con sofosbuvir y simeprevir en hepatitis C. [Sofosbuvir and simeprevir-based schemes for the management of hepatitis C] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rapida

2015 Health Technology Assessment (HTA) Database.

57. Ledipasvir-sofosbuvir for treating chronic hepatitis C

Ledipasvir-sofosbuvir for treating chronic hepatitis C L Ledipasvir–sofosbuvir for treating edipasvir–sofosbuvir for treating chronic hepatitis C chronic hepatitis C T echnology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta363 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived (...) . Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Ledipasvir–sofosbuvir for treating chronic hepatitis C (TA363) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 85Contents Contents 1 Guidance 5 T able 1 Ledipasvir–sofosbuvir for treating adults

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

58. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. Full Text available with Trip Pro

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received (...) such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients

2015 NEJM Controlled trial quality: predicted high

59. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. Full Text available with Trip Pro

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase.We conducted a phase 3, open-label study involving both previously treated and previously untreated patients infected with HCV genotypes 1 through 6 who had decompensated cirrhosis (classified as Child-Pugh-Turcotte class B). Patients were randomly assigned in a 1:1:1 (...) ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily for 12 weeks, sofosbuvir-velpatasvir plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.Of the 267 patients who received treatment, 78% had HCV genotype 1, 4% genotype 2, 15% genotype 3, 3% genotype 4, and less than 1% genotype 6; no patients had genotype 5. Overall rates

2015 NEJM Controlled trial quality: uncertain

60. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. Full Text available with Trip Pro

Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. A simple treatment regimen that is effective in a broad range of patients who are chronically infected with the hepatitis C virus (HCV) remains an unmet medical need.We conducted a phase 3, double-blind, placebo-controlled study involving untreated and previously treated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection, including those with compensated cirrhosis. Patients with HCV genotype 1, 2, 4, or 6 were (...) randomly assigned in a 5:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir in a once-daily, fixed-dose combination tablet or matching placebo for 12 weeks. Because of the low prevalence of genotype 5 in the study regions, patients with genotype 5 did not undergo randomization but were assigned to the sofosbuvir-velpatasvir group. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.Of the 624 patients who

2015 NEJM Controlled trial quality: predicted high