Latest & greatest articles for sofosbuvir

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Top results for sofosbuvir

61. Bradyarrhythmias Associated with Sofosbuvir Treatment. (Abstract)

Bradyarrhythmias Associated with Sofosbuvir Treatment. 26535532 2015 11 13 2018 12 02 1533-4406 373 19 2015 11 05 The New England journal of medicine N. Engl. J. Med. Bradyarrhythmias Associated with Sofosbuvir Treatment. 1888 10.1056/NEJMc1505967 Brainard Diana M DM McHutchison John G JG eng Letter Comment United States N Engl J Med 0255562 0028-4793 0 Antiviral Agents E2OU15WN0N Uridine Monophosphate N3RQ532IUT Amiodarone AIM IM N Engl J Med. 2015 Nov 5;373(19):1886-8 26535533 Amiodarone

2015 NEJM

62. Bradyarrhythmias Associated with Sofosbuvir Treatment. Full Text available with Trip Pro

Bradyarrhythmias Associated with Sofosbuvir Treatment. 26535533 2015 11 12 2018 04 13 1533-4406 373 19 2015 11 05 The New England journal of medicine N. Engl. J. Med. Bradyarrhythmias Associated with Sofosbuvir Treatment. 1886-8 10.1056/NEJMc1505967 Fontaine Hélène H Lazarus Arnaud A Pol Stanislas S Pecriaux Caroline C Bagate François F Sultanik Philippe P Boueyre Estelle E Corouge Marion M Mallet Vincent V Vallet-Pichard Anaïs A Sogni Philippe P Duboc Denis D Cochin Hepatology and Cardiology (...) Group eng Case Reports Letter United States N Engl J Med 0255562 0028-4793 0 Antiviral Agents E2OU15WN0N Uridine Monophosphate N3RQ532IUT Amiodarone WJ6CA3ZU8B Sofosbuvir AIM IM N Engl J Med. 2015 Nov 5;373(19):1888 26535532 Aged Amiodarone adverse effects Antiviral Agents adverse effects Bradycardia chemically induced Drug Therapy, Combination adverse effects Female Hepatitis C, Chronic drug therapy Humans Male Middle Aged Sofosbuvir Uridine Monophosphate adverse effects analogs & derivatives 2015

2015 NEJM

63. Ledipasvir/sofosbuvir (Addendum to Commission A14-44)

Ledipasvir/sofosbuvir (Addendum to Commission A14-44) 1 Translation of addendum A15-14 Ledipasvir/Sofosbuvir (Addendum zum Auftrag A14-44) (Version 1.0; Status: 30 April 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 30 April 2015 1.0 Commission: A15-14 Version: Status: IQWiG Reports – Commission No. 15-14 Ledipasvir/sofosbuvir (Addendum (...) to Commission A14-44) 1 Addendum A15-14 Version 1.0 Ledipasvir/sofosbuvir (Addendum to Commission A14-44) 30 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ledipasvir/sofosbuvir (Addendum to Commission A14-44) Commissioning agency: Federal Joint Committee Commission awarded on: 8 April 2015 Internal Commission No.: A15-14 Address of publisher: Institute for Quality and Efficiency in Health

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

64. Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal)

Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal) Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal) | Guidance | NICE Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal) Technology appraisal [TA361] Published date: 28 October 2015 Guidance The appraisal has been withdrawn because Janssen withdrew

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

65. [Ledipasvir/sofosbuvir - benefit assessment according to §35a Social Code Book V (dossier assessment)]

[Ledipasvir/sofosbuvir - benefit assessment according to §35a Social Code Book V (dossier assessment)] Ledipasvir/sofosbuvir – nutzenbewertung gemäß § 35a SGB V [Ledipasvir/sofosbuvir - benefit assessment according to §35a Social Code Book V (dossier assessment)] Ledipasvir/sofosbuvir – nutzenbewertung gemäß § 35a SGB V [Ledipasvir/sofosbuvir - benefit assessment according to §35a Social Code Book V (dossier assessment)] 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 IQWiG. Ledipasvir/sofosbuvir – nutzenbewertung gemäß § 35a SGB V. [Ledipasvir/sofosbuvir - benefit assessment according to §35a Social Code Book V (dossier assessment)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 282. 2015 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Hepatitis C

2015 Health Technology Assessment (HTA) Database.

66. [Ledipasvir/sofosbuvir (addendum to Commission A14-44)]

[Ledipasvir/sofosbuvir (addendum to Commission A14-44)] Ledipasvir/Sofosbuvir (addendum zum Auftrag A14-44) [Ledipasvir/sofosbuvir (addendum to Commission A14-44)] Ledipasvir/Sofosbuvir (addendum zum Auftrag A14-44) [Ledipasvir/sofosbuvir (addendum to Commission A14-44)] 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 IQWiG (...) . Ledipasvir/Sofosbuvir (addendum zum Auftrag A14-44). [Ledipasvir/sofosbuvir (addendum to Commission A14-44)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 300. 2015 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Hepatitis C, Chronic; Humans; Outcome Assessment (Health Care) Language Published German Country of organisation Germany English summary There is no English language summary available. Address for correspondence

2015 Health Technology Assessment (HTA) Database.

67. Ledipasvir/sofosbuvir (Harvoni®)

Ledipasvir/sofosbuvir (Harvoni®) Ledipasvir/sofosbuvir (Harvoni®) Ledipasvir/sofosbuvir (Harvoni®) All Wales Medicines Strategy Group (AWMSG) 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 All Wales Medicines Strategy Group (AWMSG). Ledipasvir/sofosbuvir (Harvoni®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales (...) Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 1887. 2015 Authors' conclusions Ledipasvir/sofosbuvir (Harvoni®) is recommended as an option for restricted use within NHS Wales for the treatment of chronic hepatitis C in adults with hepatitis C virus genotype 1 and 4 without cirrhosis or with compensated cirrhosis for up to 12 weeks. Ledipasvir/sofosbuvir (Harvoni®) is not recommended for use within NHS Wales outside of this subpopulation/these circumstances. Key factor

2015 Health Technology Assessment (HTA) Database.

68. Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. (Abstract)

Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. 26398092 2015 10 08 2015 11 19 1533-4406 373 13 2015 Sep 24 The New England journal of medicine N. Engl. J. Med. Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. 1279-81 10.1056/NEJMc1506108 Liao Joshua M JM Brigham and Women's Hospital, Boston, MA mfischer@partners.org. Fischer Michael A MA eng Letter United States N Engl J Med 0255562 0028-4793 0 Antiviral Agents E2OU15WN0N Uridine Monophosphate (...) WJ6CA3ZU8B Sofosbuvir AIM IM Antiviral Agents economics therapeutic use Drug Utilization Health Expenditures Hepatitis C, Chronic drug therapy Humans Medicaid economics Sofosbuvir United States Uridine Monophosphate analogs & derivatives economics therapeutic use 2015 9 24 6 0 2015 9 24 6 0 2015 10 9 6 0 ppublish 26398092 10.1056/NEJMc1506108

2015 NEJM

69. Ledipasvir/sofosbuvir (Harvoni) - for the treatment of chronic hepatitis C

Ledipasvir/sofosbuvir (Harvoni) - for the treatment of chronic hepatitis C AWMSG ADVICE SUPERSEDED BY NICE GUIDANCE (TA363) NICE GUIDANCE ISSUED NOVEMBER 2015 (Refer to NICE website for full guidance on NICE recommendations, including any specific restrictions on the use of the technology) Final Appraisal Recommendation Advice No: 0915 – April 2015 Ledipasvir/sofosbuvir (Harvoni ® ? ) 90 mg/400 mg film-coated tablets Submission by Gilead Sciences Limited In reaching the above recommendation (...) AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 1887), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. Recommendation of AWMSG Ledipasvir/sofosbuvir (Harvoni ® ? ) is recommended as an option

2015 All Wales Medicines Strategy Group

70. Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone

Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics (...) cannot be given. Published 19 August 2015 From: Therapeutic area: , When treating patients with both heart rhythm disorders and hepatitis C: closely monitor patients taking amiodarone if they start taking the combination simeprevir and sofosbuvir; sofosbuvir and daclatasvir; and the fixed-dose combination of sofosbuvir and ledipasvir (particularly during the first weeks of treatment) only start amiodarone in patients taking any of these antiviral combinations when other antiarrhythmics

2015 MHRA Drug Safety Update

71. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. Full Text available with Trip Pro

Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1).This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients, all (...) of whom were coinfected with HIV-1. Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses. The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated

2015 NEJM Controlled trial quality: uncertain

72. Ledipasvir/sofosbuvir - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Ledipasvir/sofosbuvir - Benefit assessment according to §35a Social Code Book V (dossier assessment) Ledipasvir/Sofosbuvir (Addendum zum Auftrag A14-44) Addendum 30.04.2015 1.0 Auftrag: A15-14 Version: Stand: IQWiG-Berichte – Nr. 300 Addendum A15-14 Version 1.0 Ledipasvir/Sofosbuvir (Addendum zum Auftrag A14-44) 30.04.2015 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - i - Impressum Herausgeber: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Thema (...) : Ledipasvir/Sofosbuvir (Addendum zum Auftrag A14-44) Auftraggeber: Gemeinsamer Bundesausschuss Datum des Auftrags: 08.04.2015 Interne Auftragsnummer: A15-14 Anschrift des Herausgebers: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 (KölnTurm) 50670 Köln Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de ISSN: 1864-2500 Addendum A15-14 Version 1.0 Ledipasvir/Sofosbuvir (Addendum zum Auftrag A14-44) 30.04.2015 Institut für

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

73. Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone

Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone Avoid concomitant use of amiodarone with ledipasvir (...) -sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given. Published 20 May 2015 From: Therapeutic area: , When treating patients with both heart rhythm disorders and hepatitis C: closely monitor patients taking amiodarone if they start taking the fixed-dose combination of sofosbuvir and ledipasvir, or sofosbuvir in combination with daclatasvir (particularly during the first weeks of treatment) only start amiodarone

2015 MHRA Drug Safety Update

74. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related child`s class A cirrhosis (Abstract)

The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related child`s class A cirrhosis The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus (HCV) infections require further evaluation and comparison with those of interferon-containing regimens. We compared a regimen of peginterferon, ribavirin, and sofosbuvir with a regimen of simeprevir and sofosbuvir (...) given simeprevir (150 mg/day) and sofosbuvir (400 mg/day) (n = 58 in the final analysis) or peginterferon alfa 2b (1.5 mcg/kg/wk), ribavirin (1000-1200 mg/day), and sofosbuvir (400 mg/day) (n = 24 in the final analysis). Both regimens were given for 12 weeks. The primary trial end point was the proportion of patients with undetectable HCV-RNA levels 12 weeks after therapy completion (SVR12).A significantly greater percentage of patients (93%) given simeprevir and sofosbuvir achieved an SVR12 than

2015 EvidenceUpdates Controlled trial quality: uncertain

75. Harvoni (Sofosbuvir/ Ledipasivir) Treatment for Patients with Chronic Hepatitis C Genotype 1 and Decompensated Cirrhosis

Harvoni (Sofosbuvir/ Ledipasivir) Treatment for Patients with Chronic Hepatitis C Genotype 1 and Decompensated Cirrhosis Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within (...) for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Harvoni (Sofosbuvir

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

76. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. (Abstract)

Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Although interferon-free regimens are approved for patients co-infected with HIV and genotype-2 or genotype-3 hepatitis C virus (HCV), interferon-based regimens are still an option for those co-infected with HIV and HCV genotypes 1 or 4. These regimens are limited by clinically significant toxic effects and drug interactions (...) with antiretroviral therapy. We aimed to assess the efficacy and safety of an interferon-free, all-oral regimen of sofosbuvir plus ribavirin in patients with HIV and HCV co-infection.We did this open-label, non-randomised, uncontrolled, phase 3 study at 45 sites in seven European countries and Australia. We enrolled patients (aged ≥18 years) co-infected with stable HIV and chronic HCV genotypes 1-4, including those with compensated cirrhosis. Once-daily sofosbuvir (400 mg) plus twice-daily ribavirin (1000 mg

2015 Lancet

77. Sofosbuvir for treating chronic hepatitis C

Sofosbuvir for treating chronic hepatitis C Sofosbuvir for treating chronic Sofosbuvir for treating chronic hepatitis hepatitis C C T echnology appraisal guidance Published: 25 February 2015 nice.org.uk/guidance/ta330 © 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 at after careful consideration (...) to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Sofosbuvir for treating chronic hepatitis C (TA330) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 103Contents Contents 1 Guidance 5 T able 1 Sofosbuvir for treating adults with chronic hepatitis C 5 2 The technology 7 3 The company's

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

78. Sofosbuvir (Sovaldi) with GS-5816 for chronic hepatitis C

Sofosbuvir (Sovaldi) with GS-5816 for chronic hepatitis C Sofosbuvir (Sovaldi) with GS-5816 for chronic hepatitis C Sofosbuvir (Sovaldi) with GS-5816 for chronic hepatitis C NIHR HSC 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 HSC. Sofosbuvir (Sovaldi) with GS-5816 for chronic hepatitis C. Birmingham: NIHR Horizon Scanning Centre

2015 Health Technology Assessment (HTA) Database.

79. Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C

Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C TITLE: Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C: A Review of the Clinical Evidence DATE: 16 January 2015 CONTEXT AND POLICY ISSUES An estimated 250,000 Canadians (approximately 1% of the population) have chronic hepatitis C (CHC) infection, which peaks in prevalence in young to middle-aged adults (...) DAAs with differing mechanisms of action (12.4 mg ombitasvir, 75 mg paritaprevir, and 50 mg ritonavir) with 250 mg dasabuvir. 10 The combination tablets (ombitasvir/paritaprevir/ritonavir) are co-packaged with the dasabuvir tablets and dispensed in weekly cartons of each daily dose for convenience. 10 In October of 2014, Harvoni (ledipasvir 90 mg plus sofosbuvir 400 mg as a fixed dose combination) was the first interferon-free DAA regimen to be issued a notice of compliance (NOC) in Canada. 8

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

80. [Addendum to commission A14-05 (sofosbuvir)]

[Addendum to commission A14-05 (sofosbuvir)] Addendum zum auftrag A14-05 (sofosbuvir) [Addendum to commission A14-05 (sofosbuvir)] Addendum zum auftrag A14-05 (sofosbuvir) [Addendum to commission A14-05 (sofosbuvir)] 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 IQWiG. Addendum zum auftrag A14-05 (sofosbuvir). [Addendum (...) to commission A14-05 (sofosbuvir)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 226. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antiviral Agents; Drug Therapy, Combination; Genotype; Hepatitis C, Chronics; Liver Language Published German Country of organisation Germany English summary There is no English language summary available. Address for correspondence IQWiG, Im Mediapark 8, DE-50670 Cologne, GERMANY, Tel: +49

2015 Health Technology Assessment (HTA) Database.