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Top results for sofosbuvir

61. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial.

Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. 26551263 2015 12 01 2016 04 07 2016 11 26 1539-3704 163 11 2015 Dec 01 Annals of internal medicine Ann. Intern. Med. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. 809-17 10.7326/M15-1014 Effective treatment options are needed for patients (...) with genotype 1 or 3 hepatitis C virus (HCV) infection in whom previous therapy has failed. To assess the efficacy and safety of sofosbuvir plus velpatasvir, with and without ribavirin, in treatment-experienced patients. Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT01909804). 58 sites in Australia, New Zealand, and the United States. Treatment-experienced adults with genotype 3 HCV infection without cirrhosis (cohort 1) and with compensated cirrhosis (cohort 2) and patients with genotype 1

Annals of Internal Medicine2015

62. Bradyarrhythmias Associated with Sofosbuvir Treatment.

Bradyarrhythmias Associated with Sofosbuvir Treatment. Bradyarrhythmias Associated with Sofosbuvir Treatment. - PubMed - NCBI Warning: The NCBI web site requires JavaScript to function. Search database Search term Search Result Filters Format Summary Summary (text) Abstract Abstract (text) MEDLINE XML PMID List Apply Choose Destination File Clipboard Collections E-mail Order My Bibliography Citation manager Format Create File 1 selected item: 26535532 Format MeSH and Other Data E-mail Subject (...) Additional text E-mail Add to Clipboard Add to Collections Order articles Add to My Bibliography Generate a file for use with external citation management software. Create File 2015 Nov 5;373(19):1888. doi: 10.1056/NEJMc1505967. Bradyarrhythmias Associated with Sofosbuvir Treatment. , . Comment on [N Engl J Med. 2015] PMID: 26535532 DOI: [Indexed for MEDLINE] Free full text Publication types MeSH terms Substances Full Text Sources PubMed Commons 0 comments How to cite this comment: Supplemental Content

NEJM2015

63. Bradyarrhythmias Associated with Sofosbuvir Treatment.

Bradyarrhythmias Associated with Sofosbuvir Treatment. Bradyarrhythmias Associated with Sofosbuvir Treatment. - PubMed - NCBI Warning: The NCBI web site requires JavaScript to function. Search database Search term Search Result Filters Format Summary Summary (text) Abstract Abstract (text) MEDLINE XML PMID List Apply Choose Destination File Clipboard Collections E-mail Order My Bibliography Citation manager Format Create File 1 selected item: 26535533 Format MeSH and Other Data E-mail Subject (...) Additional text E-mail Add to Clipboard Add to Collections Order articles Add to My Bibliography Generate a file for use with external citation management software. Create File 2015 Nov 5;373(19):1886-8. doi: 10.1056/NEJMc1505967#SA1. Bradyarrhythmias Associated with Sofosbuvir Treatment. , , , , , , , , , , , ; . Comment in [N Engl J Med. 2015] PMID: 26535533 DOI: [Indexed for MEDLINE] Publication types MeSH terms Substances Full Text Sources PubMed Commons 0 comments How to cite this comment

NEJM2015 Full Text: Link to full Text with Trip Pro

64. 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

Institute for Quality and Efficiency in Healthcare (IQWiG)2015

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

Health Technology Assessment (HTA) Database.2015

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

Health Technology Assessment (HTA) Database.2015

67. 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 and guidelines | 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

National Institute for Health and Clinical Excellence - Technology Appraisals2015

68. 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

Health Technology Assessment (HTA) Database.2015

69. Early Patterns of Sofosbuvir Utilization by State Medicaid Programs.

Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. - PubMed - NCBI Warning: The NCBI web site requires JavaScript to function. Search database Search term Search Result Filters Format Summary Summary (text) Abstract Abstract (text) MEDLINE XML PMID List Apply Choose Destination File Clipboard Collections E-mail Order My Bibliography Citation manager Format Create File 1 selected item: 26398092 Format MeSH (...) and Other Data E-mail Subject Additional text E-mail Add to Clipboard Add to Collections Order articles Add to My Bibliography Generate a file for use with external citation management software. Create File 2015 Sep 24;373(13):1279-81. doi: 10.1056/NEJMc1506108. Early Patterns of Sofosbuvir Utilization by State Medicaid Programs. 1 , . 1 Brigham and Women's Hospital, Boston, MA mfischer@partners.org. PMID: 26398092 DOI: [Indexed for MEDLINE] Free full text Publication type MeSH terms Substances Full

NEJM2015

71. 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. Search Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone From: Published: 19 August 2015 Therapeutic area: and Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi (...) ▼) combination therapy, unless other antiarrhythmics cannot be given. 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 are not tolerated

MHRA Drug Safety Update2015

72. 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

All Wales Medicines Strategy Group2015

73. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.

Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. BACKGROUND: 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). METHODS: 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

NEJM2015

74. 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

Institute for Quality and Efficiency in Healthcare (IQWiG)2015

75. 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. Search Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone From: Published: 20 May 2015 Therapeutic area: and Avoid (...) concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given. Contents 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

MHRA Drug Safety Update2015

76. 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 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 25557952 2015 03 25 2015 05 28 2016 11 25 1528-0012 148 4 2015 Apr Gastroenterology Gastroenterology 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. 762-70.e2; quiz e11-2 10.1053 (...) /j.gastro.2014.12.027 S0016-5085(14)01579-0 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 in patients with HCV infection and unfavorable treatment features. We performed a prospective open-label study of 82 patients with chronic HCV

EvidenceUpdates2015

77. 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

Canadian Agency for Drugs and Technologies in Health - Rapid Review2015

78. 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.

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. BACKGROUND: 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. METHODS: 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

Lancet2015

80. 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

Health Technology Assessment (HTA) Database.2015