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Top results for sofosbuvir

81. Simeprevir in combination with sofosbuvir (with or without ribavirin) for chronic hepatitis C

Simeprevir in combination with sofosbuvir (with or without ribavirin) for chronic hepatitis C Simeprevir in combination with sofosbuvir (with or without ribavirin) for chronic hepatitis C Simeprevir in combination with sofosbuvir (with or without ribavirin) for chronic hepatitis C NIHR HSRIC 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 NIHR HSRIC. Simeprevir (...) in combination with sofosbuvir (with or without ribavirin) for chronic hepatitis C. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Simeprevir (Olysio) is a potent inhibitor of the NS3/4A proteins of the hepatitis C virus (HCV) genotypes 1 and 4. Sofosbuvir (Sovaldi) is a second generation uridine nucleotide analogue that inhibits the HCV NS5B protein. Together, in combination (with or without ribavirin) they are intended for the treatment

2015 Health Technology Assessment (HTA) Database.

82. Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence

Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence CADTH 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 CADTH. Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response. 2015 Authors' conclusions Six clinical trials demonstrated the superiority

2015 Health Technology Assessment (HTA) Database.

83. Addendum to Commission A14-05 (sofosbuvir)

Addendum to Commission A14-05 (sofosbuvir) 1 Translation of addendum A14-20 Addendum zum Auftrag A14-05 (Sofosbuvir) (Version 1.0; Status: 27 June 2014). 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 27 June 2014 1.0 Commission: A14-20 Version: Status: IQWiG Reports – Commission No. A14-20 Addendum to Commission A14-05 (sofosbuvir) 1 Addendum A14-20 (...) Version 1.0 Addendum to Commission A14-05 (sofosbuvir) 27 June 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Addendum to Commission A14-05 (sofosbuvir) Commissioning agency: Federal Joint Committee Commission awarded on: 13 June 2014 Internal Commission No.: A14-20 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

84. Second-wave direct-acting antivirals for hepatitis C: Sofosbuvir and Ledipasvir

Second-wave direct-acting antivirals for hepatitis C: Sofosbuvir and Ledipasvir Second-wave direct-acting antivirals for hepatitis C: Sofosbuvir and Ledipasvir Second-wave direct-acting antivirals for hepatitis C: Sofosbuvir and Ledipasvir 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 Second-wave direct-acting antivirals for hepatitis C: Sofosbuvir (...) . Second-wave DAA agents include simeprevir, sofosbuvir, and the combination of sofosbuvir and ledipasvir. Timeliness warning This report has been archived and may contain outdated information. To request a copy of the report please contact the organisation directly. Final publication URL The report may be purchased from: Indexing Status Subject indexing assigned by CRD MeSH Antiviral Agents; Hepatitis C, Chronic; Humans Language Published English Country of organisation United States English summary

2014 Health Technology Assessment (HTA) Database.

85. Sofosbuvir - Chronic Hepatitis C

Sofosbuvir - Chronic Hepatitis C Common Drug Review CDEC Meeting – July 15, 2014 Notice of Final Recommendation – August 18, 2014 Page 1 of 8 © 2014 CADTH CDEC FINAL RECOMMENDATION SOFOSBUVIR (Sovaldi — Gilead Sciences Canada, Inc.) Indication: Chronic Hepatitis C Infection Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that sofosbuvir (SOF) be listed for the treatment of chronic hepatitis C (CHC) virus infection in adult patients with compensated liver disease, including

2014 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

86. Sofosbuvir (Sovaldi): dangerous pricing

Sofosbuvir (Sovaldi): dangerous pricing Prescrire IN ENGLISH - Spotlight ''Sofosbuvir (Sovaldi°): dangerous pricing'', 1 September 2014 {1} {1} {1} | | > > > Sofosbuvir (Sovaldi°): dangerous pricing Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight Sofosbuvir (Sovaldi°): dangerous pricing Clinical evaluation data that are less substantial than had (...) previously been announced, and a wildly excessive turn in the setting of drug prices. The price being charged by the pharmaceutical firm Gilead Sciences for its drug Sovaldi° (sofosbuvir), an antiviral drug against hepatitis C virus, has been causing indignation in many countries, including France. In the US for example, drug spending for 12 weeks of sofosbuvir has been set at 80 000 dollars per patient (around 62 000 euros) (1). Our investigation as of 16 July 2014 indicated that the price in France

2014 Prescrire

87. Sofosbuvir - Benefit assessment according to §35a Social Code Book V

Sofosbuvir - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sofosbuvir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 2014). 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. IQWiG Reports – Commission No. A14-05 Sofosbuvir – Benefit assessment according to §35a (...) Social Code Book V 1 Extract of dossier assessment A14-05 Version 1.0 Sofosbuvir – Benefit assessment acc. to §35a Social Code Book V 29 April 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sofosbuvir – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 21 January 2014 Internal Commission No.: A14-05 Address

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

88. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. Full Text available with Trip Pro

Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.Open-label (...) , nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients

2014 JAMA

89. Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection

Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection 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. Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antiviral Agents; Hepatitis C, Chronics; Uridine Monophosphate Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence The NIHR Horizon

2014 Health Technology Assessment (HTA) Database.

90. [Sofosbuvir: benefit assessment according to § 35a Social Code Book V (dossier assessment)]

[Sofosbuvir: benefit assessment according to § 35a Social Code Book V (dossier assessment)] Sofosbuvir – Nutzenbewertung gemäß § 35a SGB V [Sofosbuvir: benefit assessment according to § 35a Social Code Book V (dossier assessment)] Sofosbuvir – Nutzenbewertung gemäß § 35a SGB V [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. Sofosbuvir – Nutzenbewertung gemäß § 35a SGB V. [Sofosbuvir: benefit assessment according to § 35a Social Code Book V (dossier assessment)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 219. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Hepatitis C, Chronic; Humans; Uridine Monophosphate Language Published German Country

2014 Health Technology Assessment (HTA) Database.

91. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. Full Text available with Trip Pro

Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection.We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly (...) assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosbuvir plus ribavirin for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had HCV genotype 1a infection

2014 NEJM Controlled trial quality: uncertain

92. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. Full Text available with Trip Pro

Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen.In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 (...) infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy.The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92

2014 NEJM Controlled trial quality: uncertain

93. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. Full Text available with Trip Pro

Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. All-oral combination therapy is desirable for patients with chronic hepatitis C virus (HCV) infection. We evaluated daclatasvir (an HCV NS5A replication complex inhibitor) plus sofosbuvir (a nucleotide analogue HCV NS5B polymerase inhibitor) in patients infected with HCV genotype 1, 2, or 3.In this open-label study, we initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection (...) and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily, with or without ribavirin, for 24 weeks. The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir, with or without ribavirin, for 12 weeks (82 previously untreated patients) or 24 weeks (41 patients who had previous virologic failure with telaprevir or boceprevir

2014 NEJM Controlled trial quality: uncertain

94. Sovaldi - sofosbuvir

Sovaldi - sofosbuvir 21 November 2013 EMA/CHMP/688774/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Sovaldi International non-proprietary name: sofosbuvir Procedure No. EMEA/H/C/002798/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E (...) /2013 Page 5/100 SmPC summary of product characteristics SOF sofosbuvir (GS-7977; formerly PSI-7977) SVR, SVRxx sustained virologic response, sustained virologic response at “xx” weeks following completion of all treatment TDF tenofovir disoproxil fumarate TND target not detected TTC threshold of toxicological concern ULN upper limit of the normal range US UV United States ultra-violet Assessment report EMA/CHMP/688774/2013 Page 6/100 1. Background information on the procedure 1.1. Submission

2014 European Medicines Agency - EPARs

95. Harvoni - sofosbuvir / ledipasvir

Harvoni - sofosbuvir / ledipasvir 25 September 2014 EMA/702742/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Harvoni International non-proprietary name: ledipasvir / sofosbuvir Procedure No. EMEA/H/C/003850/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile (...) -Cyclen Lo OCT organic cation transporter Peg-IFN pegylated interferon P-gp p-glycoprotein PI protease inhibitor PopPK Population Pharmacokinetics PXR Pregnane X receptor Q QD Quartile Once Daily /r boosted with ritonavir RAL raltegravir RAV resistance-associated variant RBV ribavirin SOF sofosbuvir Assessment report EMA/702742/2014 Page 4/80 SVR sustained virologic response TE treatment experienced TFV Tenofovir TGV Tegobuvir TN treatment naive UGT uridine disphosphate glucuronosyltransferase ULN

2014 European Medicines Agency - EPARs

96. Harvoni (ledipasvir / sofosbuvir) - To treat chronic hepatitis C virus (HCV) genotype 1 infection

Harvoni (ledipasvir / sofosbuvir) - To treat chronic hepatitis C virus (HCV) genotype 1 infection Drug Approval Package:Harvoni (ledipasvir and sofosbuvir) Tablets NDA 205834 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Harvoni (ledipasvir and sofosbuvir) Tablets Company: Gilead Sciences, Inc. Application No.: 205834 Approval Date: 10/10/2014 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance

2014 FDA - Drug Approval Package

97. Ledipasvir/Sofosbuvir

Ledipasvir/Sofosbuvir CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205834Orig1s000 MEDICAL REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION OF ANTIVIRAL PRODUCTS DATE: September 25, 2014 TO: NDA 205834 SDN 32, received August 7, 2014 FROM: Medical Officer, Division of Antiviral Products SUBJECT: GS-US-337-0115 and NIAID-13-I-0159 Summary Interim Safety Data GS-US-337 (...) -0115, A Phase 3, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects with Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co Infections NIAID-13-I-0159, An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-5885 and GS-7977 in HCV Genotype 1 Subjects Coinfected with HIV Summary interim safety data are available from

2014 FDA - Drug Approval Package

98. Sofosbuvir for the treatment of patients with genotype 4 hepatitis C: a review of the clinical efficacy, cost-effectiveness, and guidelines

Sofosbuvir for the treatment of patients with genotype 4 hepatitis C: a review of the clinical efficacy, cost-effectiveness, and guidelines Sofosbuvir for the treatment of patients with genotype 4 hepatitis C: a review of the clinical efficacy, cost-effectiveness, and guidelines Sofosbuvir for the treatment of patients with genotype 4 hepatitis C: a review of the clinical efficacy, cost-effectiveness, and guidelines CADTH 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 CADTH. Sofosbuvir for the treatment of patients with genotype 4 hepatitis C: a review of the clinical efficacy, cost-effectiveness, and guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response. 2014 Authors' conclusions Sofosbuvir in combination with peginterferon and ribavirin is recommended for treatment of naïve-patients

2014 Health Technology Assessment (HTA) Database.

99. Randomised controlled trial: Ledipasvir/Sofosbuvir administration achieves very high rate of viral clearance in patients with HCV genotype 1 infection without cirrhosis, regardless of ribavirin co-administration or length of treatment

Randomised controlled trial: Ledipasvir/Sofosbuvir administration achieves very high rate of viral clearance in patients with HCV genotype 1 infection without cirrhosis, regardless of ribavirin co-administration or length of treatment Ledipasvir/Sofosbuvir administration achieves very high rate of viral clearance in patients with HCV genotype 1 infection without cirrhosis, regardless of ribavirin co-administration or length of treatment | BMJ Evidence-Based Medicine We use cookies to improve (...) * Password * your user name or password? You are here Ledipasvir/Sofosbuvir administration achieves very high rate of viral clearance in patients with HCV genotype 1 infection without cirrhosis, regardless of ribavirin co-administration or length of treatment Article Text Therapeutics Randomised controlled trial Ledipasvir/Sofosbuvir administration achieves very high rate of viral clearance in patients with HCV genotype 1 infection without cirrhosis, regardless of ribavirin co-administration or length

2014 Evidence-Based Medicine

100. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. (Abstract)

Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Interferon-free regimens are needed to treat hepatitis C virus (HCV) infections. We investigated the efficacy of combined simeprevir and sofosbuvir.We enrolled patients with chronic HCV genotype 1 infections who had previously not responded to pegylated interferon (...) (peginterferon) and ribavirin or were treatment naive. Patients were randomly assigned in a 2:1:2:1 ratio to receive 150 mg simeprevir and 400 mg sofosbuvir daily for 24 weeks with (group 1) or without (group 2) ribavirin or for 12 weeks with (group 3) or without (group 4) ribavirin, in two cohorts: previous non-responders with METAVIR scores F0-F2 (cohort 1) and previous non-responders and treatment-naive patients with METAVIR scores F3-F4 (cohort 2). The primary endpoint was sustained virological response

2014 Lancet Controlled trial quality: uncertain