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Top results for sofosbuvir

81. 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

National Institute for Health and Clinical Excellence - Technology Appraisals2015

82. [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

Health Technology Assessment (HTA) Database.2015

83. 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

Canadian Agency for Drugs and Technologies in Health - Rapid Review2015

84. 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

Health Technology Assessment (HTA) Database.2015

85. 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

Health Technology Assessment (HTA) Database.2015

86. 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

Institute for Quality and Efficiency in Healthcare (IQWiG)2014

87. 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

Health Technology Assessment (HTA) Database.2014

88. 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

Canadian Agency for Drugs and Technologies in Health - Common Drug Review2014

89. 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

Prescrire2014

90. 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

Institute for Quality and Efficiency in Healthcare (IQWiG)2014

91. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection.

Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. IMPORTANCE: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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

JAMA2014

92. [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

Health Technology Assessment (HTA) Database.2014

93. 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

Health Technology Assessment (HTA) Database.2014

95. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection.

Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. BACKGROUND: 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. METHODS: 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. RESULTS: Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had

NEJM2014 Full Text: Link to full Text with Trip Pro

96. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis.

Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. BACKGROUND: 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. METHODS: 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. RESULTS: 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

NEJM2014

97. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.

Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. BACKGROUND: 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. METHODS: 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

NEJM2014

98. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection.

Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. 24725238 2014 04 17 2014 05 06 2015 11 19 1533-4406 370 16 2014 Apr 17 The New England journal of medicine N. Engl. J. Med. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. 1483-93 10.1056/NEJMoa1316366 Effective treatment for hepatitis C virus (HCV) genotype 1 infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need (...) . We conducted a phase 3, randomized, open-label study involving patients infected with HCV genotype 1 who had not had a sustained virologic response after treatment with peginterferon and ribavirin, with or without a protease inhibitor. Patients were randomly assigned to receive the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily, fixed-dose combination tablet for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24

NEJM2014

99. Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3.

Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3. 24795201 2014 05 22 2014 05 29 2016 07 01 1533-4406 370 21 2014 May 22 The New England journal of medicine N. Engl. J. Med. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. 1993-2001 10.1056/NEJMoa1316145 In clinical trials, treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus (HCV) genotype 2 infection (...) , with lower response rates among patients with HCV genotype 3 infection. We conducted a study involving patients with HCV genotype 2 or 3 infection, some of whom had undergone previous treatment with an interferon-based regimen. We randomly assigned 91 patients with HCV genotype 2 infection and 328 with HCV genotype 3 infection, in a 4:1 ratio, to receive sofosbuvir-ribavirin or placebo for 12 weeks. On the basis of emerging data from phase 3 trials indicating that patients with HCV genotype 3 infection

NEJM2014

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.

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. 25078309 2014 12 03 2015 02 10 2016 11 25 1474-547X 384 9956 2014 Nov 15 Lancet (London, England) Lancet 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. 1756-65 10.1016/S0140-6736(14)61036-9 S0140-6736(14)61036-9 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

Lancet2014