Latest & greatest articles for sofosbuvir

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Top results for sofosbuvir

101. Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3. Full Text available with Trip Pro

Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3. 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 had higher response rates when they were treated for 16 weeks, as compared with 12 weeks, the study was unblinded, treatment for all patients with genotype 3 infection was extended to 24 weeks

2014 NEJM Controlled trial quality: predicted high

102. Randomised controlled trial: Sofosbuvir with ribavirin is safe and effective in hepatitis C genotype 1 with unfavourable pretreatment characteristics

Randomised controlled trial: Sofosbuvir with ribavirin is safe and effective in hepatitis C genotype 1 with unfavourable pretreatment characteristics Sofosbuvir with ribavirin is safe and effective in hepatitis C genotype 1 with unfavourable pretreatment characteristics | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies (...) , please see our . Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Sofosbuvir with ribavirin is safe and effective in hepatitis C genotype 1 with unfavourable pretreatment

2014 Evidence-Based Medicine

103. Pharmacoeconomic review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection

Pharmacoeconomic review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Pharmacoeconomic review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Pharmacoeconomic review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection 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. Pharmacoeconomic review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Pharmacoeconomic Review Report; SR0356. 2014 Authors' conclusions The ICURs of sofosbuvir versus appropriate comparators varied widely across genotypes and various subgroups. Analyses in genotype 1 patients were

2014 Health Technology Assessment (HTA) Database.

104. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection

Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection 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 (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDEC Final Recommendation; SR0356. 2014 Authors' conclusions 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 cirrhosis, if conditions are met. Final publication URL

2014 Health Technology Assessment (HTA) Database.

105. Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection

Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection 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. Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0356. 2014 Authors' conclusions There were four RCTs included in this review that enrolled patients with genotypes 2 or 3 (FISSION, FUSION, POSITRON, and VALENCE), but only one single-arm study (NEUTRINO

2014 Health Technology Assessment (HTA) Database.

106. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. Full Text available with Trip Pro

Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. 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 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.Among the 440 patients who underwent randomization and were treated, 20% had

2014 NEJM Controlled trial quality: uncertain

107. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. (Abstract)

Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Interferon-based treatment is not suitable for many patients with hepatitis C virus (HCV) infection because of contraindications such as psychiatric illness, and a high burden of adverse events. We assessed the efficacy and safety of an interferon-free regimen--a fixed-dose (...) combination of the nucleotide polymerase inhibitor sofosbuvir (400 mg) and the HCV NS5A inhibitor ledipasvir (90 mg), with and without ribavirin--in patients with genotype-1 hepatitis C infection who were treatment-naive or previously treated with a protease-inhibitor regimen.For this open-label study, we enrolled 100 adult patients (>18 years) with HCV infection at a centre in the USA between Nov 2, 2012, and Dec 21, 2012. In cohort A, we used a computer-generated sequence to randomly assign (1:1:1

2013 Lancet Controlled trial quality: predicted high

108. Sofosbuvir with ledipasvir for hepatitis C, genotype 1

Sofosbuvir with ledipasvir for hepatitis C, genotype 1 Sofosbuvir with ledipasvir for hepatitis C, genotype 1 Sofosbuvir with ledipasvir for hepatitis C, genotype 1 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 with ledipasvir for hepatitis C, genotype 1. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC

2013 Health Technology Assessment (HTA) Database.

109. Continuing Medical Education: Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options. (Abstract)

Continuing Medical Education: Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options.

2013 NEJM

110. Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options. Full Text available with Trip Pro

Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options. Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection.We conducted two (...) randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection. In one trial, patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin (207 patients) or matching placebo (71) for 12 weeks. In a second trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks (103 patients) or 16 weeks (98). The primary end point was a sustained virologic response at 12 weeks after

2013 NEJM Controlled trial quality: predicted high

111. Sovaldi (sofosbuvir) - To treat chronic hepatitis C virus (HCV) infection

Sovaldi (sofosbuvir) - To treat chronic hepatitis C virus (HCV) infection Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - SOVALDI sofosbuvir Tablets Company: Gilead Sciences, Inc. Application No.: 204671 Approval Date: 12/06/2013 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

2013 FDA - Drug Approval Package

112. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. (Abstract)

Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. The uridine nucleotide analogue sofosbuvir is a selective inhibitor of hepatitis C virus (HCV) NS5B polymerase. We assessed the safety and efficacy of sofosbuvir in combination with pegylated interferon alfa-2a (peginterferon) and ribavirin in non-cirrhotic treatment-naive, patients with HCV.For this open (...) ), with randomisation stratified by IL28B (CC vs non-CC allele) and HCV RNA (<800,000 IU/mL vs ≥800,000 IU/mL). Patients received sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks (cohort A) or for 24 weeks (cohort B), or 12 weeks of sofosbuvir plus peginterferon and ribavirin followed by 12 weeks of either sofosbuvir monotherapy or sofosbuvir plus ribavirin (cohort C). We enrolled patients with all other eligible genotypes in cohort B. The primary efficacy endpoint was sustained virological response

2013 Lancet Controlled trial quality: predicted high

113. Sofosbuvir for previously untreated chronic hepatitis C infection. Full Text available with Trip Pro

Sofosbuvir for previously untreated chronic hepatitis C infection. In phase 2 trials, the nucleotide polymerase inhibitor sofosbuvir was effective in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection.We conducted two phase 3 studies in previously untreated patients with HCV infection. In a single-group, open-label study, we administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4 (...) , 5, or 6 (of whom 98% had genotype 1 or 4). In a noninferiority trial, 499 patients with HCV genotype 2 or 3 infection were randomly assigned to receive sofosbuvir plus ribavirin for 12 weeks or peginterferon alfa-2a plus ribavirin for 24 weeks. In the two studies, the primary end point was a sustained virologic response at 12 weeks after the end of therapy.In the single-group study, a sustained virologic response was reported in 90% of patients (95% confidence interval, 87 to 93

2013 NEJM Controlled trial quality: uncertain

114. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. Full Text available with Trip Pro

Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. The standard treatment for hepatitis C virus (HCV) infection is interferon, which is administered subcutaneously and can have troublesome side effects. We evaluated sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, in interferon-sparing and interferon-free regimens for the treatment of HCV infection.We provided open-label treatment to eight groups of patients. A total of 40 previously untreated patients (...) with HCV genotype 2 or 3 infection were randomly assigned to four groups; all four groups received sofosbuvir (at a dose of 400 mg once daily) plus ribavirin for 12 weeks. Three of these groups also received peginterferon alfa-2a for 4, 8, or 12 weeks. Two additional groups of previously untreated patients with HCV genotype 2 or 3 infection received sofosbuvir monotherapy for 12 weeks or sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks. Two groups of patients with HCV genotype 1

2013 NEJM Controlled trial quality: uncertain

115. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. Full Text available with Trip Pro

Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. The efficacy of directly acting antiviral agents in interferon-free regimens for the treatment of chronic hepatitis C infections needs to be evaluated in different populations.To determine the efficacy and safety of sofosbuvir with weight-based or low-dose ribavirin among a population with unfavorable treatment characteristics.Single-center, randomized, 2-part (...) , open-label phase 2 study involving 60 treatment-naive patients with hepatitis C virus (HCV) genotype 1 enrolled at the National Institutes of Health (October 2011-April 2012).In the study's first part, 10 participants with early to moderate liver fibrosis were treated with 400 mg/d of sofosbuvir and weight-based ribavirin for 24 weeks. In the second part, 50 participants with all stages of liver fibrosis were randomized 1:1 to receive 400 mg of sofosbuvir with either weight-based or low-dose 600 mg

2013 JAMA Controlled trial quality: uncertain

116. Sofosbuvir for chronic hepatitis C infection with compensated liver disease

Sofosbuvir for chronic hepatitis C infection with compensated liver disease Sofosbuvir for chronic hepatitis C infection with compensated liver disease Sofosbuvir for chronic hepatitis C infection with compensated liver disease 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 for chronic hepatitis C infection

2012 Health Technology Assessment (HTA) Database.