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Dataset results
134 results for “Sofosbuvir”
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a
ClinicalTrials.gov study NCT02939989. IPD Sharing: YES. Countries: 12. Publications: 1.
Ultra-short response-guided Hepatitis C treatment with sofosbuvir and daclatasvir: the SEARCH study HCV sequence data
<p><strong>Background</strong></p> <p>WHO has called for research into predictive factors for selecting persons who could be successfully treated with shorter durations of antiviral therapy for Hepatitis C. We evaluated early virological response as a means of shortening treatment and explored host, viral and pharmacokinetic contributors to treatment outcome.</p> <p class="MsoNormal"><strong><span>Methods</span></strong></p> <p class="MsoNormal"><span>Duration of sofosbuvir and daclatasvir (SOF/DCV)</span> was determined according to <span>day 2 (D2) virologic response</span> for <span>HCV genotype (gt) 1- or 6-infected adults in Vietnam with mild liver disease. Participants received 4 or 8 weeks of treatment according to whether D2 HCV RNA was above or below 500 IU/ml (standard duration is 12 weeks). Primary endpoint was sustained virological response (SVR12). Those failing therapy were retreated with 12 weeks SOF/DCV. Host IFNL4 genotype and viral sequencing was performed at baseline, with repeat viral sequencing if virological rebound was observed. Levels of SOF, its inactive metabolite</span> <span>GS-331007 and DCV were measured on day 0 and 28. </span></p> <p class="MsoNormal"><strong>Findings</strong></p> <p class="MsoNormal"><span>Of 52 adults enrolled, 34 received 4 weeks SOF/DCV, 17 got 8 weeks and one withdrew. SVR12 was achieved in 21/34 (62%) treated for 4 weeks, and 17/17 (100%) treated for 8 weeks. Overall, 38/51 (75%) were cured with first-line treatment </span><span>(mean duration of 37 days). Despite a high prevalence of putative </span>NS5A-inhibitor <span>resistance-associated substitutions (RAS), all first-line treatment failures were cured after retreatment (13/13). We found no evidence treatment failure was associated with host </span><span>IFNL4 genotype, viral</span><span> subtype, baseline RAS or DCV levels. SOF metabolite levels were higher in those failing 4-week therapy.</span></p> <p class="MsoNormal"><strong>Interpretation</strong></p> <p class="MsoNormal">Shortened SOF/DCV therapy with retreatment if needed, reduces DAA use while maintaining high cure rates. D2 virologic response alone does not adequately predict SVR12 with 4 weeks of treatment.</p>
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
ClinicalTrials.gov study NCT01329978. IPD Sharing: Not stated. Countries: 2. Publications: 2.
Safety of Sofosbuvir in People With Advanced Kidney Failure
ClinicalTrials.gov study NCT03883698. IPD Sharing: UNDECIDED. Countries: 1. Publications: 4.
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
ClinicalTrials.gov study NCT02673489. IPD Sharing: Not stated. Countries: 2. Publications: 1.
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants Wi
ClinicalTrials.gov study NCT02421211. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
ClinicalTrials.gov study NCT02021643. IPD Sharing: Not stated. Countries: 5. Publications: 3.
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
ClinicalTrials.gov study NCT02480166. IPD Sharing: Not stated. Countries: 1. Publications: 5.
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
ClinicalTrials.gov study NCT01559844. IPD Sharing: Not stated. Countries: 3. Publications: 2.
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
ClinicalTrials.gov study NCT02292706. IPD Sharing: YES. Countries: 10. Publications: 2.
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
ClinicalTrials.gov study NCT02250807. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
ClinicalTrials.gov study NCT01682720. IPD Sharing: Not stated. Countries: 10. Publications: 2.
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
ClinicalTrials.gov study NCT02262728. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
ClinicalTrials.gov study NCT02220998. IPD Sharing: YES. Countries: 2. Publications: 3.
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Wee
ClinicalTrials.gov study NCT01565889. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
ClinicalTrials.gov study NCT02600351. IPD Sharing: YES. Countries: 3. Publications: 1.
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
ClinicalTrials.gov study NCT02175758. IPD Sharing: Not stated. Countries: 8. Publications: 3.
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
ClinicalTrials.gov study NCT01641640. IPD Sharing: Not stated. Countries: 2. Publications: 3.
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infe
ClinicalTrials.gov study NCT01783678. IPD Sharing: Not stated. Countries: 6. Publications: 2.
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
ClinicalTrials.gov study NCT01687270. IPD Sharing: Not stated. Countries: 5. Publications: 1.
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