{"id":"sofosbuvir-plus-ledipasvir","safety":{"commonSideEffects":[{"rate":"14-17%","effect":"Headache"},{"rate":"12-14%","effect":"Fatigue"},{"rate":"8-10%","effect":"Nausea"},{"rate":"5-8%","effect":"Diarrhea"},{"rate":"5-7%","effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, essential for viral replication. Ledipasvir is an NS5A inhibitor that disrupts viral protein function and assembly. Together, this combination targets two critical steps in the HCV replication cycle, achieving high cure rates across multiple HCV genotypes.","oneSentence":"Sofosbuvir and ledipasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:24.227Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6"},{"name":"Chronic hepatitis C virus (HCV) infection, genotype 2 and 3 (with ribavirin)"}]},"trialDetails":[{"nctId":"NCT02583685","phase":"PHASE2","title":"Switching Regimen in Treating Cirrhotic HCV GT1b Subjects","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2015-05-15","conditions":"Chronic Hepatitis C Infection","enrollment":138},{"nctId":"NCT02759861","phase":"PHASE4","title":"Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics","status":"COMPLETED","sponsor":"University of Nebraska","startDate":"2016-08-01","conditions":"Genotype 1 Hepatitis C Virus","enrollment":16},{"nctId":"NCT02292706","phase":"","title":"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","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2014-12-29","conditions":"Hepatitis C Virus Infection","enrollment":1609},{"nctId":"NCT02992457","phase":"PHASE4","title":"Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection","status":"COMPLETED","sponsor":"Tanta University","startDate":"2015-01","conditions":"Hepatitis C","enrollment":10000},{"nctId":"NCT03903185","phase":"PHASE1, PHASE2","title":"Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2019-03-01","conditions":"Hepatitis C, Chronic, Hematologic Malignancy","enrollment":24},{"nctId":"NCT03118674","phase":"PHASE2","title":"Harvoni Treatment Porphyria Cutanea Tarda","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2017-09-06","conditions":"Porphyria Cutanea Tarda, Hepatitis C","enrollment":23},{"nctId":"NCT03823911","phase":"PHASE4","title":"Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2018-11-18","conditions":"Cardiovascular Diseases, Hepatitis C, Hiv","enrollment":87},{"nctId":"NCT03702218","phase":"EARLY_PHASE1","title":"Hepatitis C Positive Donor Into Hepatitis C Negative Recipients","status":"WITHDRAWN","sponsor":"University of Maryland, Baltimore","startDate":"2019-07-01","conditions":"Hepatitis C","enrollment":""},{"nctId":"NCT02836925","phase":"PHASE2","title":"Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection","status":"COMPLETED","sponsor":"Fondazione Italiana Linfomi - ETS","startDate":"2016-03","conditions":"Indolent B-cell Lymphoma, Hepatitis C","enrollment":40},{"nctId":"NCT04353986","phase":"PHASE3","title":"PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2018-06-11","conditions":"HCV Infection, Beta Thalassemia Major","enrollment":24},{"nctId":"NCT02333292","phase":"","title":"Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions","status":"COMPLETED","sponsor":"Valme University Hospital","startDate":"2014-12","conditions":"Chronic Hepatitis C Infection","enrollment":1128},{"nctId":"NCT03483987","phase":"NA","title":"Re-treatment of HCV Following DAA Failure","status":"TERMINATED","sponsor":"Sanjay Gandhi Postgraduate Institute of Medical Sciences","startDate":"2018-02-10","conditions":"Chronic Hepatitis C","enrollment":18},{"nctId":"NCT02573376","phase":"NA","title":"Antiviral Pharmacology and Adherence in Drug Users","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2015-11","conditions":"HEPATITIS C, Virus, Human Immunodeficiency","enrollment":73},{"nctId":"NCT02786537","phase":"PHASE4","title":"Study of Oral Treatments for Hepatitis C","status":"COMPLETED","sponsor":"University of Florida","startDate":"2016-06","conditions":"Chronic Hepatitis C","enrollment":1275},{"nctId":"NCT02951364","phase":"","title":"Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-12-05","conditions":"Hepatitis C Virus","enrollment":1081},{"nctId":"NCT05091008","phase":"PHASE2","title":"Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children","status":"COMPLETED","sponsor":"Mansoura University Children Hospital","startDate":"2018-03-01","conditions":"Hepatitis C, Chronic","enrollment":50},{"nctId":"NCT03312023","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2018-02-01","conditions":"Hepatitis B","enrollment":21},{"nctId":"NCT02555943","phase":"PHASE2, PHASE3","title":"DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2015-02","conditions":"Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation","enrollment":23},{"nctId":"NCT04952207","phase":"","title":"Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C","status":"UNKNOWN","sponsor":"Qing XIe","startDate":"2019-03-06","conditions":"Hepatitis C, Chronic","enrollment":300},{"nctId":"NCT03126370","phase":"PHASE4","title":"Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2018-01-08","conditions":"Hepatitis C, HIV Coinfection","enrollment":10},{"nctId":"NCT02533934","phase":"PHASE4","title":"Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2016-08","conditions":"HIV, Hepatitis C, Cirrhosis","enrollment":68},{"nctId":"NCT02825212","phase":"PHASE2, PHASE3","title":"Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2016-02","conditions":"Hepatitis C, Cryoglobulinemia","enrollment":10},{"nctId":"NCT04498936","phase":"PHASE4","title":"Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19","status":"COMPLETED","sponsor":"Assiut University","startDate":"2020-07-15","conditions":"COVID","enrollment":240},{"nctId":"NCT04530422","phase":"PHASE3","title":"Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment","status":"COMPLETED","sponsor":"Almaza Military Fever Hospital","startDate":"2020-04-15","conditions":"Covid19","enrollment":250},{"nctId":"NCT04457050","phase":"PHASE4","title":"Effect of Hepatitis C Clearance on Insulin Resistance","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2017-10-30","conditions":"Insulin Resistance, Hepatitis C","enrollment":160},{"nctId":"NCT02858180","phase":"PHASE4","title":"Hepatitis C Virus(HCV) Heart and Lung Study","status":"COMPLETED","sponsor":"Duke University","startDate":"2016-12","conditions":"Hepatitis C, Chronic, Heart Failure, Pulmonary Disease, Chronic Obstructive","enrollment":15},{"nctId":"NCT02613871","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-12-22","conditions":"Hepatitis C Virus Infection","enrollment":111},{"nctId":"NCT02021656","phase":"PHASE3","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-12-10","conditions":"Chronic HCV Infection","enrollment":384},{"nctId":"NCT02683005","phase":"PHASE1","title":"Study of Hepatitis C Treatment During Pregnancy","status":"COMPLETED","sponsor":"Catherine Chappell","startDate":"2016-09","conditions":"Hepatitis C, Pregnancy","enrollment":9},{"nctId":"NCT03036839","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-06-27","conditions":"Hepatitis C Virus Infection","enrollment":95},{"nctId":"NCT02249182","phase":"PHASE2","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-11-05","conditions":"Hepatitis C Virus Infection","enrollment":226},{"nctId":"NCT02503735","phase":"NA","title":"Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2015-07-15","conditions":"Hepatitis C, Chronic Kidney Disease","enrollment":14},{"nctId":"NCT04211844","phase":"","title":"Metabolic Changes in Chronic HCV Patients Receiving DAAS","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2019-10-01","conditions":"Chronic Hepatitis C","enrollment":100},{"nctId":"NCT03880682","phase":"","title":"Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Istanbul University","startDate":"2018-11-01","conditions":"Kidney Transplant; Complications, Hepatitis C, Chronic","enrollment":30},{"nctId":"NCT02347345","phase":"PHASE4","title":"Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs","status":"COMPLETED","sponsor":"Rockefeller University","startDate":"2016-11-15","conditions":"Hepatitis C","enrollment":34},{"nctId":"NCT02601573","phase":"PHASE2","title":"Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2016-01-05","conditions":"Hepatitis C","enrollment":101},{"nctId":"NCT04047680","phase":"","title":"eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2015-02","conditions":"Hepatitis C, Renal Disease, Viral Hepatitis C","enrollment":441},{"nctId":"NCT03423641","phase":"","title":"An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2011-01-01","conditions":"Hepatitis C, Chronic","enrollment":33808},{"nctId":"NCT04038320","phase":"","title":"Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine","status":"COMPLETED","sponsor":"Right to Care","startDate":"2018-03-26","conditions":"Hepatitis C Virus","enrollment":868},{"nctId":"NCT03639207","phase":"","title":"IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir","status":"WITHDRAWN","sponsor":"National Cancer Institute (NCI)","startDate":"2018-06-15","conditions":"Hepatitis C Virus","enrollment":""},{"nctId":"NCT03481036","phase":"NA","title":"DAA Therapy in Pediatric Patients With Chronic Hepatitis C","status":"UNKNOWN","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2016-06-18","conditions":"Chronic Hepatitis c","enrollment":100},{"nctId":"NCT03488485","phase":"NA","title":"Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model","status":"UNKNOWN","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2016-06-18","conditions":"Chronic Hepatitis c","enrollment":50000},{"nctId":"NCT03965286","phase":"","title":"Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2019-06-01","conditions":"Antiviral Drug","enrollment":80},{"nctId":"NCT03961828","phase":"PHASE4","title":"Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus","status":"COMPLETED","sponsor":"Tanta University","startDate":"2017-10-01","conditions":"Beta-Thalassemia, Hepatitis C","enrollment":50},{"nctId":"NCT02631772","phase":"PHASE4","title":"LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2016-06-01","conditions":"Hepatitis C","enrollment":32},{"nctId":"NCT02760355","phase":"NA","title":"Extrahepatic Insulin Resistance in Chronic Hepatitis C","status":"COMPLETED","sponsor":"University Hospital, Geneva","startDate":"2016-03","conditions":"Insulin Resistance","enrollment":17},{"nctId":"NCT02421211","phase":"PHASE2","title":"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 With Chronic Hepatitis C Virus Genotype 1 Infection","status":"COMPLETED","sponsor":"Janssen Sciences Ireland UC","startDate":"2015-05-19","conditions":"Hepatitis C, Chronic","enrollment":41},{"nctId":"NCT02591277","phase":"","title":"Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-11-30","conditions":"Hepatitis C","enrollment":3294},{"nctId":"NCT02717949","phase":"PHASE4","title":"Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study","status":"TERMINATED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2016-02-25","conditions":"Liver Disease","enrollment":1},{"nctId":"NCT03164902","phase":"NA","title":"Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence","status":"UNKNOWN","sponsor":"Proteus Digital Health, Inc.","startDate":"2017-07-21","conditions":"Hepatitis C, Chronic, Nonadherence, Patient","enrollment":253},{"nctId":"NCT02350569","phase":"PHASE2","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-05-22","conditions":"Hepatitis C Virus Infection","enrollment":17},{"nctId":"NCT01987453","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-07","conditions":"HCV Infection","enrollment":100},{"nctId":"NCT01984294","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-10","conditions":"Chronic HCV Infection","enrollment":101},{"nctId":"NCT02081079","phase":"PHASE2","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-03","conditions":"Chronic Genotype 4 HCV, Chronic Genotype 5 HCV","enrollment":85},{"nctId":"NCT02251717","phase":"PHASE2","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-10-14","conditions":"Hepatitis C Virus Infection","enrollment":114},{"nctId":"NCT02010255","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-01","conditions":"Chronic HCV Infection","enrollment":334},{"nctId":"NCT01924949","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-07","conditions":"Hepatitis C","enrollment":5},{"nctId":"NCT02301936","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-03-02","conditions":"Hepatitis C Virus Infection","enrollment":10},{"nctId":"NCT02202980","phase":"PHASE2","title":"Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-08-04","conditions":"Chronic Hepatitis C","enrollment":273},{"nctId":"NCT02487030","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-09-07","conditions":"Hepatitis C Virus Infection","enrollment":255},{"nctId":"NCT03743727","phase":"PHASE4","title":"Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir","status":"UNKNOWN","sponsor":"Yassin Abdelghaffar Charity Center for Liver Disease and Research","startDate":"2018-08-01","conditions":"Hepatitis C Genotype 4","enrollment":25},{"nctId":"NCT02226549","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-07","conditions":"Hepatitis C Virus Infection","enrollment":47},{"nctId":"NCT02600351","phase":"PHASE3","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2015-11-11","conditions":"Hepatitis C Virus Infection","enrollment":87},{"nctId":"NCT01938430","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-09","conditions":"Chronic HCV Infection","enrollment":339},{"nctId":"NCT01826981","phase":"PHASE2","title":"Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-04","conditions":"Chronic Hepatitis C","enrollment":359},{"nctId":"NCT02457611","phase":"PHASE2","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-06","conditions":"Hepatitis C Infection With HIV Co-Infection","enrollment":26},{"nctId":"NCT01726517","phase":"PHASE2","title":"Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-10","conditions":"Chronic Hepatitis C Virus","enrollment":100},{"nctId":"NCT02219685","phase":"PHASE2","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-08","conditions":"Hepatitis C Virus Infection","enrollment":40},{"nctId":"NCT01965535","phase":"PHASE2","title":"Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-10","conditions":"HCV Infection","enrollment":155},{"nctId":"NCT02413593","phase":"PHASE2","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-04","conditions":"Hepatitis C Virus Infection","enrollment":111},{"nctId":"NCT01975675","phase":"PHASE3","title":"Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-10","conditions":"Chronic HCV Infection","enrollment":341},{"nctId":"NCT01768286","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-01","conditions":"Chronic Hepatitis C Virus","enrollment":441},{"nctId":"NCT02472886","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-06-17","conditions":"Hepatitis C Virus Infection","enrollment":153},{"nctId":"NCT02073656","phase":"PHASE3","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-02","conditions":"Hepatitis C Virus, HIV","enrollment":335},{"nctId":"NCT01701401","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-09","conditions":"Chronic Hepatitis C Virus","enrollment":870},{"nctId":"NCT02738333","phase":"PHASE3","title":"Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-04-12","conditions":"Hepatitis C Virus Infection","enrollment":239},{"nctId":"NCT01851330","phase":"PHASE3","title":"Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-05","conditions":"Chronic Hepatitis C Virus","enrollment":647},{"nctId":"NCT02707601","phase":"PHASE3","title":"Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-04-01","conditions":"HIV-1 Infection, HCV Infection","enrollment":150},{"nctId":"NCT03721627","phase":"PHASE4","title":"Chronic Hepatitis C Treatment in Egyptian Children With Gaucher Disease.","status":"UNKNOWN","sponsor":"Mansoura University Children Hospital","startDate":"2018-04-03","conditions":"Gaucher Disease, HCV","enrollment":10},{"nctId":"NCT02597166","phase":"PHASE3","title":"Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2016-01","conditions":"Hepatitis C, Chronic, Cirrhosis, Decompensated","enrollment":14},{"nctId":"NCT03032666","phase":"PHASE4","title":"Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial","status":"COMPLETED","sponsor":"Ala'a Sharara","startDate":"2017-05-01","conditions":"Thalassemia, Hepatitis C","enrollment":7},{"nctId":"NCT01457755","phase":"","title":"Gilead Sustained Virologic Response (SVR) Registry","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-04-13","conditions":"Hepatitis C, Chronic","enrollment":6625},{"nctId":"NCT03279133","phase":"PHASE4","title":"Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients.","status":"WITHDRAWN","sponsor":"Kaiser Permanente","startDate":"2017-09-01","conditions":"Hematopoietic Stem Cell Transplantation","enrollment":""},{"nctId":"NCT03402165","phase":"PHASE4","title":"Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C","status":"UNKNOWN","sponsor":"Sherief Abd-Elsalam","startDate":"2017-01-01","conditions":"Hepatitis C","enrollment":1200},{"nctId":"NCT02339038","phase":"PHASE4","title":"Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2015-01-07","conditions":"HCV HIV","enrollment":600},{"nctId":"NCT01958281","phase":"PHASE2","title":"Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-10-07","conditions":"HCV Infection","enrollment":38},{"nctId":"NCT03343444","phase":"PHASE3","title":"Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents","status":"UNKNOWN","sponsor":"Egyptian Liver Hospital","startDate":"2017-04-15","conditions":"Hepatitis C Virus Infection, Response to Therapy of","enrollment":80},{"nctId":"NCT02758509","phase":"","title":"Impact of Antiviral Therapy on Gastroesophageal Varices.","status":"COMPLETED","sponsor":"Parc de Salut Mar","startDate":"2010-01-01","conditions":"Chronic Hepatitis C, Cirrhosis","enrollment":237},{"nctId":"NCT01457768","phase":"","title":"A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2011-12-19","conditions":"Hepatitis C, Chronic","enrollment":570},{"nctId":"NCT02605304","phase":"PHASE2","title":"12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF","status":"TERMINATED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2016-02-17","conditions":"HIV-1 Infection, Hepatitis C","enrollment":7},{"nctId":"NCT02705534","phase":"PHASE3","title":"Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2016-09","conditions":"Hepatitis C, Cirrhosis","enrollment":50},{"nctId":"NCT02128217","phase":"PHASE1","title":"Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection","status":"COMPLETED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2014-05-30","conditions":"HIV-1 Infection, Hepatitis","enrollment":44},{"nctId":"NCT02576314","phase":"PHASE3","title":"Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2015-05","conditions":"Chronic Hepatitis C Infection","enrollment":48},{"nctId":"NCT02482077","phase":"PHASE4","title":"Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2015-01","conditions":"Chronic Hepatitis C Infection","enrollment":112},{"nctId":"NCT02405013","phase":"PHASE2","title":"Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2015-10","conditions":"Hepatitis C, HIV Infection","enrollment":120},{"nctId":"NCT03169348","phase":"NA","title":"The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2017-11-01","conditions":"Hepatitis C","enrollment":50},{"nctId":"NCT02480166","phase":"PHASE4","title":"Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6","status":"COMPLETED","sponsor":"Stanford University","startDate":"2015-06","conditions":"PT-NANBH","enrollment":60},{"nctId":"NCT02628717","phase":"","title":"Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2013-07","conditions":"Chronic Hepatitis C, Cirrhosis","enrollment":558},{"nctId":"NCT02309918","phase":"PHASE2","title":"HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection","status":"COMPLETED","sponsor":"HepNet Study House, German Liverfoundation","startDate":"2014-11","conditions":"Acute Hepatitis C","enrollment":20},{"nctId":"NCT02959359","phase":"PHASE4","title":"DAA in the Risk of Recurrence After Curative Treatment of HCC","status":"WITHDRAWN","sponsor":"Taipei Veterans General Hospital, Taiwan","startDate":"2016-11","conditions":"Hepatocellular Carcinoma","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":36,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Oseltamivir plus Hydroxychloroquine & Azithromycin","Harvoni"],"phase":"phase_3","status":"active","brandName":"Sofosbuvir plus Ledipasvir","genericName":"Sofosbuvir plus Ledipasvir","companyName":"Almaza Military Fever Hospital","companyId":"almaza-military-fever-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sofosbuvir and ledipasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication. Used for Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6, Chronic hepatitis C virus (HCV) infection, genotype 2 and 3 (with ribavirin).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}