{"id":"ledipasvir-sofosbuvir","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":"claude-haiku-4.5","explanation":"Ledipasvir is an NS5A inhibitor that prevents the hepatitis C virus from replicating and assembling viral particles. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, essential for viral RNA synthesis. Together, this combination directly targets two critical steps in the HCV replication cycle, achieving high cure rates across multiple HCV genotypes.","oneSentence":"Ledipasvir inhibits hepatitis C virus NS5A protein while sofosbuvir inhibits the viral NS5B polymerase, together blocking HCV replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:51:45.755Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)"},{"name":"Chronic hepatitis C virus infection genotype 2 and 3 (in combination 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":"NCT02510300","phase":"","title":"A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2015-10-21","conditions":"Hepatitis C Virus Infection","enrollment":461},{"nctId":"NCT02660905","phase":"PHASE3","title":"HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2016-04","conditions":"Human Immunodeficiency Virus, Hepatitis C, Chronic","enrollment":25},{"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":"NCT02964091","phase":"PHASE4","title":"Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World","status":"COMPLETED","sponsor":"Partners in Health","startDate":"2016-10","conditions":"Chronic Hepatitis C","enrollment":300},{"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":"NCT02588287","phase":"NA","title":"Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2015-11","conditions":"Hepatitis C and HIV Coinfection","enrollment":14},{"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":"NCT02609893","phase":"PHASE4","title":"Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs","status":"COMPLETED","sponsor":"Phillip Coffin, MD, MIA","startDate":"2015-12","conditions":"Chronic Hepatitis C","enrollment":31},{"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":"NCT02402218","phase":"NA","title":"CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2015-08","conditions":"Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus","enrollment":144},{"nctId":"NCT02740556","phase":"NA","title":"Evaluation of HepCure Toolkit to Improve Harvoni Adherence","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2016-02","conditions":"Hepatitis C, Medication Adherence","enrollment":71},{"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":"NCT02868242","phase":"PHASE2","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-08-28","conditions":"Hepatitis C Virus Infection","enrollment":19},{"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":"NCT04063839","phase":"","title":"HCV Treatment in a Low-threshold Clinic","status":"UNKNOWN","sponsor":"University Hospital, Akershus","startDate":"2015-01","conditions":"Hepatitis C, Substance Use Disorders","enrollment":300},{"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":"NCT04039958","phase":"PHASE1","title":"A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)","status":"COMPLETED","sponsor":"Genuine Research Center, Egypt","startDate":"2017-04-05","conditions":"Healthy","enrollment":30},{"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}],"_emaApprovals":[],"_faersSignals":[{"count":477,"reaction":"HEADACHE"},{"count":476,"reaction":"FATIGUE"},{"count":297,"reaction":"DRUG INEFFECTIVE"},{"count":285,"reaction":"DEATH"},{"count":253,"reaction":"NAUSEA"},{"count":242,"reaction":"HEPATOCELLULAR CARCINOMA"},{"count":225,"reaction":"ASTHENIA"},{"count":215,"reaction":"HEPATITIS C"},{"count":201,"reaction":"VOMITING"},{"count":191,"reaction":"INSOMNIA"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["LDV/SOF","Harvoni®","GS-7977","GS-5885","Harvoni"],"phase":"marketed","status":"active","brandName":"Ledipasvir/Sofosbuvir","genericName":"Ledipasvir/Sofosbuvir","companyName":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","companyId":"advancing-clinical-therapeutics-globally-for-hiv-aids-and-other-infections","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ledipasvir inhibits hepatitis C virus NS5A protein while sofosbuvir inhibits the viral NS5B polymerase, together blocking HCV replication. Used for Chronic hepatitis C virus infection, genotypes 1, 4, 5, and 6 (with or without ribavirin), Chronic hepatitis C virus infection, genotypes 2 and 3 (in combination with sofosbuvir and ribavirin).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}