{"id":"combined-therapy-ldv-and-sof","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Fatigue"},{"rate":"10-15","effect":"Headache"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ledipasvir is an NS5A inhibitor that prevents viral protein complex formation and RNA replication. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, a critical enzyme for HCV genome replication. Together, they provide potent pan-genotypic activity against hepatitis C virus with high barrier to resistance.","oneSentence":"LDV (ledipasvir) and SOF (sofosbuvir) are direct-acting antivirals that inhibit hepatitis C virus NS5A and NS5B polymerase, respectively, blocking viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:40:22.698Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotypes 1-6)"}]},"trialDetails":[{"nctId":"NCT02613403","phase":"PHASE2","title":"Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-12-10","conditions":"Hepatitis, Hepatitis C, Digestive System Diseases","enrollment":94},{"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":"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":"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":"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":"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":"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":"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":"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":"NCT03888729","phase":"PHASE4","title":"Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)","status":"UNKNOWN","sponsor":"Partners in Health","startDate":"2019-08-26","conditions":"Hepatitis C, Chronic","enrollment":100},{"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":"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":"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":"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":"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":"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":"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":"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":"NCT02363517","phase":"PHASE3","title":"The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach","status":"UNKNOWN","sponsor":"Macfarlane Burnet Institute for Medical Research and Public Health Ltd","startDate":"2015-02","conditions":"Hepatitis C, Drug Abuse, Intravenous","enrollment":420},{"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":"NCT02125500","phase":"PHASE2","title":"Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2014-08","conditions":"Viral Hepatitis C, HIV","enrollment":68},{"nctId":"NCT02120300","phase":"PHASE2","title":"Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2014-04","conditions":"Chronic HCV Infection","enrollment":122},{"nctId":"NCT02478229","phase":"PHASE3","title":"Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)","status":"TERMINATED","sponsor":"University Health Network, Toronto","startDate":"2015-06","conditions":"Hepatitis C Viral Infection","enrollment":1},{"nctId":"NCT02691728","phase":"PHASE4","title":"Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease","status":"UNKNOWN","sponsor":"Peter J. Ruane, M.D., Inc.","startDate":"2016-02","conditions":"Chronic Hepatitis C","enrollment":40},{"nctId":"NCT01260350","phase":"PHASE2","title":"Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2010-12","conditions":"Chronic Hepatitis C Infection","enrollment":292}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":16,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ledipasvir and sofosbuvir"],"phase":"marketed","status":"active","brandName":"Combined therapy LDV and SOF","genericName":"Combined therapy LDV and SOF","companyName":"Yassin Abdelghaffar Charity Center for Liver Disease and Research","companyId":"yassin-abdelghaffar-charity-center-for-liver-disease-and-research","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LDV (ledipasvir) and SOF (sofosbuvir) are direct-acting antivirals that inhibit hepatitis C virus NS5A and NS5B polymerase, respectively, blocking viral replication. Used for Chronic hepatitis C virus infection (genotypes 1-6).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}