Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

References

• MackCLGonzalez-PeraltaRPGuptaNNASPGHAN practice guidelines: diagnosis and management of hepatitis C infection in infants, children, and adolescentsJ Pediatr Gastroenterol Nutr201254683885522487950
   PubMed Web of Science ®Google Scholar
• El-ShabrawiMHKamalNMBurden of pediatric hepatitis CWorld J Gastroenterol201319447880788824307782
   PubMed Web of Science ®Google Scholar
• ArmstrongGLWasleyASimardEPMcquillanGMKuhnertWLAlterMJThe prevalence of hepatitis C virus infection in the United States, 1999 through 2002Annu Int Med2006144705714
   PubMed Web of Science ®Google Scholar
• JhaveriRGrantWKaufTLMchutchisonJThe burden of hepatitis C virus infection in children: estimated direct medical costs over a 10-year periodJ Pediatr2006148335335816615966
   PubMed Web of Science ®Google Scholar
• PhamYHRosenthalPChronic hepatitis C infection in childrenAdv Pediatr201663117319427426900
   PubMedGoogle Scholar
• SlowikMKJhaveriRHepatitis B and C viruses in infants and young childrenSemin Pediatr Infect Dis200516429630516210109
   PubMedGoogle Scholar
• GoossensNNegroFIs genotype 3 of the hepatitis C virus the new villain?Hepatology20145962403241224155107
   PubMed Web of Science ®Google Scholar
• SerrantiDBuonsensoDCeccarelliMGargiulloLRannoOValentiniPPediatric hepatitis C infection: to treat or not to treat … what’s the best for the child?Eur Rev Med Pharmacol Sci20111591057106722013729
   PubMed Web of Science ®Google Scholar
• OmlandLHKrarupHJepsenPMortality in patients with chronic and cleared hepatitis C viral infection: a nationwide cohort studyJ Hepatology20105313642
   Web of Science ®Google Scholar
• IndolfiGHierroLDezsofiATreatment of chronic hepatitis C virus infection in children: a position paper by the Hepatology Committee of European Society of Paediatric Gastroenterology, Hepatology and NutritionJ Pediatr Gastroenterol Nutr201866350551529287014
   PubMed Web of Science ®Google Scholar
• BalistreriWFMurrayKFRosenthalPThe safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12–17 years old with hepatitis C virus genotype 1 infectionHepatology201766237137827997679
   PubMed Web of Science ®Google Scholar
• KoneruANelsonNHaririSIncreased hepatitis C virus (HCV) detection in women of childbearing age and potential risk for vertical transmission – United States and Kentucky, 2011–2014MMWR Morb Mortal Wkly Rep2016652870571027442053
   PubMed Web of Science ®Google Scholar
• BakerRDBakerSSHepatitis C in children in times of changeCurrent Opinion Pediatrics20152715
   Web of Science ®Google Scholar
• El-KhayatHRKamalEMEl-SayedMHThe effectiveness and safety of ledipasvir plus sofosbuvir in adolescents with chronic hepatitis C virus genotype 4 infection: a real-world experienceAliment Pharmacol Ther201847683884429349793
   PubMed Web of Science ®Google Scholar
• OmlandLHKrarupHJepsenPMortality in patients with chronic and cleared hepatitis C viral infection: a nationwide cohort studyJ Hepatol2010531364220400197
   PubMed Web of Science ®Google Scholar
• RodrigueJRBalistreriWHaberBImpact of hepatitis C virus infection on children and their caregivers: quality of life, cognitive, and emotional outcomesJ Pediatr Gastroenterol Nutr200948334134719242286
   PubMed Web of Science ®Google Scholar
• YounossiZMStepanovaMBalistreriWHealth-related quality of life in adolescent patients with hepatitis C genotype 1 treated with sofosbuvir and ledipasvirJ Pediatr Gastroenterol Nutr201866111211628957984
   PubMed Web of Science ®Google Scholar
• GhanyMGStraderDBThomasDLSeeffLBAmerican Association for the Study of Liver Diseases, Aaftsol D. Diagnosis, management, and treatment of hepatitis C: an updateHepatology20094941335137419330875
   PubMed Web of Science ®Google Scholar
• KandaTSteeleRRayRRayRBSmall interfering RNA targeted to hepatitis C virus 5’ nontranslated region exerts potent antiviral effectJ Virol200781266967617079316
   PubMed Web of Science ®Google Scholar
• MoradpourDPeninFHepatitis C virus proteins: from structure to functionCurr Top Microbiol Immunol201336911314223463199
   PubMed Web of Science ®Google Scholar
• KohlerJJNettlesJHAmblardFApproaches to hepatitis C treatment and cure using NS5A inhibitorsInfect Drug Resist20147415624623983
   PubMed Web of Science ®Google Scholar
• FridellRAQiuDValeraLWangCRoseREGaoMDistinct functions of NS5A in hepatitis C virus RNA replication uncovered by studies with the NS5A inhibitor BMS-790052J Virol201185147312732021593143
   PubMed Web of Science ®Google Scholar
• NettlesREGaoMBifanoMMultiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1Hepatology20115461956196521837752
   PubMed Web of Science ®Google Scholar
• LeeCDaclatasvir: potential role in hepatitis CDrug Des Devel Ther2013712231233
   PubMed Web of Science ®Google Scholar
• SerrantiDIndolfiGRestiMNew treatments for chronic hepatitis C: an overview for paediatriciansWorld J Gastroenterol20142043159651597425473150
   PubMed Web of Science ®Google Scholar
• KochUNarjesFAllosteric inhibition of the hepatitis C virus NS5B RNA dependent RNA polymeraseInfect Disord Drug Targets200661314116787302
   PubMedGoogle Scholar
• YakootMAbdoAMAbdel-RehimSHelmySResponse tailored protocol versus the fixed 12 weeks course of dual sofosbuvir/daclatasvir treatment in Egyptian patients with chronic hepatitis C genotype-4 infection: a randomized, open-label, non-inferiority trialEBioMedicine20172118218728647541
   PubMed Web of Science ®Google Scholar
• AfdhalNZeuzemSKwoPLedipasvir and sofosbuvir for untreated HCV genotype 1 infectionN Engl J Med2014370201889189824725239
   PubMed Web of Science ®Google Scholar
• AfdhalNReddyKRNelsonDRLedipasvir and sofosbuvir for previously treated HCV genotype 1 infectionN Engl J Med2014370161483149324725238
   PubMed Web of Science ®Google Scholar
• MizokamiMYokosukaOTakeharaTLedipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trialLancet Infect Dis201515664565325863559
   PubMed Web of Science ®Google Scholar
• ScottLJLedipasvir/sofosbuvir: a review in chronic hepatitis CDrugs201878224525629380288
   PubMed Web of Science ®Google Scholar
• KowdleyKVSundaramVJeonCYEight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infectionHepatology20176541094110328027579
   PubMed Web of Science ®Google Scholar
• ButtAAYanPShaikhOSChungRTShermanKEERCHIVES study, Study E. Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir-based regimens: results from ERCHIVESLiver Int20163691275128326928927
   PubMed Web of Science ®Google Scholar
• TerraultNAZeuzemSdi BisceglieAMEffectiveness of ledipasvir-sofosbuvir combination in patients with hepatitis C virus infection and factors associated with sustained virologic responseGastroenterology2016151114061131
   Web of Science ®Google Scholar
• TapperEBBaconBRCurryMPReal-world effectiveness for 12 weeks of ledipasvir-sofosbuvir for genotype 1 hepatitis C: the Trio Health studyJ Viral Hepat2017241222727730717
   PubMed Web of Science ®Google Scholar
• TapperEBBaconBRCurryMPEvaluation of proton pump inhibitor use on treatment outcomes with ledipasvir and sofosbuvir in a real-world cohort studyHepatology20166461893189927533287
   PubMed Web of Science ®Google Scholar
• CurryMPTapperEBBaconBEffectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patientsAliment Pharmacol Ther201746554054828691377
   PubMed Web of Science ®Google Scholar
• BackusLIBelperioPSShahoumianTALoomisTPMoleLAReal-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patientsHepatology201664240541427115523
   PubMed Web of Science ®Google Scholar
• BackusLIBelperioPSShahoumianTALoomisTPMoleLAComparative effectiveness of ledipasvir/sofosbuvir± ribavirin vs. ombitasvir/paritaprevir/ritonavir+dasabuvir± ribavirin in 6961 genotype 1 patients treated in routine medical practiceAliment Pharmacol Ther201644440041027291852
   PubMed Web of Science ®Google Scholar
• BackusLIBelperioPSShahoumianTALoomisTPMoleLAReal-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patientsAntivir Ther201722648149327934775
   PubMed Web of Science ®Google Scholar
• GaneEJHylandRHYangYEfficacy of ledipasvir plus sofosbuvir for 8 or 12 weeks inpatients with hepatitis C virus genotype 2 infectionGastroenterology201715261366137128137593
   PubMed Web of Science ®Google Scholar
• FeldJJRamjiAShafranSDLedipasvir-sofosbuvir plus ribavirin in treatment-naive patients with hepatitis C virus genotype 3 infection: an open-label studyClin Infect Dis2017651131928535298
   PubMed Web of Science ®Google Scholar
• GaneEJHylandRHAnDEfficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infectionGastroenterology20151491461614541461
   Web of Science ®Google Scholar
• AbergelAMetivierSSamuelDLedipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infectionHepatology20166441049105627351341
   PubMed Web of Science ®Google Scholar
• KohliAKapoorRSimsZLedipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort studyLancet Infect Dis20151591049105426187031
   PubMed Web of Science ®Google Scholar
• AbergelAAsselahTMetivierSLedipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 studyLancet Infect Dis201616445946426803446
   PubMed Web of Science ®Google Scholar
• NguyenMHTrinhHdoSNguyenTNguyenPHenryLOpen label study of 8 vs. 12 weeks of ledipasvir/sofosbuvir in genotype 6 treatment naïve or experienced patientsAm J Gastroenterol2017112121824183129087397
   PubMed Web of Science ®Google Scholar
• AlqahtaniSAAfdhalNZeuzemSSafety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trialsHepatology2015621253025963890
   PubMed Web of Science ®Google Scholar
• HaberBAlonsoEPedreiraALong-term follow-up of children treated with peginterferon and ribavirin for hepatitis C virus infectionJ Pediatr Gastroenterol Nutr2017641899427111344
   PubMed Web of Science ®Google Scholar
• KellyDAHaberBGonzález-PeraltaRPDurability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirinJ Viral Hepat201219426327022404724
   PubMed Web of Science ®Google Scholar
• BalisteriWRosenthalPBansalSLedipasvir/sofosbuvir for 12 weeks is safe and effective in adolescents with chronic hepatitis C infectionJ Pediatr Gastroenterol Nutr201663Suppl. 2S140141
   Google Scholar
• WirthSRosenthalPGonzalez-PeraltaRPSofosbuvir and ribavirin in adolescents 12–17 years old with hepatitis C virus genotype 2 or 3 infectionHepatology20176641102111028543053
   PubMed Web of Science ®Google Scholar
• KirbyBAdult Doses of Sofosbuvir Plus Ribavirin or Ledipasvir/Sofosbuvir Provided Comparable Plasma Exposures and Tolerable Safety Profile in Adolescents with Hepatitis C Virus (HCV) InfectionSan Francisco, CAAmerican Association for the Study of Liver Disease Annual MeetingNovember 13–17, 2015
   Google Scholar
• GarrisonKLMathiasAKerseyKPharmacokinetics of once-daily sofosbuvir and ledipasvir/sofosbuvir in HCV-infected pediatrics aged 6 to <12 years old. Paper presented at: The Liver Meeting2016Boston, MA
   Google Scholar
• SquiresJEBalistreriWFHepatitis C virus infection in children and adolescentsHepatol Commun201712879829404447
   PubMed Web of Science ®Google Scholar
• YakootMAbdoAMYousryAHelmySVery rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapyDrug Des Devel Ther20161026592667
   PubMed Web of Science ®Google Scholar
• European Association for the Study of the LiverElectronic address [email protected]. EASL recommendations on treatment of hepatitis C 2016J Hepatol201766115319427667367
   PubMed Web of Science ®Google Scholar
• El-ShabrawiMHAbdoAMEl-KhayatHRYakootMShortened 8 weeks course of dual sofosbuvir/daclatasvir therapy in adolescent patients, with chronic hepatitis C infectionJ Pediatr Gastroenterol Nutr201866342542729135824
   PubMed Web of Science ®Google Scholar
• RizzaSANehraVTemesgenZSofosbuvir/ledipasvir fixed-dose combination for treatment of chronic hepatitis C virus infection in childrenDrugs Today201753844745129119149
   PubMed Web of Science ®Google Scholar
• MurrayKFBalistreriWBansalSLedipasvir/sofosbuvir +/− ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection52nd Annual Meeting of the European Association for the Study of the Liver (EASL)April 19–23, 2017Amsterdam
   Google Scholar
• MillerMMSofosbuvir-velpatasvir: a single-tablet treatment for hepatitis C infection of all genotypesAm J Health Syst Pharm201774141045105228687550
   PubMed Web of Science ®Google Scholar
• Sofosbuvir/Velpatasvir in adolescents and children with chronic HCV infection Available from: https://clinicaltrials.gov/ct2/show/NCT03022981Accessed June 3, 2018
   Google Scholar
• CarrionAFMartinPGlecaprevir + pibrentasvir for treatment of hepatitis CExpert Opin Pharmacother201819441341929465262
   PubMed Web of Science ®Google Scholar
• AbutalebAKottililSWilsonEGlecaprevir/pibrentasvir expands reach while reducing cost and duration of hepatitis C virus therapyHepatol Int201812321422229845496
   PubMed Web of Science ®Google Scholar
• A study to evaluate the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in pediatric subjects with genotypes 1–6 chronic hepatitis C virus (HCV) infection (DORA) Available from: https://clinicaltrials.gov/ct2/show/NCT03067129Accessed June 3, 2018
   Google Scholar
• HuysentruytKStephenneXVarmaSSofosbuvir/ledipasvir and ribavirin tolerability and efficacy in pediatric liver transplant recipientsLiver Transpl201723455255328006874
   PubMed Web of Science ®Google Scholar
• Psaros EinbergAFischlerBSuccessful treatment of paediatric hepatitis C with direct acting antivirals in select casesPaper presented at: ESPGHAN 50th Annual Meeting2017Prague
   Google Scholar