6533b7dafe1ef96bd126e163
RESEARCH PRODUCT
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B
Study Group PegbeliverM ColomboF FacchettiB MassettoL RegepC IannaconeT GiubertiS FargionP FarciS BoninsegnaV Di MarcoM FasanoE SagnelliGg Di CostanzoM ViganòP LamperticoP AndreoneA RiiliA ScuteriC CursaroA AndriulliGa NiroG AngaranoM FasanoTa SantantonioMs PalattellaMaurizia Rossana BrunettoP ColombattoB CocoP CiccorossiF OliveriR SaccoS BrunoS BollaniA ChiesaG CarosiC BaigueraS RossiS ZaltronM PuotiM ColomboP LamperticoM ViganòR CozzolongoV GiannuzziA CraxìV Di MarcoV CalvarusoG VeneziaGg Di CostanzoAg LanzaG Di PerriG CaritiO MollarettiT De BlasiC KulmiyeR RostagnoP FarciMe LaiG SerraL ChessaC BalestrieriC CauliSr FargionC BertelliE FattaG FattovichM PasinoS ZanniN OlivariI ZagniC FerrariS SchivazappaT GiubertiD LaccabueA PennaG GaetaM StanzioneG StornaiuoloD MartinesS BoninsegnaG RaimondoG CaccamoG SquadritoG IsgròM RizzettoM LaggetS CarenziG RuggieroA MarroneE SagnelliV MessinaDu Di CaprioV SelvaP. Toniuttosubject
AdultMaleHBsAgmedicine.medical_specialtyHepatitis B virusTime FactorsAnti-HIV Agentsmedicine.disease_causeGastroenterologyAntiviral AgentsGroup Blaw.inventionPolyethylene GlycolsPharmacotherapyHepatitis B ChronicRandomized controlled triallawPegylated interferonInternal medicinemedicineHumansHepatitis B e AntigensHepatitis B virusbusiness.industryGastroenterologyLamivudineInterferon-alphaAlanine TransaminaseHepatitis BMiddle Agedmedicine.diseaseHepatitis BRecombinant ProteinsTreatment OutcomeLamivudineImmunologyDNA ViralInterferonDrug Therapy CombinationFemaleHepatitis B; Interferonbusinessmedicine.drugdescription
Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA3400 IU/ml (primary), HBV DNA2000 IU/ml and HBsAg clearance at 48 weeks after treatment.Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events.In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment.http://ClinicalTrials.gov registration number: NCT01095835.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2013-01-01 |