Tsai, NaokyPetersen, JoergFlisiak, RobertKrastev, ZaharySchall, Raul AguilarFlaherty, John F.Martins, Eduardo B.Charuworn, PristaKitrinos, Kathryn M.Subramanian, G. ManiGane, EdwardMarcellin, Patrick2022-05-102022-05-102015-05Buti, M. vd. (2009). "Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis b virus ınfection". Digestive Diseases and Sciences, 60(5), 1457-1464.0163-2116https://doi.org/10.1007/s10620-014-3486-7https://link.springer.com/article/10.1007/s10620-014-3486-7http://hdl.handle.net/11452/26360Background Long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 (240 weeks) and no TDF resistance through 6 years (288 weeks). Aim We assessed the efficacy, safety, and resistance of TDF for up to 7 years (336 weeks) in HBeAg-positive and HBeAg-negative CHB patients. Methods Patients who completed 1 year (48 weeks) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years (384 weeks). Results Of 641 patients initially randomized, 585 (91.3 %) entered the open-label phase; 437/585 (74.7 %) remained on study at year 7. For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and in HBeAg-positive patients, 84/154 (54.5 %) and 25/154 (11.8 %) achieved HBeAg and HBsAg loss, respectively. One/375 (0.3 %) HBeAg-negative patients achieved HBsAg loss. No resistance to TDF was detected through 7 years. During the open-label phase, grade 3/4 drug-related adverse events were uncommon (1.0 %); ten (1.7 %) patients had elevation of serum creatinine >= 0.5 mg/dL above baseline. No significant change in bone mineral density was observed from year 4 to year 7 (week 192 to week 336). Conclusions Long-term TDF treatment was associated with sustained virologic, biochemical, and serologic responses, without resistance. TDF treatment was well tolerated, with a low incidence of renal and bone events. These data confirm the safety and efficacy of long-term TDF for CHB.eninfo:eu-repo/semantics/openAccessAntiviral agentCirrhosisHepatitis B e antigenLiver diseaseLong-term efficacyAdefovir dipivoxilEntecavir treatmentNaive patientsLamivudineCirrhosisRiskGastroenterology & hepatologyAdenineAntiviral agentsBiomarkersDNA, viralDrug administration scheduleDrug resistance, viralHepatitis B e antigensHepatitis B virusHepatitis B, chronicHumansPhosphorous acidsTime factorsTreatment outcomeViral loadArticle0003555702000452-s2.0-849396504681457146460525532501Gastroenterology & hepatologyHepatitis B E Antigen; Entecavir; Liver Cell Carcinoma9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenineAdenineAntivirus agentBiological markerHepatitis B(e) antigenPhosphorous acidVirus DNAAnalogs and derivativesAntiviral resistanceBloodControlled studyDrug administrationDrug effectsGeneticsHepatitis B virusHepatitis B, chronicHumanImmunologyRandomized controlled trialTimeTreatment outcomeVirus load