title: Tenofovir disoproxil fumarate monotherapy maintains HBV suppression achieved by a "de novo" combination of lamivudine-adefovir: a pilot study.
abstract: Chronic hepatitis B (CHB) treatment aims at long-term suppression of HBV replication and improvement in clinical outcomes. We describe the data of a pilot, non-profit study in which patients with CHB were treated with de novo combination lamivudine-adefovir (LAM-ADV) for at least four years with a view to HBV suppression and resistance prevention, and shifted to tenofovir (TDF) when new antiviral agents were available. Fifty-one HBeAg negative patients were enrolled. Histology was available for 39 patients and data of liver stiffness (LS) for 24 patients at baseline. Serum quantification of HBsAg and HBVDNA was obtained regularly during the follow-up. In 10 and 7 patients, a paired histology and LS were available at the end of LAM-ADV treatment, respectively. The de novo LAM-ADV combination was able to obtain HBVDNA suppression and ALT normalization in one year in most of the patients and in the second year in the remaining. Histology improved in patients with paired biopsy, but tissue HBsAg was present in all but one patient after 48 months of therapy. TDF maintained biochemical and virological response throughout the follow-up. Renal impairment during LAM-ADV therapy improved on shifting to TDF; only in 4 cases was a second shift to entecavir needed. TDF was safe and effective in maintaining HBV DNA suppression achieved by a long-term course of LAM-ADV de novo combination for the treatment of HBeAg-negative CHB.
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ruggiero
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Aldo
authors.initials: A
authors.lastname: Marrone
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Rainone
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Adriana
authors.initials: A
authors.lastname: Boemio
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Luigi Elio
authors.initials: LE
authors.lastname: Adinolfi
authors.affiliation: Infectious Diseases, Second University of Naples, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pasquale
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Rinaldi
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Guerrera
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Andreana
authors.affiliation: Internal Medicine and Hepatology, Department of Medical, Surgical, Neurological, Metabolic and Aging Science, Second University of Naples, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Zampino
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D024882:Drug Resistance, Viral / Q000235:genetics; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006514:Hepatitis B Surface Antigens / Q000187:drug effects; D006515:Hepatitis B virus / Q000187:drug effects*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D010865:Pilot Projects; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D063065:Organophosphonates; D019259:Lamivudine; C053001:adefovir; D000068698:Tenofovir; D000225:Adenine