Buti, MariaFung, ScottGane, EdwardAfdhal, Nezam H.Flisiak, RobertFlaherty, John F.Martins, Eduardo B.Yee, Leland J.Dinh, PhillipBornstein, Jeffrey D.Subramanian, G. ManiJanssen, Harry L. A.George, JacobMarcellin, Patrick2022-06-102022-06-102015-04Buti, M. vd. (2015). "Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years". Hepatology International, 9(2), 243-250.1936-0533https://doi.org/10.1007/s12072-015-9614-4https://link.springer.com/article/10.1007/s12072-015-9614-4http://hdl.handle.net/11452/27027Phase 3 clinical studies have shown that long-term treatment with tenofovir disoproxil fumarate (TDF) can suppress hepatitis B viral load and promote significant fibrosis regression and cirrhosis reversal in a majority of treated chronic hepatitis B (CHB) patients. This retrospective analysis investigated the impact of baseline cirrhosis status on virologic, serologic, and histologic outcomes in patients treated with TDF. Patients enrolled in studies GS-US-174-0102 and GS-US-174-0103 who had baseline liver biopsy-diagnosed cirrhosis and entered the open-label phase of the studies were included in the virologic and serologic analyses. Patients (both HBeAg positive and negative) with paired liver biopsies at baseline and 5 years (N = 348) were included in a histologic analysis. After 5 years on study, comparing patients with and without baseline cirrhosis, respectively: 99.2 and 98.0 % achieved virologic response (hepatitis B viral load < 69 IU/ml) (p = 0.686); 79.7 and 81.9 % had normal serum levels of alanine aminotransferase (p = 0.586); 4.0 and 1.2 % developed hepatocellular carcinoma (p = 0.044). In HBeAg-positive patients with and without baseline cirrhosis, HBsAg loss occurred in 14.4 and 8.3 % of patients, respectively (p = 0.188). One HBeAg-negative patient had HBsAg loss. This represents the largest analyses to date of CHB patients with sequential liver biopsies demonstrating that treatment with TDF for up to 5 years is associated with favorable virologic, serologic, and histologic outcomes, regardless of baseline cirrhosis status. Notably, histologic improvement was observed in the majority of cirrhotic and noncirrhotic patients.eninfo:eu-repo/semantics/openAccessAntiviral agentChronic hepatitis BCirrhosisHepatitis B e antigenHepatitis B surface antigenTenofovir disoproxilHepatocellular-carcinomaAdefovir dipivoxilFollow-upLamivudineRegressionTherapyDiseaseLevelRiskGastroenterology & hepatologyAdultAlanine transaminaseAntiviral agentsCarcinoma, hepatocellularFemaleHepatitis B e antigensHepatitis B surface antigensHepatitis B, chronicHumansLiver cirrhosisLiver neoplasmsMaleRetrospective studiesTenofovirTime factorsViral loadArticle0003524801000122-s2.0-849399832832432509225788199Gastroenterology & hepatologyHepatitis B E Antigen; Entecavir; Liver Cell CarcinomaAlanine aminotransferaseAntivirus agentHepatitis B surface antigenHepatitis B(e) antigenTenofovirAdultBloodClinical trialControlled studyDrug effectsFemaleHepatitis B, chronicHumanLiver cell carcinomaLiver cirrhosisLiver tumorMalePathologyPhase 3 clinical trialRandomized controlled trialRetrospective studyTime factorVirologyVirus load