OBJECTIVES: The aims of this long-term, prospective randomized study were to evaluate the clinical usefulness of alpha-interferon in treating chronic HBV infection and to establish whether clearance of viral replication markers and normalization of liver function tests induced by alpha-interferon were sustained. METHODS:Sixty-four patients with chronic wild type (HBeAg-positive) hepatitis B, enrolled between 1983 and 1987, were randomized into two groups. Thirty-three patients received alpha-interferon (5 MU/m2 three times weekly for 6 months; treated group), and 31 were not treated (controls). Treated and control patients were prospectively followed for a mean of 86.4 +/- 6.96 and 79.7 +/- 6.8 (p = NS) months, respectively. RESULTS: Clearance of the following viral markers was found in treated and control patients as follows: HBV-DNA, 26 (78.9%) and 18 (58.1%) (p = 0.106); HBeAg, 30 (90.9%) and 19 (61.2%) (p < 0.007); and HBsAg, 12 (36.4%) and three (9.8%) (p < 0.017). Persistent abnormal ALT levels were found in 11 (33.3%) treated and in 22 (70.9%) control patients (p < 0.025). Four control and three treated patients developed portal hypertension whereas two control and one treated patient developed hepatocellular carcinoma. Seven patients (five treated and two controls) were retrospectively found to have hepatitis C virus (HCV) coinfection before enrollment. To date, all coinfected patients remain positive for HCV-RNA. Also, all HCV coinfected patients, except one in the treated group, had persistent increased serum ALT levels. One of the coinfected patients developed portal hypertension. CONCLUSIONS:Chronic HBV hepatitis patients responding to interferon treatment had a faster, more complete, and sustained clearance of viral markers than controls; HCV coinfection does not seem to negatively affect the clearance of HBV replicative markers. However when coinfection occurs, hepatic disease persists despite HBV marker clearance.
RCT Entities:
OBJECTIVES: The aims of this long-term, prospective randomized study were to evaluate the clinical usefulness of alpha-interferon in treating chronic HBV infection and to establish whether clearance of viral replication markers and normalization of liver function tests induced by alpha-interferon were sustained. METHODS: Sixty-four patients with chronic wild type (HBeAg-positive) hepatitis B, enrolled between 1983 and 1987, were randomized into two groups. Thirty-three patients received alpha-interferon (5 MU/m2 three times weekly for 6 months; treated group), and 31 were not treated (controls). Treated and control patients were prospectively followed for a mean of 86.4 +/- 6.96 and 79.7 +/- 6.8 (p = NS) months, respectively. RESULTS: Clearance of the following viral markers was found in treated and control patients as follows: HBV-DNA, 26 (78.9%) and 18 (58.1%) (p = 0.106); HBeAg, 30 (90.9%) and 19 (61.2%) (p < 0.007); and HBsAg, 12 (36.4%) and three (9.8%) (p < 0.017). Persistent abnormal ALT levels were found in 11 (33.3%) treated and in 22 (70.9%) control patients (p < 0.025). Four control and three treated patients developed portal hypertension whereas two control and one treated patient developed hepatocellular carcinoma. Seven patients (five treated and two controls) were retrospectively found to have hepatitis C virus (HCV) coinfection before enrollment. To date, all coinfectedpatients remain positive for HCV-RNA. Also, all HCV coinfectedpatients, except one in the treated group, had persistent increased serum ALT levels. One of the coinfectedpatients developed portal hypertension. CONCLUSIONS:Chronic HBV hepatitispatients responding to interferon treatment had a faster, more complete, and sustained clearance of viral markers than controls; HCV coinfection does not seem to negatively affect the clearance of HBV replicative markers. However when coinfection occurs, hepatic disease persists despite HBV marker clearance.
Authors: Francesca Lodato; Giuseppe Mazzella; Davide Festi; Francesco Azzaroli; Antonio Colecchia; Enrico Roda Journal: World J Gastroenterol Date: 2006-12-07 Impact factor: 5.742
Authors: G Vourli; G Papatheodoridis; M Raptopoulou; G N Dalekos; A Hounta; G Nikolopoulou; I Zouboulis-Vafeiadis; E Manesis; G Kitis; C Gogos; I Ketikoglou; G Hatzis; T Vasilialdis; S Karatapanis; K Mimidis; C Drakoulis; G Touloumi Journal: Hippokratia Date: 2016 Jul-Sep Impact factor: 0.471
Authors: Karen Colbert Maresso; Kenneth Y Tsai; Powel H Brown; Eva Szabo; Scott Lippman; Ernest T Hawk Journal: CA Cancer J Clin Date: 2015-08-18 Impact factor: 508.702
Authors: M Francesca Jaboli; Carlo Fabbri; Stefania Liva; Francesco Azzaroli; Giovanni Nigro; Silvia Giovanelli; Francesco Ferrara; Anna Miracolo; Sabrina Marchetto; Marco Montagnani; Antonio Colecchia; Davide Festi; Letizia Bacchi Reggiani; Enrico Roda; Giuseppe Mazzella Journal: World J Gastroenterol Date: 2003-07 Impact factor: 5.742