147. Krogsgaard K. The long-term effect of treatment with interferon-alpha 2a in chronic hepatitis B. The Long-Term Follow-up Investigator Group. The European Study Group on Viral Hepatitis (EUROHEP). Executive Team on Anti-Viral Treatment. J Viral Hepat 1998;5:389-397. 148. Carreno V, Castillo I, Molina J, Porres JC, Bartolome J. Long-term follow-up of hepatitis B chronic carriers who responded to interferon therapy. J Hepatol 1992;15:102-106. 149. Yuen MF, Hui CK, Cheng CC, Wu CH, Lai YP, Lai CL. Long-term follow-up of interferon alfa treatment in Chinese patients with chronic hepatitis B infection: The effect on hepatitis B e antigen seroconversion and the development of cirrhosis-related complications. HEPATOLOGY 2001;34:139-145. 150. van Zonneveld M, Honkoop P, Hansen BE, Niesters HG, Murad SD, de Man RA, et al. Long-term follow-up of alpha-interferon treatment of patients with chronic hepatitis B. HEPATOLOGY 2004;39:804-810. 151. Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, et al. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305. 152. Chan HL, Leung NW, Hui AY, Wong VW, Liew CT, Chim AM, et al. A randomized, controlled trial of combination therapy for chronic hepatitis B: comparing pegylated interferon-alpha2b and lamivudine with lamivudine alone. Ann Intern Med 2005;142:240-250. 153. Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004;351:1206-1217. 154. Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. New Engl J Med 1999;341:1256-1263. 155. Lai CL, Chien RN, Leung NW, Chang TT, Guan R, Tai DI, et al. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. [see comments]. New Engl J Med 1998;339:61-68. 156. Schalm SW, Heathcote J, Cianciara J, Farrell G, Sherman M, Willems B, et al. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial. [see comments]. Gut 2000;46:562-568. 157. Liaw YF, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. [see comments]. Gastroenterology 2000;119:172-180. 158. Leung NW, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, et al. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. HEPATOLOGY 2001;33:1527-1532. 159. Chang TT, Lai CL, Chien RN, Guan R, Lim SG, Lee CM, et al. Four years of lamivudine treatment in Chinese patients with chronic hepatitis B. J Gastroenterol Hepatol 2004;19:1276-1282. 160. Lok AS, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003;125:1714-1722. 161. Chien RN, Liaw YF, Atkins M. Pretherapy alanine transaminase level as a determinant for hepatitis B e antigen seroconversion during lamivudine therapy in patients with chronic hepatitis B. Asian Hepatitis Lamivudine Trial Group. HEPATOLOGY 1999;30:770-774. 162. Perrillo RP, Lai CL, Liaw YF, Dienstag JL, Schiff ER, Schalm SW, et al. Predictors of HBeAg loss after lamivudine treatment for chronic hepatitis B. HEPATOLOGY 2002;36:186-194. 163. Jonas MM, Kelley DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Clinical trial of lamivudine in children with chronic hepatitis B. N Engl J Med 2002;346:1706-1713. 164. Sokal EM, Kelly DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Long-term lamivudine therapy for children with HBeAg-positive chronic hepatitis B. HEPATOLOGY 2006;43:225-232. 536 LOK AND MCMAHON HEPATOLOGY, February 2007 165. Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, et al. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/ hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. HEPATOLOGY 1999;29:889- 896. 166. Santantonio T, Mazzola M, Iacovazzi T, Miglietta A, Guastadisegni A, Pastore G. Long-term follow-up of patients with anti-HBe/HBV DNApositive chronic hepatitis B treated for 12 months with lamivudine. J Hepatol 2000;32:300-306. 167. Lok AS, Hussain M, Cursano C, Margotti M, Gramenzi A, Grazi GL, et al. Evolution of hepatitis B virus polymerase gene mutations in hepatitis B e antigen-negative patients receiving lamivudine therapy. [see comments]. HEPATOLOGY 2000;32:1145-1153. 168. Hadziyannis SJ, Papatheodoridis GV, Dimou E, Laras A, Papaioannou C. Efficacy of long-term lamivudine monotherapy in patients with hepatitis B e antigen-negative chronic hepatitis B. HEPATOLOGY 2000;32: 847-851. 169. Lau DT, Khokhar MF, Doo E, Ghany MG, Herion D, Park Y, et al. Long-term therapy of chronic hepatitis B with lamivudine. HEPATOLOGY 2000;32:828-834. 170. Rizzetto M, Volpes R, Smedile A. Response of pre-core mutant chronic hepatitis B infection to lamivudine. J Med Virol 2000;61:398-402. 171. Papatheodoridis GV, Dimou E, Laras A, Papadimitropoulos V, Hadziyannis SJ. Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease. HEPATOLOGY 2002;36:219-226. 172. Papatheodoridis GV, Dimou E, Dimakopoulos K, Manolakopoulos S, Rapti I, Kitis G, et al. Outcome of hepatitis B e antigen-negative chronic hepatitis B on long-term nucleos(t)ide analog therapy starting with lamivudine. HEPATOLOGY 2005;42:121-129. 173. Schiff ER, Dienstag JL, Karayalcin S, Grimm IS, Perrillo RP, Husa P, et al. Lamivudine and 24 weeks of lamivudine/interferon combination therapy for hepatitis B e antigen-positive chronic hepatitis B in interferon nonresponders. J Hepatol 2003;38:818-826. 174. Perrillo RP, Wright T, Rakela J, Levy G, Schiff E, Gish R, et al. A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B. HEPATOLOGY 2001;33:424-432. 175. Villeneuve JP, Condreay LD, Willems B, Pomier-Layrargues G, Fenyves D, Bilodeau M, et al. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. HEPATOLOGY 2000;31:207-210. 176. Yao FY, Bass NM. Lamivudine treatment in patients with severely decompensated cirrhosis due to replicating hepatitis B infection. [see comments]. J Hepatol 2000;33:301-307. 177. Fontana RJ, Hann HW, Perrillo RP, Vierling JM, Wright T, Rakela J, et al. Determinants of early mortality in patients with decompensated chronic hepatitis B treated with antiviral therapy. Gastroenterology 2002; 123:719-727. 178. Dienstag JL, Cianciara J, Karayalcin S, Kowdley KV, Willems B, Plisek S, et al. Durability of serologic response after lamivudine treatment of chronic hepatitis B. HEPATOLOGY 2003;37:748-755. 179. Song BC, Suh DJ, Lee HC, Chung YH, Lee YS. Hepatitis B e antigen seroconversion after lamivudine therapy is not durable in patients with chronic hepatitis B in Korea. HEPATOLOGY 2000;32:803-806. 180. Lee KM, Cho SW, Kim SW, Kim HJ, Hahm KB, Kim JH. Effect of virological response on post-treatment durability of lamivudine-induced HBeAg seroconversion. J Viral Hepat 2002;9:208-212. 181. Ryu SH, Chung YH, Choi MH, Kim JA, Shin JW, Jang MK, et al. Long-term additional lamivudine therapy enhances durability of lamivudine- induced HBeAg loss: a prospective study. J Hepatol 2003;39:614- 619. 182. Lee HC, Suh DJ, Ryu SH, Kim H, Shin JW, Lim YS, et al. Quantitative polymerase chain reaction assay for serum hepatitis B virus DNA as a predictive factor for post-treatment relapse after lamivudine induced hepatitis B e antigen loss or seroconversion. Gut 2003;52:1779-1783. 183. Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. HEPATOLOGY 2003; 38:1267-1273. 184. van Nunen AB, Hansen BE, Suh DJ, Lohr HF, Chemello L, Fontaine H, et al. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut 2003;52:420-424. 185. Fung SK, Wong F, Hussain M, Lok AS. Sustained response after a 2-year course of lamivudine treatment of hepatitis B e antigen-negative chronic hepatitis B. J Viral Hepat 2004;11:432-438. 186. Allen MI, Deslauriers M, Andrews CW, Tipples GA, Walters KA, Tyrrell DL, Brown N, et al. Identification and characterization of mutations in hepatitis B virus resistant to lamivudine. Lamivudine Clinical Investigation Group. HEPATOLOGY 1998;27:1670-1677. 187. Stuyver LJ, Locarnini SA, Lok A, Richman DD, Carman WF, Dienstag JL, Schinazi RF. Nomenclature for antiviral-resistant human hepatitis B virus mutations in the polymerase region. HEPATOLOGY 2001;33:751-757. 188. Yuen MF, Sablon E, Hui CK, Yuan HJ, Decraemer H, Lai CL. Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. HEPATOLOGY 2001;34:785-791. 189. Melegari M, Scaglioni PP, Wands JR. Hepatitis B virus mutants associated with 3TC and famciclovir administration are replication defective. HEPATOLOGY 1998;27:628-633. 190. Liaw YF, Chien RN, Yeh CT, Tsai SL, Chu CM. Acute exacerbation and hepatitis B virus clearance after emergence ofYMDDmotif mutation during lamivudine therapy. [see comments]. HEPATOLOGY 1999;30:567-572. 191. Bartholomew MM, Jansen RW, Jeffers LJ, Reddy KR, Johnson LC, Bunzendahl H, et al. Hepatitis-B-virus resistance to lamivudine given for recurrent infection after orthotopic liver transplantation. [see comments]. Lancet 1997;349:20-22. 192. Tipples GA, Ma MM, Fischer KP, Bain VG, Kneteman NM, Tyrrell DL. Mutation in HBV RNA-dependent DNA polymerase confers resistance to lamivudine in vivo. HEPATOLOGY 1996;24:714-717. 193. Liaw YF, Chien RN, Yeh CT. No benefit to continue lamivudine therapy after emergence of YMDD mutations. Antivir Ther 2004;9:257-262. 194. Wong VW, Chan HL, Wong ML, Tam JS, Leung NW. Clinical course after stopping lamivudine in chronic hepatitis B patients with lamivudine- resistant mutants. Aliment Pharmacol Ther 2004;19:323-329. 195. Dienstag JL, Goldin RD, Heathcote EJ, Hann HW, Woessner M, Stephenson SL, et al. Histological outcome during long-term lamivudine therapy. Gastroenterology 2003;124:105-117. 196. Di Marco V, Marzano A, Lampertico P, Andreone P, Santantonio T, Almasio PL, et al. Clinical outcome of HBeAg-negative chronic hepatitis B in relation to virological response to lamivudine. HEPATOLOGY 2004; 40:883-891. 197. Honkoop P, de Man RA, Niesters HG, Zondervan PE, Schalm SW. Acute exacerbation of chronic hepatitis B virus infection after withdrawal of lamivudine therapy. HEPATOLOGY 2000;32:635-639. 198. Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003;348:808-816. 199. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med 2003;348:800-807. 200. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Long-term therapy with adefovir dipivoxil for HBeAgnegative chronic hepatitis B. N Engl J Med 2005;352:2673-2681. 201. Hadziyannis S, Tassopoulos N, Chang TT, Heathcote J, Kitis G, Rizzetto M, et al. Long-term adefovir dipivoxil treatment induces regression of liver fibrosis in patients with HBeAg-negative chronic hepatitis B: Results after 5 years of therapy [Abstract]. HEPATOLOGY 2005;42(Suppl):754A. 202. Schiff ER, Lai CL, Hadziyannis S, Neuhaus P, Terrault N, Colombo M, et al. Adefovir dipivoxil therapy for lamivudine-resistant hepatitis B in pre- and post-liver transplantation patients.HEPATOLOGY 2003;38:1419- 1427. 203. Schiff E, Lai CL, Neuhaus P, Tillmann HL, Samuel D, Villeneuve JP. Adefovir Dipivoxil (ADV) provides significant clinical benefit, reduces HEPATOLOGY, Vol. 45, No. 2, 2007 LOK AND MCMAHON 537 meld score and prevents transplantation in chronic hepatitis B patients wait-listed for liver transplantation (OLT) with Lamivudine-Resistance (LAM-R) [Abstract]. J Hepatol 2005;42(Suppl 2):5. 204. Snow A, Thibault V, Qi X, Zhu Y, Westland C, Arterburn S, et al. Combination of Adefovir Dipivoxil (ADV) and Lamivudine (LAM) prevented emergence of ADV resistance Mutations in chronic Hepatitis B (CHB) patients with LAM-Resistant HBV [Abstract]. Gastroenterology 2005;128:M945. 205. Benhamou Y, Thibault V, Vig P, Calvez V, Marcelin AG, Fievet MH, et al. Safety and efficacy of adefovir dipivoxil in patients infected with lamivudine- resistant hepatitis B and HIV-1. J Hepatol 2006;44:62-67. 206. Chang TT, Gish R, Man R, Gadano A, Sollano J, Han KH, et al. Entecavir is superior to Lamivudine for the treatment of HBEAg( ) chronic hepatitis B: Results of Phase III study ETV - 022 in Nucleoside-Naive patients [Abstract]. HEPATOLOGY 2004;40(Suppl):193A. 207. Westland CE, Yang H, Delaney WE, Gibbs CS, Miller MD, Wulfsohn M, et al. Week 48 resistance surveillance in two phase 3 clinical studies of adefovir dipivoxil for chronic hepatitis B.HEPATOLOGY 2003;38:96-103. 208. Angus P, Vaughan R, Xiong S, Yang H, Delaney W, Gibbs C, et al. Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology 2003;125: 292-297. 209. Villeneuve JP, Durantel D, Durantel S, Westland C, Xiong S, Brosgart CL, et al. Selection of a hepatitis B virus strain resistant to adefovir in a liver transplantation patient. J Hepatol 2003;39:1085-1089. 210. Locarnini S, Qi X, Arterburn S, Snow A, Brosgart CL, Currie G, et al. Incidence and predictors of emergence of Adefovir resistant HBV during four years of Adefovir Dipivoxil (ADV) Therapy for patients with chronic hepatitis B (CHB) [Abstract]. J Hepatol 2005;42:17. 211. Lee YS, Suh DJ, Lim YS, Jung SW, Kim KM, Lee HC, et al. Increased risk of adefovir resistance in patients with lamivudine-resistant chronic hepatitis B after 48 weeks of adefovir dipivoxil monotherapy. HEPATOLOGY 2006;43:1385-1391. 212. Fung SK, Andreone P, Han SH, Reddy KR, Regev A, Keeffe EB, et al. Adefovir-resistant hepatitis B can be associated with viral rebound and hepatic decompensation. J Hepatol 2005;43:937-943. 213. Durantel S, Werle B, Durantel D, Pichoud C, Currie G, Xiong S, et al. Different profiles of response to Adefovir Dipivoxil and factors that may influence response in patients with chronic Hepatitis B. HEPATOLOGY 2004;40:654A. 214. Westland C, Delaney Wt, Yang H, Chen SS, Marcellin P, Hadziyannis S, et al. Hepatitis B virus genotypes and virologic response in 694 patients in phase III studies of adefovir dipivoxil1. Gastroenterology 2003;125:107- 116. 215. Ono SK, Kato N, Shiratori Y, Kato J, Goto T, Schinazi RF, et al. The polymerase L528M mutation cooperates with nucleotide binding-site mutations, increasing hepatitis B virus replication and drug resistance. J Clin Invest 2001;107:449-455. 216. Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-1010. 217. Gish R, Chang TT, de Man R, Gadano A, Sollano J, Han KH, et al. Entecavir results in substantial virologic and biochemical improvement and HBeAg seroconversion through 96 weeks of treatment in HBeAg( ) Chronic hepatitis B patients (Study ETV-022) [Abstract]. HEPATOLOGY 2005;42(Suppl) :267A. 218. Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006;354:1011-1020. 219. Chang TT, Gish RG, Hadziyannis SJ, Cianciara J, Rizzetto M, Schiff ER, et al. A dose-ranging study of the efficacy and tolerability of entecavir in Lamivudine-refractory chronic hepatitis B patients. Gastroenterology 2005;129:1198-1209. 220. Sherman M, Yurdaydin C, Sollano J, Silva M, Liaw YF, Cianciara J, et al. Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006;130:2039-2049. 221. Colonno R, Rose R, Baldick C, Levine S, Pokornowski K, Yu C, et al. Resistance after two years of entecavir treatment in nucleoside-naive patients is rare. HEPATOLOGY 2006;45:1656-1665. 222. Tenney DJ, Levine SM, Rose RE, Walsh AW, Weinheimer SP, Discotto L, et al. Clinical emergence of entecavir-resistant hepatitis B virus requires additional substitutions in virus already resistant to Lamivudine. Antimicrob Agents Chemother 2004;48:3498-3507. 223. LokA, Schiff E, Tsai SL, Rustsgi VK, Schiffman M, Martin P, et al. Entecavir is effective irrespective of Baseline Alt nad HBVDNAStrata for Histological and Virological Endpoints [Abstract]. Gastroenterology 2005;128:742. 224. Entecavir Review Team. Briefing document for NDA 21-797, entecavir 0.5 and 1 mg tablets and NDA 21-798, entcavir oral solution 0.05 mg/mL. www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4094B1_02_ FDA-Background-Memo.pdf. 225. Lai CL, Leung N, Teo EK, Tong M, Wong F, Hann HW, et al. A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology 2005; 129:528-536. 226. Lai CL, Leung NW, Teo EK, Tong M, Wong F, HannHwY, et al. Phase Iib extended-treatment trial of telbivudine (LdT) vs lamivudine vs combination treatment in hepatitis B patients: two year results [Abstract]. Gastroenterology 2005;128:A692. 227. Lai CL, Gane E, Liaw YF, Thongsawat S, Wang y, Chen Y, et al. Telbivudine (LDT) Vs. Lamivudine for Chronic Hepatitis B: First year results from the international phase III globe trial [Abstract]. HEPATOLOGY 2005;42(Suppl):748A. |