PMID- 12044531
OWN - NLM
STAT- MEDLINE
DCOM- 20021210
LR  - 20190817
IS  - 0168-8278 (Print)
IS  - 0168-8278 (Linking)
VI  - 36
IP  - 6
DP  - 2002 Jun
TI  - Lamivudine/interferon combination therapy in anti-HBe positive chronic hepatitis 
      B patients: a controlled pilot study.
PG  - 799-804
AB  - BACKGROUND/AIMS: In this study, lamivudine-interferon (LAM/IFN) combination 
      therapy was compared to LAM monotherapy to verify if the combination treatment 
      might improve efficacy and reduce the emergence of LAM-resistant mutants. 
      METHODS: Fifty patients with anti-HBe-positive chronic hepatitis B were treated 
      for 12 months with LAM at 100mg/day (26 pts) or with IFN at 5MU t.i.w.+LAM 
      100mg/day (24 pts). Serum ALT, HBV DNA and IgM anti-HBc were monitored during 
      treatment and a 6-month follow-up. The polymerase gene was amplified by PCR and 
      the region coding for YMDD motif was directly sequenced. RESULTS: All patients 
      normalized ALT and cleared HBV DNA during treatment. The response was maintained 
      until the end of therapy in the LAM/IFN group, while in 5/26 initial responders 
      treated with LAM alone, a virological and biochemical breakthrough was observed 
      after 6-10 months, and selection for YMDD variants resulted. After therapy 
      discontinuation, most patients relapsed; the response rate after 6 months was 17% 
      in the LAM/IFN group and 19% in the LAM group. CONCLUSIONS: In anti-HBe-positive 
      chronic hepatitis B, a 12-month course of LAM/IFN combination therapy is as 
      beneficial as LAM monotherapy, however, the combination regimen appeared to 
      prevent or delay the emergence of YMDD variants.
FAU - Santantonio, Teresa
AU  - Santantonio T
AD  - Department of Internal Medicine, Immunology and Infectious Diseases, University 
      of Bari, Bari, Italy. t.santantonio@clininf.uniba.it
FAU - Niro, Grazia Anna
AU  - Niro GA
FAU - Sinisi, Emanuele
AU  - Sinisi E
FAU - Leandro, Gioacchino
AU  - Leandro G
FAU - Insalata, Maria
AU  - Insalata M
FAU - Guastadisegni, Angela
AU  - Guastadisegni A
FAU - Facciorusso, Domenico
AU  - Facciorusso D
FAU - Gravinese, Eleonora
AU  - Gravinese E
FAU - Andriulli, Angelo
AU  - Andriulli A
FAU - Pastore, Giuseppe
AU  - Pastore G
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Netherlands
TA  - J Hepatol
JT  - Journal of hepatology
JID - 8503886
RN  - 0 (Antiviral Agents)
RN  - 0 (Hepatitis B Antigens)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 9008-11-1 (Interferons)
SB  - IM
MH  - Adult
MH  - Antiviral Agents/*administration & dosage
MH  - Drug Resistance, Viral
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepatitis B Antigens/analysis
MH  - Hepatitis B, Chronic/*drug therapy
MH  - Humans
MH  - Interferons/*administration & dosage
MH  - Lamivudine/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Reverse Transcriptase Inhibitors/*administration & dosage
MH  - Treatment Outcome
EDAT- 2002/06/05 10:00
MHDA- 2002/12/11 04:00
CRDT- 2002/06/05 10:00
PHST- 2002/06/05 10:00 [pubmed]
PHST- 2002/12/11 04:00 [medline]
PHST- 2002/06/05 10:00 [entrez]
AID - S0168827802000569 [pii]
AID - 10.1016/s0168-8278(02)00056-9 [doi]
PST - ppublish
SO  - J Hepatol. 2002 Jun;36(6):799-804. doi: 10.1016/s0168-8278(02)00056-9.