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Digestive Diseases and Sciences

, Volume 54, Issue 9, pp 2026–2030 | Cite as

Efficacy of Pre-S-containing HBV Vaccine Combined with Lamivudine in the Treatment of Chronic HBV Infection

  • Hakan Senturk
  • Fehmi Tabak
  • Resat Ozaras
  • Levent Erdem
  • Billur Canbakan
  • Ali Mert
  • Ibrahim Yurdakul
Original Article

Abstract

Treatment of chronic hepatitis B (CHB) is difficult. The response rate to interferon (IFN) as well as nucleoside analogs is not more than 30% in general. While interferon has many side effects, development of resistance in most of the nucleoside analogs precludes long-term use. Both groups of drugs are most efficacious in patients who already had or develop strong cellular immunity with treatment. A pre-S2-containing vaccine was shown to enhance cellular immunity and suppress hepatitis B virus (HBV)-DNA in subjects with chronic hepatitis B. We aimed to test the efficacy of short-term use of a nucleoside analog in combination with a pre-S2-containing vaccine in patients with CHB. In this open study, 48 consecutive patients (32 males and 16 females, mean age ± SD: 33 ± 12 years) with CHB without cirrhosis were treated with 100 mg/day lamivudine and four weekly intramuscular injections of Genhevac B 20 mcg (six doses) for 24 weeks. While 19 patients were hepatitis B e antigen (HBeAg) positive (+ve), 29 patients were Anti-HBe/HBV-DNA +ve at the outset. Response was defined as seroconversion to anti-HBe in HBeAg +ve subjects and normalization of alanine aminotransferase (ALT) with loss of HBV-DNA in anti-HBe/HBV-DNA +ve subjects. HBeAg seroconversion occurred in 5/19 subjects (26%). Eighteen of 29 anti-HBe/HBV-DNA +ves responded. In the follow-up, while relapse was not observed in any of the patients who seroconverted, 11/18 from the anti-HBe/HBV-DNA +ve group relapsed, resulting in a sustained response (SR) rate of 24% in this group. All the relapses happened in the first 48 weeks of follow-up, with no relapse thereafter. Pretreatment high serum HBV-DNA was a strong negative predictor of sustained response (SR) in HBeAg +ve group. Pretreatment serum ALT over 2 × upper limit of normal and HBV-DNA less than 200 pg/ml appeared positive predictors. None of HBeAg +ve previous interferon failures responded. Twenty-four weeks of lamivudine and hepatitis B vaccine treatment induces SR in around 1/4 of the patients with CHB. Most of the responders had high ALT and relatively low DNA.

Keywords

Hepatitis B Therapeutic vaccination Lamivudine 

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Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Hakan Senturk
    • 1
  • Fehmi Tabak
    • 2
  • Resat Ozaras
    • 2
  • Levent Erdem
    • 3
  • Billur Canbakan
    • 1
  • Ali Mert
    • 2
  • Ibrahim Yurdakul
    • 1
  1. 1.Department of Gastroenterology, Cerrahpasa Medical FacultyIstanbul UniversityIstanbulTurkey
  2. 2.Department of Infectious Diseases and Clinical Microbiology, Cerrahpasa Medical FacultyIstanbul UniversityCerrahpasa, IstanbulTurkey
  3. 3.Department of Internal MedicineSisli Etfal HospitalIstanbulTurkey

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