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

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http://www.ncbi.nlm.nih.gov/pubmed/19016327?dopt=Abstract

Dig Dis Sci. 2008 Nov 19. [Epub ahead of print]

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

Treatment of Chronic HBV Infection.

Senturk H, Tabak F, Ozaras R, Erdem L, Canbakan B, Mert A, Yurdakul I.

Department of Gastroenterology, Cerrahpasa Medical Faculty, Istanbul University,

Istanbul, Turkey.

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 x 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.

PMID: 19016327 [PubMed - as supplied by publisher]