Article Text

Download PDFPDF

P47 De-novo antiviral therapy with nucleos(t)ide analogues in ‘real-life’ patients with chronic hepatitis B infection: comparison of virological responses between lamivudine + adefovir vs entecavir vs tenofovir therapy
  1. I Carey,
  2. H Nguyen DorothyJoe,
  3. M Al-Freah,
  4. S Knighton,
  5. M Bruce,
  6. A Suddle,
  7. P M Harrison,
  8. K Agarwal
  1. Institute of Liver Studies, King's College Hospital NHS Foundation Trust


Introduction Several nucleos(t)ide analogues (NA) are approved for the treatment of chronic hepatitis B (CH-B); all aim to control HBV replication with minimal risk of drug-resistance and toxicity. Limited comparative data exist assessing differences between viral responses to different de-novo therapeutic regimens in real-life cohorts.

Aim To assess and compare virological and serological responses in 3 real-life CH-B de-novo therapeutic cohorts—lamivudine 100 mg/d + adefovir 10 mg/d (LAM+ADV) combination therapy vs entecavir 0.5 mg/d (ETV) vs tenofovir 245 mg/d (TDF) monotherapies.

Method Patients: NA therapy naive 406 CH-B patients treated at a single-centre practice [median 30 months (m), range 3–72] were split into three groups according therapy regimen: LAM+ADV (n=192, 78% males, median age 40 y, 35% HBeAg+, 34% cirrhosis, median duration 36 months), ETV (n=154, 79% males, median age 42 y, 31% HBeAg+, 34% cirrhosis, median duration 28 months) and TDF (n=60, 50% males, median age 40 y, 23%HBeAg+, 25% cirrhosis, median duration 9 months). HBV DNA viral load tested by real-time PCR [log10 IU/ml], serology for HBeAg/HBsAg were compared between baseline, months 3, 6, 9 and 12. Five responses, evaluated by change in serum HBV DNA, were recorded: (1) complete (CR) <12 IU/ml; (2) partial (PR), fall >3log10 but >12 IU/ml; (3) slow (SR), fall 2–3 log10; (4) non-response (NR), fall <1 log10; 5) viral breakthrough (VB), rise >1 log10 from nadir. HBV genotypic resistance was tested pre-treatment and at the time of SR, NR or VB by direct sequencing.

Results Baseline HBV DNA was similar in all cohorts (median log10 4.6 vs 4.4 vs 4.2 IU/ml), higher proportions achieved CR in TDF cohort than LAM+ADV and ETV (m3: 78%vs 48% and 53%, p<0.01; m6: 82% vs 60% and 65%, p=0.02; m9: 86% vs 62% and 55%, p<0.01), but were similar at m12: 80% vs 73% and 76% and there were no differences in PR, SR and NR in all groups. HBV DNA decreased in analogous rate in all groups. 2 patients in LAM+ADV and ETV groups developed VB. No viral mutations associated with drug resistance were detected in the LAM + ADV and TDFgroup, including those with VB, NR or SR; in contrast 1 ETV patient with SR at m12 (genotype C) developed mutation rtM204I. HBeAg seroconversion was more frequent in LAM + ADV cohort vs ETV and TDF (21% vs 8% and 7%, p=0.06) and HBsAg seroconversion occurred only in LAM + ADV and ETV patients (2% and 1%).

Conclusion De-novo antiviral therapy with different therapeutic approaches of nucleos(t)ide analogues LAM+ADV, ETV and TDF achieves similar efficacy within 12 months of treatment in real-life patient cohorts with CH-B.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.