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. 2017 May 12;11(5):590–603. doi: 10.5009/gnl16215

Table 4.

Summary of Switch Therapies for Chronic Hepatitis B

Treatment arm Control arm No., HBeAg Setting/genotype Results of study Reference
Switch to PegIFN
 1 LAM 4 wk+PegIFN-α2b 24 wk PegIFN-α2b 24 wk 63, pos India

  1. HBV DNA <4,700 cps/mL (EOT 24 wk): 50% vs 14.8% (p=0.028)

  2. HBeAg loss (EOT 24 wk): 38.9% vs 14.8% (p=0.05)

 Sarin et al. (2007)46
 2 ADV/ETV 1–6 wk+PegIFN-α2a 5–52 wk Placebo 1–6 wk+ PegIFN-α2a 5–52 wk 280, pos Taiwan (NEED study), RCT

  1. HBeAg seroconversion (EOT): 21% vs 22% vs 27% (all p>0.05)

  2. HBeAg seroconversion (EOT 24 wk): 23% vs 28% vs 36% (all p>0.05)

 Su et al. (2014)47
 3 ETV 9–36 mo +ETV/PegIFN-α2a 8 wk+ PegIFN-α2a 40 wk ETV 9–36 mo+ ETV 48 wk 192, pos China (OSST trial)

  1. HBeAg seroconversion (EOT): 14.9% vs 6.1%, p=0.0467

  2. HBsAg loss (EOT): 8.5% vs 0%, p=0.0028

  3. HBsAg levels <1,000 IU/mL (EOT): 52.4% vs 30.4%, p=0.0032

 Ning et al. (2014)48
 4 NUC 1–3 yr+NUC/PegIFN-α2a12 wk+ PegIFN-α2a 36 wk NUC 1–3 yr+ NUC/PegIFN-α2a 12 wk+ PegIFN-α2a 84 wk 271, pos China (NEW SWITCH)

  1. HBsAg loss (48 wk): 17.3%

  2. The combination of HBsAg <1,500 IU/mL at baseline and HBsAg <200 IU/mL at wk 24 had the highest response rate (PPV 51.35%, NPV 100%)

 Hu et al. (2015)49
Switch to NUC
 5 PegIFN 48 wk*+stop PegIFN 48 wk*+LdT 48 wk 36, pos China

  1. HBeAg seroconversion: 28% (EOT 48 wk) vs 61% (EOT)

  2. HBV DNA <100 IU/mL: 50% (EOT 48 wk) vs 100% (EOT)

  3. ALT normalization: 61% (EOT 48 wk) vs 100% (EOT)

 Huang et al. (2013)50
 6 PegIFN 24 wk+LdT 24 wk LdT 24 wk+PegIFN 24 wk 30, neg Italy

  1. HBV DNA <2,000 IU/mL (EOT 24 wk): 13.3% vs 46.7% (p=0.046)

  2. ALT (EOT 24 wk): 3.2×ULN vs 1.3×ULN (p=0.03)

 Piccolo et al. (2013)51

HBeAg, hepatitis B e antigen; PegIFN, pegylated interferon; LAM, lamivudine; pos, positive; HBV, hepatitis B virus; EOT 24 wk, 24 weeks after the end of therapy; ADV, adefovir; ETV, entecavir; RCT, randomized controlled trial; HBsAg, hepatitis B surface antigen; NUC, nucleos(t)ide analogue; PPV, positive predictive value; NPV, negative predictive value; LdT, telbivudine; ALT, alanine aminotransferase; neg, negative; ULN, upper limit of normal.

*

Partial responder: HBV DNA decline greater than 2 log, and HBeAg decline is without complete response at week 48.