Safety and efficacy of entecavir for the treatment of chronic hepatitis B

Figures & data

Table 1 Summary of clinical trials of entecavir

	ALT normalization	Drop in HBV viral load (log copies/ml)	Undetectable HBV DNA by PCR	HBeAg loss	HBeAg seroconversion	HBsAg loss	HBsAg seroconversion	Histological improvement
Nucleoside naïve, HBeAg positive
Year 1
Chang et al^Citation12	68%	−6.9	67%	22%	21%	2%		72%
Leung et al^Citation15	76%		58%	18%	15%			Not reported
Yao et al^Citation14	89%	−6.0	74%	18%	15%			Not reported
Year 2
Gish et al^Citation16	87%		80%		31%	5%	2%
Nucleoside naïve, HBeAg negative
Year 1
Lai et al^Citation13	78%	−5.0	90%					70%
Yao et al^Citation14	94%	−5.22	94%					Not reported
Year 2
Shouval et al^Citation17	27%		85%			0%
Lamivudine refractory
Year 1
Chang et al^Citation10	68%	−5.06	26%	11%	4%
Sherman et al^Citation18	61%	−5.11	19%	10%	8%			55%
Yao et al^Citation19	85%	−5.08	27%		6%			Not reported
Suzuki et al^Citation20	78%	−3.75	33%		15%			60%
Year 2
Sherman et al^Citation21	85%	−5.9	30%		16%	1.4%	0.7%
Yao et al^Citation22	80%		47%	13%	11%
Year 3
Yao et al^Citation22	65%		55%	17%	12%

Abbreviations: ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; PCR, polymerase chain reaction.

Table 2 Comparative efficacies at 1 year of available nucleos(t)ide analogs for the treatment of hepatitis B

	ALT normalization	Drop in HBV DNA (log copies/mL)	Undetectable HBV DNA by PCR	HBeAg loss	HBeAg seroconversion	HBsAg loss	HBsAg seroconversion	Histological response
HBeAg positive
Lamivudine^Citation25,Citation26	41%–72%			32%	16%–17%	0%–2%	0%	14%–32%
Adefovir^Citation27,Citation28	48%–79%	−3.52	21%	13%–24%	8%–12%			53%
Entecavir^Citation12,Citation14,Citation15	68%–89%	−6.9	58%–74%	18%–22%	15%–21%	2%		72%
Telbivudine^Citation29^–^Citation31	77%–87%	−6.56	60%–67%	25%–30%	22%–27%			64.7%
Tenofovir^Citation32	68%	Not reported	76%		21%	3.2%		74%
HBeAg negative
Adefovir^Citation33	72%	−5.23	51%					64%
Entecavir^Citation13,Citation14	78%–94%	−5.22	90%–94%					70%
Telbivudine^Citation30,Citation31	74.4%–100%	−5.5	85%–88%					66.6%
Tenofovir^Citation32	76%	Not reported	93%			0%	0%	72%

Abbreviations: ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; PCR, polymerase chain reaction.

Figure 1 Resistance rates of available nucleos(t)ide analogs in hepatitis B patients. Note that no tenofovir resistance has been seen through 4 years of follow-up.^31,36–42

Abbreviations: e+, hepatitis B e-antigen positive; e−, hepatitis B e-antigen negative; lam-ref, lamivudine refractory.

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