Telbivudine vs tenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Table 2 Virologic response, roadmap intent-to-treat population

Parameters	Telbivudine (n = 113)	Tenofovir (n = 117)	Difference between arms and 95%CI
Patients achieving HBV DNA < 300 copies/mL (51 IU/mL) at week 52, n (%)
± 7 d protocol-prespecified visit window	104 (91.9)	111 (95.0)	-3.1% (-9.4%, 3.1%)1
Treating missing as failure	103 (91.0)	111 (95.0)	-4.0% (-10.5%, 2.5%)1
28 d imputation	105 (92.7)	111 (95.0)	-2.3% (-8.3%, 3.8%)1
Last observation carried forward	108 (95.4)	116 (99.2)	-3.8% (-7.9%, 0.4%)1
Change from baseline in HBV DNA levels (log10 copies/mL) by visit, mean (SD)			P-value
Week 24	-4.001 (1.256)	-4.122 (1.165)	P < 0.00012
Week 52	-4.356 (1.473)	-4.305 (1.343)	P < 0.00012
Week 104	-4.281 (1.753)	-4.349 (1.382)	P < 0.00012

¹Percentages and 95%CIs were calculated using Mantel-Haenszel weighted estimates stratified by baseline HBV DNA and alanine aminotransferase levels;

²P-values were calculated using paired t-test comparing post-baseline timepoints to baseline timepoints. CI: Confidence interval; HBV: Hepatitis B virus; SD: Standard deviation.