In first-line use, demonstrated long-term efficacy for up to 5 years1  |
maintained undetectable HBV DNA
(<1,000 copies/mL).1 | Study 4381,3 - Randomized, double-blind, placebo-controlled study in 184 HBV patients who were HBeAg negative/anti-HBe positive/HBV DNA positive at baseline. Patients were randomized to receive Hepsera® (n=123) or placebo (n=61).
- Patients who received Hepsera for the first 48 weeks were rerandomized to Hepsera or placebo during weeks 49 through 96.
- Patients who received Hepsera during year 2 were eligible to continue Hepsera during year 3.
- From 141 eligible patients, there were 125 (89%) patients in Study 438 who chose to continue Hepsera for up to 192 weeks or 240 weeks (4 years or 5 years).
- Of these patients, 89/125 (71%) and 47/70 (67%) had an undetectable HBV DNA level (≤1,000 copies/mL) at week 192 and week 240, respectively.
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maintained durable seroconversion
(off treatment, 41 of 45 patients).6* | Study 4371,7 - Randomized, double-blind, placebo-controlled study in HBV patients who were HBeAg positive at baseline.
- At week 48, patients who received placebo during the first 48 weeks (n=167) were reassigned to Hepsera 10 mg, and patients who had previously been assigned to Hepsera 10 mg (n=171) were rerandomized to continued Hepsera or placebo.
- HBeAg seroconversion rates were 12% at week 48 and 23% at week 72.
Study 4816 - Observational study evaluating the durability of seroconversion in 107 patients with CHB who seroconverted while participating in a previous Gilead-sponsored study of Hepsera (105 from Study 437).
- Of the 105 patients from Study 437, 59 had originally been randomized to Hepsera 10 mg.
*Seroconversion defined as HBeAg loss with development of anti-HBe.
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(<1,000 copies/mL, 77 of 109 patients).1†‡ | Study 4351,5 - Open-label
- Hepsera was added on to lamivudine in CHB patients with LAM-resistant HBV who were:
- Wait-listed for liver transplantation (n=226; 60% Child-Pugh-Turcotte [CPT] Class B or C) or
- Post-liver transplantation (n=241; 23% CPT Class B or C)
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(96% of pre-transplant patients, n=90, and 93% of post-transplant patients, n=115).1† |
† Data are missing for 29% (HBV DNA) and 37%-45% (CPT score, normalization of ALT, albumin, bilirubin, and PT) of total patients enrolled in the study.
‡ Denominator is the number of patients with serum HBV DNA ≥1,000 copies/mL at baseline using the Roche Amplicor Monitor PCR Assay (LLOQ=1,000 copies/mL) and non-missing value at week 48.
Not intended to imply comparative efficacy or appropriateness of therapy.
 § Data reported at week 72.
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