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ABI-H0731
LP-1
Title: Continued Therapy with ABI-H0731+Nrtl Results in Sequential Reduction/Loss of HBV DNA, HBV RNA, HBeAg, HBcrAg and HBsAg in HBeAg-Positive Patients
Session: Late-breaking Poster Session
Location: Hall B
Date: Monday, November 11, 2019
Time: 8:00am ET-5:30pm ET; Poster presentation: 12:30pm ET-1:30pm ET
Presenter: Mark Sulkowski, MD, Medical Director, Viral Hepatitis Center, Johns Hopkins University School of Medicine
Abstract Summary: Final results from Phase 2a are reported for HBeAg+ patients with chronic HBV infection treated with 731+Nrtl for 24 weeks. In Study 202 (Rx naïve patients), greater mean log10 declines in HBV DNA (5.27 vs 3.99; p=0.017) and RNA (2.34 vs 0.61; p<0.001) were achieved with 731+Nrtl (entecavir) versus entecavir alone. In Study 201 (Nrtl-suppressed patients), the proportion of patients on 731+Nrtl versus Nrtl alone achieving DNA target not detected (TND) was 69% vs 0% (p<0.001), and the proportion of patients achieving RNA <35 U/mL whose RNA was ≥35 U/mL at baseline was 52% vs 0% (p=0.0013) respectively. In Study 211, there are 64 HBeAg+ patients currently on extended treatment beyond 24 weeks. Among the 27 HBeAg+ patients receiving 731+Nrtl in Study 201, 41% (11/27) have now achieved DNA TND along with RNA <35 U/mL and HBeAg <1 IU/mL. At their last timepoint, Study 202 patients now in Study 211 (n=22) have demonstrated mean DNA and RNA declines of 6.1 and 3.0 logs, respectively, with observed mean log changes of ≥0.6 for HBeAg (11 patients ≥0.5, 4 patients ≥1.0), >0.8 log for HBcrAg (7 patients ≥1.0, 3 patients ≥2.0) and ≥0.4 log for HBsAg (7 patients ≥0.5, 3 patients ≥1.0). 731 continues to exhibit a favorable safety and tolerability profile in patients treated for up to 1 year, with only mild/moderate adverse events and lab abnormalities, and only a single discontinuation due to a Grade 1 rash. The combination of 731+NrtI results in faster and deeper declines in HBV DNA and RNA than NrtI alone, as well as subsequent declines in the surrogate markers of cccDNA (pgRNA, HBeAg and HBcrAg) predictive of cccDNA pool depletion, and HBsAg. The emergent data supports the continued development of 731. Abstract data are as of the time of submission; the poster is expected to include updated safety and efficacy results. |
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