Session: Slide Session: Antiretroviral Therapy
Sunday, October 26, 2008: 12:00 AM
Room: Independence A (Grand Hyatt)
Background: Elvucitabine (ACH123,446)(ELV) is a cytosine NRTI analog with potent in-vitro activity against wild type HIV-1 virus Methods: A Phase II, prospective, randomized, blinded, comparison of ELV 10 mg versus lamivudine (LAM) 300 mg both administered daily in combination with efavirenz 600 mg and tenofovir DF 300 mg in HIV-1-infected, treatment-naïve subjects. Results: 77 subjects were randomized with 76 subjects receiving at least one dose of study medication. Seventy-four subjects (37 per treatment group) had both baseline and post-baseline HIV-1 RNA measurements.Fifty-five subjects completed 48 weeks of treatment. The reasons for not completing 48 weeks were: physician decision (n=5), voluntary withdrawal (n=5), adverse event (n=4), lost to follow-up (n=4), sponsor decision (n=3), and death (n=1). Baseline characteristics were similar between treatment groups. The proportion of subjects at week 48 with HIV-1 levels of less than 50 copies/mL in the ITT patient population was : 65% in the ELV and 78% in the LAM treatment group (95% CI for the difference = -0.34, 0.07)( as-treated patient population was 96% for ELV and 97% for LAM). At week 48, the ELV treatment group experienced a mean (SD) change in percent CD4 of +9.9 (6.3) versus +9.1 (7.2) with LAM. The incidence, frequency, type, and severity of adverse events were similar between treatment groups. Conclusions: ELV administered in combination with tenofovir and efavirenz demonstrates substantial anti-viral activity.