Rodriguez Allan E, Dejesus Edwin, Williams Vanessa, Irlbeck David, Ross Lisa, Ha Belinda, Lancaster Charles T
University of Miami, Miami, Florida, USA.
Open AIDS J. 2010 Oct 21;4:167-70. doi: 10.2174/1874613601004010167.
In HBV/HIV-coinfected patients, the risk of end-stage liver disease and death is increased. This open-label, prospective, pilot study evaluated abacavir/lamivudine/zidovudine twice daily plus tenofovir once daily in HBV/HIV-coinfected antiretroviral-naïve subjects. Nine adults (8 males) enrolled, with baseline mean HIV-1 RNA = 4.5 log(10) copies/mL, HBV DNA = 9.0 log(10) copies/mL, and median CD4 count =158 cells/mm(3). No subject had baseline ALT >5x ULN.SIX SUBJECTS COMPLETED THE STUDY: 1 withdrew due to non-treatment-related toxoplasmosis and 2 were lost-to-follow-up. At week 48, 100% (6/6) of remaining subjects had ≥2 log(10) decrease in HBV DNA, and 100% (6/6) and 83% (5/6) had HIV-1 RNA <400 and <50 copies/mL, respectively. Median change from baseline in CD4 count was 157 cells/mm(3). One subject experienced treatment-related grade 3 leukopenia. These results demonstrate that abacavir/lamivudine/zidovudine and tenofovir were well tolerated with sustained HIV-1 and HBV antiviral activity through 48 weeks in HBV/HIV-coinfected, antiretroviral-naïve subjects.
在乙肝病毒/艾滋病毒合并感染患者中,终末期肝病和死亡风险会增加。这项开放标签、前瞻性的试点研究评估了在初治的乙肝病毒/艾滋病毒合并感染受试者中,每日两次服用阿巴卡韦/拉米夫定/齐多夫定加每日一次服用替诺福韦的疗效。9名成年人(8名男性)入组,基线时平均艾滋病毒-1核糖核酸为4.5 log(10)拷贝/毫升,乙肝病毒脱氧核糖核酸为9.0 log(10)拷贝/毫升,CD4细胞计数中位数为158个/立方毫米。没有受试者基线时谷丙转氨酶>5倍正常上限值。6名受试者完成了研究:1名因与治疗无关的弓形虫病退出,2名失访。在第48周时,其余受试者中100%(6/6)的乙肝病毒脱氧核糖核酸下降≥2 log(10),100%(6/6)和83%(5/6)的艾滋病毒-1核糖核酸分别<400和<50拷贝/毫升。CD4细胞计数相对于基线的中位数变化为157个/立方毫米。1名受试者出现了与治疗相关的3级白细胞减少症。这些结果表明,在初治的乙肝病毒/艾滋病毒合并感染受试者中,阿巴卡韦/拉米夫定/齐多夫定和替诺福韦耐受性良好,在48周内具有持续的艾滋病毒-1和乙肝病毒抗病毒活性。