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Efficacy and Safety of Abacavir/Lamivudine/Zidovudine Plus Tenofovir in HBV/HIV-1 Coinfected Adults: 48-Week Data

机译:阿巴卡韦/拉米夫定/齐多夫定加替诺福韦在HBV / HIV-1合并感染成人中的疗效和安全性:48周数据

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摘要

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 log10 copies/mL, HBV DNA = 9.0 log10 copies/mL, and median CD4 count =158 cells/mm3. 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 log10 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/mm3. 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.
机译:在HBV / HIV合并感染的患者中,晚期肝病和死亡的风险增加。这项开放性,前瞻性,前瞻性研究在HBV / HIV感染的未接受过抗逆转录病毒治疗的受试者中,每天两次评估阿巴卡韦/拉米夫定/齐多夫定加替诺福韦一次。纳入9名成人(8名男性),基线平均HIV-1 RNA = 4.5 log10个拷贝/ mL,HBV DNA = 9.0 log10个拷贝/ mL,中位数CD4计数= 158细胞/ mm 3 。没有受试者的基线ALT> 5倍ULN。六位受试者完成了研究:1位因与治疗无关的弓形虫病退出,而2位则失去随访。在第48周时,剩余受试者中100%(6/6)的HBV DNA下降≥2log10,而HIV-1 RNA <400和<50拷贝的100%(6/6)和83%(5/6) / mL。 CD4计数从基线的中位变化为157个/ mm 3 。一名受试者经历了与治疗相关的3级白细胞减少症。这些结果表明,在HBV / HIV感染,未接受抗逆转录病毒治疗的受试者中,经过48周,阿巴卡韦/拉米夫定/齐多夫定和替诺福韦具有持续的HIV-1和HBV抗病毒活性。

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