Sosa Nestor, Hill-Zabala Christina, Dejesus Edwin, Herrera Gisella, Florance Allison, Watson Maria, Vavro Cindy, Shaefer Mark
Social Security Hospital, Panama City, Panama.
J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):422-7. doi: 10.1097/01.qai.0000184859.24071.bd.
Abacavir (ABC) and lamivudine (3TC) administered twice daily were compared with an ABC + 3TC fixed-dose combination (Epzicom, Kivexa; EPZ) administered once daily, both in combination with a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).
Two hundred sixty HIV-infected subjects with more than 6 months of ABC and 3TC administered twice daily plus a PI or NNRTI with an HIV-1 RNA level less than 400 copies/mL for more than 3 months and a CD4 count greater than 50 cells/mm were randomized 1:1 to ABC + 3TC administered twice daily or EPZ administered once daily.
At baseline, median time on ABC and 3TC administered twice daily was 22 months, and median CD4 count and HIV-1 RNA level were 554 cells/mm and <50 copies/mL, respectively. EPZ administered once daily was established as not inferior to ABC + 3TC administered twice daily based on the proportion of nonvirologic failures (confirmed HIV-1 RNA level > or =1265 copies/mL; 90% confidence interval: -3.4 to 6.4; (intent to treat [ITT]: missing [M] = failure [F]). Proportions with an HIV-1 RNA level <50 copies/mL were 81% of those taking EPZ once daily and 82% of those taking ABC + 3TC twice daily at week 48 (ITT: M = F). Virologic failure was rare (2 patients taking the once-daily regimen, 4 patients taking the twice-daily regimen). There was a low incidence of grade 2 through 4 adverse events (AEs) and no drug-related serious AEs or hypersensitivity reactions.
EPZ administered once daily was established as not inferior to ABC + 3TC administered twice daily in a regimen containing an NNRTI or a PI over 48 weeks. A dual-nucleoside backbone of ABC and 3TC administered once or twice daily is effective, durable, and well tolerated.
将每日两次服用的阿巴卡韦（ABC）和拉米夫定（3TC）与每日一次服用的ABC + 3TC固定剂量复方制剂（依非韦伦/拉米夫定片，Kivexa；EPZ）进行比较，二者均与蛋白酶抑制剂（PI）或非核苷类逆转录酶抑制剂（NNRTI）联合使用。
260名感染HIV的受试者，每日两次服用ABC和3TC超过6个月，同时联合PI或NNRTI，HIV-1 RNA水平低于400拷贝/mL超过3个月，CD4细胞计数大于50个/mm³，将其按1:1随机分为每日两次服用ABC + 3TC组或每日一次服用EPZ组。
基线时，每日两次服用ABC和3TC的中位时间为22个月，中位CD4细胞计数和HIV-1 RNA水平分别为554个/mm³和<50拷贝/mL。基于非病毒学失败的比例（确认的HIV-1 RNA水平>或=1265拷贝/mL；90%置信区间：-3.4至6.4；（意向性治疗[ITT]：缺失[M]=失败[F]），确定每日一次服用EPZ不劣于每日两次服用ABC + 3TC。在第48周时，HIV-1 RNA水平<50拷贝/mL的比例在每日一次服用EPZ的受试者中为81%，在每日两次服用ABC + 3TC的受试者中为82%（ITT：M = F）。病毒学失败罕见（每日一次给药方案组2例患者，每日两次给药方案组4例患者）。2至4级不良事件（AE）的发生率较低，未出现与药物相关的严重AE或过敏反应。
在含有NNRTI或PI的方案中，每日一次服用EPZ在48周内被确定不劣于每日两次服用ABC + 3TC。每日一次或两次服用的ABC和3TC双核苷主干有效、持久且耐受性良好。
