Malan D R Niel, Krantz Edrich, David Neal, Mathew Marina, Iloeje Uchenna H, McGrath Donnie
Triple M Research, Port Elizabeth, South Africa.
J Int Assoc Physicians AIDS Care (Chic). 2010 Jan-Feb;9(1):34-42. doi: 10.1177/1545109709355828.
This study assesses virologic response, safety, tolerability, and changes in health-related quality of life (HRQoL) in antiretroviral (ARV)-naive patients treated with 2 atazanavir (ATV)-based regimens over 96 weeks. Treatment-naive adult patients (n = 200) were randomized to receive either ATV 300 mg with ritonavir (RTV) 100 mg (ATV300/r, n = 95) or ATV 400 mg (ATV400; n = 105). At week 96, 75% of ATV300/r-treated and 70% of ATV400-treated patients achieved viral loads <400 copies/mL (difference estimate [95% confidence interval, CI] = 5.1 [-7.1 to 17.2]). Five and 20 patients, respectively, experienced virologic failure. Adverse event-related discontinuations occurred among 8% receiving ATV300/r and 3% receiving ATV400. Plasma lipid elevations were generally low. Both regimens were well tolerated and associated with sustained improvements in HRQoL. These findings demonstrate long-term efficacy, tolerability, and safety of both ATV300/r and ATV400 in ARV-naive patients through 96 weeks with improvements in HRQoL.
本研究评估了初治抗逆转录病毒（ARV）患者接受两种基于阿扎那韦（ATV）的治疗方案治疗96周后的病毒学应答、安全性、耐受性以及健康相关生活质量（HRQoL）的变化。未接受过治疗的成年患者（n = 200）被随机分为两组，分别接受阿扎那韦300 mg联合利托那韦（RTV）100 mg（ATV300/r，n = 95）或阿扎那韦400 mg（ATV400；n = 105）治疗。在第96周时，接受ATV300/r治疗的患者中有75%以及接受ATV400治疗的患者中有70%实现了病毒载量<400拷贝/mL（差异估计值[95%置信区间，CI]=5.1[-7.1至17.2]）。分别有5例和20例患者出现病毒学失败。接受ATV300/r治疗的患者中有8%以及接受ATV400治疗的患者中有3%因不良事件而停药。血浆脂质升高情况总体较低。两种治疗方案耐受性均良好，且与HRQoL的持续改善相关。这些研究结果表明，ATV300/r和ATV400在初治ARV患者中均具有长达96周的长期疗效、耐受性和安全性，且HRQoL有所改善。
