Lowe S H, Wensing A M J, Hassink E A M, ten Kate R W, Richter C, Schreij G, Koopmans P P, Juttmann J R, van der Tweel I, Lange J M A, Borleffs J C C
International Antiviral Therapy Evaluation Center (IATEC), University of Amsterdam, Amsterdam, The Netherlands.
HIV Clin Trials. 2005 Sep-Oct;6(5):235-45. doi: 10.1310/A686-M37Y-J2PT-E9GJ.
To improve the dosing frequency and pill burden of antiretroviral therapy, we compared two once-daily dosed regimens to a twice-daily dosed regimen.
HIV-1-infected, antiretroviral drug-naïve adults were randomized to either twice-daily nelfinavir and stavudine and once-daily didanosine (regimen A) or simplified once-daily dosed antiretroviral regimens consisting of nevirapine, didanosine, and lamivudine (regimen B) or saquinavir, ritonavir, didanosine, and lamivudine (regimen C).
At 48 weeks of therapy, the proportion of patients with a blood plasma HIV-1 RNA concentration (pVL) <50 copies/mL by intention-to treat analysis was 42.3%, 50.0%, and 56.5% for regimens A (n = 26), B (n = 22), and C (n = 23), respectively. The time to a pVL <50 copies/mL for the first time was significantly shorter in regimen C, and there was significantly more progression to CDC events in regimen B. These differences are possibly due to differences in baseline characteristics. Adverse events were lowest for regimen C; more signs associated with mitochondrial toxicity occurred in regimen A. Increase in CD4 count was comparable between arms.
No statistically significant difference in efficacy was found between the two investigated once-daily dosed treatment regimens (B and C) and the reference (A). Regimen C possibly had a better virological response and less toxicity than regimens A and B.
为了提高抗逆转录病毒疗法的给药频率和药丸负担,我们将两种每日一次给药方案与每日两次给药方案进行了比较。
将未接受过抗逆转录病毒药物治疗的HIV-1感染成人随机分为三组,分别接受每日两次的奈非那韦和司他夫定以及每日一次的去羟肌苷(方案A),或由奈韦拉平、去羟肌苷和拉米夫定组成的简化每日一次给药抗逆转录病毒方案(方案B),或沙奎那韦、利托那韦、去羟肌苷和拉米夫定(方案C)。
在治疗48周时,根据意向性分析,血浆HIV-1 RNA浓度(pVL)<50拷贝/mL的患者比例在方案A(n = 26)、方案B(n = 22)和方案C(n = 23)中分别为42.3%、50.0%和56.5%。方案C首次出现pVL<50拷贝/mL的时间明显更短,方案B进展为CDC事件的情况明显更多。这些差异可能是由于基线特征的不同。方案C的不良事件最少;方案A中与线粒体毒性相关的体征更多。各治疗组间CD4细胞计数的增加相当。
在两种研究的每日一次给药治疗方案(B和C)与对照方案(A)之间,未发现疗效有统计学显著差异。方案C可能比方案A和B具有更好的病毒学反应和更低的毒性。