Pérez-Elías Maria Jesús, Moreno Ana, Moreno Santiago, Antela Antonio, Dronda Fernando, Muñoz Vicente, Casado Jose Luis, Quereda Carmen, Lopez Dolores, Navas Enrique
Infectious Diseases Unit, Hospital Ramón y Cajal, Madrid, Spain.
HIV Clin Trials. 2003 Nov-Dec;4(6):391-9. doi: 10.1310/HVQX-7Q27-X4V1-GJA1.
The durability of virologic response to antiretroviral therapy is dependent on the potency, tolerability, and adherence level of the regimen. In a prospective, nonrandomized cohort study, we compared the treatment outcome of a nelfinavir-based highly active antiretroviral therapy (HAART) regimen with that of an indinavir-based regimen, over 1 year of routine clinical practice. Information was derived from 134 treatment-naïve HIV-1-infected patients initiated on triple therapy with either nelfinavir (n = 44) or indinavir (n = 90). The proportions of patients achieving a virological response were similar between treatment groups (>1 log(10) reduction in HIV RNA at 3 months in 95% of patients taking nelfinavir and 88% taking indinavir; HIV RNA <50 copies/mL after 1 year in 79% and 69% of patients, respectively). Predicting factors for 1-year virological suppression were initial virological response (p =.02) and adherence >90% (p =.0001). Over 90% adherence was achieved in 70% of patients taking nelfinavir compared with 41% of those taking indinavir (p =.01). The probability of remaining on the initial protease inhibitor (PI) after 12 months was 77% in the nelfinavir group and 66% in the indinavir group, with the median time to changing treatment being 519 days and 462 days, respectively. Gastric intolerance and nephritic colic were the most common reasons for changing therapy in the indinavir group. In the clinical setting, HAART based on initial nelfinavir and indinavir therapy was associated with similarly good virological and immunological suppression at 1 year, however, nelfinavir-based treatment was associated with a longer durability, probably due to a better adherence and tolerance pattern.
对抗逆转录病毒疗法的病毒学应答的持久性取决于治疗方案的效力、耐受性和依从性水平。在一项前瞻性、非随机队列研究中，我们在1年的常规临床实践中比较了基于奈非那韦的高效抗逆转录病毒疗法（HAART）方案与基于茚地那韦的方案的治疗结果。信息来源于134例初治的HIV-1感染患者，他们开始接受三联疗法，其中44例使用奈非那韦，90例使用茚地那韦。治疗组之间实现病毒学应答的患者比例相似（服用奈非那韦的患者中95%在3个月时HIV RNA降低>1 log(10)，服用茚地那韦的患者中88%；1年后分别有79%和69%的患者HIV RNA<50拷贝/mL）。1年病毒学抑制的预测因素为初始病毒学应答（p = 0.02）和依从性>90%（p = 0.0001）。服用奈非那韦的患者中有70%实现了超过90%的依从性，而服用茚地那韦的患者中这一比例为41%（p = 0.01）。奈非那韦组在12个月后仍使用初始蛋白酶抑制剂（PI）的概率为77%，茚地那韦组为66%，更换治疗的中位时间分别为519天和462天。胃不耐受和肾绞痛是茚地那韦组更换治疗的最常见原因。在临床环境中，基于初始奈非那韦和茚地那韦治疗的HAART在1年时具有相似良好的病毒学和免疫学抑制效果，然而，基于奈非那韦的治疗具有更长的持久性，可能是由于更好的依从性和耐受性模式。
