Maggiolo Franco, Ripamonti Diego, Gregis Gianpietro, Quinzan Gianpaolo, Callegaro Annapaola, Arici Claudio, Ravasio Laura, Suter Fredy
Division of Infectious Diseases, Ospedali Riuniti, Bergamo, Italy.
Antivir Ther. 2003 Aug;8(4):339-46.
Complex antiretroviral regimens require optimal adherence to maintain long-lasting effectiveness. Simpler regimens, possibly with easy schedule and low pill burden, are needed for the long-term treatment of HIV infection.
To assess the efficacy and tolerability of a once-a-day highly active antiretroviral therapy (HAART) compared with two other conventional twice-a-day regimens.
In a prospective and randomized study, antiretroviral-naive patients received either EFV+ddl+3TC (once-a-day regimen; OD), or EFV+Combivir (twice-a-day and low-pill burden regimen; BID-low) or NFV+Combivir (twice-a-day and high-pill burden regimen; BID-high). Primary outcome was the proportion of patients with viral load <50 copies/ml at week 52 of follow-up. Results were evaluated according to intention-to-treat and on-treatment analysis.
Thirty-four patients in each arm were enrolled. Baseline characteristics were similar in the three groups. The proportion of patients with viral load <50 copies/ml at week 52 were 74.4, 74.4 and 50.0% for OD group, BID-low group and BID-high group, respectively (P=0.02, ITT analysis). According to on-treatment analysis, the same figures were 88.9, 85.7 and 60% (P<0.02). Overall, 26 (25.5%) patients discontinued treatment for different reasons and immune recovery was similar in all study arms.
Once-a-day HAART with ddl+3TC+EFV is a safe and effective alternative to twice-a-day regimens. Once-a-day therapy, with its simple daily schedule, may be proposed as one of the first choice treatments in HIV infection.
复杂的抗逆转录病毒疗法需要最佳的依从性以维持长期疗效。对于HIV感染的长期治疗，需要更简单的疗法，可能具有易于安排的服药时间和较低的服药负担。
评估每日一次的高效抗逆转录病毒疗法（HAART）与另外两种传统的每日两次疗法相比的疗效和耐受性。
在一项前瞻性随机研究中，初治抗逆转录病毒治疗的患者接受依非韦伦（EFV）+去羟肌苷（ddl）+拉米夫定（3TC）（每日一次疗法；OD组），或EFV+复方新诺明（每日两次且服药负担低的疗法；BID-low组）或奈韦拉平（NFV）+复方新诺明（每日两次且服药负担高的疗法；BID-high组）治疗。主要结局是随访第52周时病毒载量<50拷贝/毫升的患者比例。根据意向性分析和治疗中分析评估结果。
每组招募了34名患者。三组的基线特征相似。随访第52周时，OD组、BID-low组和BID-high组病毒载量<50拷贝/毫升的患者比例分别为74.4%、74.4%和50.0%（意向性分析，P = 0.02）。根据治疗中分析，相应数字分别为88.9%、85.7%和60%（P<0.02）。总体而言，26名（25.5%）患者因不同原因停药，所有研究组的免疫恢复情况相似。
每日一次的ddl + 3TC + EFV HAART是每日两次疗法的一种安全有效的替代方案。每日一次疗法因其简单的每日服药安排，可被推荐为HIV感染的首选治疗方法之一。
