Nicastri Emanuele, Chiesi Antonio, Angeletti Claudio, Sarmati Loredana, Palmisano Lucia, Geraci Andrea, Andreoni Massimo, Vella Stefano
National Institute of Infectious Diseases, IRCCS L. Spallanzani, Rome, Italy.
J Med Virol. 2005 Jun;76(2):153-60. doi: 10.1002/jmv.20352.
The duration of the clinical, virologic, and immunologic response to HAART, is not well defined. In this observational multi-center study 2,143 patients were enrolled classified according to virologic suppression (<500 cp/ml) and immune recovery (>100 CD4+ cells/mul from baseline) at month 12 of HAART as complete responders, virologic only responders, immunologic only responders and non-responders. Kaplan Meyer curves, multivariate and politomous regression analysis were used. Complete responders patients were 781 (36.4%), immunologic only responders 441 (20.6%), virologic only responders 336 (15.7%), and non-responders 585 (27.3%). Using multivariate analysis, being antiretroviral-naive increased the probability of having both a virologic only or a complete response and reduced the probability of an immunologic only response (P < 0.001 for all tests). Older age was associated directly with a virologic only response and inversely associated with an immunologic only response (P = 0.027 and P = 0.035, respectively). Using politomous analysis, patients baseline HIV-RNA level more than 5 log cp/ml had a 1.9-fold higher probability of an immunologic response than of a complete response (P = 0.001). After 4 years, the clinical progression rate was six times greater in non-responders, 1.9 times greater in virologic only responders, and 2.3 times greater in immunologic only responders than for responders. However, patients with virologic only response or with immunologic only response had a significantly reduced risk for clinical progression than non-responders (P < 0.001). After 4 years of HAART, the risk of clinical progression in patients with immunologic only or virologic only response is low but still higher than in complete responder patients.
高效抗逆转录病毒治疗（HAART）的临床、病毒学及免疫学反应持续时间尚未明确界定。在这项多中心观察性研究中，2143例患者入组，根据HAART治疗12个月时的病毒学抑制情况（<500拷贝数/ml）和免疫恢复情况（较基线水平CD4+细胞计数增加>100个/μl）分为完全缓解者、仅病毒学缓解者、仅免疫学缓解者和无反应者。采用Kaplan-Meier曲线、多变量及多分类回归分析。完全缓解者781例（36.4%），仅免疫学缓解者441例（20.6%），仅病毒学缓解者336例（15.7%），无反应者585例（27.3%）。多变量分析显示，初治抗逆转录病毒治疗增加了仅出现病毒学缓解或完全缓解的概率，并降低了仅出现免疫学缓解的概率（所有检验P<0.001）。年龄较大直接与仅病毒学缓解相关，而与仅免疫学缓解呈负相关（分别为P = 0.027和P = 0.035）。多分类分析显示，基线HIV-RNA水平超过5 log拷贝数/ml的患者出现免疫学缓解的概率比完全缓解高1.9倍（P = 0.001）。4年后，无反应者的临床进展率比缓解者高6倍，仅病毒学缓解者高1.9倍，仅免疫学缓解者高2.3倍。然而，仅病毒学缓解或仅免疫学缓解的患者临床进展风险比无反应者显著降低（P<0.001）。HAART治疗4年后，仅免疫学或仅病毒学缓解患者的临床进展风险较低，但仍高于完全缓解患者。
