CID：洛匹那韦/利托那韦单一疗法可有效预防HIV-1的母婴传播

临床上，HIV母婴传播（PMTCT）的预防采用的通常是以齐多夫定（ZDV）为基础药物的疗法，但这一疗法存在的潜在毒性风险。因此，来自法国巴黎Hopital Pitié Salpêtrière 医院的Roland Tubiana等人展开一项研究，研究结果在线发表于2013年6月12日的《临床感染性疾病》（Clinical Infectious Diseases）杂志上。作者发现，在仅仅为了预防母婴传播HIV而接受治疗的妇女中，洛匹那韦/利托那韦（LPV/r）单一药物疗法取得了令人满意的病毒学疗效。

这项多中心试验以自身不需要服用抗逆转录病毒药物的HIV-1感染女性为研究对象，对洛匹那韦/利托那韦（LPV/r）单一药物疗法能否有效控制母体的病毒载量（VL）进行了评估。总的说来，105例基线VL小于30000 拷贝/mL且CD4大于350 细胞/μL的怀孕女性被随机非盲分为两组，从妊娠第26周起至分娩期间分别单用LPV/r 400/100 mg bid（单一疗法组，n=69），或是联用ZDV/3TC 300/150 mg bid（三联疗法组，n=36）。根据Fleming的两阶段二期临床试验设计，当单一疗法组有至少59例患者在第8周时的VL小于200 拷贝/mL时，可认为单一疗法有效（主要终点）。次要终点为分娩时的VL水平和患者对药物的耐受情况。

根据定义，单一疗法有效：在妊娠第34周时，单一疗法组有62名女性实现VL小于200 拷贝/mL，也就是，在经过8周的治疗后，单一疗法的有效率达89.9%（95% CI：80.2-95.8）。在分娩时，单一疗法组和三联疗法组VL小于200 拷贝/mL的参试者所占的比例相当（92.8% vs 97.2%；P=0.66），然而，单一疗法组VL小于50拷贝/mL的参试者所占的比例要低一些（78.3% vs 97.2%；p=0.01）。单一疗法组无法耐受治疗药物的参试者比例低于三联疗法组（1.4% vs 11.2%；p=0.046）。两个组别剖腹产和早产的比例没有差别。所有都是活产婴儿；三联疗法组发生1例HIV传播，单一疗法组未出现（95% CI上限=5.2%）。

研究发现，在仅仅为了预防母婴传播HIV而接受治疗的妇女中，LPV/r单一疗法取得令人满意的病毒学疗效，这一疗法比三联疗法更加简单且耐受性更好，为未来核苷酸类似物节省策略的实施提供了循证依据。 

Lopinavir/ritonavir Monotherapy as a Nucleoside Analogue-Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission. The ANRS 135 PRIMEVA phase II/III Randomized Trial.
Abstract
Background. Prevention of HIV mother-to-child transmission (PMTCT) is usually based on zidovudine (ZDV)-containing regimens, despite potential toxicities. This multicenter trial evaluated whether lopinavir/ritonavir (LPV/r) monotherapy in HIV-1 infected women not requiring antiretrovirals for themselves could control maternal viral load (VL). Methods. Overall, 105 pregnant women with baseline VL<30000 copies/mL and CD4>350 cells/µL were randomized to start open-label LPV/r 400/100 mg bid alone (monotherapy group, n=69) or combined with ZDV/3TC 300/150 mg bid (triple therapy group, n= 36) from 26 gestational weeks to delivery. According to a Fleming's two-stage phase II design, monotherapy was considered to be efficacious if at least 59 patients achieved VL <200 copies/mL at 8 weeks of treatment (primary endpoint). Secondary endpoints were VL at delivery and tolerance. Results. Monotherapy was efficacious as defined: 62 women in the monotherapy group achieved VL<200 copies/mL at 34 weeks gestation, i.e. 8 weeks of treatment, (89.9%; 95%CI: 80.2-95.8). At delivery, proportions with VL<200 copies/mL were similar in monotherapy and triple therapy groups (92.8 vs 97.2%; p=0·66), however fewer had VL<50 copies/mL in the monotherapy group (78.3% vs 97.2 %; p=0.01). Changes for intolerance were less frequent in the monotherapy than in the triple therapy group, 1.4% vs 11.1%, respectively (p=0.046). Caesarean section and preterm delivery rates did not differ. All children were liveborn ; one case of HIV transmission occurred in the triple therapy group, none in the monotherapy group (upper 95% CI limit=5.2%). Conclusions. LPV/r monotherapy achieved satisfactory virologic efficacy in women treated solely for PMTCT, providing proof-of-concept for future nucleoside-sparing strategies.