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
2013-06-18 CID dxy
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
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.
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#CID#
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#单一疗法#
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#母婴#
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#利托那韦#
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