Stringer Jeffrey S A, Sinkala Moses, Stout Julia P, Goldenberg Robert L, Acosta Edward P, Chapman Victoria, Kumwenda-Phiri Rosemary, Vermund Sten H
Department of Obstetrics and Gynecology, Schools of Medicine and Public Health, University of Alabama at Birmingham, Alabama, USA.
J Acquir Immune Defic Syndr. 2003 Apr 15;32(5):506-13. doi: 10.1097/00126334-200304150-00007.
Universal nevirapine (NVP) therapy (provision of the drug without HIV testing) has been suggested as potentially superior to targeted NVP therapy (provision of the drug to seropositive patients identified through voluntary HIV counseling and testing [VCT]) for perinatal HIV prevention in low-resource, high-prevalence settings. The authors postulated that uptake (the proportion of women who accept the strategy when offered) may be higher for universal therapy, since it does not require a woman to learn her serostatus; they further postulated that adherence (the proportion of women who actually ingest the NVP tablet at labor onset) may be higher for targeted therapy, since knowledge of serostatus could motivate better adherence. Two clinics in Lusaka, Zambia were assigned to provide either the targeted or universal strategy. Halfway through the study period, the approach offered at each clinic was crossed over. Adherence was assessed by liquid chromatographic assay for NVP of cord blood. Regarding uptake, 1524 pregnant women were offered participation, and 1025 (67%) accepted. Of 694 women offered enrollment in the universal strategy, 496 (71%) accepted; of 830 women offered enrollment in the targeted strategy, 529 (64%) accepted (p <.01). Uptake was similar at both clinics for the universal strategy: 250 of 339 (74%) at clinic A and 246 of 355 (69%) at clinic B (p =.2), but differed significantly between clinics for the targeted strategy: 229 of 316 (72%) at clinic A and 300 of 514 (58%) at clinic B (RR, 1.51; 95% CI, 1.23, 1.86). Increased uptake correlated with having been offered the universal rather than the targeted strategy (AOR, 1.5; 95% CI, 1.1, 2.1), attendance at clinic A (AOR, 1.4; 95% CI, 1.01, 2.0), and maternal report of a prior fetal or infant death (AOR, 1.6; 95% CI, 1.1, 2.5). Regarding adherence, in the universal strategy, 40 of 103 women (39%) were nonadherent compared with 25 of 98 women (26%) in the targeted strategy (RR, 1.5; 95% CI, 1.004, 2.3). Failure to adhere correlated with participation in the universal strategy (AOR, 2.0; 95% CI, 1.04, 4.2) and illiteracy (AOR, 2.6; 95% CI, 1.2, 5.3). In high-prevalence settings with adequate VCT services, uptake of NVP using the universal or targeted approach appears comparable. However, the universal strategy may result in better uptake in clinics with less well-functioning VCT services (as with clinic B). Adherence to the single-dose NVP intervention was lower among women who did not learn their HIV status. Programs that seek to save the greatest possible number of infants from perinatal HIV acquisition should consider a combination approach, in which women who desire HIV testing can access NVP through a targeted strategy, and women who do not desire testing can access NVP through a universal strategy.
对于资源匮乏、艾滋病高发地区的围产期艾滋病预防，有人提出通用奈韦拉平（NVP）疗法（不进行HIV检测就提供药物）可能优于靶向NVP疗法（向通过自愿HIV咨询和检测[VCT]确诊为血清阳性的患者提供药物）。作者推测，通用疗法的接受率（提供该策略时接受该策略的女性比例）可能更高，因为它不需要女性了解自己的血清学状态；他们进一步推测，靶向疗法的依从性（分娩开始时实际服用NVP片剂的女性比例）可能更高，因为了解血清学状态可能会促使更好的依从性。赞比亚卢萨卡的两家诊所被分配提供靶向或通用策略。在研究期过半时，对每个诊所提供的方法进行了交叉。通过液相色谱法检测脐血中的NVP来评估依从性。关于接受率，1524名孕妇被邀请参与，1025名（67%）接受。在被邀请参加通用策略的694名女性中，496名（71%）接受；在被邀请参加靶向策略的830名女性中，529名（64%）接受（p<.01）。通用策略在两家诊所的接受率相似：A诊所339名中的250名（74%）和B诊所355名中的246名（69%）（p=.2），但靶向策略在两家诊所之间存在显著差异：A诊所316名中的229名（72%）和B诊所514名中的300名（58%）（相对危险度，1.51；95%置信区间，1.23，1.86）。接受率的提高与被提供通用而非靶向策略（优势比，1.5；95%置信区间，1.1，2.1）、在A诊所就诊（优势比，1.4；95%置信区间，1.01，2.0）以及产妇报告有过胎儿或婴儿死亡史（优势比，1.6；95%置信区间，1.1，2.5）相关。关于依从性，在通用策略中，103名女性中有40名（39%）不依从，而在靶向策略中，98名女性中有25名（26%）不依从（相对危险度，1.5；95%置信区间，1.004，2.3）。不依从与参与通用策略（优势比，2.0；95%置信区间，1.04，4.2）和文盲（优势比，2.6；95%置信区间，1.2，5.3）相关。在艾滋病高发且有足够VCT服务的地区，使用通用或靶向方法接受NVP的情况似乎相当。然而，通用策略可能在VCT服务运作不太良好的诊所（如B诊所）导致更好的接受率。未了解自己HIV状态的女性对单剂量NVP干预的依从性较低。旨在尽可能多地挽救婴儿免受围产期HIV感染的项目应考虑采用联合方法，即希望进行HIV检测的女性可以通过靶向策略获得NVP，而不希望检测的女性可以通过通用策略获得NVP。
