Fisher Stephanie A, Miller Emily S, Yee Lynn M, Grobman William A, Premkumar Ashish
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL (Drs Fisher, Miller, Yee, and Premkumar).
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL (Drs Fisher, Miller, Yee, and Premkumar).
Am J Obstet Gynecol MFM. 2022 Sep;4(5):100676. doi: 10.1016/j.ajogmf.2022.100676. Epub 2022 Jun 15.
Recent studies have suggested a possible benefit of valaciclovir prophylaxis to prevent vertical transmission after a positive serologic screen for primary maternal cytomegalovirus infection during pregnancy, although its cost-effectiveness remains uncertain.
This study aimed to determine the circumstances under which universal first-trimester maternal serologic screening for maternal cytomegalovirus infection, with valaciclovir prophylaxis to prevent congenital cytomegalovirus, is cost-effective.
This study was a decision analysis from the perspective of the pregnant person to assess whether universal maternal screening in the first trimester of pregnancy, with subsequent valaciclovir prophylaxis (8 g/day from the time of positive serologic screen for primary maternal cytomegalovirus infection to 21 weeks of gestation) for those who are acutely infected, is cost-effective compared with usual care (ie, no routine serologic screening but with amniocentesis if midtrimester sonographic findings suggest cytomegalovirus). For baseline estimates, this study assumed a 35% risk of congenital cytomegalovirus after primary maternal infection and a 71% risk reduction with valaciclovir. This study varied valaciclovir's efficacy to identify whether and at what threshold universal screening would be estimated to be cost-effective, compared with usual care. Monte Carlo analyses were performed. A willingness-to-pay threshold of $100,000/quality-adjusted life year was used to define cost-effectiveness.
Under base case estimates, first-trimester universal screening and valaciclovir prophylaxis for seropositive pregnant persons with acute cytomegalovirus infection were not cost-effective, with a cost of $137,854 per maternal quality-adjusted life year but resulted in 14 fewer children affected with cytomegalovirus per 100,000 pregnancies compared with usual care. In 1-way sensitivity analysis, universal screening and treatment were estimated to be the cost-effective strategy if the incidence of primary maternal cytomegalovirus infection exceeds 2.6%, the baseline risk of vertical transmission of cytomegalovirus without prophylaxis is greater than 36.8%, and the risk reduction of vertical transmission of cytomegalovirus with valaciclovir prophylaxis exceeds 75.9%. In Monte Carlo analyses, first-trimester universal serologic screening with valaciclovir prophylaxis was estimated to be the cost-effective strategy in 46.8% of runs.
Universal first-trimester serologic screening with valaciclovir prophylaxis is not the cost-effective strategy for antenatal management of cytomegalovirus under the base case estimates. Although universal screening is cost-effective in certain circumstances when the efficacy of valaciclovir exceeds the base case, that result was not robust to variation of estimates across their reasonable ranges. These data can inform future studies to evaluate screening and treatment to prevent congenital cytomegalovirus.
近期研究表明,对于孕期初次母体巨细胞病毒感染血清学筛查呈阳性的情况,使用伐昔洛韦进行预防可能有助于防止垂直传播,但其成本效益仍不确定。
本研究旨在确定在何种情况下,对孕妇进行普遍的孕早期母体巨细胞病毒感染血清学筛查,并使用伐昔洛韦预防以防止先天性巨细胞病毒感染具有成本效益。
本研究是从孕妇的角度进行的决策分析,以评估与常规护理(即不进行常规血清学筛查,但如果孕中期超声检查结果提示巨细胞病毒感染则进行羊膜穿刺术)相比,在孕早期对孕妇进行普遍筛查,随后对急性感染的孕妇使用伐昔洛韦预防(从初次母体巨细胞病毒感染血清学筛查呈阳性时起至妊娠21周,每天8克)是否具有成本效益。对于基线估计,本研究假设初次母体感染后先天性巨细胞病毒感染的风险为35%,使用伐昔洛韦可使风险降低71%。本研究改变伐昔洛韦的疗效,以确定与常规护理相比,普遍筛查在何种情况下以及在什么阈值下估计具有成本效益。进行了蒙特卡洛分析。使用100,000美元/质量调整生命年的支付意愿阈值来定义成本效益。
在基线病例估计下,对血清学阳性且患有急性巨细胞病毒感染的孕妇进行孕早期普遍筛查和伐昔洛韦预防不具有成本效益,每母体质量调整生命年的成本为137,854美元,但与常规护理相比,每100,000例妊娠中受巨细胞病毒感染的儿童减少14例。在单因素敏感性分析中,如果初次母体巨细胞病毒感染的发生率超过2.6%、未进行预防时巨细胞病毒垂直传播 的基线风险大于36.8%、使用伐昔洛韦预防后巨细胞病毒垂直传播的风险降低超过75.9%,则普遍筛查和治疗估计是具有成本效益的策略。在蒙特卡洛分析中,孕早期普遍血清学筛查并使用伐昔洛韦预防在46.8%的模拟运行中被估计为具有成本效益的策略。
在基线病例估计下,孕早期普遍血清学筛查并使用伐昔洛韦预防并非巨细胞病毒产前管理的成本效益策略。虽然在伐昔洛韦疗效超过基线病例的某些情况下,普遍筛查具有成本效益,但该结果对于在合理范围内估计值的变化并不稳健。这些数据可为未来评估预防先天性巨细胞病毒感染的筛查和治疗的研究提供参考。