PURPOSE OF THE STUDY:
To identify the birth prevalence of congenital CMV (cCMV) and related neurodevelopmental (ND) and hearing outcomes in HIV-exposed uninfected children in mothers treated with combination antiretroviral therapy (cART).
The study population was composed of participants from the Surveillance Monitoring for ART Toxicities (SMARTT) cohort, which is an ongoing observational cohort study established in 22 sites in the US and Puerto Rico. The SMARTT cohort has been enrolling HIV-exposed uninfected infants since 2007, and as of February 1, 2017, 2579 infants and children were monitored with medical history, physical examinations, and frequent neurodevelopmental (ND) testing.
Participants for this specific study included SMARTT cohort subjects who (1) have completed at least 1 of 6 ND assessments and audiology evaluation and (2) had a peripheral blood mononuclear cell (PBMC) pellet collected ≤3 weeks of life. The PBMC pellet had cCMV diagnosed by CMV DNA polymerase chain reaction assay.
Two thousand two-hundred and twelve participants in the SMARTT cohort were labeled as HIV-exposed uninfected ≥1 year of age. Of these 2212 participants, 895 had a birth PBMC sample that was assessed for cCMV birth prevalence. The included participants were less often African American, more often Hispanic, and had slightly better maternal HIV disease control compared with the excluded participants. In this group of 895 participants, 8 had a positive CMV DNA PCR suggesting birth prevalence for cCMV of 0.89% (95% CI, 0.39% to 1.75%). There was no difference in neurodevelopmental outcomes through 5 years of age when comparing the cCMV patients and those uninfected.
This study determined a cCMV birth prevalence of 0.9% in HIV-exposed uninfected children born in the US and Puerto Rico between 2007 and 2015 in the setting of maternal combined antiretroviral therapy. When accounting for the 70% to 75% sensitivity rate in detecting infants with cCMV by PBMC DNA PCR, they concluded that the projected birth prevalence is 1.2% to 1.3%. This prevalence is higher than the general population but less than previously suggested values in the literature.
This study sought to assess a new birth prevalence of cCMV in the era of maternal combined antiretroviral therapy. Accounting for sensitivity of the testing, they concluded that the projected prevalence to be 1.2% to 1.3% in the HIV-exposed uninfected children who met study inclusion criteria. The major limitation of this study is that more than half of the SMARTT cohort was not eligible for this study, and there were significant differences in ethnicity and maternal CD4 control. This study maintains that good HIV control with suppressed viral loads and CD4 cell counts of >200 cells/µL before delivery is essential to improving related complications and maintaining the health of the exposed infants including lowering the rate of co-infections such as cCMV.