H1. Epidemiology and screening
Oral Abstract Submission
Safety data are needed regarding HIV treatment in women of reproductive potential and during pregnancy. This review is to evaluate pregnancy outcomes following prospective exposures (exposure report prior to knowledge of pregnancy outcome) to raltegravir during pregnancy.
Methods : Exposures to raltegravir during pregnancy reported cumulatively through 26-March-2019 to the internal safety database at Merck & Co., Inc. were reviewed. This database includes all reports of pregnancy from clinical trials sponsored by the company, spontaneous post-marketing reports, and non-interventional data sources. Prospective pregnancy reports were evaluated to determine rates of spontaneous abortion, stillbirth and congenital anomalies, including neural tube defects. Data from two ongoing cohorts of pregnant women with HIV-1 infection, not included in the internal safety database, were also reviewed.
A total of 2508 prospective pregnancy reports with reported outcomes were identified among women exposed to raltegravir: 919 from the internal safety database (Table 1) and 1589 from the United Kingdom/Ireland and French pregnancy cohorts. Among the 2508 prospective pregnancy exposures, 945 were in the first trimester, of which 757 were within the periconception period (within 28 days of conception). Of the 471 documented first trimester exposures identified in the internal safety database, the rates of spontaneous abortion (6.9%), stillbirth (1%), and congenital anomalies (1.5% per live births) were similar to the rates observed in the background populations of the U.S. Among outcomes following any exposure, the rate of congenital anomalies was 3.4% per live births. There were no reports of neural tube defects identified within the internal safety database or among the cohort data.
Conclusion : Prospectively collected pregnancy outcome data do not suggest an association between raltegravir exposure and spontaneous abortion, stillbirth or congenital anomalies, including neural tube defects. These data support the current HIV treatment recommendations for the use of raltegravir 400mg twice daily in women of reproductive potential and during pregnancy.