Infants born to women who used the anti-HIV
drug tenofovir as part of an anti-HIV drug regimen during pregnancy do not
weigh less at birth and are not of shorter length than infants born to women
who used anti-HIV drug regimens that do not include tenofovir during pregnancy,
according to findings from a National Institutes of Health network study.
However,
at 1 year of age, children born to the tenofovir-treated mothers were slightly
shorter and had slightly smaller head circumference—about 1 centimeter each, on
average—than were infants whose mothers did not take tenofovir.
The
study authors described the findings as reassuring, noting that the study did
not identify any serious safety concerns during pregnancy for
tenofovir. In combination with other anti-HIV drugs, tenofovir is the first
line of treatment for adults with HIV. The researchers called for
additional studies to follow the children as they grow and develop, to identify
any potential long term effects of the treatment.
The
study was undertaken because earlier studies had shown laboratory animals
exposed to tenofovir in the womb were smaller at birth than were their
unexposed peers.
Because
of its safety and effectiveness, many women who have HIV take the drug for
their health, often before they become pregnant. Similarly, because the drug is
so effective for adult use and because there have been no problems reported in
human infants related to their mother's use of tenofovir, many physicians will
prescribe it for pregnant women, both to safeguard the women's health and to
prevent the virus from being passed on to their infants. However, before the
current research, the drug had not been specifically studied for its potential
effects on infants whose mothers took it during pregnancy.
"Physicians
treating pregnant women for HIV face a dilemma: do they continue treating a
pregnant woman with a drug that is highly effective for adults but which has
not been studied for its effects on infants, or do they switch the woman to
another therapy, which may not be as effective and well-tolerated?" said
first author George K. Siberry, M.D., of the Pediatric, Adolescent and Maternal
AIDS Branch of the NIH's Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD), the NIH institute that conducted the
study. "Our findings indicate that tenofovir does not affect the growth of
the fetus."
Over
the seven years of the study, the number of participants being treated with
tenofovir increased sharply, the study authors noted. In 2003, 14 percent of
mothers in the study had been prescribed the drug, compared with 43 percent in
2010.
"The
priority has been to treat mothers and prevent an infant's infection,"
said co-author Paige L. Williams, Ph.D., of the Harvard School of Public
Health, Boston. "However, it's important to monitor the effects of these
drugs on the infant."
The
research was conducted as part of the Pediatric HIV/AIDS Cohort Study (PHACS),
which is supported by the NICHD, the National Institute of Allergy and
Infectious Diseases, the National Institute on Drug Abuse, the National
Institute of Mental Health, the National Institute on Deafness and other
Communication Disorders, the National Heart, Lung, and Blood Institute, the
National Institute of Neurological Disorders and Stroke, and the National
Institute on Alcohol Abuse and Alcoholism.
Dr.
Siberry and Dr. Williams collaborated with colleagues at the State University
of New York Downstate, Brooklyn; University of Miami School of Medicine;
Indiana University School of Medicine, Indianapolis; Harvard; and the NICHD.
Their
findings appear online in the journal AIDS.
The
study included 2,000 U.S. infants born to HIV-positive mothers between 2003 and
2010. The researchers collected data for the infants' size relative to their
gestational age (time they had spent in the womb), their birth weight, length
at birth, and the circumference of their head. The researchers recorded similar
measurements when the child was 1 year old.
They
found that mothers taking tenofovir in combination with other anti-HIV
medications and mothers on anti-HIV drug combinations that did not include
tenofovir gave birth to infants who were smaller, on average, than infants born
to HIV-negative mothers. However, they did not find significant differences
between infants from the two groups of HIV-positive mothers.
The
tenofovir-exposed infant's smaller average size and head circumference at one
year of age suggests tenofovir could have a delayed effect on growth. Further
research on this and other classes of anti-HIV drugs is ongoing in the PHACS.
"Overall,
this study produced reassuring information regarding the use of
tenofovir," said Dr. Siberry.
"Although
further research is needed, on balance, our findings favor the use of tenofovir in pregnancy
to ensure good outcomes in the mother and prevent transmission of HIV to the
infant."
More
information: http://www.ncbi.nl … /PMH0000198/
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