One drug used to prevent HIV transmission during pregnancy shows evidence of developmental effects

February 22, 2016

February 22, 2016 - The antiretroviral (ARV) drug atazanavir--sometimes included in treatments to prevent mother-to-child HIV transmission during pregnancy--may have small but significant effects on infant development, reports a study in the journal AIDS, official journal of the International AIDS Society. AIDS is published by Wolters Kluwer.

One-year-olds whose mothers took atazanavir during pregnancy have slightly reduced scores for language and social-emotional development, compared to ARV regimens not containing atazanavir, according to the new research by Dr. Ellen C. Caniglia, ScD, of Harvard T.J. Chan School of Public Health and colleagues.

Small Developmental Effects after Exposure to Atazanavir--Not Other ARV Drugs

Members of the Pediatric HIV/AIDS Cohort Study (PHACS) group analyzed data on 917 infants who were born to HIV-positive mothers but did not acquire HIV infection. As recommended by current US and European guidelines, all mothers took ARV therapy during pregnancy to reduce the risk of transmitting HIV.

At around one year old, the infants were assessed on a standard test of infant development--the Bayley Scales of Infant and Toddler Development-Third Edition, or "Bayley III." Scores on the five Bayley III subscales were compared for 167 infants whose mothers took atazanavir-containing ARV regimens versus 750 infants whose mothers received ARV, but not atazanavir.

The results showed lower language development scores were lower for infants whose mothers received atazanavir. That was so for infants whose mothers initiated atazanavir during the first trimester of pregnancy as well as during the second or third trimester.

Scores for social-emotional development were also lower for infants whose mothers took atazanavir. However, the difference was significant only for infants whose mothers initiated ARV during the second or third trimester--but not the first trimester. This may have reflected the fact that many women who started taking atazanavir during the first trimester switched to a different ARV regimen later in pregnancy.

Other Bayley III subscales--cognitive, motor (movement), and adaptive behavior--were similar for atazanavir-exposed versus unexposed infants. On all subscales, the average scores in this group of infants born to HIV-infected mothers were within the normal range.

Atazanavir is a type of drug called a protease inhibitor, which is included in some of the combination ARV regimens used for HIV treatment. The new study was prompted by previous research suggesting delayed language development in infants whose mothers took atazanavir during pregnancy.

The findings add to those concerns, suggesting small reductions in scores for language and social-emotional development among infants exposed to atazanavir. And yet, they emphasize that the "absolute differences" between groups are small.

Language score was about three points lower in the atazanavir group, compared to an average subscale score of 93; while social-emotional score was five points lower, compared to an average of 100. These differences "may not have large clinical implications, but they add another risk to the constellation of existing biological and socio-environmental risk factors to which these children are often exposed," according to Dr. Caniglia and coauthors.

Further studies are needed to assess whether the differences persist beyond one year of age, Other key questions include the mechanism by which the apparent developmental effects of atazanavir occur; and whether they could be related to another drug, tenofovir, which is typically used together with atazanavir. The researchers conclude, "These results may be useful in treatment planning for women with HIV Infection."
-end-
The study was supported by several NIH institutes, including the National Institute on Child Health and Human Development, National Institute of Drug Abuse, the National Institute of Allergy and Infectious Diseases, the Office of AIDS Research, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute of Deafness and Other Communication Disorders, the National Heart, Lung and Blood Institute, the National Institute of Dental and Craniofacial Research, and the National Institute of Alcohol Abuse and Alcoholism.

Click here to read "Atazanavir exposure in utero and neurodevelopment in infants: A comparative safety study."

Article: "Atazanavir exposure in utero and neurodevelopment in infants: A comparative safety study" (doi: 10.1097/QAD.0000000000001052)

About AIDS

AIDS publishes the very latest ground-breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of even more significant advances. The Editors, themselves noted international experts who know the demands of HIV/AIDS research, are committed to making AIDS the most distinguished and innovative journal in the field. Visit the journal website at http://www.aidsonline.com.

About Wolters Kluwer

Wolters Kluwer is a global leader in professional information services. Professionals in the areas of legal, business, tax, accounting, finance, audit, risk, compliance and healthcare rely on Wolters Kluwer's market leading information-enabled tools and software solutions to manage their business efficiently, deliver results to their clients, and succeed in an ever more dynamic world.

Wolters Kluwer reported 2014 annual revenues of €3.7 billion. The group serves customers in over 170 countries, and employs over 19,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands. Wolters Kluwer shares are listed on NYSE Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY).

For more information about our products and organization, visit http://www.wolterskluwerhealth.com, follow @WKHealth or @Wolters_Kluwer on Twitter, like us on Facebook, follow us on LinkedIn, or follow WoltersKluwerComms on YouTube.

Wolters Kluwer Health

Related HIV Articles from Brightsurf:

BEAT-HIV Delaney collaboratory issues recommendations measuring persistent HIV reservoirs
Spearheaded by Wistar scientists, top worldwide HIV researchers from the BEAT-HIV Martin Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy (BEAT-HIV Collaboratory) compiled the first comprehensive set of recommendations on how to best measure the size of persistent HIV reservoirs during cure-directed clinical studies.

The Lancet HIV: Study suggests a second patient has been cured of HIV
A study of the second HIV patient to undergo successful stem cell transplantation from donors with a HIV-resistant gene, finds that there was no active viral infection in the patient's blood 30 months after they stopped anti-retroviral therapy, according to a case report published in The Lancet HIV journal and presented at CROI (Conference on Retroviruses and Opportunistic Infections).

Children with HIV score below HIV-negative peers in cognitive, motor function tests
Children who acquired HIV in utero or during birth or breastfeeding did not perform as well as their peers who do not have HIV on tests measuring cognitive ability, motor function and attention, according to a report published online today in Clinical Infectious Diseases.

Efforts to end the HIV epidemic must not ignore people already living with HIV
Efforts to prevent new HIV transmissions in the US must be accompanied by addressing HIV-associated comorbidities to improve the health of people already living with HIV, NIH experts assert in the third of a series of JAMA commentaries.

The Lancet HIV: Severe anti-LGBT legislations associated with lower testing and awareness of HIV in African countries
This first systematic review to investigate HIV testing, treatment and viral suppression in men who have sex with men in Africa finds that among the most recent studies (conducted after 2011) only half of men have been tested for HIV in the past 12 months.

The Lancet HIV: Tenfold increase in number of adolescents on HIV treatment in South Africa since 2010, but many still untreated
A new study of more than 700,000 one to 19-year olds being treated for HIV infection suggests a ten-fold increase in the number of adolescents aged 15 to 19 receiving HIV treatment in South Africa, according to results published in The Lancet HIV journal.

Starting HIV treatment in ERs may be key to ending HIV spread worldwide
In a follow-up study conducted in South Africa, Johns Hopkins Medicine researchers say they have evidence that hospital emergency departments (EDs) worldwide may be key strategic settings for curbing the spread of HIV infections in hard-to-reach populations if the EDs jump-start treatment and case management as well as diagnosis of the disease.

NIH HIV experts prioritize research to achieve sustained ART-free HIV remission
Achieving sustained remission of HIV without life-long antiretroviral therapy (ART) is a top HIV research priority, according to a new commentary in JAMA by experts at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The Lancet HIV: PrEP implementation is associated with a rapid decline in new HIV infections
Study from Australia is the first to evaluate a population-level roll-out of pre-exposure prophylaxis (PrEP) in men who have sex with men.

Researchers date 'hibernating' HIV strains, advancing BC's leadership in HIV cure research
Researchers have developed a novel way for dating 'hibernating' HIV strains, in an advancement for HIV cure research.

Read More: HIV News and HIV Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.