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ICAAC 2009: Antiretroviral Pregnancy Registry Indicates Use of Tenofovir (Viread) by Pregnant Women Does Not Raise Risk of Birth Defects

Data submitted to the Antiretroviral Pregnancy Registry (APR), which collects reports of adverse events associated with use of antiretroviral drugs by HIV positive women during pregnancy, show no link between use of tenofovir (Viread, also in the Truvada and Atripla coformulation) and congenital abnormalities, according to a presentation at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2009) this week in San Francisco.

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Does Vitamin D Deficiency Increase the Risk of Mother-to-child HIV Transmission?

Having a low level of vitamin D may increase the odds that HIV positive women will transmit the virus to their babies during pregnancy, delivery, or breast-feeding, according to a study conducted in Tanzania and reported in the August 12, 2009 advance online issue of the Journal of Infectious Diseases.

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Antiretroviral Therapy Interruption during Pregnancy Increases the Risk of Mother-to-Child HIV Transmission

Evidence continues to accumulate indicating that interruption of antiretroviral therapy (ART) has deleterious effects. According to an Italian study published in the March 23, 2009 issue of Clinical Infectious Diseases, stopping treatment during pregnancy can increase the risk of mother-to-child HIV transmission.

With prophylactic therapy, such as the ACTG 076 regimen of zidovudine (AZT; Retrovir) given during pregnancy, labor, and to the baby for 6 weeks after birth, the risk of perinatal transmission has decreased dramatically. But combination therapy can reduce the risk even further by fully suppressing HIV viral load, and the latest DHHS treatment guidelines recommend that pregnant women should receive a complete ART regimen even if they would not otherwise need treatment based on CD4 cell count.

Many experts, however, have traditionally advised pregnant women on ART to interrupt therapy during the first trimester, when the developing fetus is most susceptible to adverse effects of drug exposure. Although most HIV transmission is thought to occur during late pregnancy or delivery, this recommendation is not well supported by data.

In the present study, Luisa Galli and colleagues used logistic regression models to estimate adjusted odds ratios for factors potentially contributing to mother-to-child transmission, including maternal ART interruption, in a prospective cohort of pediatric patients in the Italian Register for HIV Infection in Children.

Results

  • Among 937 pregnant HIV positive women, 81 (8.6%) interrupted ART during the first trimester and 11 (1.2%) did so during the third trimester.
  • During the first trimester, the median time of ART interruption was 6 weeks gestation, and the median time without treatment was 8 weeks.
  • During the third trimester, the median time of ART suspension was 32 weeks gestation and the median time off treatment was 6 weeks.
  • Plasma HIV viral load was similar in women who interrupted treatment during the first trimester and those who did not stop therapy.
  • Overall, the rate of mother-to-child HIV transmission in the entire cohort was 1.3%.
  • However, the transmission rate was higher when ART was interrupted, 4.9% if stopped during the first trimester and 18.2% if stopped during the third trimester.
  • In the multiple logistic regression models, only the following factors were independently associated with an increased risk of mother-to-child HIV transmission:
  • Interruption of ART during either the first or third trimester;
  • Maternal use of antiretroviral monotherapy or dual therapy, as opposed to a complete regimen of at least 3 drugs;
  • Delivery by a method other than elective cesarean section (i.e., vaginal birth or emergency cesarean);
  • Delivery when HIV RNA was greater than 4.78 log10 copies/mL.

Based on these results, the study authors concluded, "Discontinuing ART during pregnancy increases the rate of mother-to-child transmission of HIV-1, either when ART is stopped in the first trimester and subsequently restarted or when it is interrupted in the third trimester."

"This finding supports recommendations to continue ART in pregnant women who are already receiving treatment for their health," they added.

The results are also compatible with the U.S. recommendation that untreated HIV positive women start combination ART during pregnancy even if they don't yet need treatment for their own health.

University of Florence and Centre for the Study and Prevention of Tumours, Research Institute of the Tuscany Region, Florence; University of Turin, Turin; Mangiagalli Hospital; University of Milan, Sacco Hospital and S. Paolo Hospital, Milan; University of Padua, Padua; Gemelli Hospital, Spallanzani Hospital and Bambino Gesù Children's Hospital, Rome; University of Brescia, Brescia; Federico II University, Naples; University of Pavia, Pavia; University of Modena, Modena; Hospital of Bergamo, Bergamo University of Bari, Bari, Italy.

3/27/09

Reference

L Galli, D Puliti, E Chiappini, and others.Is the Interruption of Antiretroviral Treatment During Pregnancy an Additional Major Risk Factor for Mother-to-Child Transmission of HIV Type 1? Clinical Infectious Diseases. March 23, 2009 (Epub ahead of print). (Abstract).

IAS 2009: Lipid and Glucose Changes Related to Boosted Darunavir (Prezista) in Children and Adolescents with HIV: DELPHI Study

Ritonavir-boosted darunavir (Prezista) was effective and generally well-tolerated at week 48 among treatment-experienced children and adolescents with HIV in the DELPHI study, according to a presentation at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) last month in Cape Town, South Africa. No change was seen in glucose levels after starting the drug, and triglyceride levels decreased significantly.

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Individuals 50 Years of Age and Older Are at Risk for HIV Infection and Other Sexually Transmitted Diseases

People aged 50 and older are more likely to have unprotected sex than younger individuals with HIV infection, which increases their risk for HIV and other sexually transmitted infections (STDs), according to results of a recent study supported by the World Health Organization (WHO) published in the current Bulletin of the World Health Organization.

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