IAS: Valacyclovir in moms with HIV doesn't harm babies
ROME -- The use of the anti-herpes-simplex-2 treatment valacyclovir (Valtrex) in pregnant, HIV-infected women does not appear to harm their infants when administered along with therapy to prevent mother-to-child transmission of HIV, researchers said here.
There were no significant differences between the 73 children whose moms took valacyclovir and the 73 children whose moms were on placebo as far as the incidence of diarrhea, cough, rhinorrhea, urinary tract infections, rash, or fever were concerned, said Alison Drake, PhD, a post-doctoral fellow in global health at the University of Washington, Seattle.
Similarly, the researchers did not observe significant differences in creatinine clearance or changes in liver enzymes among children whose moms were breastfeeding and taking valacyclovir, she told MedPage Today at a meeting of the International AIDS Society.
"We did find valacyclovir concentrations in the breast milk of most of the women we tested," Drake said, "but there did not appear to be any consequences among the babies."
Breast milk samples were taken from 71 women in the study, and 44 of those samples were randomly selected for further analysis. The researchers determined that valacyclovir was detectable in 35 (80%) of these women, the researchers reported in their poster presentation.
"While we know that valacyclovir treatment for herpes simplex virus 2 is beneficial during and after pregnancy for the women, we were interested in determining what prolonged exposure to valacyclovir through breast milk might mean for infants," Drake said. "We can see through this study that a negative impact on children is not apparent."
The researchers saw little difference in adverse events between the women treated with valacyclovir along with short-course zidovudine (AZT, Retrovir) or nevirapine (Viramune) for prevention of HIV transmission to the infants, and those taking the mother-to-child-transmission prevention therapy and placebo.
"The incidence of maternal antenatal fever was significantly increased among women on valacyclovir compared with placebo," Drake said. "No other differences between treatment arms in maternal and infant adverse events, hospitalizations or deaths were observed."
Creatinine clearances were not significantly different at baseline and at follow-up, and differences in adverse events before birth and following birth were similarly not significant, Drake reported at her poster presentation.
"The results of this study are what we would have expected to see," said Julio Montaner, MD, of the University of British Columbia, Vancouver. He told MedPage Today that the trial confirms that use of valacyclovir to suppress herpes simplex virus 2 helps the mother without causing harm to the child.
The researchers enrolled women who were diagnosed with co-infections in 2008 in Nairobi, Kenya. They received 500 mg of valacyclovir twice daily from 34 weeks' gestation until 12 months postpartum. The study did not enroll women with late-stage HIV infection or women with CD4-positive counts less than 250 cells/microliter.
Women were treated with zidovudine 300 mg after 28 weeks or longer gestation during pregnancy and every three hours during labor. Single dose nevirapine was administered during labor and administered to the infant after birth. The women were given questionnaires regarding adverse events and adherence to the regimen 10 times during the course of the study, which extended from enrollment to 12 months postpartum.
Drake had no disclosures.
Montaner has previously reported financial links with Abbott, Gilead Sciences, GlaxoSmithKline, and Merck.
By Ed Susman
Primary source: IAS Conference on HIV Pathogenesis and Treatment
Source reference:
Drake A et al, "MOPE174 -- Safety of prolonged maternal valacyclovir administration in infants receiving antiretroviral HIV-1 prophylaxis" IAS 2011; Abstract Book, p. 68.
MedPage Today
http://www.medpagetoday.com/MeetingCoverage/IAS/27627
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