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New trial investigates use of Tivicay against vertical HIV transmission
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An $8.9 million grant recently awarded to researchers at the University of Liverpool will support a trial examining the efficacy of Tivicay in preventing mother-to-child transmission of HIV, according to a press release.
Each year, approximately 1.6 million women living with HIV become pregnant, the release said. In the absence of ART, the rate of mother-to-child HIV transmission ranges from 15% to 45%. However, the risk for vertical transmission decreases to under 5% when ART is administered early in pregnancy.
Nevertheless, many pregnant women in sub-Saharan Africa often receive maternity care during the last 3 months of pregnancy, which is not enough time for current frontline therapy to effectively prevent infection in infants. According to the release, late treatment is associated with a sevenfold higher risk for mother-to-child HIV transmission and doubles infant mortality during the first year of life.
The new drug Tivicay (dolutegravir, ViiV Healthcare) has been shown to work faster than currently recommended treatment, reducing viral load within 3 months of treatment initiation, the release said. However, the drug’s safety and efficacy in pregnant women is unknown. Thus, an international consortium led by researchers at the University of Liverpool launched the DolPHIN-2 study to better understand dolutegravir’s activity against mother-to-child HIV transmission during pregnancy, childbirth and while breastfeeding.
For the trial, conducted in Uganda and South Africa, researchers will randomly assign an ART regimen containing dolutegravir or standard-of-care treatment to pregnant women with HIV who present late to maternity care. The researchers will follow mothers and their infants for at least 1 year to compare the outcomes of those receiving dolutegravir vs. standard therapy. Additional studies will be conducted to assess the cost-effectiveness of dolutegravir in sub-Saharan Africa and to examine factors that may increase or prevent transmission.
“Mother-to-child transmission of HIV is preventable, and we have a duty to ensure the burden of HIV is not handed down across generations,” Saye Khoo, MD, PhD, lead researcher of the University of Liverpool’s Institute of Translational Medicine, said in a press release. “We have both a moral imperative to make new treatments available and affordable, and an ethical imperative to ensure these treatments are supported by robust evidence for safety and efficacy. As this evidence is gathered, we will work closely with international agencies involved in enlarging access and developing clinical guidelines in order to ensure that this research translates into real benefit for such a vulnerable population.”
Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.