A project that aims to reduce mother-to-child transmission of HIV was given the green light on December 1st, World Aids Day.
The DolPHIN-2 investigators were funded as part of a major UNITAID initiative to gather evidence on the use of new priority antiretroviral regimens for first-line therapy in developing countries. The DolPHIN-2 study is seeking to reduce mother-to-child transmission of HIV during pregnancy, childbirth, and breastfeeding in women most at risk of transmitting the virus.
According to the researchers, around 1.6 million women living with HIV become pregnant each year globally. Without antiretroviral therapy, the rates of mother-to-child transmission of HIV range from 15 to 45 per cent. With current HIV treatment this risk can be reduced to below five per cent, provided treatment is started early in pregnancy.
However, a significant number of pregnant women in sub-Saharan Africa present late to maternity services, often in the last three months of pregnancy where current first-line therapy does not have sufficient time to act to prevent infant transmission. This late initiation of HIV treatment is associated with a seven-fold higher risk of infant transmission, and a doubling of infant mortality in the first year of life.
A new drug, Dolutegravir (DTG), has the ability to act much more quickly than current recommended therapy. DTG rapidly reduces the amount of HIV in blood in the first three months of starting treatment, and thus potentially has considerable advantages in preventing infant transmission. However, the safety and efficacy of DTG in pregnant women is unknown, and this lack of knowledge is the major barrier to its widespread use in pregnancy, say the researchers.
DolPHIN-2 will comprise a large clinical trial in Uganda and South Africa, where these late-presenting mothers will be randomised to receive a DTG-containing regimen compared with standard-of-care treatment. Both mothers and infants will be followed up for at least one year. The researchers will also seek to examine the cost-effectiveness of implementing DTG across sub-Saharan Africa, identify and address the challenges the mothers face, and examine a number of factors which may enhance or prevent transmission.
The DolPHIN-2 consortium is led by the University of Liverpool; other members include the Liverpool School of Tropical Medicine (LSTM), the Infectious Disease Institute in Kampala, the University of Cape Town and Radboud University Nijmegen.
Professor Saye Khoo, Principle Investigator, University's Institute of Translational Medicine, said that mother-to-child transmission of HIV is preventable.
“We have a duty to ensure the burden of HIV is not handed down across generations. Over 100,000 babies acquired HIV last year worldwide. 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.”