The purpose of Dolomite is to assess the safety, effectiveness and “real-world” outcomes of dolutegravir (DTG) use in pregnant women and babies living with HIV. In 2014, the European Commission recommended the authorisation of DTG, for use in the European Union to treat HIV in adults and adolescents aged 12 years and older in combination with other antiretroviral agents. However, there are no adequate and well-controlled studies evaluating the use of DTG in pregnant women.
What is Dolomite?
Dolutegravir in pregnant women and exposed infants in Europe
Dolomite is comprised of two studies:
The European treatment network for HIV, hepatitis and global infectious diseases (NEAT ID) which is leading on a multi-site prospective observational study to define the safety and effectiveness of dolutegravir use in HIV positive pregnant women. Approximately, 250 HIV positive pregnant women from NEAT ID sites across Europe will be enrolled in the 3-year long study.
The Dolomite-EPPICC study which is looking at pregnancy and neonatal outcomes following prenatal exposure to dolutegravir by analysing retrospective data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC).
Why is Dolomite needed?
As DTG becomes more accessible, there will be a growing number of pregnant women who either conceive on DTG-regimens or start a regimen containing DTG. Furthermore, as European infant feeding recommendations for women living with HIV change, it is likely that some treated women with suppressed viral load will be supported to breastfeed.
What questions is Dolomite trying to answer?
Paediatric Studies
- Is DTG safe to take in pregnancy?
- Does DTG use in pregnancy affect pregnancy outcomes?
- Does DTG use at different stages of pregnancy impact babies in the womb?
- How are babies born to mothers on DTG affected?
Dolomite study is sponsored by ViiV Healthcare and coordinated by Penta.