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Based on new evidence evaluating benefits and risks, WHO recommends the use of dolutegravir (DTG), an HIV drug, as the first- and second-line treatment of choice for all populations, including pregnant women and women of childbearing age.
Initial studies have found a possible link between DTG and neural tube defects (conbad brain and spinal cord abnormalities that cause conditions such as spina bifida) in infants born to women using this drug at the time of the design. This potential safety concern was reported in May 2018 in a study in Botswana that found 4 cases of neural tube defects in 426 women who became pregnant while taking DTG. On the basis of these preliminary results, many countries have advised pregnant women and women of childbearing age to take efavirenz (EFV).
New data from two major clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now broadened the evidence base. The risks of neural tube defects are significantly lower than those suggested by the original studies.
The guidelines group also examined mathematical models of the advantages and disadvantages of both drugs; the values and preferences of people living with HIV, as well as the factors related to the implementation of HIV programs in different countries, as well as their costs.
DTG is a more effective medicine that is easier to take and has fewer side effects than alternative medicines currently in use. DTG also has a high genetic barrier to the development of drug resistance, which is important given the growing trend towards resistance to EFV and nevirapine regimens. In 2019, 12 of the 18 countries studied by the WHO reported pre-treatment drug resistance levels above the recommended threshold of 10%.
All of the above findings motivated the decision to update the 2019 Guidelines.
In 2019, 82 low- and middle-income countries reported transitioning to treatment regimens for HIV-based DTG. The new updated recommendations are intended to help more countries improve their HIV policies.
As with any medication, knowingly choosing is important. Each treatment decision should be based on an informed discussion with the health provider badessing the benefits and potential risks.
The WHO also emphasizes the importance of providing information and options to help women make an informed choice. To this end, WHO has convened an advisory group of women living with HIV from a variety of backgrounds to advise them on policy issues related to their health, including badual and reproductive health. The WHO stresses the need to continuously monitor the risk of neural tube defects badociated with DTG.
Distributed by APO Group on behalf of the World Health Organization (WHO).
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