DOLUTEGRAVIR HAS GENERATED SERIOUS PROBLEMS IN THE TRAINING OF THE CERVICAL COLUMN OF THE FETUS BETWEEN THE 2ª AND 12ª WEEK OF GESTATION
Treatment of women with HIV by dolutegravir at the time of conception is associated with an increased risk of neural tube defects in children exposed to the drug when compared to efavirenz, a study in Botswana has shown. Rebecca Zash of Beth Israel Deaconess Medical Center in Boston emphasized that the results are a preliminary sign of Biosafety risks and require more follow-up and protracted attention.
The results of the Botswana surveillance study, released in May, safety alerts by the European Medicines Agency and the US Food and Drug Administration.
Agencies have warned that women living with HIV who can become pregnant should not use the integrase inhibitor dolutegravir (Tivicay, also in Triumeq e Juluca) without effective contraception. Subsequent guidelines of the World Health Organization (WHO) treatment, which were released yesterday, emphasize the importance of consistent and reliable contraception if women of childbearing age choose to take dolutegravir. Even in its mixed presentation, as in the case of JULUCA.
The alert has caused controversy over the balance between the risks and benefits of dolutegravir treatment for women living with HIV and plans to introduce dolutegravir-based treatment in some sub-Saharan African countries have been paralyzed.
The development of new WHO treatment guidelines
More details on the Botswana surveillance study were 22A International AIDS Conference (AIDS 2018) on Tuesday by Dr. Rebecca Zash, on behalf of the Tsepamo study team. The surveillance study Tsepamo analyzed birth outcomes at eight government hospitals in Botswana between August of 2014 and May of 2018 and covered about 45% of all babies brought to light alive during the period.
The study was originally designed to collect information on birth outcomes in women taking antiretroviral therapy (ART) at conception and during pregnancy. And was able to collect information on the results of deliveries in women exposed to efavirenz, dolutegravir, or protease inhibitor-based regimens. Tsepamo started at 2014 when efavirenz-based antiretroviral therapy was the preferred option for first-line treatment and Botswana had just started a policy of treating everyone. At 2016, Botswana switched to a first-line regimen of dolutegravir, tenofovir and lamivudine for all adults.
A new analysis, which looked at women who started treatment based on dolutegravir or another antiretroviral regimen prior to conception, was performed at 2018 in preparation for the development of new WHO treatment guidelines. It is a capital moment this ....
Editor's note. That is what the African Continent serves ... (...) .... To Test Dolutegravir, Other Drugs and Certain Fatalities
This analysis specifically evaluated neural tube defects also related to Dolutegravir.
Um Neural tube defect occurs when the spinal cord, brain and related structures do not form properly. The neural tube develops between the 2ª and 8ª week of the gestation. The spina bifida - a poorly formed spinal cord - is the most common neural tube defect. The most common cause of neural tube defects is the lack of folic acid during pregnancy, but defects can also be caused by some medications. The risk of neural tube defects is greater at conception and in the first trimester of pregnancy, so it is important to rule out any harmful effects of medications taken at this time.
Researchers compared pregnancy outcomes in women exposed to dolutegravir at conception, women exposed to ART based on efavirenz at conception, women taking other ARV regimens at the time of conception, women who started dolutegravir during pregnancy and HIV patients women.
The surveillance study previously reported that women who started dolutegravir during pregnancy did not show high risk of adverse pregnancy outcome at delivery (stillbirth, preterm delivery, small for gestational or neonatal age) compared to women who started efavirenz.
A total of 89.064 births were recorded in this surveillance study for neural tube defects (426 in women taking dolutegravir, 5787 in women taking efavirenz and 5513 taking other antiretroviral regimen at conception).
After delivery, 99,7% of the children underwent a physical examination by a midwife to check for neural tube defects. Midwives reported 86 cases (an incidence of 0,10%, IC 95% 0,08-0,12%), of which 42 were spina bifida (incomplete spinal development leading to protrusion of the neural tube through the vertebrae). The rest were more serious defects that affected the brain and skull. Twenty-two of the 86 cases occurred in stillborn children.
The prevalence of neural tube defects was higher in children born to women exposed to dolutegravir at conception compared to women exposed to efavirenz or other regimens.
Four cases occurred in women who used dolutegravir at the time of conception; Neither was taking folate supplements before pregnancy. No neural tube defect was identified in children born to women who started treatment
with dolutegravir during pregnancy.
The prevalence of neural tube defects was 0,94% (IC95% 0,37-2,4%) in women exposed to dolutegravir in designing compared with a prevalence of 0,12% (IC 95% 0,07-0,21%) in women exposed to any regime ART that does not contain dolutegravir in the design, a risk difference of 0,82%. The prevalence of neural tube defects in women exposed to efavirenz was at conception of 0,05% (% IC95 0,02-0,05%) in HIV-negative women and the prevalence was 0,09% (0,07-0,12%).
Potential impact of avoiding dolutegravir
The news of a potential security problem and subsequent guidance from regulatory agencies and WHO have led some ministries of health in low- and middle-income countries to discontinue their plans to implement dolutegravir-based treatment as the preferred line treatment, WHO Meg Doherty said at an organized symposium to discuss the results of the Tsepamo study.
Seven countries have already decided not to offer dolutegravir to women of childbearing age and six countries have decided to allow women to take dolutegravir only if they are using contraceptives.
However, a modeling study presented by Caitlin Dugdale of Massachusetts General Hospital shows that avoiding the use of dolutegravir in women of childbearing age carries risks for women, children and their partners who may overcome the risk of neural tube defects.
Using a well-tested model of the HIV epidemic in South Africa and treatment patterns in South Africa (CEPAC model), Dugdale and her colleagues analyzed the impact on mortality, sexual transmission, vertical transmission, and adverse outcomes of delivery using dolutegravir or a efavirenz-based regimen in the next five years in 3,5 million women who will be on treatment (1,8 million starting treatment in this period). The model also examined the impact of the two regimens on 1,1 million statistically likely births in women on antiretroviral treatment.
Assuming dolutegravir is more effective than efavirenz in suppressing viral load and assuming that the neural tube defects occur with similar prevalence reported in the study and other studies Tsepamo of efavirenz dolutegravir would save 28.400 adult lives more than efavirenz, preventing 52.800 more cases of sexual transmission and avoiding more 5000 infantile infections than efavirenz, the model found.
What happened to the condom, the condom, the Venus shirt? !!!
But treatment based on efavirenz 10.000 prevent more neural tube defects in children and more 8400 pediatric deaths than dolutegravir, leaving 5400 more vivid and children free of HIV that dolutegravir.
The model was sensitive to the assumptions about fertility, treatment efficacy, and the prevalence of neural tube defects, which means that more surveillance data will help adjust the projections.
The results highlight the trade-offs inherent in making decisions about the most appropriate first-line regimen, especially in countries with large treatment programs and high fertility rates. Ours, for example. Where there is no talk of condoms at different times of the first week of December and in the carnival. I live, live, live, ask, ask, ask, and ask exhaustively, exhaustively, and exhaustively.
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Published in: 24 July 2018
Dugdale C et al. Risks and benefits of dolutegravir-based antiretroviral therapy (DTT) for women living with HIV in childbearing age in South Africa: a model-based analysis. 22 International AIDS Conference (AIDS 2018), Amsterdam, Symposium presentation (Dolutegravir Safety in Pregnancy), 2018.
Zash R et al. Surveillance of neural tube defects after antiretroviral exposure since conception.22A International AIDS Conference (AIDS 2018), Amsterdam, Symposium Presentation (Dolutegravir Safety during Pregnancy), 2018.