 |
|
|
| |
WHO recommends dolutegravir as preferred
HIV treatment option in all populations
|
| |
| |
Meanwhile, multiple sessions looked at a related issue also driven by community leadership
- the safety of the antiretroviral drug dolutegravir (DTG) for women. When data presented at AIDS 2018 indicated a possible increased risk for neural tube defects (NTDs) among infants born to women taking DTG, it was women who demanded better science and greater community involvement in determining the safety of the drug. Studies presented here showed less risk of NTDs than previously reported and helped inform updated WHO guidanceon antiretroviral treatment including DTG. IAS 2019 International Scientific Chair Anton Pozniak reinforced the vital role of the community: "Community engagement, including input from women living with HIV, has played a key role in updating these guidelines and community engagement will be critical to rolling them out."
IAS: Neural Tube Defect Rate 0.40% With Dolutegravir in Pregnancy--But Data Still Slim - (07/25/19)
----------------------------------
WHO recommends dolutegravir as preferred HIV treatment option in all populations
22 July 2019
News release
Mexico City
Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.
Initial studies had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception. This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead.
New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.
The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost.
DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.
All of above findings informed the decision to update the 2019 guidelines.
In 2019, 82 low- and middle-income countries reported to be transitioning to DTG-based HIV treatment regimens. The new updated recommendations aim to help more countries improve their HIV policies.
As for any medications, informed choice is important. Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks.
WHO also stresses 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 diverse backgrounds to advise on policy issues related to their health, including sexual and reproductive health. WHO highlights the need to continually monitor the risk of neural tube defects associated with DTG.
---------------------------------------------
Safety of Dolutegravir in pregnancy: Late breaking findings, interpretations, and implications
Symposia Session
Tuesday 24 July, 16:30 - 18:00
Co-Chairs:
Wame Mosime, International Treatment Preparedness Coalition, Botswana
Elaine J. Abrams, ICAP at Columbia University, United States
Rapporteur Summary
AUTHOR
Graeme Meintjes
SUMMARY
Dolutegravir is a preferred drug for inclusion in ART regimens given its tolerability, efficacy and high resistance barrier. A recent safety concern of excess neural tube defects (NTDs) in infants born to mothers who conceived while on dolutegravir has been reported. This session reviewed that data and its implications.
HIGHLIGHTS
The Tsepamo study ascertains birth outcomes at 8 sites across Botswana. Recently, it was reported that four infants with NTDs were born to women who conceived while taking dolutegravir. The neural tube closes in the first 28 days of pregnancy; making this the risk period for NTDs. Updated Tsepamo data show that these four NTDs occurred among 596 women who conceived on dolutegravir (incidence = 0.67%, 95%confidence interval=0.26%-1.7%). The risk in women conceiving on non-dolutegravir regimens was 0.12% (95%confidence interval=0.07%-0.21%); confidence intervals do not overlap. This an early signal; more data is required to confirm or refute whether dolutegravir is definitely associated with higher risk for NTDs. This risk, if confirmed, also needs to be weighed against dolutegravir's benefits: a modelling study suggested that dolutegravir-based ART would avert >25,000 deaths among women of childbearing age and 5,000 pediatric HIV infections compared to efavirenz-based ART over five-years in South Africa.
CRITICAL ASSESSMENT
Updated WHO guidelines released this week advise dolutegravir as a preferred drug in first-line, an option in second-line and third line ART. It is advised that women of childbearing potential who do not currently want to become pregnant can receive dolutegravir together with consistent and reliable contraception. Speakers in the session emphasised that until further data is available, caution should be exercised to avoid conception occurring in women taking dolutegravir; women should be engaged in decision-making regarding ART choices while being provided with information of the risks and benefits of dolutegravir, and ready access to reliable and effective contraception.
|
| |
|
|
|
|
|
