Based on new evidence assessing benefits and risks, the WHO has said the 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,” the statement issued by the WHO said.
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.
It 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 per cent.
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, the statement said.
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. ENDS
ICMR launches national data quality forum
New Delhi: The Indian Council of Medical Research (ICMR)’s National Institute for Medical Statistics (ICMR- NIMS) in partnership with the Population Council on Wednesday launched the National Data Quality Forum (NDQF) here.
The launch was attended by representatives from the government, academic institutions, technology and developmental partners who work towards strengthening the data ecosystem in the country.
NDQF will integrate learnings from scientific and evidence-based initiatives and guide actions through periodic workshops and conferences.
Its activities will gear towards establishing protocols and good practices when dealing with data collection, storage, use and dissemination that can be applied to health and demographic data, as well as replicated across industries and sectors.
India has a rich resource of data on its population, its health status and demographic behavior and economic condition among many other aspects of life and environment.
This wealth of data is translated into insights and, eventually, into policy through a layered process involving human and technological inputs at every stage. However, these data often suffer from some common challenges related to human and technological factors and affect its quality.
While in recent years data quality improvement efforts have been undertaken in both the public and private sectors at independent institution levels, a convergence of these efforts is yet to be achieved in the form of an integrated platform at the national level that can guide data quality improvement efforts in a cohesive manner.
With a renewed emphasis on improving the quality of data that feeds into evidence based decision making at different levels, the NDQF hopes to bring together relevant stakeholders,subject matter experts, industry leaders, decision makers, and data scientists / analysts onto a common platform.
This platform will be guided by the direction provided by a high level steering committee and operationalized with the help of a technical advisory group composed of subject matter experts.
With a mandate to create a dialogue for data quality, and build a like-minded community of practice.
“We are delighted to launch the National Data Quality Forum and embark upon a fruitful collaboration to generate meaningful dialogue around the improvement of data quality in general, and for health and medical research in particular.” Prof. (Dr.) Balram Bhargava, Director General of the Indian Council of Medical Research.
Shekhar Shah, Director General for the National Council of Applied Economic Research said, “NCAER is committed to the improvement of data quality in India by fostering an innovation driven culture of data collection through its activities and partnerships.”
“We are excited about the community of practice that the National Data Quality Forum hopes to establish for producers and consumers of data across the country,” he said.