Health
African women will soon have access to the Dapivirin ring, reducing their risk of HIV
The flexible silicone ring releases the antiretroviral drug dapivirine locally and slowly to potentially infected sites, minimizing absorption in other parts of the body. Image: Attached
In a world where good news is lacking due to the deadly and infectious effects of the Covid-19 coronavirus pandemic, the areas of HIV prevention and female sexual reproductive health are reasons to celebrate.
Designed to address women’s unmet needs for new ways to protect themselves from infection with HIV, the Dapivirin vaginal ring could be ready for immediate use by women over 18 in Africa there is. This is after approval approval from the European Medicines Agency (EMA) on Friday.
This key validation is the development of new HIV prevention tools such as rings and other sexual and reproductive health technologies for women, and the non-profit organization International Microbicide (IPM) that enables these tools to be used. Are welcomed by Developing countries.
“African women have been left behind by HIV progress for too long. This announcement is a landmark for women to prevent HIV.”
Dr. Linda Galebecker
EMA is responsible for the scientific evaluation, supervision and safety monitoring of pharmaceuticals in the EU.
How the Dapivirin Vaginal Ring Works
The flexible silicone ring releases the antiretroviral drug dapivirine locally and slowly to potentially infected sites, minimizing absorption in other parts of the body.
Users insert the device themselves and replace it monthly.
“The EMA view is an important step forward for women who deserve and urgently need new and prudent options to manage HIV risk on their terms,” said Dr. Zeda F Rosenberg, IPM’s founding CEO. Mentioned in.
“To celebrate today’s news with many partners around the world involved in the development of the ring, it is still needed to obtain national approval to make the ring available to women in sub-Saharan Africa. We look forward to joint efforts.”
read: Young in the age of Covid-19, living with HIV
Efficacy data, including additional data provided during the EMA review, showed that Dapivirine Rings reduced women’s HIV risk by 35% without concerns about the safety of long-term use.
More recent data from product studies suggest significant reductions in HIV risk, but these findings are based on statistical modeling and are therefore limited.
The ring was also found to have a favorable safety profile in all clinical trials to date.
Rings are being studied in South Africa through the Aspire (a study to prevent infection by rings for extended use) trials.
“The EMA view is an important step forward for women who deserve and urgently need new and prudent options to manage HIV risk on their terms.”
Dr. Zeda F Rosenberg
The Human Medicines EMA Committee reviewed the ring based on Article 58 procedures. This will be done in collaboration with the World Health Organization (WHO) to promote access to essential medicines in low and middle income countries using the same strict criteria for products intended for use in the EU. ..
“African women have been left behind by HIV progress for too long. This announcement is a milestone in the prevention of HIV in women,” said PhD, Desmond Tutu Health Foundation. Dr. Linda-Gail Bekker said.
read more: Covid-19 warns UNAids that it could boost AIDS deaths
Becker, who is also the South African state principal investigator in ring studies, added: “Providing women with multiple methods, monthly rings and daily pre-exposure prophylaxis are essential for controlling epidemics and ensuring sexual and reproductive health.”
In 2021, some of the most needed African communities in IPM went through several next steps, including WHO pre-qualification and quality assurance, and regulatory reviews in the African countries where it is used. It may be possible to make it available.
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