Health European Medicines Agency recommends vaginal rings to protect against...

European Medicines Agency recommends vaginal rings to protect against HIV

Dhe former head of the United Nations AIDS control program (UN AIDS), Peter Piot, should be right. 16 years ago, he told the FAZ that he was certain that microbicides would be on the market sooner than an AIDS vaccine. Microbicides are micro-killing substances that women can also use vaginally as protection against HIV without their sexual partners knowing about it. Experiments with vaginal rings began as early as 16 years ago. Four years ago, two studies showed that vaginal rings that gradually release the anti-viral active ingredient dapivirine reduce the overall risk of contracting HIV by 35 percent. A few days ago, these rings are now from European Medicines Agency (Ema) get a positive scientific opinion. Ema recommends its use in developing countries for women aged 18 and over.

The International Partnership for Microbicides (IPM) has cleared an important hurdle. The non-profit organization founded in 2002 can now begin, together with the World Health Organization to prepare for the launch of their dapivirine ring in southern Africa. Many African countries recognize Ema’s opinion, which can help speed up reviews. IPM will also file an application with the United States Food and Drug Administration. As early as next year women in Kenya, Malawi, Rwanda, Zimbabwe, South Africa, Tanzania and Uganda could have additional HIV protection.

The importance of such protection can also be seen with a view to the Corona-Pandemie. A second pandemic is now underway in South Africa, among others, which the country’s president, Cyril Ramaphosa, had already publicly flagged in June: the number of violent attacks on women and girls, which is already much higher than in Europe, for example , reached new highs in Corona times. Police statistics recorded five rapes per hour in South Africa in 2019, with a girl or woman murdered every three hours. According to preliminary figures from the National Education, Health, and Allied Workers’ Union in Johannesburg, the number of sexual assaults, especially among families and friends, increased by 500 percent during the corona lockdown.

Encouraging study results

Girls and women in Africa often have little opportunity to protect themselves from infection with an STD. Many men reject condoms as protection because they are considered to be manly and promise less pleasure, and many men do not want to be suspected of being infected with HIV. That is why her partners cannot take antiretroviral medication (ARV) as a precautionary measure, that is, prepare themselves for the virus with a prep, a pre-exposure prophylaxis, which would certainly be possible.

This is exactly where the vaginal ring comes in, which – unnoticed by the male sexual partner – enables the controlled release of a medication over longer periods of time. The IPM ring with an outer diameter of 56 millimeters and a cross-sectional diameter of 7.7 millimeters consists of a new type of flexible silicone. 25 milligrams of ARV dapivirine are evenly distributed in its matrix. The ring releases the drug slowly over a month – right at the site of a potential infection. Since the ARV is otherwise hardly absorbed by the body, there are few side effects. Dapivirine has long been successful in the fight against HIV and Aids used to prevent mother-to-child transmission of the virus at birth.

The fact that the dapivirine ring can protect against HIV infection was demonstrated above all by two studies in 2015 and 2016, in which a total of around 4,600 women in four African countries took part. In the so-called ring study (South Africa and Uganda), 35 percent less women were infected with HIV in the Aspire study (Malawi, South Africa, Uganda and Zimbabwe) than in the respective comparison group who received placebos. Younger study participants in particular became infected more often than older ones. As it turned out, the younger ones tended not to use the microbicides properly after being told they could also get an inactive ring. HIV protection among women older than 25 years was significantly higher at 67 percent.

The results of two further studies from 2016 (Hope: 1456 women in Malawi, South Africa, Uganda and Zimbabwe; Dream: 950 women in South Africa and Uganda), in which there was increased ring use, are also encouraging, which according to IPM data resulted in a greater risk reduction of more than 50 percent. Further studies on the vaginal ring, the research of which will be funded by the Federal Ministry of Education and Research as part of a five-year product development partnership with ten million euros until 2021, will test whether the ARV levy can be increased to up to 90 days and whether it is possible to equip a ring with active ingredients that protect against HIV and pregnancy.



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