AWAITING APPROVAL

Vaginal ring: New PrEP option to support women's fight against HIV

Vaginal ring delivers dapivirine directly at the site of potential infection, with slow systemic absorption.

In Summary

• The ring is to be used by women aged 18 and above in developing countries.

They should replace it with a new one every 28 days and immediately the previous one is removed to maintain its efficacy. 

The Dapivirine Vaginal Ring
The Dapivirine Vaginal Ring
Image: Courtesy

Women at a high risk of being exposed to HIV will soon have access to a new infection prevention option in the form of a vaginal ring.

The dapivirine vaginal ring, which is still under development, can be used as pre-exposure prophylaxis where women lack access to or cannot use oral PrEP.

PrEP is the use of antiretrovirals by HIV negative individuals to block them from acquiring the virus.

 
 

The International Partnership For Microbicides said the ring once placed in the vagina slowly releases the antiretroviral medicine dapivirine over 28 days.

The ring is made of a flexible silicon matrix polymer and contains ARV dapivirine which is slowly released over the course of the month. It is to be used by women aged above 18 years.

“They should replace it with a new one every 28 days and immediately the previous one is removed to maintain its efficacy,” IPM said.

Dapivirine reduces the risk of HIV-1 infection after 24 hours of ring insertion. 

The ring delivers dapivirine directly at the site of potential infection, with slow systemic absorption.

IMP founding CEO Dr Zeda Rosenberg said once approved, the ring is expected to provide a comprehensive HIV prevention method that could help avert infections that would not be prevented by another method.

“These findings give hope to many women at high risk who need more and different options to effectively protect themselves from HIV,” Rosenberg said.

“IPM will seek approval for the monthly depirivine ring and work with partners to determine its role in strengthening HIV prevention efforts.”

Two Phase 3 studies found that the method reduced the risk of HIV-1 infection in women and was well tolerated with long term use.

The study led by IPM found that the ring reduced overall risk by 35 per cent.

Women in the study were randomly assigned to two study groups, one used the dapirivine ring and the other a placebo ring that contained no drug.

“Open-label studies are now underway among adolescents and young women and pregnant women, and planned among breastfeeding women,” they said.

Pending regulatory approval, the monthly dapivirine ring that has since received a positive opinion from the European Medicines Agency is expected to provide women with the first-ever discreet, long-acting prevention option.

“Through the WHO collaborative registration procedure, IPM plans to submit the first applications this year to countries in Eastern and Southern Africa where studies of the ring took place, HIV prevalence remains high and where IPM  can build on oral PrEP implementation.”

The countries include Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe.

The organisation will also submit an application to the US Food and Drug Administration this year.

In addition, IPM is working with a global network of government, donor, private and civil society partners to determine how the ring could best fit into the HIV prevention programmes and prepare for a potential rollout of the ring at an affordable cost.

IPM is currently developing a three months ring to help reduce annual costs and cut down on provider visits.

Clinical trials began in 2017 with results expected to be out early next year.