SA’s medicines regulator approves vaginal ring for HIV prevention

• Move hailed as milestone as device joins pre-exposure pills in providing more options to women to reduce risk of contracting virus

SA’s medicines regulator has approved a vaginal ring that slowly releases the drug dapirivine, offering women protection from HIV for up to a month at a time.

The development has been hailed by HIV advocates as a milestone in the quest to provide women with more options for reducing their risk of contracting the virus, but it is not clear when it will be available in SA.

The SA Health Products Regulatory Authority (Sahpra) has already approved daily HIV prevention pills, known as preexposure prophylaxis (PrEP), and is expected to give the green light to an injectable version later this year.

Globally, 37.7-million people are infected with HIV, more than half of them women. In SA, almost 2,700 women aged 15 or older are infected each week.

The ring was developed by the nonprofit International Partnership for Microbicides (IPM) and tested in several African countries, including SA. “This approval is a positive step towards offering women more prevention options they can use to control their health on their own terms,” said IPM founder and CEO Zeda Rosenberg.

The procurement cost of the ring would be between $12 and $13, said IPM vice-president for product access and external affairs Leonard Solai.

“IPM is exploring cost-cutting measures that could be realised with increased production volume and alternative manufacturers. In the future, a threemonth version of the ring, now advancing in clinical trials, would reduce costs further with only four rings needed each year,” he said.

IPM was prioritising the introduction of the ring in the public sector, he said.

The health department was still considering whether to provide the dapivirine ring to state patients, said spokesperson Foster Mohale. “The department will review and assess [its] effectiveness, the cost of procurement, the delivery requirements and the potential impact on HIV incidence,” he said.

The ring is the first of a new generation of less frequently dosed interventions for HIV prevention, and had few side effects, said Linda-Gail Bekker, executive director of the Desmond Tutu HIV research centre.

“For women who struggle to take a pill daily this becomes a very useful alternative. We need it to be written into guidance and put into clinics where oral PrEP is currently being offered so that women can be given [a] choice. We also need lots of education of civil society and healthcare workers alike,” she said.

Wits HIV researcher Francois Venter said it was important to ensure HIV prevention products were readily available to the people who needed them.

“We really need pre-exposure prophylaxis made far more available. At the moment access is dreadful throughout the world, not just SA — inventing funky new tech isn’t going to solve delivery issues,” he said.

The global uptake of oral PrEP has been slower than anticipated, said Mitchell Warren, executive director of the HIV prevention advocacy group Avac.

“Taking a pill every day is not for everyone. Having other options is critical,” he said.

About 370,000 people had been initiated on PrEP in SA to date, a significant proportion of the less than 2-million people using it worldwide, he said.