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HomeNews UpdateSAHPRA approves ‘game-changer’ vaginal ring but DoH still undecided

SAHPRA approves ‘game-changer’ vaginal ring but DoH still undecided

The SA Health Products Regulatory Authority (SAHPRA) has approved the widely hailed vaginal dapivirine ring to protect women from HIV for up to a month at a time, writes MedicalBrief. However, the national Department of Health has not yet decided on whether to provide it to state patients.

The DoH was still considering whether to provide the dapivirine ring to state patients, said spokesperson Foster Mohale, told Business Day. “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 was developed by the non-profit International Partnership for Microbicides (IPM) and tested in several African countries, including SA. As reported in MedicalBrief on 2 December 2020, the silicone ring reduces HIV infection by 35%. Women insert the product and replace it every month.

IPM said it was prioritising the introduction of the ring in the public sector, and did not yet have a time line or price for the private sector market.

“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, in Business Day.

The procurement cost of the ring would be between $12 and $13, said IPM vice-president Leonard Solai. “IPM is exploring cost-cutting measures that could be realised with increased production volume and alternative manufacturers. In the future, a three-month version of the ring, now advancing in clinical trials, would reduce costs further with only four rings needed each year,” he said.

The long-acting ring has been in development for about five years and was first designed for contraceptive use, but has since been hailed as a game-changer in protecting against both HIV infection and unintended pregnancy, writes MedicalBrief.

It is the first biomedical HIV prevention method developed specifically for women, and will have important public health impacts in regions like sub-Saharan Africa, where HIV is not the only risk women face. Many women also experience high rates of complications during pregnancy and childbirth, often resulting in maternal and new-born death.

"We believe in the promise of multipurpose prevention and the dapivirine-contraceptive ring is welcome progress toward meeting women's overlapping sexual and reproductive health needs," said IPM’s Rosenberg.

The ring was given the seal of approval from both the World Health Organization (WHO) in 2020, and from the European Medicines Agency.

At the time of the 2020 green light from WHO, Prof Linda-Gail Bekker, chief operating officer of the Desmond Tutu HIV Centre and a principal South African investigator of the ring study, said getting the prequalification status “takes us another step towards access”.

“It means that … WHO can also now write the use of the dapivirine ring into guidelines,” she said.

Spotlight reported (MedicalBrief 12 August 2020) that the dapivirine ring had been 16 years in the making. IPM received the licence to use the drug in 2004, and the first prototype was developed in 2005. The current ring is the fourth rendition of the product and was developed primarily for low and middle-income countries with high HIV infection rates.

“After a number of rounds refining the design, we’ve finally got a product that is easy to use, relatively inexpensive to manufacture and one that has a long shelf-life, lasting up to five years,” Rosenberg was quoted as saying then.

"Currently one ring, which lasts one month, costs $8 (about R137). We fully anticipate the number to go down as efficiencies in manufacturing and volumes go up. The goal is to get the cost down to under $5 a ring,” she said at the time, adding that the three-month-ring, when ready, should reduce costs even further.

 

BusinessDay Pressreader article – SA’s medicine regulator approves vaginal ring for HIV prevention (Open access)

 

See more from MedicalBrief archives:

 

EMA position on vaginal ring paves the way for its adoption

 

Ring releasing ARV and contraceptive hormone well tolerated

 

REACH study: Adolescent girls and young women in Africa will use HIV prevention products

 

Dapivirine vaginal ring receives WHO prequalification for HIV prevention

 

 

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