South Africa approves dapivirine vaginal ring for HIV prevention

Simon Collins, HIV i-Base

On 11 March 2022, the South African regulatory authority (SAHPRA) approved a monthly vaginal ring for use by adult women to protect against sexual transmission of HIV. [1]

This is approximately 18 months after the EMA issued a positive opinion supportive approval in countries with high HIV incidence. [2]

The press release from the International Partnership for Microbicides (IPM) emphasises the high need for better options for women and the advantages of the formulation that is easy to self-administer.

But it also notes that efficacy is significantly lower that other methods of PrEP.

The two phase 3 studies supporting approval reported overall efficacy rates of only 31% and 27% in the Ring and ASPIRE studies respectively. Subgroup and post-hoc analyses showed higher efficacy with greater adherence, as with other PrEP studies, and that this was higher in older women. [3, 4, 5]

References

1. IMP press statement. South Africa approves dapivirine vaginal ring for use by women. (11 March 2022).
   https://www.ipmglobal.org/content/south-africa-approves-dapivirine-vaginal-ring-use-women
2. EMA supports use of dapivirine vaginal ring to prevent HIV in high-incidence countries. HTB (August 2020).
   https://i-base.info/htb/38818
3. IMP press statement. Two large studies show IPM’s monthly vaginal ring helps protect women against HIV. (22 February 2016).
   https://www.ipmglobal.org/publications/two-large-studies-show-ipm’s-monthly-vaginal-ring-helps-protect-women-against-hiv
4. Baeten JM et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med 2016;375:2121-2132.
   https://www.nejm.org/doi/full/10.1056/NEJMoa1506110
5. Nel A et al. Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women. N Engl J Med 2016;375:2133-2143.
   https://www.nejm.org/doi/full/10.1056/NEJMoa1602046

This report was first published on 16 March 2022.