By Sharon Atieno
With the HIV prevention field focusing on expanding choice for women and long-acting prevention technologies, efforts are underway to roll out a three-month dapivirine vaginal ring by 2026.
Jeremy Nutall, Preclinical pharmaceutical development executive, Population Council Center for Biomedical Research, said during the HIV Research for Prevention (HIV4RP) Conference in Lima, Peru.
According to Nutall, the three-month dapivirine vaginal ring would reduce the burden on the user in terms of fewer insertions and visits to the clinic. This would in turn lead to increased adherence and effectiveness of the product.
He also noted that there would be reduced annual cost requiring only four rings instead of 12 as with the current one-month ring. The estimated cost is not more than 16 U.S. dollars, excluding distribution costs, and that represents a 60% reduction in cost per year compared to the one-month ring.
“The three-month dapiverine ring is identical to the one-month ring, except that it contains 100 milligrams of dapiverine rather than 25. It’s made using the same silicone, and it looks the same and it feels the same because the rings are so similar,” he said.
A study, IPM 054, carried out by the Population Council Center for Biomedical Research in South Africa to investigate the rate and extent to which the drug circulates in the body for both the one and three-month rings found that the efficacy of the three-month ring is at least equal to the one-month ring (50% effective in reducing the risk of HIV infection).
The study enrolled 124 women, of which 104 completed the trial with each participant using three consecutive one-month rings, followed by a single three-month ring, or vice versa. Plasma and vaginal fluid samples were taken regularly throughout the trial for drug-level measurements.
Additionally, the phase one trials showed that there was no notable difference in safety findings, and no infections were reported.
The company is currently preparing to seek regulatory approval for the three-month ring as a line extension to the one-month ring.
The one-month ring, which provides HIV protection for 28 days, is the first long-acting prevention technology to receive a positive regulatory assessment. It received a positive opinion from the European Medicines Agency (EMA) in 2020 and World Health Organization (WHO) recommendation in 2021.
It’s currently approved for use in 11 African countries including Botswana, Eswatini, Kenya, Lesotho, Malawi, Namibia, Rwanda, South Africa, Uganda, Zambia, and Zimbabwe.
