Dapivirine Microbicide Ring
What is the dapivirine microbicide ring?
IPM’s long-acting dapivirine vaginal ring would provide women with a practical method they can use to protect themselves against HIV for a month at a time. The monthly ring, which slowly releases the ARV drug dapivirine over time to protect against HIV, is currently in two Phase III trials, with efficacy results expected as soon as early 2016.
Benefits of the ring
- One ring could provide protection against HIV for a month or longer.
- Because the ring is long-acting, it may help women use it consistently and help ensure effectiveness.
- The ring is convenient and discreet.
- IPM studies show the ring is highly acceptable to women in Africa, where the need is most urgent.
- The ring is physically stable, durable and easy to distribute, making it suitable for use in developing countries.
- The ring delivers the ARV locally where it's needed, with low systemic drug absorption.
- Dual-purpose rings that combine an ARV with a contraceptive could offer women both HIV protection and contraception in a single product.
- Combination rings could one day deliver multiple ARV drugs to increase the breadth of protection.
The active ingredient: dapivirine
Dapivirine is a highly potent ARV drug known as a non-nucleoside reverse transcriptase inhibitor (NNRTI). As an NNRTI, dapivirine works by preventing HIV from replicating its genetic material after the virus enters a healthy cell.
Dapivirine has been shown to be well-tolerated and has demonstrated a good safety profile in all 19 IPM trials to date and in 11 studies conducted by other organizations. The ring itself uses novel matrix technology to disperse the active drug evenly throughout the ring.
IPM's ring licensure program
Given the ring's promise, IPM launched the ring in a product licensure program in 2012.
Two parallel Phase III trials are now under way to evaluate the ring's ability to prevent new HIV infections in women as well as its long-term safety. One study, called The Ring Study, is led by IPM, and the other study, called ASPIRE, is led by IPM's clinical trial partner, the US National Institutes of Health-funded Microbicide Trials Network. Efficacy results for the ring are expected as soon as early 2016.
In addition, the licensure program includes studies to examine safety in adolescents and women over 45, condom compatibility, drug interactions, and use during menses and with tampons. Results for these supporting studies are expected in 2016.
If the dapivirine ring is found to be safe and effective, IPM will seek regulatory approval for product licensure and collaborate with key partners to help ensure the ring is made available to women in developing countries at a low cost and as soon as possible.