Dapivirine Microbicide Ring
What are microbicide rings?
IPM’s long-acting vaginal rings would provide women with a practical method they can use to protect themselves against HIV. The ring, which slowly releases the ARV drug dapivirine over time to provide women with monthly protection, will enter efficacy and long-term safety trials in 2012.
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 acceptable to women in Africa, where the need is most urgent
- The ring is physically stable, durable and easy to distribute, making them suitable for use in developing countries
- The ring delivers the ARV locally where it's needed with low systemic drug absorption
- Combination rings could one day deliver multiple ARV drugs
- Dual-purpose rings could one day combine an ARV with a contraceptive to offer women around the world both HIV protection and contraception in a single product.
The active ingredient: dapivirine
Dapivirine is a highly potent ARV drug that acts 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.
IPM has tested dapivirine in both vaginal gel and ring formulations in multiple safety trials involving more than 900 women. It has also been tested in oral formulations in 11 other clinical trials.
Dapivirine has been shown to be well-tolerated and has demonstrated a good safety profile in all IPM trials to date and those 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 will launch the ring in a product licensure program in 2012.
The program will include studies to determine the ring's ability to prevent new HIV infections in women as well as its long-term safety.
One study, called ASPIRE, will be led by IPM's partner the US National Institutes of Health-funded Microbicide Trials Network and the other, called the Ring Study, will be led by IPM.
In addition, the licensure program will include studies to examine safety in adolescents, condom compatibility and any drug interactions. Results expected in 2015.