- Acts against: HIV-1
- Formulation: Silicone matrix vaginal ring
- Active ingredient: Dapivirine
- Length of action: One month, with a three-month ring in development
- Status: Two open-label extension studies ongoing; first regulatory review underway
Why is the dapivirine ring important?
Existing prevention methods have not done enough to stop the spread of HIV among women. The monthly dapivirine ring would provide women with the first discreet, easy-to-use and long-acting prevention option.
How does the dapivirine ring work?
The ring is made of a flexible silicone matrix polymer and contains the ARV dapivirine, an NNRTI, which is slowly released over the course of a month.
The ring delivers dapivirine directly at the site of potential infection, with low systemic absorption. Women insert the flexible, long-acting ring themselves into the vagina and replace it every month.
What is its development history?
IPM brought the dapivirine ring from concept to Phase III clinical trials in just seven years. In 2004, IPM embarked on an extensive program of preclinical assessments of dapivirine in various formulations. To provide discreet, long-acting protection to women, IPM prioritized a ring formulation in 2010. IPM collaborated with partners to develop and evaluate early prototypes, ultimately advancing Ring-004 to late-stage clinical trials.
What is its clinical history?
IPM conducted two Phase I and one Phase I/II safety trials of Ring-004 from 2009 to 2012, all of which found the ring to be safe and well-tolerated. Given the ring’s promise as a long-acting HIV prevention method, IPM launched two Phase III studies in 2012: The Ring Study, led by IPM, and ASPIRE, led by IPM’s clinical trial partner, the US National Institutes of Health-funded Microbicide Trials Network (MTN). Enrolling more than 4,500 women in Malawi, South Africa, Uganda and Zimbabwe, these two pivotal trials assessed the ring’s efficacy and long-term safety. They make up the centerpiece of IPM’s Dapivirine Ring Licensure Program, which includes additional safety trials and is designed to collect the safety and efficacy data required by global and national regulatory authorities to seek licensure for the ring’s public use.
Two open-label extension studies launched in July 2016 to provide the ring to former Phase III trial participants for one year and help determine how the ring could fit into women’s lives. Both studies are expected to be completed by December 2018.
What are the results so far?
In February 2016, The Ring Study and ASPIRE announced that the monthly dapivirine ring developed by IPM safely helped reduce the risk of HIV-1 infection in women. Additional analyses indicate that higher efficacy is associated with increased ring use. Learn more about the Phase III results.
What are the next steps for the dapivirine ring?
IPM is pursuing approvals from global and national regulatory authorities for the ring's use in countries where women face the highest risk for HIV. IPM is working with a global network of government, donor, private and civil society partners to determine how the ring could best fit into HIV prevention programs and prepare for the potential roll-out of the ring at an affordable cost, pending its approval.
Who is IPM currently partnering with to develop and test the ring?
- ARV licenses: Janssen Sciences Ireland UC
- Development: Queens University Belfast
- Manufacturing and raw materials: QPharma; Trelyst
- Clinical trials: Microbicide Trials Network