The Promise of ARV-Based Microbicides
After decades of research, there is great reason to believe that safe and effective microbicides are within reach.
Researchers are now focused on microbicides containing the same types of antiretroviral (ARV) drugs being used successfully to treat people living with HIV/AIDS and to prevent mother-to-child transmission of the virus. Recent research shows that ARVs can prevent HIV when they are used consistently.
Next Steps for Microbicides
A range of microbicides containing different ARVs are now in preclinical development and clinical trials. One microbicide is in late-stage clinical trials: the monthly dapivirine vaginal ring, developed by IPM.
The ring slowly releases the ARV dapivirine over time to provide women with monthly protection against HIV. In 2012, IPM launched a licensure program to collect the evidence needed to license the ring. Two parallel Phase III trials assessed the ring's long-term safety and efficacy: The Ring Study, led by IPM, and the ASPIRE study, led by our clinical trial partner the Microbicide Trials Network (MTN). In 2016, the two "sister" studies found that IPM's monthly dapivirine ring safely helped prevent HIV in women. Learn more about the Phase III results. Two open-label extension studies, DREAM and HOPE, are now under way to provide the ring to former Ring Study and ASPIRE participants, respectively, as well as to young women using the ring for the first time.
Other products in IPM's pipeline include a multipurpose vaginal ring that would prevent HIV and unintended pregnancy in one product and that entered a Phase I trial in 2017, a vaginal tablet that uses an ARV with a new mechanism of action and entered a Phase I study in 2015 that will inform the development of a long-acting vaginal ring, and combination ARV vaginal rings.
As is the case with HIV treatment, microbicides based on combinations of ARVs that target different points in the HIV life cycle may offer greater protection than a single drug alone.
From its inception, IPM’s product pipeline has focused exclusively on ARV-based microbicides and prevention products for women. These products are following the lead of other life-saving prevention methods that have been created by adapting successful treatments for diseases such as malaria, influenza and pneumonia.
Through five non-exclusive and one exclusive royalty-free licenses--and one exclusive worldwide rights agreement--from industry partners, IPM is researching nine different ARVs for development as microbicides.