1,959 women ages 18-45 across six
sites in South Africa and one site in Uganda are
enrolled for the study.
The full licensure program also
includes ASPIRE, a "sister" efficacy and safety study of the dapivirine
ring led by IPM's clinical trial partner, the US NIH-funded Microbicide Trials Network (MTN). ASPIRE
completed participant follow-up of 2,629 women ages 18-45 across 15 sites in
Malawi, South Africa, Uganda, and Zimbabwe. Together, the two
"sister" Phase III studies involve thousands of women volunteers
across Africa.
The Ring Study and ASPIRE, in
February 2016, found that the monthly dapivirine ring could safely help prevent
HIV infection in women, with differences in efficacy dependent on age of the
woman and level of use.
The ring uses a novel delivery method
that slowly releases the dapivirine over time, and is designed to remain in
place for at least one month to provide sustained, discreet and easy-to-use
protection against HIV.
The Ring Study and ASPIRE have shown that a monthly
vaginal ring containing the antiretroviral drug dapivirine can help prevent HIV
in women and is safe for long-term use.
Developed by IPM over the past 10 years, the ring reduced
infections by approximately 30 percent overall in the “sister” studies, with
differences in efficacy seen by age. Notably, a strong trend was seen toward
higher efficacy with more consistent ring use.
This is the first time two Phase III studies have
confirmed statistically significant efficacy for a microbicide to prevent HIV.
As the first long-acting HIV prevention method, the dapivirine ring could be an
important new self-initiated option for women, who bear the greatest burden of
the global HIV/AIDS epidemic. IPM, also the regulatory sponsor for the ring,
plans to apply for regulatory approval to license the product.
The researchers said the ring is necessary because 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.
The ring is made of a flexible silicone matrix polymer
and contains the ARV dapivirine, 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.
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 are
assessing 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.
IPM plans to seek regulatory approval for the ring in
multiple countries. IPM is working with a global network of government, donor, and
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.
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