One of the recent innovative solutions developed to protect women against Human Immunodeficiency Virus (HIV) is vagina ring and South Africa has taken the lead to begin to produce the device in Africa.
But what is this ring and how can it protect you?
A dapivirine vaginal ring is a flexible vaginal ring made of silicone that slowly releases an antiretroviral medication (ARV) called dapivirine into the body over a month to reduce the risk of HIV infection.
The ring was first developed by the International Partnership for Microbicides (IPM), a non-profit research and development organization dedicated to developing and delivering effective HIV prevention methods for women.
IPM is the regulatory sponsor of the ring and holds intellectual property rights to both the drug (dapivirine) and the medical device (the ring itself).
While IPM was the driving force behind the ring’s development, many scientists, researchers, clinicians, and other individuals played key roles in bringing this product to fruition.
Researchers at the International AIDS Vaccine Initiative (IAVI) conducted early research on dapivirine as a microbicide.
Scientists at CONRAD and other research institutions collaborated with IPM on the development of the ring technology.
Clinical trial participants also volunteered to test the safety and efficacy of the ring.
The dapivirine vaginal ring received a positive scientific opinion in July 2020 for use by cisgender women and other people assigned female at birth (AFAB) ages 18 and older from the European Medicines Agency (EMA).
The monthly ring is the first long-acting HIV prevention product and is designed to help address unmet need among females for new methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa.
How does vaginal ring work?
Vaginal rings provide controlled release of drugs over extended periods. The ring is a formulation made of flexible silicone with 25mg of the ARV drug dapivirine dispersed uniformly throughout its matrix (56mm outer diameter, 7.7mm cross-sectional diameter).
The ring slowly delivers the drug directly to the site of potential infection over a month, with low systemic exposure, which could help minimize side effects.
Dapivirine belongs to the same class of ARVs used to successfully treat HIV/AIDS and prevent perinatal transmission. Known as a non-nucleoside reverse transcriptase inhibitor (NNRTI), dapivirine works by blocking HIV from replicating inside a healthy cell.
Is it safe?
No safety concerns related to the dapivirine ring have been identified in clinical trials, according to the International Association of Providers for AIDS care.
The ring delivers dapivirine locally in the vagina where infection could occur and little of the drug is absorbed elsewhere in the body.
Data from Phase III studies show no evidence that the ring increases resistance to NNRTIs or interferes with treatment response among AFAB people who became HIV-positive during clinical trials.
Mild side effects have been reported. Some participants of clinical trials experienced mild to moderate urinary tract issues and vaginal discharge or itching, but these usually went away within 1-2 weeks.
The ring can be used with most family planning methods. An ongoing open-label study among pregnant people is collecting additional safety data about ring use during pregnancy. An additional study is planned to assess safety of ring use while breastfeeding.
Is it effective?
The dapivirine vaginal ring reduced the risk of HIV infection by 35 percent in The Ring Study and by 27 percent in the ASPIRE study.
In addition, recent open label studies showed greater adherence to the ring and modeling data suggest that HIV risk is reduced by about 50 percent. Increased ring use was associated with greater HIV risk reduction.
Is it easy to use?
The ring can be inserted by AFAB people without help from a healthcare provider. A healthcare provider may insert the first ring, if wanted, to ensure that the user is familiar with how the ring should be inserted. The ring can be stored, inserted, and removed in private.
The majority of participants in clinical trials reported that the ring didn’t interfere with their daily activities or cause any pain. Most participants in Phase III studies reported forgetting the ring was in place, and that neither they nor their partner could feel it during sex.
The dapivirine ring provides steady release of drug over one month without the need for maintenance. Low maintenance means less burden on the user to remember doses and may encourage more consistent use. Although the ring should be used consistently–that means it should be kept inside the vagina for the entire month of use–the ring does not have any visual indicators to show that dapivirine is being released.
Other rings in development
Long-acting rings that can be worn for up to 90 days
Multipurpose rings with dapivirine and other ARVs that prevent HIV plus additional medications to prevent sexually transmitted infections (STIs) and unwanted pregnancy.
Multi-purpose technologies will help meet AFAB people’s needs, increase synergy of family planning and HIV prevention services, and reduce barriers to acceptability and access. While these products and other HIV prevention technologies are still in development, the monthly dapivirine vaginal ring will help pave the way for their introduction.P