banner by Camille Sturdivant
New Developments in the Battle for Health
by Alyce Palko
At the end of 2014, 1.1 million Americans were living with HIV, or human immunodeficiency virus. This means that more likely than not, you know someone who has or is affected by HIV/AIDS. For citizens of sub-Saharan Africa, this chance is much higher. According to the World Health Organization, one in twenty-five adults in sub-Saharan Africa are infected with HIV. More than half of these people are women. But, Magee Women’s Hospital of UPMC is working to reduce this disproportionate risk and to help women globally.
Researchers from all over the world have been testing an exciting new biomedical product: a vaginal ring that could prevent HIV infections. The ring contains an anti-retroviral drug called dapivirine. HIV is a retrovirus, so dapivirine works directly against HIV’s method of reproduction. When put into a ring form and inserted into the vagina each month, dapivirine is slowly absorbed into the vaginal lining. This prevents HIV transmission during heterosexual sex, the leading cause of HIV acquisition in sub-Saharan Africa. If approved, this would be the first HIV-preventative treatment designed specifically for women.
This has especially important implications for African women because the ring provides another option of HIV prevention. Currently, a drug called Truvada is the most common method of HIV prevention. It is a daily pill that is taken as part of pre-exposure prophylaxis (PrEP), which is the action of taking medicine to prevent disease. For some people, it can be difficult or even stigmatizing to take a pill every day. If someone taking Truvada misses a dose, it could have detrimental effects on their prophylaxis treatment. On the other hand, the dapivirine ring only needs to be inserted once per month, and women can do this discreetly in the privacy of their own homes. Furthermore, the ring will be affordable and accessible. The International Partnership for Microbicides, a non-governmental organization, holds the exclusive worldwide license to dapivirine. They hope to price each ring as low as 2.50 USD.
A partner of IPM, an organization called the Microbicide Trials Network (MTN) has researched the ring. Researchers from Magee Women’s Hospital of UPMC and the University of Pittsburgh School of Medicine are members of the MTN. They made large contributions to the ring research, which was funded by the National Institutes of Health.
In February 2016, the MTN and IPM released exciting results from two clinical trials, ASPIRE and The Ring Study. They found the ring reduced HIV infections by about 30 percent overall. They also found that if the ring was used consistently, protection was even higher, between 56 and 75 percent. According to Dr. Katherine Bunge, safety physician of the ASPIRE team, member of the MTN and assistant professor at the University of Pittsburgh School of Medicine, “That was pretty groundbreaking, because it was the first time… a method designed specifically for women was found to be effective.”
However, the researchers still needed more data. They noticed the ring didn’t work as well in women ages 18 to 21, and they wanted to figure out why. It was possible the women just didn’t use the ring consistently, which would have made it seem like the ring wasn’t working properly. MTN and IPM researchers needed to ensure the ring was safe and comfortable for this age group, so they completed a trial of the ring in 96 American teenage girls. This study found the ring to be very safe, as it was not found to cause severe side effects or infections. Furthermore, 93 percent of the 15 to 17-year-olds said they liked using the ring, which was excellent feedback for the researchers. This group’s positive reaction meant young women are likely to use the ring consistently and therefore would have better protection against HIV.
This knowledge was important to apply to trials of young sub-Saharan African women. In that area, twenty-five percent of new infections occur in 15 to 24-year-old women, said Dr. Bunge. They often have older male partners who have had more sexual encounters. Because their partners have a higher chance of having HIV, the young women have a higher risk of acquiring the virus. But, if the ring were effective and safe, young African women could be protected.
After the U.S. trial showed the ring to be safe for young women, researchers decided to try it in Africa. Set to start in 2018, a study called REACH will focus on 300 African women ages 16 to 21. Not only will the study explore the efficacy of the ring, it will also compare the ring to Truvada. It will help decide which method is better-suited to the lifestyle of young African women. As Dr. Sharon Hillier, principal investigator of the MTN, notes, this study is extremely important to young women’s health: “HIV doesn’t distinguish between a 16-year-old and an 18-year-old. Access to safe and effective HIV prevention shouldn’t either. Young women of all ages deserve to be protected.” The REACH study intends to help younger women gain protection against HIV, especially in an area where they are most at risk.
The researchers are also expanding beyond studying the ring in different age categories. Upcoming trials will focus on how the ring affects pregnant and breastfeeding women. Another trial will use a ring that lasts for three months rather than one, which may be a better option for some women’s lifestyles. Probably the most hotly anticipated trial will combine dapivirine with a contraceptive hormone, an especially appealing combination for many women. This would give them a safe and easy to use method of control over multiple facets of their health.
Within the next few years, these trials could lead to the ring’s approval, and it would soon be widely accessible. The research groups, including those at Magee Women’s Hospital, are on the cusp of an innovative and highly influential product. If approved, the dapivirine ring could revolutionize the prevention of HIV in women and greatly improve sub-Saharan Africans’ quality of life. It’s quite possible that we could see those staggering infection statistics lessen, especially in sub-Saharan Africa. Worldwide, we hope to one day see our loved ones healthy and free of this terrible disease.