South Africa | The independent results of ASPIRE and The Ring Study, announced today at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston affirms the commitment by researchers to placing an additional HIV preventive option in the hands of women. A monthly vaginal ring that releases an antiretroviral (ARV) drug called dapivirine was found to prevent HIV infection in women and is safe for long term use.
The ASPIRE trial conducted at 15 sites in Uganda, Malawi, Zimbabwe and South Africa between August 2012 and June 2015 showed a 27% reduction in HIV acquisition among women using the dapivirine ring compared to women using the placebo ring (without dapivirine). Of the 2 629 HIV negative women enrolled in the trial, 168 women in total acquired HIV: 97 in the placebo group and 71 in the dapivirine ring group representing 27% reduction in HIV acquisition.
Planned analysis by age in the ASPIRE trial showed that women over the age of 25 years were 61% less likely to acquire HIV compared to women of the same age using the placebo ring. Additional analysis drawing a more precise delineation of age showed protection was confined to women over the age of 21 years, where the infection rate was reduced by 56%. No protection was observed among women between the ages of 18 – 21 years. A similar trend was observed in The Ring Study.
The Ring Study, conducted at seven (7) sites in South Africa and Uganda, showed a 31% reduction in HIV acquisition among women using the depirivine ring. Of the 1 300 participants who were given the depivirine ring, 77 acquired HIV. Of the 650 women who used the placebo ring, 56 acquired HIV showing 31% protection against HIV. These findings were statistically significant.
“It is the first time in the history of HIV prevention research in women, that two pivotal trials showed significant results in preventing HIV in women. More importantly the use of the ring was acceptable for use by women. We hope that the ring will be an additional HIV prevention option to male and female condoms, PreExposure prophylaxis, using antiretroviral drugs and medical male circumcision among others. It is hoped that a combination of prevention methods will be used by individuals at high risk of HIV infection”, said Professor Gita Ramjee, Unit Director at the SAMRC’s HIV Prevention Research Unit.
“The results are a turning point in microbicide research where we can move from clinical trial to operational research in an effort to better understand the use of the ring in the context of real life situations”, said Dr Vaneshree Govender, Principal Investigator of the ASPIRE trial in Durban for the SAMRC.
The trials found no safety concerns associated with the dapivirine ring. “The dapivirine vaginal ring is unique in that it provides women with an option of discreet use to protect themselves from HIV infection,” Ramjee elaborates. “We found that consistent use provides greater benefits.”
A female trial participant from the SAMRC Verulam site, who disclosed use of the ring to her partner said she was very happy and excited about this result. “For the first time there is hope that we may have an AIDS free generation,” she said.
"I am very excited as it means a lot to me and my family. My partner was in the trial and I knew about the ring and we used it and I am happy that she is safe. As long as this ring is affordable and accessible, I think our people will use it”, her male partner added.
Both the ASPIRE and the Ring trials suggested that young women under the age of 21 who did not use the product as directed had no protection against HIV. “It is evident that more effort needs to be directed into finding suitable acceptable prevention options that will reduce new HIV infections among young adolescent girls”, Ramjee states.
The SAMRC’s HIV Prevention Unit conducted the ASPIRE trial at six (6) community based research sites in the greater Durban area; Botha’s Hill, Chatsworth, Isipingo, Tongaat, Umkomaas and Verulam. The six SAMRC sites enrolled a total of 803 women (largest contribution to the ASPIRE trial). Of the six sites, HIV prevalence was; 23%, 19%, 30%, 40%, 20% and 26% at Botha’s Hill, Chatsworth, Isipingo, Tongaat and Verulam respectively.
The prevalence of other sexually transmitted infections among women volunteering for the trial was also very high. The number of new HIV infections among women in the placebo arm at the SAMRC sites were high suggesting, that in KwaZulu-Natal, women continue to be infected with HIV at an alarming rate. Rates of new infections were 5.4%, 8%, 5.1%, 5.9%, 7.2% and 6% in Botha’s Hill, Chatsworth, Isipingo, Tongaat, Verulam and Umkomaas respectively.
The ASPIRE trial was conducted in partnership with the community and each site had a Community Working group and stakeholders who were engaged by researchers regularly to discuss study conduct and community needs. Partners of women were invited to the sites for education and voluntary HIV testing. Throughout the course of the trial, communities educated researchers on their cultures and norms.
On the other hand researchers regularly educated the community on HIV and TB prevention and treatment options. Family planning options were provided at the site and women were referred to local hospitals/clinics for HIV and non-HIV related care through a memorandum of understanding with the KZN department of Health.
The dapivirine vaginal ring is made out of flexible silicone material and is designed to provide sustained release of dapivirine over 28 days to help protect against HIV infection. In contrast, other prevention options require daily use of products which may not be acceptable or possible for many women. Vaginal rings designed to deliver contraceptive hormones are used as contraceptives by women in the United States and Europe. The dapivirine ring adapts this commonly used medical technology to offer women long-acting protection from HIV.
The dapivirine ring is the first long-acting ARV-based product to enter efficacy testing. To date, clinical trials have primarily focused on microbicides formulated as vaginal gels. ASPIRE and its sister The Ring Study has made important strides in the fight against HIV among women and opens the door for developing the next-generation of long-acting products that suit the needs of our women.
“Women remain at the highest risk of HIV infection in South Africa, and their vulnerability to HIV can be attributed to a number of risk factors such as multiple partners, lack of condom use, women’s role in society, stigma and recurrence of sexually transmitted infections, among others. Empowering women is about protecting them and their families,” Ramjee states. “It is evident that if this monthly ring is used as directed, we can have a significant impact on reducing new HIV infections among women especially those over the age of 21 where HIV infection rates can be halved.”
“These landmark trials pave the way to deliver interventions to women to protect themselves against HIV”, says Professor Glenda Gray, President of the SAMRC. “The findings will have a profound impact in the HIV prevention field.”
NOTES TO THE EDITOR: PREVIOUS RESEARCH ON HIV PREVENTION
The ASPIRE trial was led by the Microbicides Trials Network and The Ring Study was led by the International Partnership for Microbicides (IPM). IPM provided both the placebo rings and the rings containing dapivirine for each of the trials.
IPM is a non-profit organisation dedicated to developing new HIV prevention tools and sexual and reproductive health technologies for women, and making them available in developing countries. For more information please visit: www.IPMglobal.org
The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners whose work is focused on the rigorous evaluation of promising microbicides – products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV – from the earliest phases of clinical study to large-scale trials that support potential licensure of these products for widespread use. More information about the MTN is available at http://www.mtnstopshiv.org
- Open-label extension studies are planned by both IPM and MTN where women who participated in the above trials have an opportunity to use the ring in a research setting to answer critical questions about product use. It is hoped that with the knowledge of the ring’s safety and efficacy, women will be encouraged to use it as required. Thus hoping for even a higher efficacy in the prevention of HIV. These studies are expected to be conducted while IPM seeks regulatory licensure of the ring for prevention of HIV.
Please see attached fact sheet for more information.
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