LILONGWE(MaraviPost)–The release of the vaginal ring study results in the two sister clinical trials of ASPIRE and The RING Study at the Conference on Retroviruses and Opportunistic Infections (CROI) is a huge break through for African women Malawi inclusive from contracting the deadly HIV virus.
The observation comes barely two months after the much awaited trial results of the two studies were released which shows potential reduction in HIV infection.
The Ring Study, led by IPM, showed that the monthly dapivirine ring safely reduced HIV infection overall by 31 percent compared to a placebo. Similar results were seen in ASPIRE led by the US National Institutes of Health funded Microbicide Trials Network (MTN) which found that the ring safely reduced infection by 27 percent overall.
This is the first time two Phase III studies have confirmed statistically significant efficacy for a Microbicide to prevent HIV. Notably, both studies saw important differences in efficacy by age and consistency of ring use, or adherence
ASPIRE showed that the ring reduced HIV risk by 61 percent in women older than age 25, and in a post hoc analysis by 56 percent in women older than 21, who also appeared to use the ring more consistently.
These findings were statistically significant and supported by a trend in The Ring Study which also showed higher efficacy (37 percent) for women over 21.
Conversely, little to no protection was seen in women ages 18, 21 across both studies 15 percent in The Ring Study and no protection in ASPIRE.
The Ring Study enrolled 1,959 HIV negative women ages 18-45 at seven sites in South Africa and Uganda, and ASPIRE enrolled 2,629 HIV negative women ages 18-45 at 15 sites in Malawi, South Africa, Uganda and Zimbabwe.
Both studies began in 2012 and ended in 2015 and are reporting results early after its independent data safety and monitoring board recommended the study proceed to final analysis.
In a press statement made available to The Maravi Post, Dr. Zeda Rosenberg, founding chief executive officer of IPM disclosed that the findings give new hope to many women at high risk who need more and different options to effectively protect themselves from HIV.
Dr. Rosenberg says his institution would seek regulatory approval for the monthly dapivirine ring and work with partners to determine its role in strengthening HIV prevention efforts.
“We are also hopeful we can learn more about how to help women who want to use the ring do so consistently, which could help increase protection. A planned follow on study would help answer key questions about how women would use the ring when they are aware it can safely help offer protection.
”Our thanks go out to the women who participated in the studies and their families and communities for their commitment to finding a solution to this devastating epidemic. IPM also extends its deepest thanks to the research teams that expertly conducted these multi year studies, and to its donors and civil society partners for their investment of time and resources in women’s health”, appeals Dr. Rosenberg.
South Africa’s Minister of Health, Dr.Aaron Motsoaledi welcomed the out come of the study with an appeal for further investigation on the prospects of the dapivirine ring which protects women from acquiring HIV.
“I welcome the results from the ASPIRE and Ring Study, which investigated the extent to which the dapivirine ring protects women from acquiring HIV. Every advance in science that empowers women to protect themselves from the virus should be considered for rapid adoption and implementation”, observes Dr.Aaron Motsoaledi.
The Maravi Post later caught up with Dingaan Mithi, Journalists Association Against AIDS (JournAids)’s Program Manager on the prospects of the study as what it entails to Malawian women sharing similar sentiment with Dr.Aaron Motsoaledi saying clinical research be continued because for a product to work effectively or a cure to be finally discovered it takes many years.
“It’s indeed a huge break through taking into consideration that women in Malawi are at a heightened risk of contracting the HIV virus. We must be patient and see how far we can go as scientists and researchers work tirelessly to discover the most effective and convenient method in HIV prevention among women who are more vulnerable to getting infected with HIV than men.
“The message to the general public is that the results from the ASPIRE and The RING STUDY is a clear indication that one day a product will be found that women could use to empower and protect themselves from catching the HIV virus”, assures Mithi.
Findings on efficacy and adherence Women in The Ring Study and ASPIRE were randomly assigned to one of two study groups: one used the active dapivirine ring, and the other a placebo ring that contained no drug.
The Ring Study used a 2:1 randomization, meaning for every two women who used the dapivirine ring, one woman used the placebo. Of the 1,300 participants included in the final analysis who used the dapivirine ring in The Ring Study, 77 acquired HIV of the 650 who used a placebo ring, 56 acquired HIV (31 percent efficacy).
In ASPIRE, which used a 1:1randomization, of the 1,308 participants included in the final analysis that used the dapivirine ring, 71 acquired HIV; of the 1,306 who used a placebo ring, 97 acquired HIV(27 percent efficacy).
All women in both studies received regular HIV testing and counseling, treatment for sexually transmitted infections, and condoms. Both studies found the ring to be safe, with no statistical difference between the active and placebo arms.
Previous IPM studies have shown that absorption of dapivirine is largely confined to vaginal tissue with low systemic exposure, which may help minimize side effects. The Ring Study and ASPIRE also found no evidence that use of the dapivirine ring increased the presence of ARV-resistant HIV. More on ASPIRE and Ring Studies just visit, www.ipmglobal.org