A study of almost 900 HIV negative women from KwaZulu-Natal found that there was a 39% lower HIV incidence rate in the group that used the gel containing tenofovir.
This ARV-containing gel (known as a microbicide) could save over 800,000 lives and prevent 1.3 million new HIV infections over the next two decades in South Africa alone, according to statistician Brian Williams.
The results were announced today (Tues 20th July) at the International AIDS Conference in Vienna by the South African husband-and-wife team who led the research, Professors Salim and Quarraisha Abdool Karim and published in the journal, ‘Science’ online.
‘Of course we were hopeful, but when the statistician came in and gave us the results, we were absolutely stunned. We just looked at each other in disbelief and couldn’t speak for a while,’ said Prof Salim Adbool Karim, PRO Vice-Chancellor at the University of KwaZulu-Natal and head of the Centre for the AIDS Programme of Research in SA (Caprisa), which conducted the trial.
This is the first prevention method designed specifically for women that has worked, and it is likely to electrify the HIV/AIDS prevention field which has had few successes in the past two decades.
‘This has the potential to alter the course of the HIV epidemic, especially in southern Africa where young women bear the brunt of this devastating disease. We need to find a way of getting this into women’s hands as fast as possible,’ said Prof Quarraisha Abdool Karim, associate professor at Columbia University in New York and Caprisa associate director.
In the study, half the women were randomly assigned to get tenofovir gel while the others got plain gel. They had to put gel into their vaginas 12 hours or less before sex and again within 12 hours after sex. All women were counselled on the risk of HIV and encouraged to use condoms at all times.
Xoliswa Mthethwa, one of the trial participants, said: ‘I had no problems with the gel. I mainly put it in in the afternoon. It felt like it wasn’t there.’
Fieldworkers at the study sites in Vulindlela in the KZN Midlands and Durban, said the only problem they had was when a rumour went around that there was HIV in the gel.
‘We had to address community meetings with the traditional leaders to address this myth,’ said Muke Mlotshwa.
Neither the researchers nor the women knew which group they were in until the study ended a few weeks ago.
Sixty of the 444 women who got plain gel became HIV positive over the 30 month-study, whereas only 38 of the 445 women in the tenofovir group got HIV.
The HIV rate was cut by more than half (54%) among women who used the tenofovir gel properly at least eight out of every 10 times.
In an unexpected bonus, women who got the tenofovir gel also had half the number of new herpes (HSV2) infections.
‘Since women with genital herpes are almost twice as likely to become infected with HIV, the additional protection of tenofovir gel against herpes creates a second mechanism whereby the gel may have a bigger impact in preventing HIV,’ said Salim Abdool Karim.
The Abdool Karims have been searching for an effective microbicide for the past 16 years, largely to try to give women who are unable to get their partners to use condoms the chance to protect themselves.
While the results are incredibly exciting, Salim Abdool Karim says another study is urgently needed to verify the results: ‘Although the study findings are robust, an independent confirmatory study is needed to see whether the results can be generalised to other settings.’
The researchers have ceded all rights to the tenofovir microbicide to the South African government, which plans to set up a plant in Durban via the Technology Innovation Agency to manufacture the gel for further trials and ‘ hopefully ‘ for the mass market.
Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition in New York, described the findings as ‘a true breakthrough for AIDS prevention’.
However, Warren said further studies were needed to answer a number of questions including whether the gel could be used by teenagers and in anal sex.
Ambassador Eric Goosby, US Global AIDS Coordinator said: ‘The results of the CAPRISA trial provide new hope and direction for not only HIV prevention, but also broader efforts under the Global Health Initiative. We recognize that microbicides will be a great asset to HIV prevention efforts, and the US government is pleased to support this important research.”
The US Agency for International Development (USAID) provided $16.5-million for the study while the South African government provided $1.1. ‘ Health-e News Service.