VIENNA (Reuters) - South Africa is considering rolling out use of a vaginal gel which can protect women against HIV during sex before it is officially licensed by drug regulators, the country’s health minister said on Tuesday.
Speaking at an international AIDS conference in Vienna, Aaron Motsoaledi said the need was so great for effective HIV prevention measures in his country -- where 1,000 people die from AIDS-related illnesses each day -- that his ministry was keen to act on early evidence of the gel’s success.
“We are very interested in it. We believe in an evidence-based approach and if scientists say this thing is going to work, then we will definitely be looking at it,” Motsoaledi told Reuters when asked if his government was planning to move ahead with the gel before it is licensed.
“So far, evidence is showing that it is ... very promising.”
Researchers said on Monday that the gel, which is known as a microbicide and contains a prescription drug from U.S. drugmaker Gilead Sciences, can sharply reduce HIV infections in women who use it before and after sex.
The findings caused great excitement among the 20,000 scientists, activists and HIV positive people gathered for a biennial international conference on AIDS in Vienna.
The World Health Organisation (WHO) and the United Nations AIDS group UNAIDS described the trial as ground-breaking and WHO director Margaret Chan said she would work to speed up access to the product if further results show it is safe and effective.
While there is no actual product available yet, researchers who led the study, which was funded by the South African government and USAID, said making the gel and the applicators needed to apply it is likely to be relatively cheap and easy.
Anthony Fauci, of the U.S. National Institute of Allergy and Infectious Diseases, one of the world’s most respected scientific experts on HIV, said countries with the greatest need should be able to move forward with using new HIV/AIDS medicines without having to wait for regulators such as the U.S. Food and Drug Administration to license them.
He also said he could see no reason why the U.S. Presidential AIDS campaign fund, PEPFAR, would not be free to decide to pay for such a gel for the use in developing countries even before it gets approval from drugs regulators.
“Judgments will have to be made by individual nations based on their need for such an approach as to how they will use the (trial) data to utilise the product,” he told a reporters.
“And I don’t necessarily think that there has to be a direct link between something that is approved by the FDA and something that PEPFAR will pay for.”
Results of the South African trial, which involved 889 women, showed the gel reduced HIV infections in women by 39 percent over two and a half years -- the first time such an approach has protected against sexual transmission of the virus.
Researchers are already working on another trial larger which will involve 5,000 women in South Africa, Malawi, Uganda and Zimbabwe, to further test the gel’s safety and efficacy.