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A small blue oval shaped pill taken daily by thousands of men in Australia led to an unprecedented reduction in new HIV cases proving that a highly targeted preventive approach could help end the worldwide AIDS epidemic.
A study designed to measure the effectiveness of Gilead Sciences Inc.’s Truvada pill on reducing the AIDS-causing virus in a large population showed that new cases of HIV fell by almost a third. That’s the lowest rate since HIV infections began being tracked in 1985.
The pre-exposure, or PrEP treatment (a fixed-dose combination of the drugs tenofovir disoproxil and emtricitabine), is given to high-risk men who have not yet been infected with HIV as a way to make sure that they stay negative. The study was recently published in the Lancet HIV Medical Journal.
PrEP reduces the risk of HIV from sex by more than 90 percent if the pill is taken daily, according to Gilead Sciences Inc. "Preventative treatment now accounts for about half of the pill’s US sales," Kevin Young, the firm’s COO, announced in July.
"Globally, almost 37 million people are living with HIV, however, only 51 per cent are aware of their HIV status. In Australia, there were 25,313 people living with HIV in 2015, with 10 per cent unaware of their status," according to the Kirby Institute of the University of New South Wales.
“The speed of the decline we’ve seen in new HIV infections in gay and bisexual men is a world first,” said study leader Andrew Grulich, head of HIV epidemiology and prevention at the Kirby Institute. “These numbers are the lowest on record since HIV surveillance began in 1985.”
During the first year of the study, which began in March 2016, 102 gay and bisexual men became HIV positive in the state of New South Wales, Australia as opposed to 149 infections in the year before the study.
Unfortunately, the results cannot tell if this type of treatment would also work in heterosexual populations, but they do demonstrate that PrEP is “highly cost-effective” in certain high-risk groups, Grulich told Bloomberg News.
“While we’ve known for at least three or four years now of individual-level efficacy of PrEP, there has been some reticence around the world by policy makers to properly fund the roll out of PrEP because the population impact hasn’t been shown -- and that’s what we set out to do,” Grulich said.
There have been good results for the 180,000 people in the US taking Truvada for PrEP too. "Areas of the US with the highest uptake of PrEP had achieved some of the best reductions in HIV infections," Gilead’s Chief Executive Officer John F. Milligan said at a Morgan Stanley Global Healthcare Conference in January 2019.
All of this is great news, but the cost of Truvada makes it out-of-reach for many people. According to Bloomberg the cost without any government subsidy is about $700 a month for people who are not participating in the study. There are now generics versions available from Mylan NV, Cipla Ltd. and Teva Pharmaceutical Industries Ltd in countries where the patent of Gilead Sciences patent has expired.
"Once it comes off patent, you are going to wind up a getting a much larger use of it,” said Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases in a telephone interview with Bloomberg.
When generics are widely available, more widespread testing can be done, especially in Africa where most transmissions are from heterosexual sex. If the little blue pill is effective, it is possible that the Aids epidemic could be ending. The UN has a goal to end the epidemic by 2030, and this date is now in the realm of possibility.
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