The study involved 545 volunteers and lasted two years. Those participating were considered to be in the high risk category with an average of 10 partners over a period of 90 days, according to the Guardian.
The pill had to be taken a few days before and after sex and best of all every day for those with a more promiscuous life style. Some have compared the drug to women’s contraceptive pills.
Two test groups were used. In one group participants started using the pill immediately and in another group they delayed taking it for a year. From the group who began straight away, there were 3 cases of HIV infections twelve months later, while in the group not taking the pill, 19 people became infected.
The study was called Proud (Pre-exposure Option for reducing HIV in the UK: immediate or Deferred) and it follows similar tests in other countries which also proved hopeful. But the UK one has had one of the highest success rates, along with a French-Canadian trial called IPERGAY.
The UK researchers were particularly pleased because, as they put it, “it took place in the real world,” meaning that the volunteers could choose freely whether or not to take the medication. The team said that, what was especially encouraging, was that fears that participants wouldn’t take the pill regularly proved to be unwarranted.
Health Day says that “The strategy is known as “pre-exposure prophylaxis,” or PrEP. Prior studies had suggested that chronic, daily use of Truvada (a combo pill of tenofovir plus emtricitabine) could slash rates of HIV transmission in partners where one person was already infected and the other was not.”
The chief investigator of the British study, Sheena McCormack, who is professor of clinical epidemiology at University College London, said,
“These results are extremely exciting and show PrEP [pre-exposure prophylaxis] is highly effective at preventing HIV infection in the real world.”
“Concerns that PrEP would not work so well in the real world were unfounded. These results show there is a need for PrEP, and offer hope of reversing the epidemic among men who have sex with men in this country. The findings we’ve presented today are going to be invaluable in informing discussions about making PrEP available through the NHS (National Health Service).”
The results were presented at the Conference on Retroviruses and Opportunistic Infections in Seattle. Truvada has already been approved by the FDA in the US, where doctors insist it is taken on a daily basis. With regards to the UK and French/Canadian studies, Dr. Jonathan Mermin from the U.S. Centers for Disease Control and Prevention said that,
“CDC welcomes the findings presented today by the IPERGAY and PROUD teams, which provide additional evidence of the power of PrEP to reduce the risk of HIV infection.”
Health Day also quotes him as adding that,
“Recent research, suggests that even with less than perfect daily adherence, PrEP may still offer substantial protection if taken consistently.” However, he cautioned that it was too early to give up a daily dose of the drug.
Mermin also pointed to the need for further research, which would analyze how Truvada effects men “who have sex less frequently and would therefore be taking PrEP less often.” He suggested that Truvada may need to build up in the body a few days before sex, in order to be effective..
Furthermore, Mermin proposed that similar tests should take place on heterosexuals, women and intravenous drug users, to see if the pill worked equally as well.
However, Truvada has been controversial among activists in the gay community. Times Live reported that last year, Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation (AHF), warned that the CDC would come to regret the decision to make the drug available to the public. He even went so far as to say the guidelines “will likely have catastrophic consequences in the fight against AIDS in this country.”
Weinstein and others feel it will undermine the campaign to use condoms, which they say should be the central issue in trying to control the disease. They have called Truvada a “party drug,” and warned that it would lead to an increase in infections, because people would stop using protection, citing the recent rise in syphilis among gay men.
Furthermore, they aired concerns that human nature would mean people would not take the pill everyday, something which the UK trials seemed to contradict.
Times Live also quotes Whitman-Walker, clinical research director Richard Elion on the subject, who said studies on thousands of people have shown it does not. “The evidence is quite clear. There is no documentation of increased risk behavior,” adding that “We are not seeing more syphilis in the people on PrEP studies.”
The issue has divided the gay community with some in favor jokingly calling themselves “Truvada whores.” On some gay dating sites “PrEP” has become a new category alongside HIV status, “Positive,” “Negative” or “Ask Me.”
The pill can be expensive with costs of between $1,000 and $2,000 in the US, but it is accepted by most health insurance schemes and Medicaid. In the UK, the price of the drug made by Gilead, is around £360 ($555) per month and the UK National Aids Trust is calling for the pills to be made free on the NHS (National Health Service.)
The Guardian quotes Dr Michael Brady, medical director at Terrence Higgins Trust, UK, who said: “PrEP is, quite simply, a game-changer. We know that most gay men use condoms most of the time, and that this has prevented tens of thousands of HIV infections since the epidemic began in the UK. However, we also know that condomless sex vastly increases the risk of HIV being transmitted.”
He added that PrEP offers another line of defense alongside condoms and regular testing. “It is not a vaccine and it won’t be for everyone, but once approved, we expect it to significantly increase the momentum in our fight against the virus.”