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Dublin: 6 °C Thursday 23 May, 2013

US regulators approve first daily anti-HIV drug

Truvada, which is designed for use by healthy adults who are at risk of HIV, should be mixed with safe sex and regular testing.

Truvada, which is already used to treat patients with HIV, can now be used to help prevent infection in people who don't have HIV.
Truvada, which is already used to treat patients with HIV, can now be used to help prevent infection in people who don't have HIV.
Image: Jeff Chiu/AP

THE FIRST EVER daily pill to help prevent HIV infection has been approved by US regulators, for use by healthy adults who are at risk for getting the virus that causes AIDS.

Truvada, made by Gilead Sciences in California, has been on the market since 2004 and has now been approved by the Food and Drug Administration for a new use as a tool to help ward off HIV, in combination with safe sex and regular testing.

The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against Human Immunodeficiency Virus, while other health care providers are concerned it could encourage risky sexual behaviour.

In addition, the regimen is estimated to cost around $14,000 per year, making it out of reach of many.

“Truvada alone should not be used to prevent HIV infection,” said Debra Birnkrant, director of the division of antiviral products at the FDA.

“Truvada as PrEP represents another effective, evidence-based approach that can be added to other prevention methods to help reduce the spread of HIV.”

The FDA said Truvada should be used as “part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.”

Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.

Support of independent panel

The decision by the FDA followed the advice of an independent panel in May that supported Truvada for prevention in uninfected people, after clinical trials showed it could lower the risk of HIV in gay men and heterosexual couples.

One study of men who were sexually active with other men but were not infected with the virus that causes AIDS found 44 per cent fewer infections in those taking Truvada versus a placebo. Those in the study who took the drug regularly had almost 73 per cent fewer infections.

A second study on heterosexual couples in which one partner was infected with HIV and the other was not showed that Truvada reduced the risk of becoming infected by 75 per cent compared with a placebo.

Common side effects were the same as experienced by people with HIV who were taking Truvada, and included diarrhoea, nausea, abdominal pain, headache, and weight loss.

However, the adherence rate – meaning how often people in the study actually took the drug daily – was low in the study of men who have sex with men, at just 30 per cent, Birnkrant said. In the study of heterosexual partners, adherence was much higher, at between 80 and 90 per cent.

Therefore, the drug label must include special instructions for health care providers on how to counsel potential users of the drug.

The drugmaker must also include a warning that Truvada for PrEP “must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.”

Video: HIV home test approved by US Food and Drug Administration

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Comments (19 Comments)

  • May not be a full ‘cure’ but certainly a step in the right direction which people never thought possible. Good news story :-)

    Reply
    • I’d be curious as to the Vatican stance on this. While there are those who believe HIV is a “homosexual disease”, my contention is whether this is true or not, HIV is now here to stay with any who fornicate. I realise it’s a Catch-22 situation with the no-condom rule, but a pill like this one is just absurd. It is basically telling children to have lots of sex and don’t worry about contracting HIV. See, THIS is precisely why we DO, desperately need the church back in our lives… To protect us! From evil, frosting and from HIV even!

      Reply
    • Yes Patrick, because sex or “fornication” as you put it is the only way that someone can catch HIV! It never ceases to amaze me how trolls such as yourself hide behind fake names and pictures of other people. If you have something to say, then go ahead and say it publicly!

      Reply
    • So Patrick, what your saying is, is that the church will save us from HIV?

      Reply
    • Conor – Are you serious? Are you referring to all those intravenous drug users who share needles?

      Reply
    • Anthony – I am indeed saying that the Catholic church teaches a practical morality which lessens the chance of contracting HIV. Do you disagree?

      Reply
    • Go on Patrick, tell us your real name, I dare you! If you have all of this marvellous, insightful stuff to enlighten the world with, surely the world ought to know the soldier of Christ that brought us such information!!!

      Reply
  • HIV does not discriminate…people do…..

    Reply
  • And once again we see that science has made advances in modern day medicine,then along comes a catholic church supporter to tell us that it is wrong and that god will save us. YEAH RIGHT…. Ill believe it when I see it….

    Reply
  • Good news to the developed world where HIV infection is relatively rare. What about parts of sub-Saharan Africa where infection rates vary between 1 in 4 to 1 in 10? A prophylactic treatment costing $14,000 dollars a year isn’t good news to these communities. Perhaps a generic version of the drug would be cheaper, anybody know how long the patent lasts on this ‘wonder drug’?

    Reply
    • Colin B 17/07/12 #

      About 8-14 yrs at a guess depending on other factors are usually left on a drug patent once approval is received. drugs get fasttracked sometimes and that adds a year or two.

      Reply
    • RDX862 17/07/12 #

      Appears that it will still cost too much even if it is available for cheaper prices in poorer countries and if they are not going to take it then there is not much point.

      From Businessweek

      “Gilead sells Truvada in the least-developed countries at no profit and has given the rights to sell the drug to Indian generic makers to help lower the price in 112 countries, said Cara Miller, a spokeswoman for the Foster City, California-based company, the world’s leading (GILD) maker of HIV drugs.

      The treatment sells for as little as $8 a month in some low-income countries, she said by e-mail.”

      http://www.businessweek.com/news/2012-07-15/anti-aids-pill-out-of-sex-worker-reach-in-push-for-cure#p1

      From NY Times

      “The failure of a daily pill to protect healthy African women against AIDS may not have been the pill’s fault but the women’s reluctance to take it, scientists at an important AIDS conference in Seattle were told this week.

      Last April, a promising trial of “pre-exposure prophylaxis” — giving small protective doses of antiretroviral drugs to uninfected people — was stopped early because women were getting infected anyway. It was a discouraging setback.

      But scientists at this week’s Conference on Retroviruses and Opportunistic Infections who analyzed blood samples taken from the women reported that only a quarter of those who got infected had any of the drug, Truvada, in their blood. That suggested they had not taken their pills”

      http://www.nytimes.com/2012/03/09/health/research/setback-on-aids-pill-is-re-evaluated.html

      Reply
  • Who would pay $14,000 to use a pill that is not 100% and still requires condoms .. i mean if your that terrified of getting HIV .. don’t have sex.

    Reply
    • mart_n 16/07/12 #

      No pill is 100% effective. And there’s more than one way to contract HIV..

      There are many people who would gladly pay for such a pill.. even if it only very slightly reduces their risk of acquiring a disease. People who are generally at little or no risk tend to overlook how important new drugs are, but if you’re at high risk then anything that reduces that, no matter how insignificantly; is welcome. And drugs such as this aren’t just designed to protect ‘you’.. they’re designed to protect everyone else as well.

      Reply
    • The NHS here is looking into this, if they approve it, they will pay for those that want it.

      Reply
    • @mart yes i agree but at $14,000 a year only the rich can afford this drug and even at that price its not 100% that you wont get it.. so in countries where this pill could do wonders such as any numerous African countries its completely out of reach.. so what’s the point? its a step forward and i know eventually the price will come down hopefully to a point where it is affordable but right at this moment you wonder the point of such a pill :/ @Mark if thats true thats a great thing and makes me also jealous of your free healthcare lol

      Reply
    • Our healthcare system is far from free, it is paid for by our high income tax and national insurance. Nothing is free in this world.

      Reply
  • P Wurple 17/07/12 #

    This is good news for Ireland. Truvada is manufactured here also.

    Reply
  • Colin B 17/07/12 #

    Sorry – misread and thought you were asking more generically(pun intended…sorry)

    Reply

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