It’s here! HIV Prevention in a Pill

An estimated 1.2 million Americans are currently living with HIV. Despite the availability of condoms and HIV education, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. 23% of these new cases occur among women and 61% occur among men who have sex with men.

In the 80′s and early 90′s, HIV was viewed as a life-threatening disease. In some parts of the world, it still is. And while medical advances, along with the availability of 30 or so approved HIV drugs, mean its now a chronic disease, rather than a killer disease – what we’ve all been waiting for is a drug to prevent it.

Now, this week, after decades of anticipation, the FDA  approved Truvada – an HIV combination pill for pre-exposure prophylaxis.  Truvada is the first drug that has been approved to combat HIV among uninfected individuals who are believed to be at high risk of acquiring the virus. Analysts estimate that the drug will cost $450 a year in the U.S.

In a study sponsored by the National Institutes of Health, Truvada was shown to significantly reduce the risk of HIV infection in 42% of HIV-negative gay and bisexual men and transgender women. In another, the risk was lowered in 75% of heterosexual couples in which one partner was HIV positive and the other was not.

The data clearly demonstrate that Truvada, as pre-exposure prophylaxis, is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Connie Celum, a professor of global health and medicine at the University of Washington and lead investigator of the second study.

As part of the approval, the FDA has stipulated that patients must test negative for HIV and that education guides must be distributed to healthcare providers and patients. And the manufacturer – Gilead must conduct a post-approval trial looking at levels of drug adherence, adverse events, resistance and pregnancy outcomes for women who become pregnant while taking Truvada.

The approval of Truvada comes after a long-running debate among AIDS activists. To some, FDA approval offers much-needed assistance in containing the disease. To others, it raises the possibility of creating resistant strains of HIV due to widespread use, just as we saw in the 1960’s with antibiotics, which would then undermine the effectiveness of Truvada.

While the approval may be a cause of celebration for many, some have blasted the decision. “The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” says AIDS Health Foundation president Michael Weinstein. “The FDA’s move today is negligence bordering on the equivalence of malpractice, which will sadly result in new infections, drug resistance and serious side effects among many, many people.”

So is this a watershed moment in the battle against HIV or not?  Let us know what you think.

Scientific Breakthrough of the Year

Happy New Year!

Earlier this month Hollywood announced it’s nominations for the 69th Golden Globe Awards. Among the movies in the running for best motion picture are The Descendants, The Help and War Horse.

While we will have to wait until January 15th to learn the actual winner, we already know who won the 2011 ScienceBreakthrough of the Year”.   This title went to a team of researchers, who demonstrated that HIV treatment with antiretroviral drugs  can actually prevent transmission of the virus from an infected person to his or her uninfected partner.

Their clinical research showed that early initiation of antiretroviral  therapy in people infected with HIV reduces transmission of the virus to their partners by 96%. The findings end a longstanding debate over whether treatment of HIV-infected individuals can provide a double benefit by treating the virus in individual patients while simultaneously cutting transmission rates.

The results were called “astounding” by Anthony Fauci, the government’s top HIV researcher. Others have called them a “game changer” because of the near 100 percent efficacy of the intervention.

It’s wonderful for this trial to be recognized,” says Susan H. Eshleman, M.D., Ph.D., a professor of pathology at the Johns Hopkins University School of Medicine and head of the HIV Prevention Trials Network, which supported the trial. “This research moves the field of HIV prevention science forward, leading us on a path toward curbing the HIV epidemic. It provides a new direction for HIV prevention research and is beginning to shape public health policy.”

SRxA’s Word on Health is delighted to bring you such great news to start the New Year. If you have any health related stories you’d like to share, we’d love to hear from you.