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 69^th 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 15^th to learn the actual winner, we already know who won the 2011 Science “Breakthrough 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.

Debunking Myths About HIV Vaccine

In honor of World AIDS Day tomorrow, SRxA’s Word on Health wants to share with our readers the top 10 myths about HIV vaccine research.

With the help of our friends at the HIV Vaccine Trials Network (HVTN), we’d like to set the record straight.

Myth # 1: HIV vaccines can give people HIV

HIV vaccines do not contain HIV and therefore a person cannot get HIV from the vaccine. Some vaccines, like those for typhoid or polio, may contain a weak form of the virus they are protecting against, but this is not the case for HIV vaccines. Think of it like a photocopy: It might look similar, but it isn’t the original. In the past 25 years more than 30,000 volunteers have taken part in HIV vaccine studies worldwide, and no one has been infected with HIV by any of the vaccines tested.

Myth #2: An HIV vaccine already exists

There is no licensed vaccine against HIV or AIDS, but scientists are getting closer than ever before.  In 2009, a large-scale vaccine study conducted in Thailand showed that a vaccine combination could prevent about 32% of new infections. Researchers around the world continue to search for an HIV vaccine that is even more effective. Leading this effort is the HVTN.

Myth #3: Joining an HIV-vaccine study is like being a guinea pig

Unlike guinea pigs, people can say yes or no to participating in research. All study volunteers undergo informed consent to ensure that they fully understand all of the risks and benefits of being in a study and those volunteers are reminded that they may leave a study at any time without losing rights or benefits.

Myth #4: A person must be HIV positive to be in an HIV vaccine study

Not so. While some research groups are conducting studies of vaccines that might be used in people who are already infected with HIV, the vaccines being tested by the HVTN are preventive vaccines which are tested on volunteers who are not infected with HIV.

Myth #5: Vaccine researchers want study participants to practice unsafe behaviors so they can see whether the vaccine really works

Not true. The safety of study participants is the No. 1 priority of HIV vaccine researchers and study site staff. Trained counselors work with study participants to help them develop an individual plan on how to keep from contracting HIV.

Myth #6: Now that there are pills that can prevent HIV infection, an HIV vaccine is no longer necessary

Although high risk, HIV-negative people can take antiretroviral medication to lower their chances of becoming infected if they are exposed to the virus, it has not yet been recommended for widespread use. This type of therapy known as  PreExposure Prophylaxis is unlikely to be an option for everyone because the pills are expensive, are not always covered by insurance, may cause side effects, and not everyone has access to them.

Myth #7: An HIV vaccine is unnecessary because AIDS is easily treated and controlled

While treatment for AIDS has dramatically improved over the last 30 years, it is no substitute for prevention.

Myth #8: The search for an HIV vaccine has been going on for a long time and it’s just not possible to find one that works

The science of HIV-vaccine development is challenging, but scientific understanding continues to improve all the time. Science has come a long way in the 30 years since AIDS was discovered. In comparing preventive HIV vaccine work to other vaccine development, the time it has taken is not so surprising; the polio vaccine took 47 years to develop.

Myth #9: Vaccines cause autism and just aren’t safe

This is not true. Numerous studies in the past decade have found this claim to be false. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data.

Myth #10: People who aren’t at risk don’t need an HIV vaccine

Not true either. A person may not currently be at risk for HIV, but life situations can change along with disease risk.

So now you know!  By correcting these myths we hope in some small way to be able to help in the mission of this World AIDS campaign – bringing the number of AIDS deaths to zero.

Looking back at 30 years of HIV

June 5, 1981. The U.S. Centers for Disease Control and Prevention issued its first warning about a rare pneumonia called pneumocystis circulating among a small group of young gay men. Unrealized at the time, it was the official beginning of the HIV/AIDS epidemic.

In October 1981 I met and cared for my first AIDS patient, while a student at the Middlesex Hospital, London, UK.  Almost thirty years later, I remember him as if it were yesterday.  He was a 32 year old family doctor, who had a busy practice helping a poor and homeless community in London’s Kings Cross.  He wasn’t in it for the money or the glory, he just wanted to make a difference in people’s lives. He wasn’t promiscuous either. He had only one lover during his all too short life. Unfortunately that partner had a one night stand while visiting friends in San Francisco, and although he didn’t become sick, “George” did.

When I first met him he had just been diagnosed with pneumocystis carinii pneumonia (PCP) a rare opportunistic infection.  And although the underlying immunodeficiency disease had not yet been identified or named, the press was already buzzing with stories of a “gay plague”.

Sadly, back then there were no medications and care was largely palliative. Essentially patients were given a terminal diagnosis and without exception they died quickly.  In the beginning, we didn’t even know it was a viral infection. However, at least this meant we could care for “George” without the Haz Mat protection suits that we were later forced to wear, by naïve, but well-meaning infection control officials.

I was with him when he died and it was calm and dignified although the disease had taken its toll and he was no longer recognizable as the vibrant young man in the photograph on his bedside locker. Sadly, his friends and family were not there. In those early days the stigma associated with the disease was too great. His family didn’t even know that he was gay. I heard later that his partner had told “George’s” mother that he’d died from cancer.

In the thirty years that have passed since the first CDC warning, millions of lives have been touched by AIDS and much has happened in the fight against it,  yet we still don’t have a vaccine to prevent it or a definitive cure.

Since AZT, the first antiretroviral drug, was introduced in 1987, and particularly since the commencement of treatment through a regime involving a cocktail of drugs- so-called highly active antiretrovial therapy (HAART)- in 1996, outcomes have improved so much that HIV is no longer regarded as a death sentence.

Instead, with the initiation of- and adherence to- the right treatment, HIV is viewed as a chronic but manageable condition.

What does the future hold?

Today there are 33 million people living with HIV/ AIDS , so HIV must remain a global health funding priority. The new head of the International AIDS Society, Bertrand Audoin, has called for investment, both scientific and financial, in pursuing a cure for HIV. Audoin, however, acknowledges that any cure could be 25 years away. On-going research is investigating potential HIV vaccine candidates, as well as microbicides that may allow HIV negative people to protect themselves from the virus. There is also compelling evidence emerging that early initiation of treatment can play a role in curbing the onward transmission of the virus, the concept of treatment as prevention.

Still, the key message remains one of prevention. Even the advances in treatment, and the increased availability of medication, do not address the fact that for every person who starts treatment, two more are newly infected with HIV. Basic HIV education is vital for the prevention of transmission in all its forms, enabling those who do not have HIV to protect themselves from infection.

“George” this blog’s for you. You may not have lived long enough to fulfill all your dreams, but you certainly made a difference to my life.